Closed Trials

Novel Intratumoral Bacterial Agent for Dogs with Lymphoma

ACI is pleased to announce a clinical trial to evaluate a novel therapeutic in dogs with lymphoma.

Trial Summary
A maximum of 10 client-owned dogs will be enrolled in this study. All dogs will receive the novel therapeutic treatment (no placebo). Enrolled patients will have the opportunity to receive up to 4 cycles of treatment.

Trial Funding
All study-related costs are fully funded including treatment agent, exam, bloodwork, and other diagnostics required by the study.

Trial Eligibility
Inclusion criteria for participation in this clinical trial includes:

  • Cytological or histological diagnosis of lymphoma (all stages)
  • At least one measurable, peripherally located lymph node measuring > 2 cm
  • Dog is generally feeling well
  • No evidence of an active infection requiring systemic antibiotics within 7 days of study enrollment
  • No anti-cancer therapy within 21 days of enrollment

Trial Participation
The following animal hospitals are offering this clinical trial:

The Oncology Service
at Friendship Hospital for Animals

4105 Brandywine St. NW
Washington, DC
(202) 567-2080
The Veterinary Cancer Center
129 Glover Ave
Norwalk, CT 06850
(203) 838-6626
Veterinary Specialty Hospital
of San Diego

10435 Sorrento Valley Rd
San Diego, CA 92121
(858) 875-7500
Southern Arizona Veterinary Specialty and Emergency Center
141 E. Fort Lowell Rd
Tucson, AZ 85705
(520) 888-3177
Veterinary Cancer Group
9599 Jefferson Blvd
Culver City, CA 90232
(310) 558-6120
Blue Pearl (NY)
410 West 55th St
New York, NY 10019
(212) 767-0099

Novel Intratumoral Bacterial Agent for Dogs with Any Measurable Cancer

ACI is pleased to announce a clinical trial to evaluate a novel therapeutic in dogs with measurable cancer.

Trial Summary
A maximum of 10 client-owned dogs will be enrolled in this study. All dogs will receive the novel therapeutic treatment (no placebo). Enrolled patients will have the opportunity to receive at least 1 cycle of treatment.

Trial Funding
All study-related costs are fully funded including treatment agent, exam, bloodwork, and other diagnostics required by the study.

Trial Eligibility
Inclusion criteria for participation in this clinical trial includes:

  • Histologic diagnosis of cancer
  • At least one measurable tumor, measuring > 1 cm
  • Dog is generally feeling well
  • No evidence of an active infection requiring systemic antibiotics within 7 days of study enrollment
  • No anti-cancer therapy within 21 days of enrollment
  • No tumors located in regions where abscess would result in major symptoms

Trial Participation
The following animal hospitals are offering this clinical trial:

The Oncology Service
at Friendship Hospital for Animals

4105 Brandywine St. NW
Washington, DC
(202) 567-2080
The Veterinary Cancer Center
129 Glover Ave
Norwalk, CT 06850
(203) 838-6626
Veterinary Specialty Hospital
of San Diego

10435 Sorrento Valley Rd
San Diego, CA 92121
(858) 875-7500
Southern Arizona Veterinary Specialty and Emergency Center
141 E. Fort Lowell Rd
Tucson, AZ 85705
(520) 888-3177
Veterinary Cancer Group
9599 Jefferson Blvd
Culver City, CA 90232
(310) 558-6120
Blue Pearl (NY)
410 West 55th St
New York, NY 10019
(212) 767-0099

Sample Collection Study for Dogs with Canine Atopic Dermatitits

ACI is conducting a study that involves collection of skin biopsy samples from dogs with canine atopic dermatitis (CAD). Two small (4mm) skin biopsy will be collected from six dogs with CAD.

Trial Support
The cost of a brief exam, skin cytology, sedation, local anesthetic, skin biopsy and intradermal allergy testing are completely covered.

Trial Eligibility

Inclusion criteria includes:

  • Dog must have a clinical diagnosis made by the Investigator of canine atopic dermatitis (CAD).
  • Dog must be sufficiently pruritic to be considered actively showing clinical signs of CAD.
  • Dog must be considered healthy enough to tolerate the sedation and local anesthesia and biopsy procedures.

Exclusion criteria includes:

  • Dog fails to meet any of the inclusion criteria above.
  • Dog is likely to be uncooperative with the study procedures.
  • Dog has an uncontrolled flea infestation.
  • Dog has received any immunomodulatory medications such as corticosteroids, cyclosporine, or oclacitinib (Apoquel®, Zoetis) according to the following schedule:
    • Injectable corticosteroids: 6 weeks
    • Oral corticosteroids: 4 weeks
    • Topical steroids (otics/dermal): 4 weeks
    • Oral cyclosporine: 4 weeks
    • Oral progestins: 4 weeks
    • Oral oclacitinib (or similar): 4 weeks
    • Antihistamines: 2 weeks
    • Ketoconazole: 48 hours

Trial Participation
The following animal hospitals are offering this clinical trial:

Southeast Veterinary Dermatology
1131 Queensborough Blvd #100
Mt Pleasant, SC 29464
(843) 849-7770
Southeast Veterinary Dermatology
393 Woods Lake Road
Greenville, SC 29607
(864) 385-6565
Southeast Veterinary Dermatology
9201-B South Tryon Street
Charlotte, NC 28273
(704) 588-7004

Funded Clinical Trial for Dogs with Lymphoma

Announcing a clinical trial to evaluate an investigational antibody-based therapy in dogs with measurable multicentric lymphoma.

Trial Summary

It is anticipated that 36 client-owned pet dogs will be enrolled in this placebo-controlled study in dogs with measurable peripheral node lymphoma. The randomization of Investigational Product to placebo will be 1:1.

Study patients will receive the Investigational Product or placebo at Day 0 and Day 7 of this 21-day study.

Trial Support and Funding

This study provides funding during the study period for all study-related costs including the screening, study visit evaluations while on study, and all necessary diagnostics, treatment and management of adverse events that are possibly attributed to therapy. Additionally, $2000 will be paid towards oncology care after the trial for each dog enrolled in the study.

Trial Eligibility

Inclusion criteria:

  • Written owner informed consent has been obtained prior to screening the dog
  • Client-owned dog > 1 yr of age with body weight > 1.7 kg
  • Cytological or histological diagnosis of lymphoma stage IIIa-Va
  • At least one peripherally located lymph node measuring > 2 cm longest diameter (LD)
  • Naïve or relapsed T-cell or B-cell lymphoma
  • Adequate organ function as determined by the investigator
  • Life expectancy of > 1 month
  • Performance Score of 0 or 1 [0 = normal activity; 1 = restricted activity: decreased activity from pre-disease status]

Exclusion criteria:

  • Glucocorticoid therapy within 2 weeks of enrollment
  • Chemotherapy within 3 weeks of enrollment
  • Prior immunotherapy
  • Evidence of diabetes mellitus or on-going gastrointestinal disorder
  • Any serious medical condition (including other concurrent malignancy) that may be disruptive to the intent and objectives of the study
  • Dog is pregnant or likely to become pregnant
  • Dog is participating in another study
  • Dog may be unavailable for the entire study duration
  • Dog has bulky disease, as interpreted by the investigator, and is considered at risk for tumor lysis syndrome

Trial Locations

The following veterinary oncology specialty practice is offering this clinical trial:

The Veterinary Cancer Center
129 Glover Ave
Norwalk, CT 06850
P: (203) 838-6626
www.vcchope.com

Novel Treatment for Dogs with First Relapse Lymphoma

ACI is pleased to announce a funded clinical trial to evaluate a novel therapeutic in dogs with first relapse lymphoma.

Trial Summary


Approximately thirty client-owned dogs will be enrolled in this exploratory study. All dogs will receive the novel therapeutic treatment (no placebo).

Trial Funding

This study is funded. The compound is provided at no cost and all study visit fees, blood tests, urine tests, and other diagnostic tests specified in the protocol are paid for by the study. The management of side effects considered directly associated with the study compound are paid for by the sponsor. All other costs, including but not limited to transportation and veterinary care that is not associated with the study, are the responsibility of the dog owner.

Trial Eligibility

Inclusion criteria for participation in this clinical trial includes:

  • Dog must be > 1 year of age.
  • Dog has first relapse lymphoma with cytological or histological diagnosis of either T or B cell type lymphoma.
  • Evidence of disease progression on study entry is based on direct tumor measurement.
  • At least one peripherally located lymph node measures ≥ 2 cm longest diameter.
  • Dog must demonstrate adequate organ function as indicated by CBC, chemistry, and urinalysis,
  • Dog must have received no or only one prior systemic chemotherapy treatment regimen (single agent or multi-agent).
  • Dog must have completed any prior chemotherapy at least 14 days prior to study entry.
  • Dog must have recovered from any acute toxicities of prior chemotherapy treatment.
  • Dog must have a Performance Score of 0 or 1 [0 = normal activity; 1 = restricted activity: decreased activity from pre-disease status].
  • Life expectancy of ≥ 1 month.
  • Owner must be able to administer drug according to designated schedule.

Exclusion criteria for participation in this study includes:

  • Dog weighs < 5 kg.
  • Dog has received radiation therapy.
  • Dog has evidence of lymphoma involving the CNS.
  • Dog has significant bulky disease such that clinical deterioration is likely to occur even in the setting of stable disease.
  • Dog has any serious medical condition (renal, cardiovascular, hepatic, concurrent malignancy) that may preclude successful treatment outcome.
  • Dog shows evidence of diabetes mellitus or other on-going serious endocrine disorder.
  • Dog has serum calcium ≥ 13.0 mg/dL.
  • Dog is participating in another study or has received investigational therapy in the past 7 days.
  • Dog is currently using complementary or alternative medicines that in the opinion of the investigator would confound the interpretation of toxicities and/or antitumor activity of the investigational product.
  • Dog is pregnant or likely to become pregnant.
  • Dog may be unavailable for the entire study duration or is felt to be unsuitable by the investigator for any other reason.

Trial Participation

The following animal hospitals are offering this clinical trial:

The Ohio State University
Clinical Trials Office
Department of Veterinary Biosciences
College of Veterinary Medicine

454 VMAB, 1925 Coffey Rd
Columbus, OH 43210
(614) 688-5713 or (614) 247-8706
Texas A&M University
College of Veterinary Medicine
Dept of Small Animal Clinical Sciences

4474 TAMU
College Station, TX 77843
(979) 845-2351
University of Minnesota
College of Veterinary Medicine

1365 Gortner Ave
St. Paul, MN 55108
(612) 626-VETS (8387)
University of Wisconsin-Madison
School of Veterinary Medicine

2015 Linden Drive
Madison, WI 53706
(608) 263-9754

Sample Collection Study For Cavalier King Charles Spaniels, Poodles, and Dachshunds

Dogs are eligible if they have a left-sided systolic heart murmur or do not have a
murmur and are at least 8 years old

ACI is conducting a study that involves collection of blood and saliva samples from
Cavalier King Charles Spaniel (CKCS), Mini/Toy Poodles, and Dachshunds, with/
without Degenerative Mitral Valve Disease (DMVD).

