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

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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