Bevacizumab and Irinotecan in Treating Patients With Recurrent or Refractory Gliomas

Sponsor

Duke University (Other)

Overall Status

Completed

CT.gov ID

NCT00268359

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Brain and Central Nervous System Tumors	Biological: bevacizumab Drug: irinotecan hydrochloride	Phase 2

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

68 participants

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Bevacizumab in Combination With Irinotecan for Malignant Gliomas

Study Start Date :

May 1, 2005

Actual Primary Completion Date :

Aug 1, 2006

Actual Study Completion Date :

Oct 1, 2009

Outcome Measures

Primary Outcome Measures

Safety []
Activity in terms of progression-free survival []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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