Posts by catharine

CLINICAL TRIAL FOR CANINE INTRANASAL ADENOCARCINOMA

October 27th, 2022 Posted by Intranasal Adenocarcinoma, Oncology 0 thoughts on “CLINICAL TRIAL FOR CANINE INTRANASAL ADENOCARCINOMA”

ACI is currently enrolling patients in a multicenter, randomized, double-masked, placebo-controlled clinical trial to evaluate a novel investigational product in dogs with stage 3 intranasal adenocarcinoma.

Participation Requirements

  • Patients will receive radiation therapy and investigational product or placebo intravenously under general anesthesia for 5 consecutive days.
  • Patients will be required to visit study site for regularly scheduled appointments over a 4-month period.
  • Owners will be required to document study associated observations and questionnaires as appropriate.


Study Benefits

  • If you elect to enroll your dog in the study, the investigational drug will be funded at no charge to you.
  • The study site will discuss the other veterinary services that are covered at no cost to you if your pet is eligible.


Eligibility Criteria

  • Dog is ≥ 12 months of age
  • Dog weighs > 5kg
  • Dog has ECOG performance status less ≤ 1
  • Dog has stage 3 intranasal adenocarcinoma and is amenable to radiotherapy
  • Dog is able to tolerate multiple anesthesia events
  • No prior radiotherapy, chemotherapy, or surgical therapy prior to enrollment
  • No clinically significant cardiovascular arrhythmias

The Veterinary Investigator at the study site will determine if your pet meets other eligibility criteria and may enroll in the study.


Study Sites

Gulf Coast Veterinary Specialists
8042 Katy Freeway
Houston, TX 77024

Iowa State University
1800 Christensen Drive
Ames, Iowa 50011

Kansas State University
1800 Denison Avenue
Manhattan, KS 66506

Purdue University
625 Harrison Street
West Lafayette, IN 47907

Southwest Veterinary Oncology
141 E. Ft. Lowell Rd
Tucson, AZ 85705

The Ohio State University
601 Vernon L. Tharp Street
Columbus, OH 43210

University of Florida
2015 SW 16th Ave
Gainesville, FL 32608

University of Illinois
1008 W Hazelwood Dr.
Champaign-Urbana, IL 61802

ORAL MELANOMA STUDY IN DOGS

August 29th, 2022 Posted by Melanoma, Oncology 0 thoughts on “ORAL MELANOMA STUDY IN DOGS”

Trial Overview

This fully funded, randomized, placebo-controlled clinical trial will assess a potential new treatment for oral melanoma in dogs.


Eligibility

  • Diagnosis of Stage III oral melanoma (not confined to lip)
  • At least one measurable lesion with a longest diameter of ≥ 10 mm (≥ 15 mm short axis for lymph node lesions)
  • Prior surgery acceptable (if performed at least 14 days prior to enrollment) if measurable disease remains which meets above criteria
  • No lung metastasis
  • No prior Oncept® melanoma vaccine
  • Dog must weigh at least 3 kg (6.6 lb)
  • Other study criteria may apply. The Investigator will decide if the dog is a good candidate for this study after examination.


Trial Details

  • Investigational product or placebo once every 2 weeks for approximately 6 months (15 scheduled visits)
  • All trial visits must occur at one of the designated trial clinics listed below
  • Periodic lab work and thoracic radiographs (x-rays) will be performed to assess each dog’s overall health
  • Owners are required to sign a consent form before their dog is enrolled, complete owner diaries at home and complete a single quality-of-life assessment question at each trial visit
  • At study end, dogs are eligible to receive the investigational product in a separate clinical trial

 

Study Sites

Dallas, TX
Malvern, PA
Middleton, WI
Overland Park, KS
San Diego, CA
Washington, DC

Additional study sites coming soon!

A MULTI-CENTER PIVOTAL STUDY TO DETERMINE THE EFFECTIVENESS AND SAFETY OF AN INVESTIGATIONAL VETERINARY PRODUCT FOR THE TREATMENT OF LYMPHOMA IN DOGS

April 6th, 2022 Posted by Lymphoma, Oncology 0 thoughts on “A MULTI-CENTER PIVOTAL STUDY TO DETERMINE THE EFFECTIVENESS AND SAFETY OF AN INVESTIGATIONAL VETERINARY PRODUCT FOR THE TREATMENT OF LYMPHOMA IN DOGS”

Study Specifics

This randomized, double-masked, placebo-controlled, GCP pivotal field study is evaluating the effectiveness and safety of verdinexor for the treatment of naïve or first relapse stages II, III and IV lymphoma in client owned dogs. Diagnosis of lymphoma must be confirmed by cytology or biopsy for the dog to be eligible for this study. Dogs will be randomized to receive the investigational veterinary product or a placebo treatment (tablets) to be administered with food twice weekly at least 72 hours apart for 8 weeks.  After receiving treatment in-hospital on Day 0, the dog will be required to return to the study site on Days 7, 14, 28, 42, and 56 for follow up evaluation visits. Owners will be required to report and record abnormal daily observations and dosing using a phone app at home throughout the study.


