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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00345163
Recruitment Status : Completed
First Posted : June 27, 2006
Last Update Posted : May 16, 2017
Information provided by:
Genentech, Inc.

Brief 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).

Condition or disease Intervention/treatment Phase
Glioblastoma Drug: bevacizumab Drug: irinotecan Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 167 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : July 2006
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Arm Intervention/treatment
Experimental: 1 Drug: bevacizumab
Intravenous repeating dose

Experimental: 2 Drug: bevacizumab
Intravenous repeating dose

Drug: irinotecan
Intravenous repeating dose

Primary Outcome Measures :
  1. Objective response, as determined by the independent review facility (IRF) [ Time Frame: Complete response or partial response, determined on two consecutive assessments ≥4 weeks apart ]
  2. Progression-free survival, as determined by the IRF [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Incidence of adverse events and serious adverse events [ Time Frame: Length of patient on study ]
  2. Duration of objective response, as determined by the IRF [ Time Frame: Complete or partial response determined on two consecutive assessments ≥4 weeks apart ]
  3. Overall survival [ Time Frame: Time from randomization to death ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  • Prior therapy with gamma knife or other focal high-dose radiation is allowed but the subject must have subsequent histologic documentation of recurrence, unless the recurrence is a new lesion outside the irradiated field
  • Karnofsky performance status ≥ 70
  • Life expectancy > 12 weeks
  • Use of an effective means of contraception in males and in females of childbearing potential
  • Ability to comply with study and follow-up procedures

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
  • History of stroke or transient ischemic attack within 6 months prior to study enrollment
  • Significant vascular disease (e.g., aortic aneurysm, aortic dissection) or recent peripheral arterial thrombosis within 6 months prior to Day 0
  • Evidence of bleeding diathesis or coagulopathy
  • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0
  • History of intracerebral abscess within 6 months prior to Day 0
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study
  • Minor surgical procedures (excluding placement of a vascular access device), stereotactic biopsy, fine needle aspirations, or core biopsies within 7 days prior to Day 0
  • Serious non-healing wound, ulcer, or bone fracture
  • Pregnancy (positive pregnancy test) or lactation
  • Known hypersensitivity to any component of bevacizumab
  • History of any other malignancy within 5 years (except non-melanoma skin cancer or carcinoma in situ of the cervix)
  • Pregnant or nursing females
  • Unstable systemic disease, including active infection, uncontrolled hypertension, or serious cardiac arrhythmia requiring medication
  • Subjects unable to undergo an MRI with contrast

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00345163

Sponsors and Collaborators
Genentech, Inc.
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Study Director: Jane Huang, M.D. Genentech, Inc.
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Clinical Trials Posting Group, Genentech, Inc. Identifier: NCT00345163    
Other Study ID Numbers: AVF3708g
First Posted: June 27, 2006    Key Record Dates
Last Update Posted: May 16, 2017
Last Verified: May 2017
Keywords provided by Genentech, Inc.:
Glioblastoma Multiforme
Brain Cancer
Additional relevant MeSH terms:
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Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action