Phase I Evaluation of STA-12-1474 in Canines with Spontaneous Cancer
Study Title
Phase I Evaluation of STA-12-1474 in Canines with Spontaneous Cancer
Purpose
To assess whether the compound STA-12-1474 has activity against specific canine cancers, including mast cell tumors, osteosarcomas, histiocytic sarcomas, and other carcinomas and sarcomas. Some of the parameters to be assessed are:
- the clinical effects of repeated dosing
- the effect of the drug on tumors
- the pharmacokinetics/pharmacodynamics of the drug in dogs with cancer
Background
This clinical trial is sponsored by Synta Pharmaceuticals Corporation and evaluates the safety and effectiveness of a novel heat shock protein 90 (HSP90) inhibitor, STA-12-1474, when given to dogs with cancer. Heat shock protein 90 (HSP90) is a chaperone protein important in the maintenance and expression of several cell proteins critical for the survival and growth of many types of cancer cells. Studies have shown that HSP90 activity is increased in cancer cells and as such, inhibition of HSP90 activity would likely have damaging effects to cancer cells. This has been supported by several laboratory studies in which inhibition of HSP90 in different tumor cell lines results in cell death. STA-12-1474 is a novel HSP90 inhibitor that exhibits superior anti-tumor effectiveness in mouse models of cancer relative to previously used HSP90 inhibitors. This study is the first use of STA-12-1474 in dogs with cancer.
Inclusion Criteria
We are seeking to enroll up to 25 dogs who meet the following criteria:
- Dogs must be at least one year of age
- Dogs must have been diagnosed with a histopathological confirmed cancer other than leukemia. A dog can have failed conventional therapy, have run out of treatment options, or the owner may elect to enter the dog in lieu of standard therapy
- Dogs must have adequate organ function as indicated by standard lab tests
- Dogs must have completed chemotherapy or radiation therapy at least 2 weeks prior to enrollment and have recovered from any side effects resulting from those treatments
- Dogs must have a life expectancy of at least 4 weeks
- Owners must be willing to give written informed consent
We cannot enroll dogs who:
- have a diagnosis of leukemia
- are less than 3 weeks post-recovery from a major surgical procedure
- have a serious systemic disorder that the investigator feels is incompatible with the study treatment
- are currently using any other investigational drug or have done so within 1 week of screening for study entry
Course of Treatment
The treatment protocol involves administration of STA-12-1474 by intravenous injection over one hour once per week for 4 weeks. The first and last administration of STA-12-1474 require an overnight stay in the hospital to permit blood collection so STA-12-147 blood levels can be measured. Routine laboratory tests (bloodwork) and imaging studies (x-rays, ultrasound) will be performed at each visit to assess tumor size and potential response to therapy. Should a response to therapy occur, additional treatments with STA-12-147 will be offered.
Client Compensation
If the dog meets the study criteria, there are no costs to the client. Al laboratory tests, diagnostic tests are covered, and if a side effect should occur, the costs for treatment are covered. If the dog fails to meet the requirements for enrollment, the client shall be liable for the costs of examination, lab work, and any imaging that may have been performed as part of the screening examination.
Additional Information
For more information on this study, contact:
Dr. Cheryl London
clinicaltrials [at] cvm [dot] osu [dot] edu
