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A Study of Bevacizumab and Extended Treatment of Temozolomide in Patients With Recurrent Glioblastoma Multiforme | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Study of Bevacizumab and Extended Treatment of Temozolomide in Patients With Recurrent Glioblastoma Multiforme

A Single Arm Phase II Study of Bevacizumab and Extended Treatment of Temozolomide in Patients With Recurrent Glioblastoma Multiforme

NCT01115491•Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

This is a Phase II, national, multicenter, open-label, non-comparative study to investigate the efficacy and safety of bevacizumab and temozolomide in patients with recurrent glioblastoma multiforme (GBM) after a first treatment failure. Patients will receive bevacizumab 10 mg/kg intravenously every two weeks until disease progression, consent withdrawal, or unacceptable toxicity. Anticipated time on study treatment is 12-24 months.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age \>= 18 years
•Histological diagnosis of glioblastoma multiforme (GBM) documented by surgical resection or biopsy.
•They should be patients in a first relapse treated with radiotherapy and chemotherapy and chemotherapy based on temozolomide 150-200 mg/m2 on days 1 to 5 every 28 days (Stupp regimen) for at least three cycles. At least 4 weeks must have lapsed since previous chemotherapy and 3 months since the last dose of radiotherapy.
•Use of an effective contraceptive method by patients and their partners.
•Stable or decreasing corticosteroid dose for the five days prior to study entry
•Adequate hematological function
•Adequate liver function
•Adequate kidney function

Exclusion Criteria

•Signs of recent bleeding at the MRI of the brain. However, patients with clinically asymptomatic presence of hemosiderin, resolving bleeding changes related to surgery, and presence of punctate hemorrhage in the tumor will be allowed to participate in the study.
•Prior treatment with bevacizumab
•Poorly controlled arterial hypertension
•History of hypertensive crises or hypertensive encephalopathy
•New York Health Association (NYHA) Class II or higher congestive heart failure
•History of myocardial infarction or unstable angina pectoris within six months of study entry
•History of stroke or TIA within six months of study entry
•Significant vascular disease within six months of study entry
•History of hemoptysis \> grade 2 according to the NCI CTC criteria within one month of study entry
•Evidence of bleeding diathesis or coagulopathy (in the absence of therapeutic anticoagulation)
+7 more criteria

Locations (8)

Barcelona, Barcelona, Spain

Madrid, Madrid, Spain

Valencia, Valencia, Spain

Key Dates

Start Date

June 1, 2010

Primary Completion Date

July 1, 2012

Completion Date

July 1, 2012

Last Updated

December 8, 2014

Enrollment

ACTUAL participants

Conditions

Glioblastoma Multiforme

Interventions

bevacizumab [Avastin]

DRUG

temozolomide

DRUG

Targeted Pediatric High-Grade Glioma Therapy

NCT05839379

High Grade GliomaDiffuse Intrinsic Pontine Glioma+7 more

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RECRUITING

Collection of Blood and Urine Samples in Patients Receiving Radiation Therapy for Glioblastoma Multiforme

NCT00083512

Glioblastoma Multiforme

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 8, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of Bevacizumab and Extended Treatment of Temozolomide in Patients With Recurrent Glioblastoma Multiforme

Inclusion Criteria

Exclusion Criteria

Targeted Pediatric High-Grade Glioma Therapy

Collection of Blood and Urine Samples in Patients Receiving Radiation Therapy for Glioblastoma Multiforme

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