Funding

This study is fully funded. Funding includes the initial study screening, the study treatment and administration, scheduled study lab work, recheck visits and exams, and management of side effects that are thought to be directly related to participation in the study. In addition, if your dog enrolls in the study and you are able to comply with all study requirements, a $1,000 credit will be applied to your account at the clinical study site to be used towards further medical care once your dog is off the study.


Eligibility

Dogs are eligible if they meet the following inclusion criteria:

  • Written informed owner consent has been obtained prior to screening.
  • Dog is ≥ 1 year, weighs ≥ 9 kg and has a life expectancy of at least 28 days.
  • Dog has naïve or first relapse lymphoma:
    • Naïve: dog who has not received any treatment for lymphoma.
    • First relapse: dog has failed a single round of any chemotherapy completed at least 14-days prior to study entry and has recovered from any acute toxicity from prior chemotherapy or is on prednisone and has exhibited progressive disease.
  • Evidence of disease (progression) at the time of screening is based on direct measurement of at least one peripheral lymph node ≥ 20 mm longest diameter (LD).
  • Dog has histological or cytological diagnosis of B-cell or T-cell lymphoma (confirmed, or confirmation is pending, by flow cytometry or Polymerase Chain Reaction (PCR) assay, known as PCR for Antigen Receptor Rearrangements or PARR, prior to or during screening procedures), stages II, III, or IV:
    • Stage II: Regional lymphadenopathy (restricted to one side of diaphragm)
    • Stage III: Generalized lymphadenopathy (enlargement of lymph nodes)
    • Stage IV: Hepatosplenomegaly (provided there is also lymphadenopathy such that the Investigator can assess disease status through a physical exam)
  • A modified Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1 [0 = normal activity, 1 = restricted activity, decreased from pre-disease status].
  • If on NSAIDs treatment, the dog has been treated for more than 2 weeks prior to enrollment.

 

Dogs are not eligible if they meet the following exclusion criteria:

  • Dog has stage I lymphoma.
  • Dog has clinical evidence of stage V lymphoma involving the CNS, gastrointestinal tract, or pulmonary system.
  • Conditions that may interfere with the outcome of the study:
    • Clinically relevant abnormal laboratory results (e.g., lymphocyte count greater than 15,000 per μL)
    • Serious, concurrent medical condition (e.g., renal, cardiovascular, hepatic, endocrine, concurrent malignancy)
    • Significant bulky disease such that clinical deterioration is likely to occur even in the setting of stable disease.
  • Dog has received prior radiation specifically for the treatment of lymphoma.
  • Dog is receiving complementary or alternative medicines that the Investigator believes could interfere with the primary endpoint of the study.
  • Dog is participating in another study or is receiving an investigational therapy.
  • Dog that is lactating, pregnant, or intended for breeding.

 

Study Sites

Akron, OH
Bartlesville, OK
Dallas, TX
Denver, NC
Franklin, IN
Madison, WI
North Grafton, MA
Pittsburgh, PA
Quakertown, PA
Salt Lake City, UT

Additional study sites coming soon!

 


 

If interested in enrolling your pet or being an Investigator on this study, please contact ACI by completing the section below.

  • This field is for validation purposes and should be left unchanged.

PILOT SAFETY AND EFFECTIVENESS STUDY OF A NOVEL STEM CELL THERAPY PREPARATION IN CLIENT-OWNED CATS WITH CHRONIC KIDNEY DISEASE (CKD)

November 10th, 2021 Posted by Chronic Kidney Disease 0 thoughts on “PILOT SAFETY AND EFFECTIVENESS STUDY OF A NOVEL STEM CELL THERAPY PREPARATION IN CLIENT-OWNED CATS WITH CHRONIC KIDNEY DISEASE (CKD)”

Study Specifics

This GCP study conducted at multiple clinical study sites will evaluate the safety and effectiveness of a novel stem cell therapy preparation in cats with naturally occurring chronic kidney disease (CKD). The study veterinarian will administer the stem cell therapy by intravenous injection on Day 0 and 14. The study will compare the investigational veterinary product (IVP) to a placebo control product (CP). Cats at a given clinic will be randomly assigned to treatment group with a 2:1 group enrollment ratio. Follow-up visits/testing or phone follow-ups are required monthly. Throughout the study the owner will be required to observe and record any abnormal observations and assess food and water intake.


Funding

This is a fully funded study that includes seven scheduled clinic visits occurring at least once before treatment for screening (2 to 3 weeks prior), once for each treatment (Day 0 and 14), and four times thereafter (Days 30, 60, 90, 180). Funding includes the initial consultation, the study treatment and administration, recheck visits, and management of side effects that are thought to be directly related to participation in the study.


Eligibility

Cats that meet eligibility criteria and have a diagnosis of stage 2 or 3 CKD with no other diseases that would interfere with the study objectives, may enroll in the study. The study veterinarian will determine the stage of the cat’s kidney disease and discuss the complete list of study requirements.

Study Sites

Washington, DC
Bartlesville, OK
Pittsburgh, PA
Quakertown, PA
Fort Collins, CO
Zachary, LA

Additional study sites coming soon!

If you are interested in enrolling your pet or being an Investigator on this study, please contact ACI at https://www.animalci.com/contact/ or call (301) 841-0014.

Coming Soon

Veterinarians interested in joining our network of professionals in clinical trials, contact us for more details.