CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 58 enrolled
Drug / intervention
Temozolomidedrug
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/NCT00657267
NCT00657267Phase 2Completed
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Phase 2 Study of Dose-Intense Temozolomide in Recurrent Glioblastoma

Patrick Y. Wen, MD·interventional·Posted Apr 14, 2008·Updated Mar 14, 2014

In Brief

A Phase 2 clinical trial evaluating Temozolomide for Glioblastoma and Gliosarcoma. Completed, enrolled 58 participants across 6 sites.

Detailed Summary

Temozolomide (Temodar) is an FDA approved medication for the treatment of newly diagnosed glioblastomas. In this study, we will be using temozolomide to treat recurrent glioblastomas. We will be using a different dose and schedule than the FDA approved dose and schedule. The purpose of this study is to determine if patients that have failed standard temozolomide treatment will respond to temozolomide when given at a different dose and schedule (21 days every 28 days).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGlioblastoma, Gliosarcoma
CountriesUnited States
CollaboratorsBrigham and Women's Hospital, Massachusetts General Hospital, University of Pennsylvania, Wake Forest University Health Sciences, Tufts Medical Center, Dartmouth-Hitchcock Medical Center, Schering-Plough

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 14, 2008
Enrollment StartMay 1, 2008
Primary CompletionNov 1, 2011
Study CompletionOct 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 18.2 years ago

Interventions

Temozolomidedrug

Taken orally daily for the first three weeks of a four-week cycle.