Trial Eligibility:

  • Any pure breed Toy/Mini Poodles, Dachshunds with DMVD
  • Any pure breed Toy/Mini Poodles, Dachshunds, and or CKCS that is >8 years of age without DMVD
  • Canine has a left-sided systolic heart murmur of any grade

Trial Support

No charge examination. All samples will be collected at no charge.

Trial Participation

Friendship Hospital for Animals
Chesapeake Veterinary Cardiology Associates at The LifeCentre

Novel therapeutic agent for the treatment of measurable soft tissue sarcomas in dogs

Introduction
ACI is currently enrolling dogs for a nationwide clinical trial to evaluate a novel cancer treatment for soft tissue sarcoma. The goal of this therapy is to specifically target the tumor and induce an inflammatory response. The proposed benefit of such a response is to shrink existing tumors and reduce or eliminate microscopic cancer cells that may not be visible by standard (or any) means. The purpose of this study is to assess the safety and potential effectiveness of repeat doses of this therapeutic agent in dogs.

Funding
This trial is fully funded. The study sponsor will pay for the costs of diagnostic tests required for enrollment into the study (bloodwork, X-rays, abdominal ultrasound), the study treatments, follow up evaluations including examinations and diagnostic tests, and management of side effects that are the result of treatment with the compound.

Eligibility
Dogs are eligible if they meet the following inclusion criteria:

  • Histologic diagnosis of grade II or III soft tissue sarcoma
  • At least one measurable soft tissue sarcoma between 1-7 cm diameter
  • Generally feeling well
  • No evidence of an active infection requiring antibiotics within 7 days of enrollment
  • No anti-cancer therapy within 21 days of enrollment, including chemotherapy, radiation therapy,
    corticosteroids, and immunotherapy

  • No tumors located in regions where abscess would result in major symptoms

Tumors best suited for this therapy:

  1. This therapy may be used to improve the success of surgery for a primary tumor. In other words, if a tumor is large or in a location where success with surgery is difficult to achieve, this investigational therapy may be given with hopes of decreasing tumor size and improving surgical outcome.
  2. This investigational therapy may be used to treat cancers for which conventional treatment is ineffective, unreasonable, or unaffordable.

Procedures
A series of tests will be performed initially (screening tests) to make sure that a dog is a suitable candidate for the study. After the dog receives the first treatment (Day 0), it may be required to stay in the hospital for a minimum of four days. During this time period, the dog will be monitored for any adverse effects (i.e. fever, nausea, blood pressure abnormalities). If at the end of four days dogs are feeling well and the dog’s temperature is normal, s/he will be discharged from the hospital. If a study dog has had any ongoing side effects, s/he will remain hospitalized for supportive care. After subsequent treatments, the dog will be discharged on treatment day if they are feeling well and their temperature is normal. The study re-check schedule will be coordinated at the time of discharge from the hospital. Following the 4th treatment, monthly recheck visits will be performed for a total study period of 3 months.

Oncology Appetite and Quality-of-Life Survey

ACI is conducting a survey of pet owners whose dogs are receiving chemotherapy for the treatment of cancer and the veterinary oncologists providing their medical care with the goal of determining the dogs’ frequency, severity, and duration of reduced appetite, gastroenteritis and altered quality of life. The following populations of dogs will be evaluated:

  1. Dogs with any cancer (excluding lymphoma and hemangiosarcoma) receiving chemotherapy (no prednisone)
  2. Dogs with lymphoma receiving chemotherapy (no prednisone)
  3. Dogs with lymphoma receiving chemotherapy with concurrent prednisone
  4. Dogs with hemangiosarcoma receiving doxorubicin chemotherapy following splenectomy (no prednisone)
  5. Dogs with any cancer receiving toceranib (no prednisone)
  6. Dogs with any cancer that is in complete remission (no prednisone) and is not receiving any therapy that is likely to negatively impact appetite (melanoma vaccine, routine follow-up on long-term cases that previously received chemotherapy or radiation therapy).

Funding

$100 is provided to the client for completion of this 2-week survey

Participation

The following animal hospitals are participating in this survey project:

  • Friendship Hospital for Animals (DC)
  • The LifeCentre (VA)
  • Red Bank Veterinary Hospital (NJ)
  • The Veterinary Cancer Center (CT)
  • The New England Veterinary Cancer Group (MA)
  • MedVet (OH)
  • Veterinary Specialty Hospital of the Carolinas (NC)
  • Veterinary Cancer Group – Tustin (CA)
  • Veterinary Specialty Hospital of San Diego (CA)
  • Southern Arizona Veterinary Specialty & Emergency Center (AZ)
  • Veterinary Cancer Group – LA (CA)
  • Great Lakes Veterinary Specialists (OH)
  • New York City Veterinary Specialists (NY)
  • University of Wisconsin (WI)

Funded Clinical Trial for Dogs with Solid Tumors

A new clinical trial option is now available for dogs with melanoma, osteosarcoma, soft tissue sarcoma or squamous cell carcinoma.

Trial Summary

A minimum of 100 dogs with solid tumors will be treated with modified anaerobic bacteria. Treated dogs will be monitored closely after treatment with follow-up required at 2,4,7, and 14 days. While the patient remains on study, there will also be rechecks at 1 and 2 months from the initial treatment.

Trial Support and Funding

Study drug, diagnostic tests, and follow-up exams will be paid for by the study sponsor. In the event that side effects are attributed to the study drug, the study will pay for medical management of the side effects.

Trial Eligibility

Inclusion Criteria Includes:

  • Client-owned dogs with solid tumors with a preference for squamous cell carcinoma and sarcomas
  • Histologic or cytologic confirmation of tumor diagnosis
  • Dogs that have failed standard therapy or whose owners have declined such therapy
  • At least one palpable lesion measuring ≥ 1 cm in diameter
  • Dogs able to function normally (Modified ECOG Performance Score of 0 or 1)

Exclusion Criteria Includes:

  • Evidence of an active bacterial infection based on physical examination and/or complete blood count evaluation
  • Received antibiotic therapy within 7 days prior to infusion for a confirmed or suspected infection
  • Cancer therapy of any type (chemotherapy, radiation therapy, immunotherapy, etc.) within 3 weeks of study treatment
  • Tumors located in areas where abscess development would be catastrophic, such as nasal tumors that extend into the brain or significant pulmonary metastatic disease

Trial Participation

The following animal hospitals are offering this clinical trial:

The Oncology Service
at Friendship Hospital for Animals

4105 Brandywine St. NW
Washington, DC
202-363-7300
The Oncology Service
at The LifeCentre

165 Fort Evans Rd NE
Leesburg, VA 20176
571-439-6655
Red Bank Veterinary Hospital
197 Hance Ave.
Tinton Falls, NJ 07724
732-747-3636
New England Veterinary Oncology Group
180 Bear Hill Rd. Suite C
Waltham, MA 02454
781-684-8688
Veterinary Oncology and Hematology Center
178 Connecticut Ave.
Norwalk, CT 06854
203-838-6626
MedVet
300 E. Wilson Bridge Rd.
Worthington, OH 43085
614-846-5800
Veterinary Specialty Hospital
of the Carolinas

6405 Tryon Rd. Suite 100
Cary, NC 27518
919-233-4911
Veterinary Cancer Group – LA
9599 Jefferson Boulevard
Culver City, CA 90232
310-558-6120
Sage Centers – Campbell
907 Dell Ave
Campbell, CA 95008
408-343-7243
Southern Arizona Veterinary Specialty
and Emergency Center

141 E Fort Lowell Rd
Tucson, AZ 85705
520-888-3177
Veterinary Cancer Group – Tustin
2887 Edinger Ave.
Tustin, CA 92780
949-552-8274
Veterinary Referral Center of Colorado
Veterinary Cancer Specialists

3550 S. Jason St.
Englewood, CO 80110
303-874-7387
Veterinary Specialty Hospital
of San Diego

10435 Sorrento Valley Rd.
San Diego, CA 92121
858-875-7500
Summit Veterinary Referral Center
2505 South 80th St.
Tacoma, WA 98409
253-983-1114
Southeast Veterinary Oncology
304 Corporate Way
Orange Park, FL 32073
904-278-3870
North Florida Veterinary Specialists
3444 Southside Blvd., Suite 102
Jacksonville, FL 32216
904-646-1279
SouthPaws Veterinary Specialists
& Emergency Center

8500 Arlington Blvd
Fairfax, VA 22031
703-752-9100
Regional Veterinary Referral Center
6651 Backlick Rd
Springfield, VA 22150
703-451-8900
Great Lakes Veterinary Specialists
5035 Richmond Rd
Cleveland, OH 44146
216-831-6789
The Ohio State University
601 Vernon L Tharp St Room 0117
Columbus, OH 43210
614-292-3551
University of Wisconsin – Madison
2015 Linden Dr.
Madison, WI 53706
608-263-7600
BrightHeart Veterinary Referral
and Emergency Center

609-5 Cantiague Rock Rd
Westbury, NY 11590
Southwest Veterinary Oncology
86 W. Juniper Ave
Gilbert, AZ 85233
480-635-1110
University of Minnesota
1365 Grotner Ave
St. Paul, MN 55108
612-626-8387
Michigan State University
D208 Veterinary Medical Center
East Lansing, MI 48824
517-353-5420
Tufts Cummings School of Veterinary Medicine
200 Westboro Rd.
North Grafton, MA 01536
508-839-5395
Animal Specialty Hospital
10130 Market St. Suite 1
Naples, FL 34102
239-263-0480
NYC Veterinary Specialists
410 West 55th Street
New York, NY 10019
212-767-0099
Animal Cancer Specialists
11536 Lake City Way
Seattle, WA 98125
206-364-3733

Canine Cancer Diagnostics Sampling Program

ACI is conducting a blood sample collection project in dogs with various forms of cancer. A small amount of whole blood (less than a teaspoon) will be collected from dogs that are eligible. Dogs of any age, breed, size, or stage are eligible. Eligible dogs may be newly diagnosed, currently receiving therapy, in remission or not, and/or have been previously treated. Dogs with the following cancers are eligible:

Eligibility:

