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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: Completed Phase 1 study of Brain Metastases, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
To determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of Vorinostat and radiotherapy in patients with brain metastases. The maximum tolerated dose (MTD) will be one dose below the DLT occurring in at least 1 out of 3 subjects. Dose level -2: 50 mg PO qd (to be used in de-escalation if toxicity occurs) Dose level -1: 100 mg PO qd (to be used in de-escalation if toxicity occurs) Dose level I: 200 mg PO qd (initial starting dose) Dose level II: 300 mg PO qd Dose level
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 |
What the finished NCT00838929 record still lists
NCT00838929 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 213-participant average among 67 other Brain Metastases trials with a reported enrollment target (92% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT00838929's enrollment target sits among peer trials
17 60th of 67 higher than 8 of 67 other Brain Metastases trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Brain Metastases trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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