Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-25 @ 4:04 AM
NCT ID:
NCT02108002
Eligibility Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02108002
Study Brief:
Protocol Section:
NCT02108002