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Pilot study to interrogate the impact of local radiation treatment on the genomic landscape and immune capacity of canine malignant melanoma

Status: Recruiting

Species: Dog

Veterinary Speciality: Oncology

Description

Malignant melanoma represents a challenging tumor to treat, and many dogs develop tumor spread to mulitple organs. Melanoma is very resistant to standard chemotherapy. However, over the past 20 years it has become clear that melanoma is susceptible to killing by the immune system. There are now several immune based treatments for people with melanoma, and a few available for dogs as well. Unfortunately, while these immunotherapies work for some people in dogs, a significant number of patients still fail to respond. There is now evidence that local radiation therapy can help promote an immune response against melanoma by helping to remove the “bad” immune cells that are suppressing responses, and by creating a better set of signals for the immune system to see. The purpose of this study is to begin characterizing how local radiation changes the immune landscape in dogs over the course of treatment with radiation with the ultimate goal of using these data to improve immune treatments in the future.

 

Inclusion Criteria

Eligible patients (any breed of dog) must meet all of the following criteria:

  • Dogs diagnosed with histologically confirmed melanoma
  • Dogs must be at least 1 year of age and body weight of 8 kg or higher.
  • Adequate organ function as indicated by standard laboratory tests (complete blood count, serum biochemistry profile, urinalysis).
    • ANC≥2000/μL and platelet count ≥ 100,000/μL
    • Liver: Total bilirubin ≤ 1.5X the institutional upper limit of normal (ULN), ALT ≤ 3X ULN
    • Renal: Serum creatinine ≤ 1.5X ULN
    • ECOG performance score of 0-1
  • Otherwise medically healthy with no underlying clinically significant cardiac, renal or hepatic disease.
  • Dogs must have an estimated life expectancy of at least 28 days.
  • Informed written consent must be obtained

 

Exclusion Criteria

Patients (dogs) meeting any of the following criteria will not be eligible for the study:

  • Pregnant or lactating dogs
  • Evidence of metastatic disease
  • 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 disease.
  • Less than 2 weeks from a major surgical procedure.
  • Any serious systemic disorder incompatible with the study (at the discretion of the principal investigators).

 

Client Benefits

The study will cover all diagnostics (bloodwork, x-rays, treatment planning) and treatments (radiation therapy). Should your dog experience side effects associated with the biopsy procedures, the study will cover treatment for those.   Except for the specific financial support described here, any tests or procedures unrelated to this study including treatment of conditions unrelated to the sarcoma are your responsibility. This includes treatment for side effects related to the radiation therapy.

Sample or Data Requirements

Your dog will undergo screening and planning for the radiation therapy to treat the melanoma. Once enrolled in the study, your dog will have biopsies of the tumor and of normal skin taken during the course of the study, as well as blood collected during each visit for radiation. The study calendar provides an overview of all the study related procedures. The study ends on the last day of radiation therapy.

Study Calendar

Screening             Day -7 to -1 Day 0/1# Day 7 Day 14 Day 21 Day 28 Day 35
Exam x x x x x x x
CBC x           x
Chemistry x           x
Urinalysis x            
Chest X-rays x            
CT for radiation planning x            
Blood collection * x x x x x x x
Radiation Treatment   x x x x x x
Tumor/skin biopsies   x   x     x

 

*Each blood collection will consist of approximately 24-30 ml (2-3 tablespoons)

#Your dog will stay overnight after the first radiation visit so a small amount of blood (1 tsp) can be obtained 24 hrs after the first treatment.

Contact Info

For questions regarding the clinical trial please email the clinical trials technician, Diane Welsh at: clinicaltrials@tufts.edu

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