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A Study to Evaluate Bevacizumab Alone or in Combination With Irinotecan for Treatment of Glioblastoma Multiforme (BRAIN) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Study to Evaluate Bevacizumab Alone or in Combination With Irinotecan for Treatment of Glioblastoma Multiforme (BRAIN)

A Phase II, Multicenter, Randomized, Non-Comparative Clinical Trial to Evaluate the Efficacy and Safety of Bevacizumab Alone or in Combination With Irinotecan for Treatment of Glioblastoma Multiforme in First or Second Relapse

NCT00345163•Genentech, Inc.

View on ClinicalTrials.gov

Summary

This is a Phase II, open-label, multicenter, randomized, non comparative study consisting of two concurrent single-arms. Approximately 160 subjects will be randomized in a 1:1 ratio to Arm 1 (bevacizumab alone) or Arm 2 (bevacizumab + irinotecan).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Signed Informed Consent Form
•Age ≥ 18 years
•Histologically confirmed GBM in first or second relapse
•Radiographic demonstration of disease progression following prior therapy
•Bi-dimensionally measurable disease with a minimum measurement of 1 cm (10 mm) in one diameter on MRI performed within 14 days prior to first treatment (Day 0)
•An interval of ≥ 4 weeks since prior surgical resection
•Prior standard radiation for GBM
•Prior chemotherapy: first-relapse subjects
•Prior chemotherapy: second-relapse subjects
•Recovery from the effects of prior therapy, including the following: 4 weeks from cytotoxic agents (except 6 weeks from nitrosoureas, 3 weeks from procarbazine, 2 weeks from vincristine); 4 weeks from any investigational agent; 1 week from non-cytotoxic agents; 8 weeks from radiotherapy to minimize the potential for MRI changes related to radiation necrosis that might be misdiagnosed as progression of disease, or 4 weeks if a new lesion, relative to the pre-radiation MRI, develops that is outside the primary radiation field
+5 more criteria

Exclusion Criteria

•Prior treatment with irinotecan, bevacizumab, or another VEGF or VEGFR-targeted agent
•Prior treatment with prolifeprospan 20 with carmustine wafer
•Prior intracerebral agents
•Need for urgent palliative intervention for primary disease (e.g., impending herniation)
•Evidence of recent hemorrhage on baseline MRI of the brain with the following exceptions: Presence of hemosiderin; Resolving hemorrhagic changes related to surgery; Presence of punctate hemorrhage in the tumor
•Received more than two treatment regimens for Grade III and/or Grade IV glioma
•Blood pressure of \> 150 mmHg systolic and \> 100 mmHg diastolic
•History of hypertensive encephalopathy
•New York Heart Association (NYHA) Grade II or greater CHF
•History of myocardial infarction or unstable angina within 6 months prior to Day 0
+14 more criteria

Key Dates

Start Date

July 1, 2006

Primary Completion Date

September 1, 2007

Completion Date

September 1, 2007

Last Updated

May 16, 2017

Enrollment

167

ACTUAL participants

Conditions

Glioblastoma

Interventions

bevacizumab

DRUG

irinotecan

DRUG

Targeted Pediatric High-Grade Glioma Therapy

NCT05839379

High Grade GliomaDiffuse Intrinsic Pontine Glioma+7 more

View study

RECRUITING

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

NCT00083512

Glioblastoma Multiforme

View study

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: May 16, 2017Data 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 to Evaluate Bevacizumab Alone or in Combination With Irinotecan for Treatment of Glioblastoma Multiforme (BRAIN)

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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