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NCT02108002 · ClinicalTrials.gov registry record · Phase 1
Effect of Vorinostat on Nervous System Hemangioblastomas in Von Hippel-Lindau Disease (Missense Mutation Only)
A Phase 1 study of Von Hippel-Lindau Disease, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- Phase 1
- Development phase
- 7
- Enrollment target
- 1
- Study location
NCT02108002 is a Phase 1 study of Von Hippel-Lindau Disease that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 7 participants, below the 2,242-participant average among 5 other Von Hippel-Lindau Disease trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02108002, a Phase 1 study of Von Hippel-Lindau Disease, has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 7 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: \- Von Hippel-Lindau (VHL) disease is a rare gene disease. People with VHL often have a brain tumor called hemangioblastoma. Standard treatment for these tumors is risky surgery. Researchers want to find new ways to treat people who have the tumors. They want to see if a drug that fights other cancers might slow the growth of hemangioblastomas in some people with VHL. Some people with VHL have mutations that make abnormal proteins. Tumors form in such people because the abnormal protein is broken down quickly. The cancer drug may work in these tumors by preventing breakdown of protein. Objective: \- To study how the drug vorinostat affects hemangioblastomas in people with VHL. Eligibility: \- Adults at least 18 old with hemangioblastomas from VHL. Design: * Participants must already be in study 03-N-0164. They must have tumor surgery scheduled. * Participants must stop taking most medications 14 days before surgery. * One week before surgery, participants will enter the hospital. They will be screened with medical history and physical and neurological exams. They will give blood and urine samples. Participants will have an electrocardiogram. For this test, small sticky patches are put on the arms, legs, and chest. Participants will lie still for a few minutes while a machine records heart rate and rhythm. * Participants will take one vorinostat by mouth each day for 7 days. * Participants will have blood drawn during the week to check for any side effects. * Participants will have their tumor removed in surgery. Researchers will study the tumor tissue for the effects of the study drug. * A nurse will call participants 1 month after surgery to check for side effects.
Conditions Studied
Interventions
- DRUG Vorinostat
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2014-04-05 |
| Est. Completion | 2018-09-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02108002
The ClinicalTrials.gov registry entry for NCT02108002 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,242-participant average among 5 other Von Hippel-Lindau Disease trials with a reported enrollment target (100% lower). The listed sponsor is National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Von Hippel-Lindau Disease appearing as the primary indexed condition, and to 1 intervention - of which Vorinostat is the first listed.
NCT02108002 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT02108002 about?
NCT02108002 is a clinical study titled "Effect of Vorinostat on Nervous System Hemangioblastomas in Von Hippel-Lindau Disease (Missense Mutation Only)". Background: \- Von Hippel-Lindau (VHL) disease is a rare gene disease. People with VHL often have a brain tumor called hemangioblastoma. Standard treatment for these tumors is risky surgery. Researchers want to find new ways to treat people who have the tumors. They want to see if a drug that fight...
What is the current status of trial NCT02108002?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2014-04-05. Estimated completion is 2018-09-12.
What conditions does trial NCT02108002 study?
This clinical trial studies the following conditions: Von Hippel-Lindau Disease.
What interventions are being tested in trial NCT02108002?
The interventions under investigation include: Vorinostat (DRUG).
Who is sponsoring clinical trial NCT02108002?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02108002 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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