  • Mast Cell Tumor
  • Melanoma
  • Naïve Lymphoma
  • Relapsed Lymphoma
  • Liver Cancer (primary)
  • Lung Cancer (primary)
  • Prostate Cancer
  • Squamous Cell Carcinoma
  • Adenocarcinoma (Ex: Salivary, Nasal, Tonsillar, Anal Sac)
  • GI Cancer
  • Transitional Cell Carcinoma (bladder)
  • Breast or Ovarian Cancer

Participating Sites

The following animal hospitals are offering this clinical trial:

Friendship Hospital for Animals
4105 Brandywine St., NW
Washington, DC 20016
(202) 363-7300
S. Arizona Veterinary Specialty and Emergency Center
141 E. Ft. Lowell Rd.
Tucson, AZ 85705
520-888-3177
Veterinary Cancer Group
2887 Edinger Avenue
Tustin, CA 92780
(949) 552-8274
Veterinary Specialty Hospital
of San Diego

10435 Sorrento Valley Road
San Diego, CA 92121
(858) 875-7500
Veterinary Specialty Hospital
of the Carolinas

6405 Tryon Road Suite 100
Cary, NC 27518
(919) 233-4911
Red Bank Veterinary Hospital
197 Hance Ave.
Tinton Falls, NJ 07724
(732) 747-3636
Veterinary Oncology and Hematology Center
178 Connecticut Avenue
Norwalk, CT 06854-1930
(203) 838-6626
New England Veterinary Oncology Group
180 Bear Hill Rd Suite C
Waltham, MA 02451-1021
(781) 684-8688
The Oncology Service
at The LifeCentre

165 Fort Evans Rd NE
Leesburg, VA 20176
571-439-6655
Veterinary Medical Specialists
907 Dell Ave.
Campbell, CA 95008
(408) 343-7243

Golden or Labrador Retrievers with Hip Dysplasia

A new study has opened for Golden or Labrador Retrievers with Hip Dysplasia.

Background

Hip Dysplasia is an abnormal formation of the hip socket, that in its most severe form, can eventually cause crippling lameness and painful arthritis of the joints. Triple Pelvic Osteotomy (TPO), Total Hip Replacement (THR), and Femoral Head Osteotomy are three of the most common procedures performed for dogs with severe Hip Dysplasia.

The current study focuses on collecting a saliva sample and buccal (cheek) swabs from an estimated 250 “Purebred” Golden Retrievers and 250 “Purebred” Labrador Retrievers that have displayed severe hip dysplasia through radiographic examinations or had one of the three listed surgeries. The samples will be used to assess the DNA from these dogs.

Trial Eligibility:

  • Any purebred (AKC Registration highly preferred but not mandatory) Golden or Labrador Retriever with Hip Dysplasia (having undergone prior TPO, THR or FHO surgery resulting from Hip Dysplasia)
  • Any purebred Golden or Labrador Retriever whose Hip Dysplasia has been confirmed or described as “severe” by Radiographic examination
  • Medical record supporting the diagnosis

Trial Support
This study is a voluntary study for pet owners whose dogs meet the above criteria.

Saliva collection kits and buccal swabs will be provided to pet owners at no charge with sampling and mailing instructions inside. A kit with prepaid return packaging will be mailed to the owners for quick and easy return.

For further information click here.

Clinical Trial for Dogs with Squamous Cell Carcinoma

ACI is pleased to announce a funded clinical trial to evaluate a novel chemotherapeutic therapy in dogs with Squamous Cell Carcinoma.

Trial Summary

A maximum of 12 client-owned dogs will be enrolled in this open-label study. All dogs will receive the novel chemotherapeutic. Enrolled patients will have the opportunity to receive a maximum of 4 treatments, each given 3 weeks apart. One week after each treatment, dogs will be seen at the study site for follow-up bloodwork.

Trial Funding

The cost of the initial consultation with the oncologist will be the responsibility of the owner; however the sponsor will pay for drug, diagnostic tests, and follow-up exams throughout the duration of the study. In the event that side effects are noted and attributed to the study drug, the study will pay for medical management of the side effects.

Trial Eligibility

Inclusion criteria for participation in this clinical trial includes:

  • Any age, weight, breed or sex, diagnosed with squamous cell carcinoma
  • A life expectancy of more than 1 month
  • Owner consent prior to enrollment in the study
  • Clinically measurable disease. Longest diameter (LD) should be ≥ 20 mm
  • Dog with normal neutrophil and platelet counts
  • Adequate liver function
  • Adequate kidney function

Exclusion criteria for participation in this clinical trial includes:

  • A condition that will need treatment with systemic glucocorticoids such as prednisone during the study period (unless this medication has been started at least 2 weeks prior to study enrollment)
  • Significant gastrointestinal signs
  • Presence of active infection
  • Dogs that are currently enrolled in another clinical trial
  • Pregnant or lactating dogs
  • Any other reason which according to the veterinarian participating in the study, would affect the safety of the dog or severely interfere with study procedures

Trial Participation

The following animal hospitals are offering this clinical trial:

The Oncology Service
at Friendship Hospital for Animals
4105 Brandywine St.
Washington, DC 20016
(202) 363-7300

The Oncology Service
at The LifeCentre
165 Ft. Evans Road NE
Leesburg, VA 20176
(571) 439-6655

Veterinary Oncology & Hematology Center
178 Connecticut Ave
Norwalk, CT 06854
(203) 838-6626

Veterinary Specialty Hospital of the Carolinas
6405 Tryon Road Suite 100
Cary, NC 27518
(919) 233-4911

Southern Arizona Veterinary
Specialty and Emergency Center
141 E. Fort Lowell Rd
Tucson, AZ 85705-3920
(520) 888-3177

Canine Tumor Sample Collection Study

ACI is conducting a tumor sample collection project in dogs with various forms of cancers. Dogs that are at least 1 year in age, of any breed, size, sex, or stage are eligible. Eligible dogs may be newly diagnosed, naïve, or relapsed patients that have received and/or failed prior chemotherapy.

Eligibility
Dogs with the following cancers are eligible:

  • Mast Cell Tumor
  • Hemangiosarcoma
  • Osteosarcoma

Participating Sites

The following animal hospitals are offering this clinical trial:

 

Friendship Hospital for Animals
4105 Brandywine St., NW
Washington, DC 20016
(202) 363-7300
Veterinary Specialty Hospital
of the Carolinas

6405 Tryon Road Suite 100
Cary, NC 27518
(919) 233-4911
Red Bank Veterinary Hospital
197 Hance Ave.
Tinton Falls, NJ 07724
(732) 747-3636
Veterinary Oncology
and Hematology Center

178 Connecticut Avenue
Norwalk, CT 06854-1930
(203) 838-6626
New England Veterinary Oncology Group
180 Bear Hill Rd Suite C
Waltham, MA 02451-1021
(781) 684-8688
The Oncology Service
at The LifeCentre

165 Fort Evans Rd NE
Leesburg, VA 20176
571-439-6655

Collection of Urine Sample In Cats with Feline Renal Disease

ACI is conducting a urine sample collection study for cats with Renal Disease at Friendship Hospital for Animals in Washington, DC (www.friendshiphospital.com). A total of 40 client-owned cats that meet the criteria below will be enrolled in this clinical trial.

Upon completion of the consent form by cat owners, the study will cover the cost of the bloodwork, urinalysis, and urine protein:creatinine ration. The pet owner will be responsible for the cost of the physical examination.

Inclusion Criteria:

  • Informed owner consent
  • Cats has been diagnosed with any stage of renal failure
  • Cats of any breed or sex
  • Cat has serum creatinine > 2.5
  • Cat has urine specific gravity < 1.030

Exclusion Criteria:

  • Cat will not tolerate urine sample collection
  • Cat has a know history or current case of pyelonephritis, nephrolithiasis, ureterolithiasis or urogenital neoplasia

Trial Participation
The following animal hospitals are offering this clinical trial:

Friendship Hospital for Animals
4105 Brandywine St., NW
Washington, DC 20016
(202) 363-7300

Funded Project for Dogs with Osteosarcoma

ACI is involved in a clinical trial in which dogs who are scheduled for amputation with a diagnosis of osteosarcoma will have tumor samples collected and analyzed. Dogs of all breed, ages, and sex are eligible. This study serves to evaluate the quality of samples collected from Osteosarcoma bone tumors from dogs for genomic profiling. Samples will be collected following the amputation procedure.

Dogs with suspected primary appendicular Osteosarcoma (based on physical exam or radiographs) or confirmed diagnosis (based on previous cytology or histopathology of the affected limb (+/- metastisis) of appendicular Osteosarcoma with a planned amputation are eligible for this trial.

An eligible dog must not have received previous treatment for cancer, including chemotherapy, bisphosphonate therapy, prednisone therapy, radiation therapy or immunotherapy, other than Non-Steroid Anti-Inflammatory Drugs (NSAIDs). Concurrent acupuncture is permitted, though the patient must have began acupuncture treatment > 2 weeks prior to sample collection.

Following amputation, patients are eligible to receive treatment as chosen by the owner, including enrollment in another clinical trial. In appreciation of participation, $500 will be provided to the pet owner to offset a portion of the amputation costs.

(SPECIAL INTEREST IN GREYHOUNDS)

Trial Participation

All Metro DC Veterinary Clinics

Funded Clinical Trial for Dogs with Soft Tissue Sarcoma

Announcing a clinical trial to evaluate a novel form of antiangiogenic therapy in dogs with measurable soft tissue sarcoma.

Trial Summary

An estimated 86 client-owned pet dogs will be enrolled in this Phase II study. The study is a randomized, investigator-masked, placebo-controlled study in dogs with measurable soft tissue sarcoma. The randomization of active Test Article to placebo will be 1:1 with a crossover option for dogs in the placebo arm that have disease progression.

The first eight (8) dogs enrolled in the study will be assigned to receive active Test Article in an open label manner and will have blood samples collected over a period of 24 hours post treatment.

Once enrolled, study patients will be evaluated at Days 14, 28 and every 28 days thereafter until tumor progression occurs.

Trial Support and Funding

Study drug, diagnostic tests, and follow-up exams will be paid for by the study sponsor. In the event that side effects are noted and attributed to the study drug, the study will pay for medical management of the side effects.

