CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 125 enrolled
Drug / intervention
Temozolomide +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00731731
NCT00731731Phase 2Completed

Phase I/II Study of Vorinostat (Suberoylanilide Hydroxamic Acid [SAHA]), Temozolomide, and Radiation Therapy in Patients With Newly Diagnosed Glioblastoma

National Cancer Institute (NCI)·interventional·Posted Aug 11, 2008·Updated Aug 4, 2022

In Brief

A Phase 2 clinical trial evaluating 3-Dimensional Conformal Radiation Therapy, Cognitive Assessment, and 3 other interventions for Adult Giant Cell Glioblastoma and 2 related conditions. Completed, enrolled 125 participants across 110 sites.

Detailed Summary

This phase I/II trial studies the side effects and best dose of vorinostat when given together with temozolomide and radiation therapy and to see how well they work in treating patients with newly diagnosed glioblastoma multiforme. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving vorinostat together with temozolomide and radiation therapy may kill more tumor cells.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 11, 2008
Enrollment StartJul 10, 2009
Primary CompletionFeb 2, 2014
Study CompletionNov 1, 2019
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 17.9 years ago

Interventions

3-Dimensional Conformal Radiation Therapyradiation

Undergo radiotherapy

Cognitive Assessmentprocedure

Ancillary studies

Laboratory Biomarker Analysisother

Correlative studies

Temozolomidedrug

Given PO

Vorinostatdrug

Given PO