Evaluation of STA-2700 HCl
Purpose
To purpose of this study is to evaluate the safety and effectiveness of a novel vascular disrupting agent (VDA), STA-2700 HCl, in dogs with soft tissue sarcomas.
Background
This clinical trial evaluates the safety and effectiveness of a novel vascular disrupting agent (VDA), STA-2700 HCl, when given to dogs with soft tissue sarcomas. VDAs are a class of drugs that block blood flow in tumors relative to normal tissues, inducing hypoxia (loss of oxygen) of tumor cells eventually resulting in tumor cell death. VDAs preferentially target the lining of tumor blood vessels resulting in decreased blood flow, loss of both oxygen and nutrient flow to the tumor, and the induction of cell death within hours of drug administration. This type of therapy is distinct from other anti-blood vessel therapies that inhibit new blood vessel growth but do not disrupt existing mature blood vessels present within the tumor and therefore do not typically induce shrinkage of tumors, but instead, stabilization of disease. STA-2700 HCl is a novel VDA with increased potency and improved activity in preclinical models relative to the first generation VDAs. Evidence suggests that STA-2700 HCl blocks blood flow by specifically disrupting tumor blood vessels not only in the center but also at the periphery of tumors. Finally, STA-2700 HCl has significant activity in preclinical models. This study will be the first evaluation of STA-2700 HCl in dogs with cancer.
Inclusion Criteria
- Have a diagnosed soft tissue sarcoma
- Patient may have failed standard therapy or there may be no other treatment options
- Owner may elect to enroll in lieu of standard therapy
- Must have adequate organ function.
- Life expectancy of 6 weeks
- Prior chemotherapy or radiation must be completed at least 2 weeks prior to study
- The tumor must be amenable to repeat biopsy
Exclusion Criteria
- Evidence of brain metastasis
- Less than 3 weeks from a major surgical procedure
- Any serious systemic disorder
Study Design/Treatment
To determine eligibility, dogs will need bloodwork, thoracic radiographs, and an echocardiogram. These tests will be performed throughout the study for patient assessment. Patients will receive an infusion of the study drug with a dose escalation once per week for 4 consecutive weeks. The patient will come in for a recheck following the last treatment and if possible the tumor will be surgically removed and a credit of $800 will be given toward the surgery.
Client Compensation
All costs related to the study per the four treatments are covered by the study. Additionally, treatment for any side effects from the treatment will be covered by the study. Following the last treatment a recheck appointment will be scheduled, if possible the tumor will be surgically removed and a credit of $800 will be given toward the surgery.
Contact Information
Dr. Cheryl London
clinicaltrials [at] cvm [dot] osu [dot] edu