Trial Eligibility

Inclusion Criteria:

  • Client-owned pet dogs;
  • Informed owner consent prior to initiation of screening/treatment;
  • Measurable soft tissue sarcoma (must have at least 1 target lesion ≥ 1cm longest diameter based on physical exam or ≥ 2cm if measured via thoracic radiographs);
  • Histological diagnosis of a Grade II or III soft tissue sarcoma (historical biopsies are accepted), excluding hemangiosarcoma;
  • Favorable Performance Score 0-1 (based on Modified Eastern Cooperative Oncology Group Performance Score);

Exclusion Criteria:

  • Dogs with a concurrent medical disorder likely to result in death or euthanasia within 4 months or a condition which may be disruptive to the intent and objectives of the study;
  • Anticipated poor owner compliance;
  • Dogs that are pregnant or likely to become pregnant;
  • Dogs that are participating in another clinical trial;
  • Dogs that will be unavailable for the duration of the trial or that are felt to be unsuitable by the Investigator for any other reason;
  • Chemotherapy within 21 days of the enrollment visit;
  • Prednisone treatment within 7 days of the enrollment visit;
  • Treatment with hormonal, immunotherapy, biological therapy, and/or small molecule inhibitors within 21 days of the enrollment visit;
  • Treatment with radiation therapy within 30 days of the enrollment visit;
  • Surgery within 14 days of the enrollment visit (with the exception of incisional biopsy if necessary at screening);
  • Treatment with Non-steroidal Anti-inflammatory Drugs (NSAIDs) within 14 days of enrollment.

Trial Participation

The following animal hospitals are offering this clinical trial:

The Oncology Service
at Friendship Hospital for Animals

4105 Brandywine St.
Washington, DC 20016
(202) 363-7300

The Oncology Service
at The LifeCentre

165 Ft. Evans Road NE
Leesburg, VA 20176
(571) 439-6655

Red Bank Veterinary Hospital
197 Hance Avenue
Tinton Falls, NJ 07724
(732) 747-3636

New England Veterinary Oncology Group
180 Bear Hill Road Suite C
Waltham, MA 02451
(781) 684-8688

Veterinary Oncology & Hematology Center
178 Connecticut Ave
Norwalk, CT 06854
(203) 838-6626

MedVet
300 E. Wilson Bridge Rd.
Worthington, OH 43085
(614) 431-4403

Veterinary Specialty Hospital of the Carolinas
6405 Tryon Road Suite 100
Cary, NC 27518
(919) 233-4911

Veterinary Medical Specialists
907 Dell Ave.
Campbell, CA 95008
(925) 771-1180

Veterinary Cancer Group
2887 Edinger Ave
Tustin, CA 92780
(949) 552-8274

Veterinary Specialty Hospital of San Diego
10435 Sorrento Valley Road
San Diego, CA 92121
(858) 875-7500

Southern Arizona Veterinary
Specialty and Emergency Center

141 E. Fort Lowell Rd
Tucson, AZ 85705-3920
(520) 888-3177

Animal Cancer Care Clinic
1122 NE 4th Ave
Ft. Lauderdale, FL 33304
(954) 527-3111

Veterinary Specialists
Vet Referral Center of Colorado
3550 S. Jason Street
Englewood, CO 80110
(303) 874-2054

Katonah Bedford Veterinary Center
546 N Bedford Rd
Bedford Hills, NY 10507
(914) 241-7700

Funded Clinical Trial for Dogs with Spontaneous Tumors

A new clinical trial option is now available for dogs with measurable malignant tumors with special interest in squamous cell carcinoma and sarcomas.

Trial Summary

A minimum of 13 dogs with spontaneous tumors will be treated with spores of a modified anaerobic bacteria. Treated dogs will be monitored closely after treatment with follow-up required 3, 5, 8 and 15 days post treatment. While the patient remains on study, there will also be rechecks after 1 month, 3 months, 6 months, 9 months, 12 months, and 24 months from the initial treatment.

Trial Support and Funding

Study drug, diagnostic tests, and follow-up exams will be paid for by the study sponsor. In the event that side effects are attributed to the study drug, the study will pay for medical management of the side effects.

Trial Eligibility

Inclusion Criteria Includes:

  • Client-owned dogs with spontaneous tumors with a preference for squamous cell carcinoma and sarcomas
  • Histologic or cytologic confirmation of tumor diagnosis
  • Dogs that have failed standard therapy or whose owners have declined such therapy
  • At least one palpable lesion measuring ≥ 1 cm in diameter
  • Weight ≥10 kg
  • Dogs able to function normally (Modified ECOG Performance Score of 0 or 1)

Exclusion Criteria Includes:

  • Evidence of an active bacterial infection based on physical examination and/or complete blood count evaluation
  • Received antibiotic therapy within 7 days prior to spore infusion for a confirmed or suspected infection
  • Cancer therapy of any type (chemotherapy, radiation therapy, immunotherapy, etc.) within 3 weeks of study treatment
  • Tumors located in areas where abscess development would be catastrophic, such as nasal tumors that extend into the brain or significant pulmonary metastatic disease

Trial Participation

The following animal hospitals are offering this clinical trial:

The Oncology Service
Friendship Hospital for Animals

4105 Brandywine St., NW
Washington, DC 20016
(202) 363-7300

The Oncology Service
The LifeCentre

165 Fort Evans Rd. NE
Leesburg, VA 20176
(571) 439-6655

Red Bank Veterinary Hospital
197 Hance Ave.
Tinton Falls, NJ 07724
(732) 747-3636

Veterinary Oncology & Hematology Center, LLC
178 Connecticut Ave
Norwalk, CT 06854
(203) 838-6626

Veterinary Specialty Hospital of the Carolinas
6405 Tyron Rd. Suite 100
Cary, NC 27511
(919) 233-4911

Novel Treatment Option for Dogs with Lymphoma, Malignant Melanoma or Mammary Adenocarcinoma

Announcing a fully funded clinical trial to evaluate a novel small molecule inhibitor in the treatment of dogs with lymphoma, malignant melanoma or mammary adenocarcinoma.

Trial Summary

The trial seeks to evaluate a novel, oral small molecule inhibitor in a maximum of 24 dogs. Dogs that meet the eligibility criteria will receive a once daily oral medication for 14-21 days followed by a decrease in frequency of the medication to two or three times weekly.

Blood samples will be collected in the first 24 hours to assess the metabolism of the drug. Follow-up evaluations are required once weekly for 4 weeks then once monthly for a total study duration of 3 months. If benefit from treatment is observed, there may be an option to continue therapy after 3 months.

Trial Support and Funding

Study drug, diagnostic tests, and follow-up exams will be paid for by the study sponsor. In the event that side effects are noted and attributed to the study drug, the study will pay for medical management of the side effects.

Trial Eligibility

Inclusion Criteria:

  • Client-owned dog
  • Informed owner consent prior to initiation of screening
  • Histological or cytological diagnosis malignant melanoma or mammary adenocarcinoma
  • Dog’s body weight allows accurate dosing according to dosing table
  • Measurable malignant melanoma or mammary adenocarcinoma (must have at least 1 target lesion > 1 cm longest diameter on physical examination or > 2 cm longest diameter on thoracic radiographs)
  • Favorable Performance Score 0-1 (Normal or Restricted Activity based on Modified Eastern Cooperative Oncology Group Performance Score)
  • Dog may have had prior surgery, but not within 14 days prior to study enrollment
  • Dog may have had prior treatment with non-steroidal anti-inflammatory drugs (NSAID) or prednisone, but not within 14 days prior to study enrollment
  • Dog may have had prior treatment with chemotherapy or small molecule inhibitor therapy, but at least 21 days prior to study enrollment
  • Dog may have had prior treatment with biological therapy, immunotherapy or radiation therapy, but at least 30 days prior to study enrollment

Exclusion Criteria:

  • Dog has a concurrent medical disorder likely to result in death or euthanasia within 4 months or a condition which may be disruptive to the intent and objectives of the study
  • Anticipated poor owner compliance
  • Dog is pregnant or likely to become pregnant
  • Dog is participating in another clinical trial
  • Dog is receiving/has received Palladia™
  • Dog will be unavailable for the duration of the trial or is felt to be unsuitable by the investigator for any other reason

Trial Participation

The following animal hospitals are offering this clinical trial:

The Oncology Service
at Friendship Hospital for Animals

4105 Brandywine St.
Washington, DC 20016
(202) 363-7300

The Oncology Service
at The LifeCentre

165 Ft. Evans Road NE
Leesburg, VA 20176
(571) 439-6655

Red Bank Veterinary Hospital
197 Hance Ave.
Tinton Falls, NJ 07724
(732) 747-3636

Veterinary Oncology & Hematology Center
178 Connecticut Ave.
Norwalk, CT 06854
(203) 838-6626

Veterinary Specialty Hospital
of the Carolinas

6405 Tyron Rd. Suite 100
Cary, NC 27511
(919) 233-4911

Veterinary Specialty Hospital of San Diego
10435 Sorrento Valley Rd.
San Diego, CA 92121
(858) 875-7500

New England Veterinary Oncology Group
180 Bear Hill Rd., Suite C
Waltham, MA 02451
(781) 684-8688

Funded Clinical Trial for Dogs with Lymphoma

A new clinical trial option is open for dogs with lymphoma, the most common cancer diagnosed and treated in veterinary practice.

Trial Summary

An estimated 18 client-owned pet dogs will be enrolled in this Phase I study. The study is an open-label, single agent, dose escalation study of a novel anti-cancer agent in dogs with lymphoma.

The study involves diagnostic testing (multiple blood sample collections and biopsies) along with administration of the study medication during a 1-week study period. After the 1-week study, dogs are eligible to receive standard care for lymphoma at the discretion of the veterinarian and dog owner.

Trial Support and Funding

The study is fully funded for 1-week study duration. Upon completion of the study, the study will pay $2000 for each patient enrolled to be used for costs associated with oncology care. The study will also pay for the management of side effects to the study medication (should they occur in the 1-week study period).

Trial Eligibility

Inclusion Criteria:

  • Client-owned pet dogs
  • Informed owner consent prior to initiation of screening/treatment
  • Naïve or relapsed Lymphoma
  • Lymphoma Stages II-V – substage a only (must have at least one target lymph node 2 cm longest diameter on physical exam)
  • Cytological or histological diagnosis of Lymphoma
  • Favorable Performance Score 0-1 (based on Modified Eastern Cooperative Oncology Group Performance Score)

Exclusion Criteria:

  • Dogs with a concurrent medical disorder likely to result in death or euthanasia within 4 months or a condition which may be disruptive to the intent and objectives of the study
  • Anticipated poor owner compliance
  • Lymphoma Stage I or Substage B
  • Dogs < 5 kg
  • Dogs that are pregnant or likely to become pregnant
  • Dogs that are participating in another clinical trial
  • Dogs that will be unavailable for the duration of the trial or that are felt to be unsuitable by the Investigator for any other reason
  • Chemotherapy within 21 days of the enrollment visit
  • Prednisone treatment within 7 days of the enrollment visit
  • Treatment with hormonal, immunotherapy, biological therapy, and/or small molecule inhibitors within 21 days of the enrollment visit
  • Treatment with radiation therapy within 30 days of the enrollment visit

Collection of Urine Samples in Cats Exhibiting Symptoms of Feline Lower Urinary Tract Disease

ACI is conducting a urine sample collection study for cats with Interstitial Cystitis at
Friendship Hospital for Animals in Washington, DC (www.friendshiphospital.com) and
Red Bank Veterinary Hospital in Tinton Falls, NJ (www.rbvh.net). A total of 30 client-
owned cats that meet the criteria below will be enrolled in this clinical trial.

