Bevacizumab and Irinotecan in Treating Patients With Recurrent or Refractory Gliomas

Duke University

Status and phase: Completed; Phase 2

Conditions: Brain and Central Nervous System Tumors

Treatments: Drug: irinotecan hydrochloride; Biological: bevacizumab

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00268359

DUMC-6771-05-1R0

GENENTECH-AVF3311s

CDR0000450832 (Other Identifier)

Pro00004091

Details and patient eligibility

About

RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with irinotecan may kill more tumors cells.

PURPOSE: This phase II trial is studying the side effects of bevacizumab and how well giving bevacizumab together with irinotecan works in treating patients with recurrent or refractory gliomas.

Full description

OBJECTIVES:

Primary

• Determine the safety of bevacizumab and irinotecan hydrochloride in patients with recurrent or refractory grade 3 or 4 malignant gliomas.

Secondary

• Determine the activity of this regimen, in terms of progression-free survival, in these patients.

OUTLINE: Patients receive bevacizumab and irinotecan hydrochloride every 2 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 68 patients will be accrued for this study.

Enrollment: 68 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed primary grade 3 or 4 malignant glioma of 1 of the following types:

  • Glioblastoma multiforme
  • Gliosarcoma
  • Anaplastic astrocytoma
  • Anaplastic oligodendroglioma

• Patients with recurrent disease whose original diagnostic pathology confirmed malignant glioma will not need re-biopsy

• Measurable recurrent or residual primary disease on contrast-enhanced MRI or CT scan

• Failed ≥ 1 prior chemotherapy regimen (with or without radiotherapy)

PATIENT CHARACTERISTICS:

• Karnofsky performance status 60-100%
• Hematocrit > 29%
• Absolute neutrophil count > 1,500/mm^3
• Platelets > 125,000/mm^3
• Serum SGOT and bilirubin < 1.5 times upper limit of normal
• Creatinine < 1.5 mg/dL
• Urine protein:creatinine ratio ≤ 1.0
• Blood pressure ≤ 150/100 mmHg
• No unstable angina
• No New York Heart Association class II or greater congestive heart failure
• No myocardial infarction within the past 6 months
• No stroke within the past 6 months
• No clinically significant peripheral vascular disease
• No evidence of bleeding diathesis or coagulopathy
• No significant traumatic injury within the past 28 days

PRIOR CONCURRENT THERAPY:

• At least 4 weeks must have elapsed since prior chemotherapy or radiotherapy unless there is unequivocal evidence of tumor progression
• At least 6 weeks since prior surgical resection
• No previous major surgical procedures or open biopsies within 28 days prior to study entry
• No previous minor surgical procedures, fine needle aspirations, or core biopsies within 7 days prior to study entry
• No anticipated need for major surgical procedures during the course of the study
• No concurrent aspirin, non-steroidal anti-inflammatory drugs, or clopidogrel