CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 120 enrolled
Drug / intervention
Temozolomidedrug
Likely dose
Temozolomide 50 mgfrom 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/NCT00392171
NCT00392171Phase 2Completed
CompareCT.gov

The Temozolomide RESCUE Study: A Phase II Trial of Continuous (28/28) Dose-intense Temozolomide (CDIT) Chemotherapy After Progression on Conventional 5/28 Day Temozolomide in Patients With Recurrent Malignant Glioma

Merck Sharp & Dohme LLC·interventional·Posted Oct 25, 2006·Updated Jun 7, 2017

In Brief

A Phase 2 clinical trial evaluating Temozolomide for Glioma and 3 related conditions. Completed, enrolled 120 participants.

Detailed Summary

The purpose of this non-randomized, open-label, multicenter, Phase II, 2-stage design, RESCUE study is to test the hypothesis that continuous 28-day oral dosing (28/28) with dose-intense temozolomide (50 mg/m\^2) for up to 12 months may overcome resistance and be effective in the management of adult patients with malignant glioma who have failed following at least 2 cycles (2 months) of conventional 5-day (5/28) cycles of high-dose temozolomide (150-200 mg/m\^2).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGlioma, Astrocytoma, Oligodendroglioma, Glioblastoma
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 25, 2006
Enrollment StartJun 9, 2006
Primary CompletionSep 15, 2009
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 19.7 years ago

Interventions

Temozolomidedrug

Subjects will receive temozolomide 50 mg/m\^2 for cycles of 28 days for 12 months or until progression