Clinical Trial Finder

DISEASE CHARACTERISTICS:

• - Diagnosis of any of the following malignant gliomas: - Glioblastoma multiforme.

• - Anaplastic astrocytoma.

• - Grade 3 or greater WHO astrocytic, oligodendroglial, or mixed glial tumors that were initially diagnosed by histologic examination of a tumor specimen obtained from biopsy or resection.

• - Recurrent disease.

• - No more than 3 prior recurrences.

• - Measurable recurrent or residual primary CNS neoplasm on contrast-enhanced MRI or CT scan.

• - No evidence of CNS hemorrhage on baseline MRI or CT scan.

PATIENT CHARACTERISTICS:

• - Karnofsky performance status 60-100% - Hematocrit > 29% - Absolute neutrophil count > 1,500/mm³ - Platelet count > 125,000/mm³ - Creatinine < 1.5 mg/dL.

• - SGOT < 1.5 times upper limit of normal (ULN) - Bilirubin < 1.5 times ULN.

• - Not pregnant or nursing.

• - Fertile patients must use effective contraception.

• - No active infection.

• - No significant traumatic injury within the past 28 days.

PRIOR CONCURRENT THERAPY:

• - At least 6 weeks since prior surgical resection.

• - More than 28 days since prior major surgical procedure or open biopsy.

• - More than 7 days since prior minor surgical procedure, fine-needle aspirations, or core biopsies.

• - At least 6 weeks since prior chemotherapy* - At least 4 weeks since prior radiotherapy* - No concurrent immunosuppressive agents.

• - No concurrent therapeutic anticoagulation.

- Concurrent corticosteroids allowed if dose has been stable for 1 week prior to study entry NOTE: * Unless there is unequivocal evidence of progressive disease

OBJECTIVES: Primary.

• - Examine the effect of bevacizumab and irinotecan on vascular permeability and blood flow in patients with recurrent malignant gliomas.

Secondary.

• - Determine the reproducibility of dynamic contrast-enhanced (DCE-MRI) in malignant gliomas.

• - Determine the predictive value of DCE-MRI in patients with recurrent malignant gliomas treated with bevacizumab and irinotecan.

• - Describe the activity of the combination of bevacizumab with irinotecan as measured by response rate and progression-free survival.

• - Describe the toxicity associated with the administration of bevacizumab with irinotecan.

OUTLINE: Patients receive bevacizumab IV on days 1, 15, and 29 and irinotecan IV on days 2, 15, and 29 during the first 6-week cycle. After the first cycle, the irinotecan and bevacizumab will be given on days 1, 15 and 29. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo dynamic contrast-enhanced MRI 4 times.

Arms

Experimental: Bevacizumab and irinotecan

The bevacizumab will be dosed at 10 mg/kg every 14 days (days 1, 15 and 29) and the irinotecan on days 2, 15, and 29 of the first six week schedule. The irinotecan dose will depend on whether the patient is on an enzyme-inducing antiepileptic drug (EIAED). If the patient is on an EIAED, the patient will receive 340 mg/m2 on days 2, 15, and 29 of the first six week schedule. If the patient is not on an EIAED, the dose of irinotecan will be 125 mg/m2 on days 2, 15, and 29 of the first six week schedule. After the first cycle, the irinotecan and bevacizumab will be given on days 1, 15 and 29.

Interventions

Drug: - bevacizumab

Drug: - irinotecan

Procedure: - dynamic contrast-enhanced magnetic resonance imaging