Cat owners will be responsible for the cost of the physical examination. Upon
completion of the consent form by cat owners, the study will cover the cost of
ultrasound guided urine collection, a urinalysis, a urine culture and abdominal
radiographs. Cats with urinary obstructions (“blocked cats”) are eligible to participate
provided that the attending veterinarian feels that the patient is medically stable for the
study procedures.

Inclusion Criteria:

  • Informed owner consent
  • Cats > 6 months of age
  • Cats of any breed or sex
  • Cats exhibiting at least one of the following clinical signs:
    • Dysuria
    • Pollakiuria
    • Hematuria

Exclusion Criteria:

  • Cats with a known bacteria UTI, urolithiasis, or urogenital neoplasia
  • Cats that will not tolerate physical exam, cystocentesis, or abdominal
    radiographs
  • Cats that are considered medically unstable for any reason
  • Cats that are pregnant

Trial Participation
The following animal hospitals are offering this clinical trial:

Friendship Hospital for Animals
4105 Brandywine St., NW
Washington, DC 20016
(202) 363-7300

Red Bank Veterinary Hospital
197 Hance Ave.
Tinton Falls, NJ 07724
(732) 747-3636

Funded Clinical Trial for Dogs with Hemangiosarcoma

Status: Closed

Trial Summary

This clinical trial will evaluate a novel anti-cancer agent in a limited number of dogs with hemangiosarcoma. All dogs will receive study drug; there is no placebo.

Dogs will receive the study drug as daily, oral treatment with evaluations performed once weekly for the first 28 days, then once monthly. Blood samples are collected throughout the study to assess the metabolism and biological activity of this drug.

During the course of the study, dogs will not be allowed any holistic therapy, chemotherapy, prednisone therapy, non-steroidal anti-inflammatory therapy or other investigational therapies unless approved by the investigator and the sponsor.

Trial Support and Funding

Study drug, diagnostic tests, and follow-up exams will be paid for by the study sponsor. In the event that side effects are attributed to the study drug, the study will pay for medical management of the side effects.

Trial Eligibility

Client-owned pet dogs with measurable hemangiosarcoma lesions (primary or metastatic); OR patients free of gross disease, having undergone splenectomy within the past 28 days.

In addition, cases must meet the following criteria:

  • Generally feeling well;
  • Prior treatment with chemotherapy acceptable with a required washout of 21 days;
  • Prior treatment with non-steroidal anti-inflammatory drugs (NSAID) and prednisone acceptable with a required 14-day washout;
  • Prior treatment with radiation therapy is acceptable with a required 30-day washout;
  • No prior small molecule inhibitors (i.e. Palladia™);
  • No prior immunotherapy (i.e. ONCEPT™ melanoma vaccine).

Trial Participation

The following animal hospitals are offering this clinical trial:

The Oncology Service
Friendship Hospital for Animals

4105 Brandywine St., NW
Washington, DC 20016
(202) 363-7300

The Oncology Service
The LifeCentre

165 Fort Evans Rd. NE
Leesburg, VA 20176
(571) 439-6655

Red Bank Veterinary Hospital
197 Hance Ave.
Tinton Falls, NJ 07724
(732) 747-3636

New England Veterinary Oncology Group
180 Bear Hill Rd., Suite C
Waltham, MA 02451
(781) 684-8688

Veterinary Oncology & Hematology Center, LLC
178 Connecticut Ave
Norwalk, CT 06854
(203) 838-6626

Veterinary Specialty Hospital of the Carolinas
6405 Tyron Rd. Suite 100
Cary, NC 27511
(919) 233-4911

Veterinary Specialty Hospital of San Diego
10435 Sorrento Valley Rd.
San Diego, CA 92121
(858) 875-7500

Funded Clinical Trial for Dogs with Malignant Tumors

Status: Closed

Trial Summary

A clinical trial to evaluate a novel anti-cancer therapy is now available. The study is designed into two phases. The initial phase will evaluate the safety of this drug in dogs with any measurable cancer (excluding hemangiosarcoma). The 2nd phase will evaluate the safety of this drug in dogs with hemangiosarcoma exclusively. No placebo is used.

In both phases, dogs will receive the study drug as daily, oral treatment with evaluations performed once weekly for the first 28 days, then once monthly. Blood sample collection and tumor biopsies are collected throughout the study to assess the metabolism and biological activity of this drug. Dogs with hemangiosarcoma will not receive biopsies.

During the course of the study, dogs will not be allowed any holistic therapy, chemotherapy, or other investigational therapies unless approved by the investigator and the sponsor.

Trial Support and Funding

Study drug, diagnostic tests, and follow-up exams will be paid for by the study sponsor. In the event that side effects are attributed to the study drug, the study will pay for medical management of the side effects.

Client-owned pet dogs that meet the following criteria:

  • Histological or cytological diagnosis of cancer – excluding hemangiosarcoma in the first phase of the study;
  • Measurable cancer that is amenable to serial biopsy;
  • Generally feeling well;
  • Prior treatment with chemotherapy accepted but a washout of 21 days is required;
  • Prior treatment with non-steroidal anti-inflammatory drugs (NSAID) and prednisone accepted but a 14-day washout is required;
  • Prior treatment with radiation therapy is accepted but a 30-day washout is required;
  • No prior small molecule inhibitors (i.e. Palladia™);
  • No prior immunotherapy (i.e. Melanoma Vaccine);

Trial Participation

The following sites are evaluating patients for participation in this clinical trial:

The Oncology Service
Friendship Hospital for Animals

4105 Brandywine St., NW
Washington, DC 20016
(202) 363-7300

The Oncology Service
The LifeCentre

165 Fort Evans Rd. NE
Leesburg, VA 20176
(571) 439-6655

Red Bank Veterinary Hospital
197 Hance Ave.
Tinton Falls, NJ 07724
(732) 747-3636

New England Veterinary Oncology Group
180 Bear Hill Rd., Suite C
Waltham, MA 02451
(781) 684-8688

Clinical Trial For Canine Lymphoma

Status: Closed

Trial Summary

Pet dogs that are enrolled in the study will receive a single dose of a novel, oral anti-cancer agent. Serial blood samples and lymph node aspirates will then be collected over a 24-hour period.  Patients will return for evaluation 7 days after the single dose of therapy is administered.

For participation, clients will receive $2000 towards oncology care.

Trial Eligibility

  • Client-owned pet dogs > 1 year of age, 10-45 kg, with life expectancy of > 1 month;
  • Informed owner consent prior to initiation of screening/treatment;
  • Histological or cytological diagnosis of non-Hodgkins lymphoma with one or more measurable lymph nodes (Minimum tumor diameter is ≥ 20 mm);
  • Stage II to V (only substage a) lymphoma of either B or T cell origin;
  • Naïve (i.e. de novo) and relapsed cases;
  • Favorable Performance Score;
  • Prior treatment with chemotherapy or prednisone therapy is accepted but a 14-day washout is required.

Trial Participation

The following sites are evaluating patients for participation in this clinical trial:

The Oncology Service
Friendship Hospital for Animals

4105 Brandywine St., NW
Washington, DC 20016
(202) 363-7300

Red Bank Veterinary Hospital
197 Hance Ave.
Tinton Falls, NJ 07724
(732) 747-3636

New England Veterinary Oncology Group
180 Bear Hill Rd., Suite C
Waltham, MA 02451
(781) 684-8688

Anthracycline chemotherapy for feline carcinoma

Trial Eligibility

* Complete radical mastectomy for feline mammary carcinoma
* No gross evidence of metastatic disease.

Trial Support

* Study sponsored by the University of Missouri in collaboration with the Veterinary Comparative Oncology Group. Study provides anthracycline chemotherapy.
* Costs associated with administration and follow up are not provided.

Thrombospondin-I antiangiogenic therapy for dogs with soft tissue sarcomas
Target Accrual= 60 cases
Status: Closed

Eligibility:

* Measurable, histologically confirmed soft tissue sarcomas not including hemangiosarcoma
* No chemotherapy within 14 days of trial entry
* No radiation therapy within 21 days of trial entry
* Prednisone or NSAID therapy permitted if introduced at least 2 weeks
* before trial entry
* No previous antiangiogenic therapy

Trial Support: Study patients receive thrombospondin-I peptide at no charge. The initial biopsy and sedation is covered by the study. Medical examinations and diagnostic tests needed to measure response are the responsibility of the owner. All cases must be evaluated and treated through a participating member of the Animal Clinical Investigations Network every 30 days following weekly visits during the first month. Diagnostic and staging tests may be performed at any veterinary hospital within 10 days of initiation of study. Gemcitabine chemotherapy available to dogs that fail the antiangiogenic phase of the study.

Dose-finding evaluation of an oral PARP inhibitor plus COP chemotherapy for dogs with lymphoma

Dog Target Accrual= 9 cases
Status: Closed
Eligibility:

* Measurable nodal lymphoma- cytological or histological diagnosis
* All clinical stages but must have nodal involvement – includes relapsed cases
* Favorable performance score
* Recent COP treatment discouraged

Trial Support: Owner is responsible for referral examination and CBC/Chemistry/UA at initial study visit. Study provides full support for radiographs, lymph node biopsies (total of 3), lymph node immunophenotyping, bloodwork required by the study, study drug, COP protocol x 6 weeks, and recheck examinations for the first 6 weeks of the protocol.

Funded Clinical Trial for Dogs with Inflammatory Bowel Disease (IBD)

Evaluation of a Novel Diet

Status: Closed

Trial Eligibility:

* Dogs 1 year of age or older
* History of diarrhea and/or vomiting (minimum of 3 weeks duration)
* Free of parasites
* Free of other metabolic, inflammatory, or neoplastic diseases causing vomiting and/or diarrhea (screening tests performed at eligibility visit)

Trial Design:

A funded clinical trial is available for the management of IBD in dogs. The objective of this trial is to evaluate a therapeutic pet food and its effects on symptoms and histology associated with IBD. Dogs enrolled in this study will receive the highest level of veterinary care and diagnostics associated with the management of IBD.

Trial Support:
Funding Includes

* All diagnostic tests and examinations required for the purpose of the study (includes examinations, bloodwork, endoscopy and/or colonoscopy)
* Well-balanced study food provided at no additional cost to all pets

The IBD trial is being conducted by Animal Clinical Investigation, LLC and participating network sites.

