Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI) With Bevacizumab and Irinotecan for Malignant Glioma

NCT ID: NCT00352521

Last Updated: 2014-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2009-07-31

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 block 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 tumor cells. Diagnostic procedures, such as MRI, may help doctors predict a patient's response to treatment and help plan the best treatment.

PURPOSE: This phase II trial is studying how well giving bevacizumab together with irinotecan works in treating patients with recurrent malignant glioma and how well MRI predicts response to treatment.

Detailed Description

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.

Conditions

Brain and Central Nervous System Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

bevacizumab

Intervention Type: DRUG

irinotecan

Intervention Type: DRUG

dynamic contrast-enhanced magnetic resonance imaging

Intervention Type: PROCEDURE

Interventions

bevacizumab

Intervention Type: DRUG

irinotecan

Intervention Type: DRUG

dynamic contrast-enhanced magnetic resonance imaging

Intervention Type: PROCEDURE

Other Intervention Names

Avastin; Camptosar

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James J. Vredenburgh, MD

Role: STUDY_CHAIR

Duke Cancer Institute

Locations

Duke Comprehensive Cancer Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

DUMC-8053-05-12R0

Identifier Type: -

Identifier Source: secondary_id

CDR0000481476

Identifier Type: OTHER

Identifier Source: secondary_id

Pro00012387

Identifier Type: -

Identifier Source: org_study_id