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RT, Temozolomide, and Bevacizumab Followed by Bevacizumab/Everolimus in First-line Treatment of GBM

NCT00805961 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2021-12-08

Study results available
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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.

Conditions

Interventions

RADIATION

Radiation therapy

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

DRUG

Temozolomide

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

DRUG

Bevacizumab

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

DRUG

Bevacizumab

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

DRUG

Everolimus

Everolimus 10mg by mouth daily, beginning Week 11

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • Novartis

    collaborator INDUSTRY

  • SCRI Development Innovations, LLC

    lead OTHER

Principal Investigators

  • John D Hainsworth, M.D. · SCRI Development Innovations, LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2009-10-31
Completion
2013-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00805961 on ClinicalTrials.gov