Clinical Trial For Canine Lymphoma

Last modified on 2010-06-21 15:00:51 GMT. 0 comments. Top.

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

Last modified on 2009-05-22 02:45:37 GMT. 0 comments. Top.

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

Last modified on 2009-05-22 02:48:15 GMT. 0 comments. Top.

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)

Last modified on 2009-05-22 02:50:23 GMT. 0 comments. Top.

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

Last modified on 2009-05-22 02:51:31 GMT. 0 comments. Top.

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

Last modified on 2009-05-22 02:52:45 GMT. 0 comments. Top.

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

Last modified on 2009-05-22 02:54:17 GMT. 0 comments. Top.

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

Last modified on 2009-05-22 02:55:22 GMT. 0 comments. Top.

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.

Last modified on 2009-05-22 02:56:19 GMT. 0 comments. Top.

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

Last modified on 2009-05-22 02:57:09 GMT. 0 comments. Top.

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

Last modified on 2009-05-22 02:58:07 GMT. 0 comments. Top.

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

Last modified on 2009-05-22 02:59:07 GMT. 0 comments. Top.

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

Last modified on 2009-05-22 03:00:10 GMT. 0 comments. Top.

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

Last modified on 2009-05-22 03:01:23 GMT. 0 comments. Top.

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

Last modified on 2009-05-22 03:02:17 GMT. 0 comments. Top.

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

Last modified on 2009-05-22 03:03:02 GMT. 0 comments. Top.

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

Last modified on 2009-05-22 03:04:20 GMT. 0 comments. Top.

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

Last modified on 2009-05-22 03:05:15 GMT. 0 comments. Top.

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.

Last modified on 2009-05-22 03:06:27 GMT. 0 comments. Top.

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

Last modified on 2009-05-22 03:07:28 GMT. 0 comments. Top.

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.

Last modified on 2009-05-22 03:08:31 GMT. 0 comments. Top.

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

Last modified on 2009-05-22 03:09:39 GMT. 0 comments. Top.

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

Last modified on 2009-05-22 03:12:47 GMT. 0 comments. Top.

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.

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

Last modified on 2009-05-22 03:14:04 GMT. 0 comments. Top.

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

Last modified on 2009-05-22 03:15:02 GMT. 0 comments. Top.

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

Last modified on 2010-06-19 21:03:18 GMT. 0 comments. Top.

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

Last modified on 2009-10-12 16:30:17 GMT. 0 comments. Top.

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.

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

Last modified on 2010-06-19 21:02:03 GMT. 0 comments. Top.

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