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New drug and radiation therapy combination treatment for soft tissue sarcomas in dogs

Exploratory Study of Combination KPT-9274 and Radiation Therapy Treatment of Soft Tissue Sarcomas in Dogs

Status: Recruiting

Species: Dog

Veterinary Speciality: Oncology

Description

The purpose of this clinical trial is to evaluate the effects of giving a novel oral drug in combination with local radiation 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.  Radiation therapy is often used to treat sarcomas after they have been removed surgically; its main purpose in that setting is to kill any remaining tumor cells that may have been missed with the surgery. Radiation can also be used when the sarcoma is too large for surgery.  In this setting, it typically does not induce significant tumor shrinkage, but usually just stops the tumor from growing for a period of time (typically around 6 months).  We have recently completed a clinical trial testing the effectiveness of combining chemotherapy 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 chemotherapy alone) and significantly increased response of the lymphoma.  Based on these results, it is possible that the KPT-9274 may also help to increase the effects of other types of treatment, such as radiation.  Therefore, the purpose of this trial is to see whether combining KPT-9274 with local radiation for sarcomas that cannot be removed with surgery will increase the response to treatment.

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 28 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)

Client Benefits

The ultimate goal of this clinical trial is to shrink your dog’s tumor by combining the radiation and KPT-9274. In some cases if a tumor is growing rapidly, treatments that stop growth without actually shrinking the tumor can provide significant benefit.

The study will cover all diagnostics (bloodwork, imaging, etc) and treatments (Radiation/9274 administration) associated with the sarcoma while your dog is enrolled in this study, except the CT planning if deemed necessary by the Radiation Oncology Service (estimated cost between $1000-$2000 depending on how much is needed to plan the radiation treatment field). 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.  Additionally, the study will not cover treatment of side effects related to the radiation (i.e, skin burn) although these tend to be relatively minor.

Sample or Data Requirements

Your dog will undergo blood tests (complete blood count, chemistry panel) and diagnostics (chest x-ray) prior to enrollment into the study. Once enrolled, your dog will receive a single dose of KPT-9274 12-18 hours prior to the planned administration of radiation once per week for a total of 4 treatments of combined radiation and 9274. The radiation requires general anesthesia and your dog will be closely monitored by the staff and doctors associated with the Radiation Oncology service. Bloodwork will be performed periodically throughout the treatment schedule to make sure that there are no negative side effects on the bone marrow, liver, and kidneys.

Contact Info

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

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