Bevacizumab and Irinotecan to Treat Brain Tumors

Conditions

• High-Grade Gliomas

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Bevacizumab — BIOLOGICAL
  10 mg/kg intravenous injection
• Irinotecan hydrochloride — DRUG
  125 mg/m\^2 if patient is on a non-enzyme inducing anti-epileptic drugs 340 mg/m\^2 if patient is on enzyme inducing anti-epileptic drugs every two weeks on a 4 week cycle

Study Details

Background: * Bevacizumab is a genetically engineered antibody that blocks the growth of new blood vessels in tumors. It has shown activity against human brain tumors in laboratory tests and human clinical trials. * Irinotecan causes damage to the deoxyribonucleic acid (DNA) in cancer cells so that the cells cannot reproduce or repair themselves. It is approved for treating patients with colorectal cancer. * Bevacizumab and irinotecan in combination are more effective against colon cancer than either drug alone. Objectives: * To determine the safety of bevacizumab and irinotecan and any side effects associated with the combination of the two drugs when given to patients with high grade gliomas. * To determine if the combination of bevacizumab and irinotecan can help patients with brain tumors that have grown after treatment with bevacizumab alone. Eligibility: -Patients 18 years of age and older who have been treated on National Cancer Institute (NCI) trial 06-C-0064 (NCT00271609), "Bevacizumab Alone for Recurrent Gliomas," and whose tumor has progressed. Design: Participants receive infusions of bevacizumab and irinotecan through a vein once every 2 weeks in 4-week treatment cycles, plus the following procedures: * History, physical and neurological examinations every 2 weeks for the first treatment cycle and then every 4 weeks * Magnetic Resonance Imaging (MRI) scan of the head every 4 weeks. * Routine lab every week. * Quality-of-life questionnaire every 4 weeks

Key Dates

First listed

Oct 26, 2006

Start date

Sep 30, 2006

Status verified

Jul 2012

Primary completion

Jan 31, 2010

Completion

Mar 31, 2010

Study Design

Enrollment

31 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Bevacizumab & Irinotecan Patients
  Bevacizumab - 10 mg/kg intravenous injection Irinotecan - 125 mg/m\^2 if patient is on a non-enzyme inducing anti-epileptic drugs 340 mg/m\^2 if patient is on enzyme inducing anti-epileptic drugs every two weeks on a 4 week cycle

Primary Outcome Measure

Radiographic Response Rate (Malignant Glioma Participants) [ Time Frame: 23 months (date of first enrollment to 1 month after last progression) ]

Locations (1)

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