CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
Bevacizumab +2 moredrug
Likely dose
Bevacizumab 10 mg/kgfrom 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/NCT01209442
NCT01209442Phase 2Completed

A Pilot Phase II Trial of Hypofractionated Intensity-Modulated Radiation Therapy (Hypo-IMRT) Combining With Temozolomide (TMZ) and Bevacizumab for Patients With Newly Diagnosed Glioblastoma Multiforme (GBM)

University of Colorado, Denver·interventional·Posted Sep 27, 2010·Updated Apr 12, 2019

In Brief

A Phase 2 clinical trial evaluating Bevacizumab, Temozolomide, and 1 other intervention for Glioblastoma Multiforme. Completed, enrolled 30 participants across 1 site.

Detailed Summary

The purpose of this study is to find out whether Hypofractionated Intensity-Modulated Radiation Therapy (Hypo-IMRT) combining with temozolomide chemotherapy can be safely given with a targeted agent, bevacizumab, and how effective this study treatment will be in controlling your brain tumor.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsGenentech, Inc.

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 27, 2010
Enrollment StartSep 16, 2010
Primary CompletionSep 7, 2014
Study CompletionFeb 3, 2017
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 15.8 years ago

Interventions

Bevacizumabdrug

Bevacizumab will be administered at 10 mg/kg on day 1 and day 15. Four to six weeks following completion of concurrent IMRT, TMZ and bevacizumab, patients will receive 6 cycles of Bevacizumab.

Temozolomidedrug

Patients will be treated with hypofractionated IMRT (60 Gy in 10 Fx) and daily temozolomide at 75 mg/m2 qd concurrent with IMRT. Four to six weeks following completion of concurrent IMRT, TMZ and bevacizumab, temozolomide will be given at 150-200 mg/m2 qd on days 1-5 of each cycle.

RT (Radiation Therapy)radiation

Patients will be treated with hypofractionated IMRT (60 Gy in 10 Fx)