Open Menu Close Menu Open Search Close Search Open Directory Close Directory

Phase I study of an experimental drug in dogs with solid tumors

Phase I study of of an experimental drug in dogs with solid tumors

Status: Recruiting

Species: Dog

Veterinary Speciality: Oncology

Description

The purpose of this clinical trial is to evaluate of an experimental drug in dogs with solid tumors (carcinomas/sarcomas). This drug works by both directly killing cancer cells and also by stimulating the immune system to kill cancer cells.  Although this drug has been tested extensively in mouse models of cancer and has been well tolerated in healthy dogs, it is not clear whether this drug will be active in dogs (or people) with spontaneous cancers. Therefore, this trial will evaluate this drug in dogs with solid tumors with the goal of identifying the best dose to give, any side effects that may occur, and whether or not the drug can induce shrinkage of tumors.

Inclusion Criteria

  • Dogs diagnosed with histologically or cytologically confirmed spontaneous carcinoma/sarcoma. The patient may have failed standard therapy, or there may be no other known effective antineoplastic therapeutic options, or the owner may elect to enter the patient in lieu of standard therapy.
  • Dogs must be at least 1 year of age and body weight of 20 kg or higher with a normal HCT, and 25 kg or higher with a HCT of 35%
  • Dogs with solid tumors must have a tumor mass that measures ≥ 2 cm and is accessible for repeated biopsy.
  • Adequate organ function as indicated by standard laboratory tests (complete blood count, serum biochemistry profile, urinalysis).
  • Otherwise medically healthy with no clinically significant physical findings upon examination, medical history, and clinical laboratory profile, as deemed by the principal investigators.
  • Dogs must have an estimated life expectancy of at least 28 days.
  • Prior chemotherapy or radiation must be completed 2 weeks prior to study entry and the patient must have recovered from the acute toxicities of these treatments.

Exclusion Criteria

  • Pregnant or lactating dogs
  • Evidence of brain metastasis
  • Dogs with uncontrolled autoimmune hemolytic anemia (AIHA) or immune mediated thrombocytopenia (ITP) are not eligible
  • Concurrent use of complementary or alternative medicines that in the opinion of the principal investigators would confound the interpretation of toxicities and/or antitumor activity of the study drug.
  • Dogs with significant cardiovascular/hepatic/renal disease.
  • Less than 2 weeks from a major surgical procedure.
  • Any serious systemic disorder incompatible with the study (at the discretion of the PI).
  • Use of any other investigational drug within 1 week of study entry.

Client Benefits

The ultimate goal of this clinical trial is to shrink your dog’s tumor by direct killing of the tumor cells and by stimulating the immune system to kill the cancer cells. However, given that this is a very early study associated with this drug and we are just beginning to figure out the best dose of drug, it is possible that the this drug will not affect your dog’s tumor at all.

The study will cover all diagnostics (bloodwork, imaging, biopsies, etc) and treatments (drug administration, supportive medications) associated with the tumor while your dog is enrolled in this study as well as the management of any study related side effects. Following completion of the study, you will receive a $2000 credit at the Foster Hospital for Small Animals for any additional therapy to treat your dog (i.e., surgery, chemotherapy, radiation therapy).  Except for the specific financial support described here, any tests or procedures unrelated to this study including treatment of conditions unrelated to the carcinoma/sarcoma (i.e., ear infection, etc) are your responsibility.

Sample or Data Requirements

Prior to enrollment, your dog will be screened for eligibility by performing blood tests and imaging (x-rays, ultrasound) as needed. If eligible and enrolled, we will next obtain a small biopsy of the tumor, blood samples for analysis, and an aspiration of the local lymph node (if possible). These events occur 4-7 days before drug administration and are part of the entire screening process. The total study duration is only 7 days from this point on.   Your dog will return to the hospital on a Monday or Tuesday to start the study.  Your dog will undergo several blood tests/diagnostics prior to and during the course of treatment to monitor blood counts, levels of this drug in the blood, and drug induced changes in the tumor, draining lymph node, and blood cells.

Contact Info

For questions regarding the clinical trial please fill out this survey: Pet Eligibility Questionnaire

Print Friendly, PDF & Email