Efficacy study of an oral antimitotic agent in the treatment of dogs with lymphoma

Status: Closed

Eligibility:

* informed consent
* client owned pet dogs
* is not pregnant or likely to become pregnant during the study
* measurable, histologically diagnosed NH lymphoma (histology collected at study entry)
* any clinical stage but must have nodal involvement- includes relapsed cases
* favorable performance score
* no concurrent chemotherapy (within 14 days of trial entry)
* no concurrent radiation therapy (within 21 days of trial entry)
* concurrent use of corticosteroids accepted providing treatment duration is greater than 21 days and/or no clinical improvement is noted. Measurable disease defined by examination, radiographs, ultra-sound, CT or MRI scan

Vet Examing Dog Trial Design:
Diagnostic and staging tests may be performed at any veterinary hospital within 10 days of initiation of study (Serum biochemistry, CBC, Urinalysis, Thoracic and abdominal radiographs). Patients will be treated at a participating Animal Cancer Institute Network clinic. Lymph node biopsies will be required at entry, Day 7, first objective response and at progression or relapse.

Trial Support:
Dogs will receive the oral medication over a 4-week initial phase. Continued therapy will be available pending response to therapy. Long-term follow-up recheck examinations will be performed monthly.

* Laboratory, biopsy and professional fees (as required for the study) from time of enrollment through Day 56 (additional monthly exams beyond Day 56 will be owner’s financial responsibility)
* Oral Antimitotic agent through Day 56 (beyond Day 56, additional monthly shipments of study drug supply will be billed to the clinic/investigator at a rate of $50 per shipment)

Funded Clinical Trial for Cutaneous Mast Cell Tumor

Status: Closed

Eligibility:

* Recurrent cutaneous mast cell tumor (following surgery, chemotherapy, or radiation therapy)
* Non-resectable cutaneous mast cell tumors
* Must be Grade 2 or 3
* Measurable cutaneous disease required
* Prior systemic chemotherapy accepted
* Prior radiation therapy accepted

Trial

Trial Design:
All patients must be evaluated at Friendship Hospital for Animals.

Trial Support:
All fees associated with diagnostic staging as required by the study are provided by the trial sponsor. Patient evaluations and randomization will be assessed at Friendship Hospital for Animals.

Compassionate Use Antiangiogenic Therapy in Dogs with Measurable Malignant Melanomas or Myelomas

Status: Closed
Eligibility:

* Owner informed consent
* Client owned pet dogs
* Histologically confirmed malignant melanoma or myeloma
* Tumors must be objectively measurable using direct caliper measurement (documented by digital image and investigator documentation on evaluation form), ultrasound, radio-graphs or CT/MRI scan.
* Favorable clinical performance status at entry (expected to remain clinically stable for 30 days)
* No previous exposure to antiangiogenic therapies
* No chemotherapy within 14 days of trial entry
* No radiation therapy administered within 21 days of trial entry
* Corticosteroids and non-steroidal anti-inflammatory agents ok to continue if patient has been receiving for >14 days at time of study entry

Trial Support:
Antiangiogenic peptide will be provided at no charge. All examination, tumor imaging and other diagnostic costs are the patient”s responsibility, including a $50 monthly service fee ($50, billable to the Network clinic/investigator). All patients must be evaluated and treated monthly through a participating Animal Cancer Institute Network site. Diagnostic and staging tests may be performed at any veterinary hospital within 10 days of initiation (full serum chemistry, CBC, U/A and thoracic radiographs). Dogs will receive a month”s supply of medication for in-home, daily subcutaneous injection. Continued therapy will be available pending response to therapy.

Oral antimitotic agent for dogs with newly diagnosed lymphoma

Status: Closed 12/04
Eligibility:

* Measurable disease defined by examination, radiographs, ultra-sound, CT or MRI scan
* Cytologically diagnosed Non-Hodgkins Lymphoma (histology collected at study entry)
* Any clinical stage but must have nodal involvement
* No previous targeted therapy (including prednisone)

Trial Design:
Diagnostic and staging tests may be performed at any veterinary hospital within 10 days of initiation of study. Patients will be treated at Friendship Hospital for Animals. Lymph node biopsies will be required at entry and 7 and 21 days later.

Trial Support:
Study patients receive the oral anti-mitotic agent at no charge. Laboratory, biopsy and professional fees required for the study will be provided by the sponsor from time of enrollment.

A genetically modified Salmonella typhimurium, for the treatment of solid tumors in dogs.

Status: Closed 11/04
Eligibility:

* Dogs with advanced or metastatic cancer
* At least one solid tumor accessible to biopsy
* All solid tumor types (including lymphoma) with the exception of hemangiosarcoma
* No concurrent therapies
* Prior therapies allowed, but must be discontinued at least 2 weeks prior to start of this trial
* No concurrent use of steroids or antibiotics

Trial Support:
All costs associated with the trial will be provided by the sponsor, excluding initial consult examination to determine patient eligibility

Feline Cancer Cachexia – Food Trial

Status: Closed 11/30/04
Eligibility:

* Histologically-confirmed feline lymphoma (all stages except oral and mycosis fungoides permitted)
* Study patients are required to receive “study approved” chemotherapy protocol for feline lymphoma
* Must not be involved in any other clinical trial
* No concurrent radiation therapy accepted

Cachexia Trial – Cat
Trial Support:
Laboratory and professional fees required for the study will be provided by sponsor. In addition, a $600 stipend will be provided to pet owners in 3 installments. Cases may be screened for eligibility by any Animal Cancer Institute Network provider. Follow-up evaluations for study purposes will occur at Day –7, 0, Wk 5, Wk 8, and Wk 20. These evaluations may also be performed by any Animal Cancer Institute Network provider.

Vascular targeted therapy for dogs with any measurable cancer following relapse on antiangiogenic therapy

Status: Closed 4/15/04
Eligibility:

* Measurable disease defined by examination, radiographs or ultrasound
* No cytotoxic therapy within 3 weeks of trial initiation
* Prednisone or NSAID therapy permitted if introduced at least 3 weeks before trial initiation
* Must receive at least 4 months of treatment with antiangiogenic therapy (described above)

Antiangiogenic therapy for dogs with any measurable cancer following relapse on antiangiogenic therapy
Trial Support: Study patients receive vascular targeted therapy at no charge. Medical examination and diagnostic tests needed to measure response are the responsibility of the owner. All cases must be evaluated and treated through the Animal Cancer Institute primary clinic site a Friendship Hospital for Animals, Washington, DC.

Antibiotic therapy for dogs with lymphoma: feasibility trial

Status: Closed
Eligibility:

* Measurable disease
* No previous treatment chemotherapy or radiation treatment
* Efficacy stage involves lymph node biopsy only

Trial support: All costs to be borne by sponsors.

Antiangiogenic therapy for dogs with any measurable cancer

Status: Closed 3/4/04
Eligibility:

* Measurable disease defined by examination, radiographs or ultrasound
* No cytotoxic therapy within 3 weeks of trial initiation
* Prednisone or NSAID therapy permitted if introduced at least 3 weeks before trial initiation
* No previous antiangiogenic therapy

Antiangiogenic therapy for dogs with any measurable cancer
Trial Support: Study patients receive Thrombospondin-I peptide at no charge. Medical examinations and diagnostic tests needed to measure response are the responsibility of the owner. All cases must be evaluated and treated through the Animal Cancer Institute primary clinic site at Friendship Hospital for Animals, Washington DC. Diagnostic tests may be performed at any veterinary hospital within 10 days of initiation of study

Chemotherapy and antiangiogenic therapy in dogs with lymphoma

Status: Closed 5/6/03
Eligibility:

* First relapse of lymphoma following complete remission on conventional chemotherapy
* Measurable disease
* -B-cell lymphoma immunophenotype

Chemotherapy and Thrombospondin-I Therapy in dogs with lymphoma
Trial Support: Approximately 90% of the costs of care are provided by trial sponsor. Entry to trial can be undertaken at several participating veterinary centers across the United States, including all centers in the Animal Cancer Institute Network.

Antiangiogenc therapy for dogs with splenic hemangiosarcoma

Status: Closed 4/01/03
Eligibility:

* Splenic hemangiosarcoma – successfully removed by splenectomy within 14 days of study entry
* No gross metastatic disease
* No concurrent chemotherapy

Trial Support: Study drug and follow up costs are supported by trial sponsor. Details on participating veterinary centers will be made available shortly.

Vascular targeted therapy for cats with any measurable cancer

Status: Closed 4/28/03
Eligibility:

* Measurable disease defined by examination, radiographs or ultrasound
* Mo cytotoxic therapy within 3 weeks of trial initiation
* Prednisone or NSAID therapy permitted if introduced at least 3 weeks before trial initiation
* No previous antiangiogenic therapy

Trial Support: Study patients receive Thrombospondin-I peptide at no charge. Medical examination and diagnostic tests needed to measure response are the responsibility of the owner. All cases must be evaluated and treated through the Animal Cancer Institute primary clinic site at Friendship Hospital for Animals, Washington, DC. Diagnostic tests may be performed at any veterinary hospital within 10 days of initiation of study.

Ifosfamide chemotherapy in cats with vaccine associated sarcoma

Status: Closed 5/31/02
Eligibility:

* Measurable disease
* No previous chemotherapy or radiation therapy
* No underlying renal or hepatic disease

Ifosfamide chemotherapy in cats with vaccine associated sarcoma
Trial Support: The majority of costs associated with chemotherapy treatment and follow up will be provided by the trial sponsor (Cornell University; Vaccine associated sarcoma task force – AVMA). Entry to the trial can be undertaken at several participating veterinary centers across the United States including all centers in the Animal Cancer Institute Network.

Non-toxic chemotherapy in dogs with lymphoma

Status: Closed 6/10/02
Eligibility:

* Measurable disease
* No previous treatment chemotherapy

Non-toxic chemotherapy in dogs with lymphoma
Trial Support: All costs associated with chemotherapy treatment and follow up will be provided by the trial sponsors. Entry to the trial can be undertaken at several veterinary centers across the United States including all centers in the Animal Cancer Institute Network.

Inhaled interleukin-2 liposomes immunotherapy: Prospective case series in dogs with pulmonary metastases or primary lung cancers.

Summary: Dogs with pulmonary metastasis and primary lung cancers were treated with aerosols of IL-2. Minimal toxicity was noted in 9 dogs that were treated. Two dogs with metastatic osteosarcoma had regression of pulmonary metastasis for greater than 1 year.
Publication: Khanna C, Hasz DE, Klausner JS, Katsanis, EM, and Anderson PM. Inhaled interleukin-2 liposome immunotherapy in dogs with spontaneous primary lung cancers and cancers metastatic to the lung. Cancer. 79(7): 1409-21, 1997.

