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NCT00302159 · ClinicalTrials.gov registry record · Phase 2
Valproic Acid With Temozolomide and Radiation Therapy to Treat Brain Tumors
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 43
- Enrollment target
NCT00302159: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00302159 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 43 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00302159, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 43 participants
- Enrollment target
Study Summary
Background: * Radiation therapy with temozolomide (an anti-cancer drug) is standard therapy for treating brain tumors called glioblastomas. * The drug valproic acid, currently approved for treating seizures, has been shown in laboratory tests to increase the radiosensitivity of glioma cells. Objectives: -To determine the effectiveness of adding valproic acid to standard treatment with radiation therapy and temozolomide for treating glioblastoma. Eligibility: -Patients 18 years of age and older with glioblastoma multiforme who have not been previously treated with chemotherapy of radiation. Design: * This Phase II trial will enroll 41 patients. * Patients will receive radiation therapy to the brain once a day, Monday through Friday, for 6 1/2 weeks. * Patients will take temozolomide once a day by mouth, Monday through Friday, during the period of radiation treatment. Starting 4 weeks after radiation therapy, patients will take temozolomide once a day for 5 days every 28 days for a total of six cycles. * Patients will receive valproic acid by mouth twice a day beginning 1 week prior to the first day of radiation therapy and continuing until the completion of chemotherapy and radiation therapy. * Patients will have follow-up visits 1 month after completing therapy, then every 3 months for 2 years, and then every 6 months for 3 years. Follow-up includes a physical examination, blood tests and magnetic resonance imaging of the brain.
Interventions
- DRUG Temozolomide
- RADIATION Radiation therapy
- DRUG Valproic Acid
- PROCEDURE adjuvant therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2006-03 |
| Est. Completion | 2014-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00302159
The ClinicalTrials.gov registry entry for NCT00302159 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 43 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 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Temozolomide is the first listed.
NCT00302159 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00302159 about?
NCT00302159 is a clinical study titled "Valproic Acid With Temozolomide and Radiation Therapy to Treat Brain Tumors". Background: * Radiation therapy with temozolomide (an anti-cancer drug) is standard therapy for treating brain tumors called glioblastomas. * The drug valproic acid, currently approved for treating seizures, has been shown in laboratory tests to increase the radiosensitivity of glioma cells. Objec...
What is the current status of trial NCT00302159?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 43 participants. The study started on 2006-03. Estimated completion is 2014-11.
What interventions are being tested in trial NCT00302159?
The interventions under investigation include: Temozolomide (DRUG), Radiation therapy (RADIATION), Valproic Acid (DRUG), adjuvant therapy (PROCEDURE).
Who is sponsoring clinical trial NCT00302159?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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