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New drug combination treatment for soft tissue sarcomas in dogs

Exploratory Study of Combination KPT-9274 and Doxorubicin for the Treatment of Soft Tissue Sarcomas in Dogs

IACUC Protocol #: G2017.86

Status: Recruiting

Species: Dog

Veterinary Speciality: Oncology

Description

The purpose of this clinical trial is to evaluate the activity of two drugs when given in combination to treat a type of cancer called soft tissue sarcoma. This tumor type is very resistant to chemotherapy and radiation, and in the setting of bulky disease, less than 10-20% of tumors will experience shrinkage.  Doxorubicin (DOX) is the most common chemotherapy agent used to treat sarcomas in both dogs and people, however it is relatively ineffective in most cases.  We have recently completed a clinical trial testing the effectiveness of combining DOX with a new oral drug (KPT-9274) in dogs with a cancer termed lymphoma.  The KPT-9274 works by blocking key proteins in cancer cells, and we found that the two drugs, when given together, were very well tolerated (no increase in side effects over DOX alone) and significantly increased response of the lymphoma to the DOX.  Based on these results, it is possible that the DOX/9274 combination may work more effectively in other cancers as well.  Therefore, the purpose of this trial is to combine DOX/9274 for a total of 4 treatments (once every 3 weeks x 4 treatments) in dogs with sarcomas.

Inclusion Criteria

  • Adequate organ function as indicated by standard laboratory tests (complete blood count, serum biochemistry profile, urinalysis).
  • Dogs must have an estimated life expectancy of at least 21 days.
  • Dogs must be at least 1 year of age
  • Dogs that have received any prior therapy must have occurred at least 14 days prior to enrollment
  • Informed written consent obtained

Exclusion Criteria

  • Pregnant or lactating dogs
  • Dogs with uncontrolled autoimmune hemolytic anemia (AIHA) or immune mediated thrombocytopenia (ITP) are not eligible.
  • Dogs with evidence of significant bone marrow, gastrointestinal or hepatic involvement.
  • 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)

Contact Info

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

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