Background: Systemic in vivo toxicity of interleukin-2 (IL-2) has been problematic. Anti-neoplastic activity of IL-2 has been modest. We have previously demonstrated the biological activity and safety of aerosols of IL-2 liposomes in normal dogs. We now report objective regression of naturally occurring pulmonary metastases in dogs after one month of nebulized IL-2 liposome therapy.
Methods: Dogs with pulmonary metastases (n=7) and primary lung carcinoma (n=2) were treated with aerosols of IL-2 liposomes. Response to therapy was monitored with serial chest radiographs. Effector populations, collected by broncho-alveolar lavage (BAL) and from heparinized whole blood, were assessed for cell type, immunophenotype, and tumor cytolytic activity. Immunogenicity of human IL-2 and human serum albumin (HSA) in dogs was assessed by immunofluoresence assay (IFA).

Results: Two of four dogs with pulmonary osteosarcoma metastases had complete regression of metastases stable for greater than 12 and greater than 20 months. One of two dogs with lung cancer had stabilization of disease for greater than 8 months; the other had progression. Toxicity was minimal. BAL cell numbers increased greater than 4 fold (p=0.01) and included significantly greater proportions and total numbers of eosinophils (p=0.006) and lymphocytes (p=0.008). Mean BAL effector lytic activity was significantly greater after 15 days of IL-2 liposome inhalation compared to pretreatment activity (p=0.01); however mean BAL lytic activity decreased after 30 days and was no longer significantly greater than pretreatment BAL lytic activity. No allergic reactions were associated with inhaled IL-2 liposome therapy. Canine antibodies against human IL-2 and HSA were detected in all dogs.

Conclusion: Pet dogs with naturally occurring pulmonary metastases and primary lung cancers accepted inhalation treatments easily. Non-toxic and effective treatment of pulmonary metastases of osteosarcoma is possible using nebulized IL-2 liposomes

L-glutamine prevention of radiation induced mucositis: Prospective placebo blinded randomized trial in dogs receiving megavoltage radiation therapy for nasal cancers

Summary: This prospective randomized trial demonstrated a significant reduction in oral radiation mucositis (ulceration) in pet dogs receiving radiation therapy for nasal tumors when dogs were given a glutamine containing suspension compared to a standard daily mouthwash. The use of the glutamine suspension was not associated with any adverse effects in dogs and did not alter the activity of the radiation therapy in the treated dogs.

Publication: Khanna C, Klausner JS, Walters P, Bell FW, James K, Lund E, Redic K, Anderson PM. L-glutamine versus placebo in the prevention of radiation induced oral mucositis. In Vivo. In progress.

Background: Oral mucositis is a common complication of radiation therapy of the head and neck. Radiation-induced mucositis of the oral cavity results in patient discomfort and may adversely affect treatment outcomes. Mucositis can lead to interruptions or early stoppages in planned radiation treatments and negatively impact on nutritional status. L-glutamine, an important fuel source for gastrointestinal epithelial cells, may decrease the severity of mucositis associated with radiation therapy. Using a relevant animal model, we evaluated of the radio-protective activity of an oral l-glutamine suspension in preventing oral mucositis.

Methods: Pet dogs, receiving radiation therapy for nasal cancers, were entered to a randomized double-blind placebo-controlled trial to evaluate an oral suspension of l-glutamine in the prevention of radiation-induced mucositis. The l-glutamine suspension, or a corn starch placebo, in a sugar-based vehicle was administered to dogs orally (4.0 gm/m2/d of l-glutamine or an equivalent volume of placebo suspension). Dogs were evaluated daily for the severity of mucositis based on a clinical grading score and a food intake score. The severity of mucositis, the duration of mucositis, and the number of interruptions (due to mucositis) in the planned radiation therapy was compared for the dogs receiving the l-glutamine and placebo oral suspension.

Results: A significant decrease in the number of interruptions in radiation therapy was seen in the dogs receiving l-glutamine compared to placebo (p=0.028). Furthermore dogs receiving l-glutamine had a significant decrease in the number of days of severe mucositis compared to the dogs receiving placebo (p=0.05). There were no adverse effects associated with administration of the l-glutamine suspension
Conclusions: Amelioration of oral radiation induced-mucositis is possible using an oral suspension of l-glutamine. Further controlled clinical trials of the radio-protective properties of l-glutamine are warranted.

Doxorubicin vs Dactinomycin containing induction chemotherapy: Prospective placebo blinded randomized trial in dogs receiving multi-agent chemotherapy for lymphoma.

Summary: Dogs receiving Doxorubicin compared to Dactinomycin as part of a multi-agent protocol were compared. Median time to first remission was not significantly different between the 2 groups. However, median duration of remission and median survival time was significantly longer for dogs treated with Doxorubicin. There were no significant differences in toxicity noted between the 2 groups

Publication: Khanna C, Lund E, Redic K, Hayden D, Bell FW, Goullaud R, Klausner JS. A randomized trial of doxorubicin versus dactinomycin in the treatment of canine lymphosarcoma. J Am Vet Med Assoc. 213(7):985-90, 1998.

Objective: To compare efficacy and toxicity of 2 multi-agent chemotherapeutic protocols, similar in all respects except that one incorporated dactinomycin and the other incorporated doxorubicin, for treatment of dogs with malignant lymphoma.

Design: Randomized double blind controlled trial.

Animals: 45 dogs with malignant lymphoma.

Methods: Dogs were randomly assigned to a doxorubicin or dactinomycin treatment group. Time to first remission, duration of first remission, survival time, and prevalence of toxicoses, particularly number of episodes of dose-limiting neutropenia and gastrointestinal toxicoses were compared between groups.

Results: 37 dogs received at least 1 dose of doxorubicin (21 dogs) or dactinomycin (16 dogs). Median time to first remission was not significantly different between groups, but median duration of first remission and median survival time were significantly longer for dogs in the doxorubicin treatment group than for dogs in the dactinomycin treatment group. Numbers of dogs that died, numbers of episodes of dose-limiting neutropenia, and numbers of episodes of gastrointestinal toxicoses were not significantly different between groups.
Conclusions: A multi-agent chemotherapeutic protocol incorporating doxorubicin was significantly more effective in dogs with malignant lymphoma than a similar protocol incorporating dactinomycin. Despite the lower cost and lack of cardiotoxicity, dactinomycin is not an equivalent substitute for doxorubicin in the initial treatment of dogs with malignant lymphoma.

IGF-I inhibition plus chemotherapy vs chemotherapy alone in osteosarcoma: enhanced tumor apoptosis

Summary: OncoLAR® is an agent that blocks the production of insulin-like growth factor (IGF-I), a hormone that is believed to enhance the survival of cancer cells. This study evaluated the effects of OncoLAR® in canine patients being treated with chemotherapy for osteosarcoma. A comparison was made in this group of study patients to osteosarcoma patients receiving chemotherapy but not OncoLAR®. Results showed significant suppression of IGF-I in patients treated with OncoLAR®, but there was no improvement in cancer cell destruction or patient survival time using this agent.

Publication: Khanna C , Prehn J, Yeung C, Caylor J, Bose S, Cassaday RJacob S, Helman L. Randomized trial of OncoLAR® (SMS-201 995pa LAR) and carboplatin versus carbplatin alone in dogs with naturally occurring osteogenic sarcoma. Clinical Cancer Res In Press, 7/1/02.

Background: Osteosarcoma is the most common primary tumor of bone. Several lines of evidence suggest the role of the insulin-like growth factor – growth hormone pathway in the biology of this cancer. Insulin like growth factor has been demonstrated to act as a survival signal for cancer cells, and as such has been hypothesized to be a mechanism of resistance against chemotherapy-induced death. OncoLAR® is a novel long acting analog of somatostatin that results in growth hormone blockade from the pituitary and therein suppression of serum insulin-like growth hormone release from the liver. The use of OncoLAR® pediatric osteosarcoma patients resulted in approximately fifty percent suppression in serum IGF-I levels with limited toxicity.

Methods: To determine if insulin-like growth factor suppression will decrease chemotherapy resistance by eliminating an important survival signal to osteosarcoma cells we conducted a randomized, blinded, placebo-controlled pre-clinical study in pet dogs with naturally occurring osteosarcoma. The trial compared primary tumor necrosis and apoptosis and survival of pet dogs receiving OncoLAR® and carboplatin chemotherapy compared to a placebo and carboplatin.

Results: demonstrated suppression of serum insulin-like growth factor levels by approximately 46% without toxicity in dogs receiving OncoLAR®. No differences in primary tumor necrosis, apoptosis, tumor insulin-like growth factor mRNA expression, or survival were seen between the two treatment groups.

Conclusions: Results suggest that suppression of insulin-like growth factor levels by the extent and/or duration achieved in the trial was not sufficient to improve chemotherapy related anti-tumor effects in pet dogs with osteosarcoma.

Thalidomide antiangiogenic therapy in dogs :Prospective case series in dogs with measurable malignant cancers

Summary: This study evaluated the effects of thalidomide in 7 canine patients with a variety of tumors. No objective response was seen in these patients. No adverse effects were noted associated with Thalidomide treatment.

Publication: Jankowski M, Fulton L, Sheafor S, Prescott D, Khanna C. Ongoing evaluation of single agent thalidomide in dogs with measurable cancer. Proc Vet Cancer Soc 1999.

Background: Angiogenesis is essential for cancer progressin and metastasis. Inhibition of angiogenesis may be an effective treatment for cancers. The anticancer activity of thalidomide has been demonstrated in early human clinical trials. The objectives of this study are: 1) to determine the safety and efficacy of oral thalidomide against measurable canine cancers, 2) to define an optimal biological dose for thalidomide in dogs, and 3) to define tumor types sensitive to antiangiogenic therapy with thalidomide.

Methods: This is a single agent, phase I/II clinical study. Entry requirements include measurable and histologically confirmed diease, body weight> 10 kg, no chemotherapy within 10 days of treatment, and informed owner consent. Three escalating dose cohorts (30 cases/cohort) have been defined: 3.3-6.5, 6.6-13, 13.3-26 mg/kg QD. Physical examinations, CBC, serum biochemistry, and tumor response will be evaluated at day 0 and every 30 days thereafter. Urine and plasma samples collected before and during thalidomide therapy will be assayed for markers of antiangiogenic activity including, basic fibroblast growth factor, vascular endothelial growth factor and interleukin-8.

Results: Seven cases to date have been evaluated. All dogs had progressive disease prior to study entry. No side effects to thalidomide have been noted in the first dose cohort.

