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NCT00268385 · ClinicalTrials.gov registry record · Phase 1
Vorinostat and Temozolomide in Treating Patients With Malignant Gliomas
A Phase 1 study of Adult Glioblastoma and Adult Giant Cell Glioblastoma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 1
- Development phase
- 83
- Enrollment target
- 17
- Study locations
NCT00268385: Active Phase 1 study of Adult Glioblastoma and Adult Giant Cell Glioblastoma, sponsored by National Cancer Institute (NCI).
NCT00268385 is a Phase 1 study of Adult Glioblastoma and Adult Giant Cell Glioblastoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 83 participants, above the 38-participant average among 14 other Adult Glioblastoma trials with a reported enrollment target (118% higher). The trial reports 17 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00268385, a Phase 1 study of Adult Glioblastoma and Adult Giant Cell Glioblastoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 83 participants
- Enrollment target
- 17
- Study locations
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.
Primary Outcome
For both parts of the study, treatment administration will be described for all cycles. Doses administered, dose modifications/delays, and duration of therapy will be evaluated. Safety variables summarized by descriptive statistics. Adverse events that occur will be reported for each dose level and described in terms of incidence and severity. Laboratory data will be presented by dose level at each observation time. Values outside of normal limits will be identified and their frequency calculate
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 83 participants |
| Start Date | 2005-12-16 |
| Est. Completion | 2026-04-24 |
| Phase | Phase 1 |
What the registry record for NCT00268385 still lists
NCT00268385 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 83 participants, a relatively small participant target, above the 38-participant average among 14 other Adult Glioblastoma trials with a reported enrollment target (118% higher).
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.
NCT00268385 lists 17 locations in 13 states (California, Maryland, North Carolina).
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.
What interventions are being tested in trial NCT00268385?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Temozolomide (DRUG), Vorinostat (DRUG), Pharmacological Study (OTHER).
Who is sponsoring clinical trial NCT00268385?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Adult Glioblastoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00268385's enrollment target sits among peer trials
83 2nd of 14 the highest of 14 other Adult Glioblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Adult Glioblastoma 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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