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This study evaluates the effect of the drug Vorinostat on nervous system hemangioblastomas (blood vessel tumors) in people with Von Hippel-Lindau disease (an inherited tumor predisposition) caused by a missense mutation in the VHL gene. It included adults with clinically progressing hemangioblastoma. It was a Phase 1 study and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
* INCLUSION CRITERIA 1. Adult patients (age greater than or equal to 18 years) 2. Known VHL disease arising from a missense mutation. 3. Demonstrated clinical progression of CNS hemangioblastoma. 4. Enrolled in 03-N-0164, Evaluation of Neurosurgical Disorders. 5. Able to provide written informed consent. EXCLUSION CRITERIA 1. Patients who have been previously treated with vorinostat. 2. Significant medical illnesses that in the investigator s opinion cannot be adequately controlled with appropriate therapy or would compromise the patient s ability to tolerate this therapy. 3. History of a second cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and off of all therapy for that disease for a minimum of 3 years. 4. Active infection or serious concurrent medical illness. 5. Pregnancy and breast-feeding. 6. Presence of any disease that will obscure toxicity or dangerously alter drug metabolism (such as uncontrolled diabetes, liver disease, bleeding disorder) 7. Currently receiving other investigational agents. 8. History of allergic reactions attributed to compounds of similar chemical or biologic composition to vorinostat, such as valproate. 9. Currently taking another HDACi, such as valproate.