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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT00345163
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Genentech, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Jane Huang, M.D.
Principal Investigator Affiliation Genentech, Inc.
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Completed
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioblastoma
Arms & Interventions

Arms

Experimental: 1

Experimental: 2

Interventions

Drug: - bevacizumab

Intravenous repeating dose

Drug: - irinotecan

Intravenous repeating dose

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

For additional contact information, you can also visit the trial on clinicaltrials.gov.