Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

ACTIVE NOT RECRUITING Phase 1

Vorinostat and Temozolomide in Treating Patients With Malignant Gliomas

NCT00268385 · View on ClinicalTrials.gov ↗

Study Summary

This phase I trial is studying the side effects and best dose of vorinostat when given together with temozolomide in treating patients with malignant gliomas. Drugs used in chemotherapy, such as vorinostat and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Vorinostat may help temozolomide work better by making tumor cells more sensitive to the drug. Giving vorinostat together with temozolomide may kill more tumor cells.

Interventions

  • OTHER Laboratory Biomarker Analysis
  • DRUG Temozolomide
  • DRUG Vorinostat
  • OTHER Pharmacological Study

Study Locations (17)

California

  • UCLA / Jonsson Comprehensive Cancer Center — Los Angeles
  • UCSF Medical Center-Mount Zion — San Francisco

Maryland

  • Johns Hopkins University/Sidney Kimmel Cancer Center — Baltimore
  • National Cancer Institute Neuro-Oncology Branch — Bethesda

North Carolina

  • Duke University Medical Center — Durham
  • Wake Forest University Health Sciences — Winston-Salem

Pennsylvania

  • University of Pennsylvania/Abramson Cancer Center — Philadelphia
  • University of Pittsburgh Cancer Institute (UPCI) — Pittsburgh

Alabama

  • University of Alabama at Birmingham Cancer Center — Birmingham

Florida

  • Moffitt Cancer Center — Tampa

Georgia

  • Emory University Hospital/Winship Cancer Institute — Atlanta

Massachusetts

  • Dana-Farber Cancer Institute — Boston

Trial Details

FieldValue
Enrollment Target 83 participants
Start Date 2005-12-16
Est. Completion 2026-04-24
Phase Phase 1

Sponsor

National Cancer Institute (NCI)

2,390 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00268385

The ClinicalTrials.gov registry entry for NCT00268385 describes a study currently listed as active not recruiting. 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 83 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 7 conditions, with Adult Glioblastoma appearing as the primary indexed condition, and to 4 interventions — of which Laboratory Biomarker Analysis 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: NCT00268385 reports 17 study locations spanning 13 distinct geographic areas — top geographies include California, Maryland, North Carolina. 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 NCT00268385 about?

NCT00268385 is a clinical study titled "Vorinostat and Temozolomide in Treating Patients With Malignant Gliomas". This phase I trial is studying the side effects and best dose of vorinostat when given together with temozolomide in treating patients with malignant gliomas. Drugs used in chemotherapy, such as vorinostat and temozolomide, work in different ways to stop the growth of tumor cells, either by killing ...

What is the current status of trial NCT00268385?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 83 participants. The study started on 2005-12-16. Estimated completion is 2026-04-24.

What conditions does trial NCT00268385 study?

This clinical trial studies the following conditions: Adult Glioblastoma, Adult Giant Cell Glioblastoma, Adult Gliosarcoma, Adult Anaplastic Astrocytoma, Adult Anaplastic Oligodendroglioma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00268385?

The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Temozolomide (DRUG), Vorinostat (DRUG), Pharmacological Study (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00268385?

This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00268385 being conducted?

This trial has 17 study locations across Alabama, California, Florida, Georgia, Maryland. 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