Histology

TNM Stage

Measurable Lesion

Prior Treatment

Treatment Length

Outcome

Malignant pericardial
mesothelioma

TSxM1pulmonary (possible
CNS)

Pulmonary

Surgery, Chemotherapy,
Immunotherapy

180 days

SD x 90 days

Nasal carcinoma

T3N2mandibular, Prescapular
M0

Lymph nodes, Orbital
proptosis

Radiation therapy,
Chemotherapy

80 days

SD x 77 days

Rib osteosarcoma

TSxM1pulmonary

Pulmonary, Local recurrence

Surgery, Chemotherapy

33 days

PD

Carcinomatosis, abdomen

 

Liver

None

27 days

PD

Hepatocellular
carcinoma

 

Liver

Surgery

36 days

PD

Osteosarcoma

TSxM1pulmonary

Pulmonary

Surgery, Chemotherapy

9 days

PD

Liposarcoma

T4N1M0

Cervical Lesion

Surgery, Radiation
therapy

Ongoing

SD


Conclusions: Thalidomide appears to be well tolerated in the current dose cohort. No objective tumor responses have been documented at this time. Additional entry of cases with smaller tumor burden may allow antiangiogenic activity to be exerted before disease progression. Surrogate markers of systemic antiangiogenic activity, measured in plasma and urine, may be helpful in defining optimal biologic doses.

ACI-002c: Thrombospondin-I antiangiogenic therapy in cats: Prospective case series in cats with measurable malignant cancers

Summary: This prospective study evaluated the effects of thrombospondin-1 peptides in 10 feline patients with various cancers. No objective response was seen in these patients. No adverse effects were noted.

ACI-004c: Thrombospondin-I antiangiogenic therapy in dogs: Prospective case series in dogs with measurable malignant cancers

Summary: This prospective study evaluated the effects of thrombospondin-I peptides in canine patients with various cancers. No adverse effects were noted. Approximately 40% of these patients showed improvements identified by stable disease unexpected for the biology of that given cancer, partial remissions, or complete remissions. Abstract submitted to the Amercian Society of Clinical Oncology Annual Meeting 2002

Genetics Study of Canine Osteosarcoma

Study Rationale

Certain breeds seem to be predisposed to the development of osteosarcoma. The AKC Canine Health Foundation, in cooperation with the AMC Cancer Research Center and Animal Clinical Investigation, is funding a study to determine the genetic basis of these cancers.

Eligibility
• Golden Retrievers, Rottweilers, Scottish Deerhounds, and Mastiffs
• Other breeds may be eligible upon approval
• Osteosarcoma diagnosis without any metastatic disease.
• At least two unaffected first degree relatives of the affected dog (includes siblings, parents and offspring)

Trial Support
$150 to the owner towards the cost of the biopsy (associated with amputation). Histopathology and shipping of samples (an approximate value of $130) will be performed at no charge by the AMC Cancer Research Center

Investigational Treatment Option For Dogs with Lymphoma


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What is Lymphoma?

Lymphoma is the most common malignant cancer treated in veterinary oncology. Lymphoma is a cancer of lymphocytes, which are white blood cells that are part of the immune system and reside in the lymph nodes, bone marrow, and spleen. In most cases, lymphoma is thought of as a disseminated disease where the malignant lymphocytes exist in many tissues throughout the body.

How is Canine Lymphoma Treated?

Multi-agent chemotherapy is the current standard option for treatment of lymphoma. Canine lymphoma is one of the most responsive cancers to chemotherapy. Other treatment options include single-agent chemotherapy or treatment with prednisone alone. Although multi-agent chemotherapy has been shown to significantly prolong the survival time of many animals with lymphoma, there is a need for treatment options that will result in long-term control, and possibly a chance for cure.

Investigational Opportunity for Dogs with Lymphoma

We are currently enrolling dogs in a clinical study using a novel drug called a PAR protein (PARP) inhibitor in combination with conventional chemotherapy agents. This treatment option is being tested to determine if it increases the effectiveness of standard chemotherapy improving long-term survival without adding significant toxicity. PARP is an enzyme that is used by cells to repair DNA damage. This enzyme may be upregulated in cancer cells, allowing the cancer cells to be able to quickly repair DNA damage caused by chemotherapy. This repair activity decreases the effectiveness of chemotherapy and increases chemotherapy resistance. Thus, the goal of using a PARP inhibitor is to potentially diminish this repair and allow chemotherapy to be more effective.

The main goals of this study are to determine an acceptable dose of the PARP inhibitor drug, to determine how the drug is metabolized, determine how effectively it reaches the target tissues (lymph nodes), and to assess the treatment benefit. There are two phases of the study. During the initial (dose-finding) phase, dogs will receive the PARP inhibitor alone. On the first day of the study, dogs will receive a single treatment with the PARP inhibitor. A total of 3 lymph node biopsies and blood samples will be collected over 24 hours. Dogs will then be sent home with the the PARP inhibitor to be administered twice daily for one week.

The second phase of the study involves combining the PARP inhibitor with conventional chemotherapy. While receiving the study drug, dogs will be treated with Vincristine (administered at the clinic once weekly for 3 weeks), Cytoxan (administered by owners in oral form on a 3-4 day regimen starting 4 days after each dose of Vincristine), and Prednisone (administered once daily). The estimated average duration of the study will be 4 weeks. Once the study period is completed, dogs may continue to receive treatment as long as benefit continues.

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What Side Effects May Be Seen with this Treatment?

Because the PARP inhibitor is an investigational treatment, the complete side effect profile cannot be predicted. Known side effects of this drug include vomiting and diarrhea. However, other side effects may occur, including life-threatening illness and death. Side effects seen with conventional chemotherapy include vomiting, diarrhea, inflammation of the bladder, and suppression of bone marrow resulting in low white blood cell or platelet counts. The frequency or magnitude of side effects seen with chemotherapy may be worsened when the PARP inhibitor is added to the treatment program.

Is My Dog Eligible for the Study?

To be eligible for the study, a dog must:

  • Have a confirmed diagnosis of lymphoma, either by biopsy or fine needle aspirate
  • Have enlarged lymph nodes
  • Have good overall health
  • Not have received chemotherapy in the past 21 days
  • Not have received prednisone in the past 21 days
  • Not have been treated with radiation therapy in the past 30 days
  • Be available for the duration of the study period (28 days)

Owner Responsibilities

Owners are required to keep a log of the time the study drug is given and any adverse effects that are observed. This log will be reviewed by the investigator at each visit. Owners must be able to bring the dog to the clinic for weekly visits (a total of 4-5 after the initial consultation). The study is funded, which means the study will pay for examinations, bloodwork, procedures, treatment and side effects associated with the study protocol. The PARP inhibitor will be provided to owners for 6 months after the completion of the study if they wish to continue treatment. Additional funding is not provided after the first 4 weeks of treatment.

FUNDED CLINICAL TRIAL FOR DOGS WITH MAST CELL TUMOR(S): A NEW THERAPEUTIC OPTION

Mast Cell Tumors

Mast cell tumors represent the most common cutaneous malignant tumors in dogs. The behavior of mast cell tumors and prognosis is in part dependent on histologic grade and anatomical location. Treatment options for cutaneous mast cell tumors include surgery, chemotherapy, corticosteroid therapy and radiation therapy. If feasible, wide surgical excision remains the treatment option of choice. If cutaneous mast cell tumors are incompletely excised or recurrent, additional surgery or regional radiation therapy may be considered. Systemic chemotherapy may be considered for mast cell tumors that are non-resectable, disseminated in the skin or metastatic. Unfortunately, long term prognosis for these more advanced presentations is guarded in most dogs. New treatment options are needed.

Evaluation of a New Therapeutic Option for Mast Cell Tumors
A new investigational drug for treating canine mast cell tumors is available. In this pivotal clinical trial, we will examine the safety and efficacy of a novel compound (compared to lomustine) in dogs with mast cell tumors.

Trial Eligibility Criteria Includes:
• Dogs with measurable cutaneous mast cell tumor(s),
• Mast cell tumor histological grade II or III,
• Dogs in whom curative intent surgery cannot be performed or has been declined by the owner,
• Regional lymph node involvement accepted,
• Dogs at any age, weight, gender, breed with satisfactory health.
• No prior chemotherapy,
• No radiation therapy to a target lesion. If prior radiation therapy is performed, a 3-week washout is required before study enrollment,
• Three-week washout period for prednisone, 2-week washout period for non-steroidal anti-inflammatory drugs.

Trial Support and Funding
There is no placebo included in this trial. Dogs will be randomized 2:1 to initially receive the new investigational drug or an active chemotherapeutic against mast cell tumors, lomustine (CeeNu®). The initial consultation fee must be paid by the owner. Once an informed consent form is signed, all diagnostic tests, study drug, follow-up evaluations, and management of potential side effects will be paid for by the study.

ACI Oncology Network Participants
New England Veterinary Oncology Group
Waltham, MA

Veterinary Oncology and Hematology Center
Norwalk, CT

Red Bank Veterinary Hospital
Tinton Falls, NJ

The Oncology Service at Friendship Hospital for Animals
Washington DC

Southpaws Veterinary Specialists and Emergency Center Fairfax, VA

Veterinary Specialists of the Carolinas
 Cary, NC

MedVet
 Worthington, OH

Southeast Veterinary Oncology
 Orange Park, FL

Southwest Veterinary Oncology
 Tucson, AZ

Veterinary Specialty Hospital of San Diego
 San Diego, CA

Veterinary Cancer Group of Orange County
 Tustin, CA

Veterinary Cancer Specialists
 Englewood, CO

Participating University Locations

Dr Lisa Barber
Department of Clinical Sciences
Oncology
Tufts Cummings School of Veterinary Medicine
200 Westboro Road
North Grafton Massachusetts 01536, United States

Dr Douglas Thamm/Dr Sue Lana
Colorado State University College of Veterinary Medicine
Animal Cancer Center
300 West Drake Rd.,
Fort Collins, CO 80523-1620, United States

Dr Elizabeth McNiell
Michigan State University
Department of Small Animal Clinical Sciences
D208 Veterinary Medical Center
East Lansing, MI 48824, United States

Dr Cheryl London
Department of Veterinary Biosciences
The Ohio State University
454 VMAB
1900 Coffey Rd.
Columbus, Ohio 43210

Dr Karin Sorenmo
University of Pennsylvania School of Veterinary Medicine
Department of Clinical Studies
VHUP, 3900 Delancey St
Philadelphia, PA 19104-6020, United States

Dr Nicole Northrup
University of Georgia College of Veterinary Medicine
Department of Small Animal Medicine
Athens, GA 30677, United States

Dr David Vail
Department of Medical Sciences
School of Veterinary Medicine
University of Wisconsin-Madison
2015 Linden Drive
Madison, WI 53706 United States