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NCT00838929 · ClinicalTrials.gov registry record · Phase 1
Study of the Combination of Vorinostat and Radiation Therapy for the Treatment of Patients With Brain Metastases
A Phase 1 study of Brain Metastases, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
- Completed
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
- 2
- Study locations
NCT00838929 is a Phase 1 study of Brain Metastases that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University. The registered enrollment target is 17 participants, below the 213-participant average among 67 other Brain Metastases trials with a reported enrollment target (92% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT00838929, a Phase 1 study of Brain Metastases, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
- 2
- Study locations
Study Summary
Vorinostat in combination with radiation therapy can be administered safely and will be tolerated in patients with brain metastases, while providing an assessment of the anti-tumor activity of this combination. This is a multi-center, open-label, non-randomized Phase I study in patients with brain metastases. Patients will be administered oral Vorinostat and radiation therapy and will be treated for 3 weeks. Patients will be enrolled in cohorts and will be treated at sequentially rising dose levels of Vorinostat combined with radiation therapy. We will initially enter 3 subjects at each dose. If none of the three experiences a dose-limiting toxicity we will proceed to the next dose. If one of the three experiences that level of toxicity, we will accrue 3 more subjects at that dose. If at any time there are two or more dose-limiting toxicities (in the 3-6 subjects) on a given dose, we will drop down to a lower dose. Dose escalation will continue until the MTD of Vorinostat and radiation therapy is established. The MTD will then be one dose below the DLT occurring in at least 1 out of 3 subjects (2 out of 6 patients).
Conditions Studied
Interventions
- RADIATION Radiation Therapy
- DRUG Vorinostat
Study Locations (2)
Pennsylvania
- Thomas Jefferson University - Philadelphia
Texas
- The University of Texas Southwestern Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2009-03 |
| Est. Completion | 2015-03 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00838929
The ClinicalTrials.gov registry entry for NCT00838929 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 213-participant average among 67 other Brain Metastases trials with a reported enrollment target (92% lower). The listed sponsor is Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University, which has 138 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Brain Metastases appearing as the primary indexed condition, and to 2 interventions - of which Radiation Therapy is the first listed.
NCT00838929 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Pennsylvania, Texas.
Frequently Asked Questions
What is clinical trial NCT00838929 about?
NCT00838929 is a clinical study titled "Study of the Combination of Vorinostat and Radiation Therapy for the Treatment of Patients With Brain Metastases". Vorinostat in combination with radiation therapy can be administered safely and will be tolerated in patients with brain metastases, while providing an assessment of the anti-tumor activity of this combination. This is a multi-center, open-label, non-randomized Phase I study in patients with brain ...
What is the current status of trial NCT00838929?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2009-03. Estimated completion is 2015-03.
What conditions does trial NCT00838929 study?
This clinical trial studies the following conditions: Brain Metastases.
What interventions are being tested in trial NCT00838929?
The interventions under investigation include: Radiation Therapy (RADIATION), Vorinostat (DRUG).
Who is sponsoring clinical trial NCT00838929?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University, which has 138 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00838929 being conducted?
This trial has 2 study locations across Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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