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COMPLETED Phase 1

Study of the Combination of Vorinostat and Radiation Therapy for the Treatment of Patients With Brain Metastases

NCT00838929 · View on ClinicalTrials.gov ↗

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

FieldValue
Enrollment Target 17 participants
Start Date 2009-03
Est. Completion 2015-03
Phase Phase 1

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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University, which has 26 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00838929 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Pennsylvania, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00838929?

The interventions under investigation include: Radiation Therapy (RADIATION), Vorinostat (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00838929?

This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University, which has 26 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial