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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.
 
ClinicalTrials.gov Identifier: NCT00345163
Recruitment Status : Completed
First Posted : June 27, 2006
Last Update Posted : May 16, 2017
Sponsor:
Information provided by:
Genentech, Inc.

Tracking Information
First Submitted Date  ICMJE June 23, 2006
First Posted Date  ICMJE June 27, 2006
Last Update Posted Date May 16, 2017
Actual Study Start Date  ICMJE July 2006
Actual Primary Completion Date September 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 10, 2009)
  • 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 ]
  • Progression-free survival, as determined by the IRF [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 26, 2006)
To evaluate 6-month progression-free survival (PFS) and objective response rate in subjects with glioblastoma multiforme (GBM) in first or second relapse treated with either bevacizumab or bevacizumab + irinotecan.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2009)
  • Incidence of adverse events and serious adverse events [ Time Frame: Length of patient on study ]
  • Duration of objective response, as determined by the IRF [ Time Frame: Complete or partial response determined on two consecutive assessments ≥4 weeks apart ]
  • Overall survival [ Time Frame: Time from randomization to death ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2006)
  • To characterize the safety of bevacizumab alone and in combination with irinotecan in subjects with GBM in first or second relapse
  • to evaluate the efficacy of bevacizumab alone and in combination with irinotecan in subjects with GBM in first or second relapse.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate Bevacizumab Alone or in Combination With Irinotecan for Treatment of Glioblastoma Multiforme (BRAIN)
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Glioblastoma
Intervention  ICMJE
  • Drug: bevacizumab
    Intravenous repeating dose
  • Drug: irinotecan
    Intravenous repeating dose
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: bevacizumab
  • Experimental: 2
    Interventions:
    • Drug: bevacizumab
    • Drug: irinotecan
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 21, 2007)
167
Original Enrollment  ICMJE
 (submitted: June 26, 2006)
160
Actual Study Completion Date  ICMJE September 2007
Actual Primary Completion Date September 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00345163
Other Study ID Numbers  ICMJE AVF3708g
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Clinical Trials Posting Group, Genentech, Inc.
Study Sponsor  ICMJE Genentech, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jane Huang, M.D. Genentech, Inc.
PRS Account Genentech, Inc.
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP