CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 68 enrolled
Drug / intervention
Temozolomide +4 moredrug
Likely dose
Temozolomide 75mg/m2from 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/NCT00805961
NCT00805961Phase 2Completed

A Phase II Study of Concurrent Radiation Therapy, Temozolomide, and Bevacizumab Followed by Bevacizumab/Everolimus in the First-line of Treatment of Patients With Glioblastoma Multiforme

SCRI Development Innovations, LLC·interventional·Posted Dec 10, 2008·Updated Dec 8, 2021

In Brief

A Phase 2 clinical trial evaluating Radiation therapy, Temozolomide, and 2 other interventions for Glioblastoma Multiforme. Completed, enrolled 68 participants across 13 sites.

Detailed Summary

In this phase II trial the investigators plan to incorporate two targeted agents, bevacizumab and everolimus, into the first-line multimodality therapy of glioblastoma. In the first portion of the treatment, bevacizumab will be added to standard concurrent radiation therapy plus temozolomide. After completing radiation therapy, patients will continue treatment with the combination of bevacizumab and everolimus.

Study Details

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

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 10, 2008
Enrollment StartJan 1, 2009
Primary CompletionOct 1, 2009
Study CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 17.6 years ago

Interventions

Radiation therapyradiation

Radiation therapy, 2.0 Gy daily, 5 days per week by single daily dose, to a total of 60 Gy over 6 weeks

Temozolomidedrug

Temozolomide 75mg/m2 by mouth daily, beginning day 1 of radiation therapy and continuing through the last day of radiation therapy

Bevacizumabdrug

Bevacizumab 10mg/kg IV, every 2 weeks, beginning day 1 of radiation therapy

Bevacizumabdrug

Bevacizumab 10mg/kg IV, every 2 weeks, beginning Week 11

Everolimusdrug

Everolimus 10mg by mouth daily, beginning Week 11