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

May 15, 2017 updated by: Genentech, Inc.

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

167

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: bevacizumab
Intravenous repeating dose
Experimental: 2
Drug: bevacizumab
Intravenous repeating dose
Drug: irinotecan
Intravenous repeating dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse events and serious adverse events
Time Frame: Length of patient on study
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
Complete or partial response determined on two consecutive assessments ≥4 weeks apart
Overall survival
Time Frame: Time from randomization to death
Time from randomization to death

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genentech, Inc.

Investigators

  • Study Director: Jane Huang, M.D., Genentech, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2006

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

June 23, 2006

First Submitted That Met QC Criteria

June 26, 2006

First Posted (Estimate)

June 27, 2006

Study Record Updates

Last Update Posted (Actual)

May 16, 2017

Last Update Submitted That Met QC Criteria

May 15, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AVF3708g

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Glioblastoma

Clinical Trials on bevacizumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ireland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe