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Looking at a new drug to enhance radiation therapy in soft tissue sarcomas

Pilot study of SQAP plus radiation therapy in dogs with soft tissue sarcoma

Status: Recruiting

Species: Dog

Veterinary Speciality: Oncology

Description

The purpose of the current pilot study is to evaluate whether the combination of SQAP and radiation can improve the response to therapy in dogs with soft tissue sarcomas (a malignant tumor that arises from the soft tissues such as muscle, etc.). These tumors are often resistant to both radiation therapy and chemotherapy and the hope is that combining radiation and SQAP will improve disease control beyond the typical 6 months that is achieved by radiation when given alone.

Inclusion Criteria

  • Dogs diagnosed with cytologically or histologically confirmed spontaneous soft tissue sarcoma are eligible for enrollment. The dog may have prior surgical resection and/or chemotherapy treatment, or there may be no other known effective therapeutic options, or the owner may elect to enter the dog in lieu of standard therapy.
  • The tumor must be at least 2 cm in size or larger
  • Dogs must be at least 1 year of age and a minimum of 8 kg in body weight.
  • Adequate organ function as indicated by standard laboratory tests (complete blood count, serum biochemistry profile, urinalysis).
    • ANC≥1000/μL and platelet count ≥ 100,000/μL
    • Liver: Total bilirubin ≤ 1.5X the institutional upper limit of normal (ULN), ALT ≤ 3X ULN
    • ECOG performance score of 0-1
  • 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 2 months.
  • Prior surgery or chemotherapy must have been completed at least 2 weeks prior to Study entry and the patient must have recovered from the acute toxicities of these treatments.
  • Informed written consent must be obtained

Exclusion Criteria

  • Pregnant or lactating dogs
  • Evidence of metastatic disease to any organ including lungs
  • Prior treatment with radiation therapy
  • Concurrent use of complementary or alternative medicines that in the opinion of the Principal Investigator would confound the interpretation of toxicities and/or antitumor activity within the context of this study.
  • Dogs with significant liver or cardiovascular disease.
  • Any serious systemic disorder incompatible with the Study (at the discretion of the PI).
  • Use of any other investigational drug within 2 weeks of Study entry.

Client Benefits

The study will cover all aspects of the study including baseline bloodwork, CT planning for radiation, delivery of radiation, administration of SQAP and follow up visits/bloodwork. The study will cover any complications associated with the SQAP should they occur. The study will NOT cover the costs of medical or surgical conditions unrelated to the SQAP administration such as ear infection, bladder infection, etc.

The potential benefit to your dog is that the combination of SQAP and local radiation treatment will be more effective than radiation treatment alone by helping to shrink the tumor and/or keeping it from growing for a long period of time.

Sample or Data Requirements

Your dog will undergo a baseline physical exam and bloodwork along with a CT scan of the mass (plus chest/lungs if needed to check for evidence of tumor spread). Your dog will then return for radiation therapy to the tumor which is given once per week over 4 weeks (total of 4 treatments). Approximately 60 minutes before the radiation is given, the SQAP will be administered through an IV catheter slowly over 20 minutes. We will be monitoring your dog closely with bloodwork and physical exam during the treatment part of the study over the first 4 weeks. Your dog will return 2 weeks after finishing the radiation, then 2 weeks after that, and then every 4 weeks up until 6 months post enrollment.

Contact Info

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

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