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

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT00352521
Phase
PHASE2
Status
Completed

Conditions

  • Brain and Central Nervous System Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • bevacizumab — DRUG
  • irinotecan — DRUG
  • dynamic contrast-enhanced magnetic resonance imaging — PROCEDURE

Study Details

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.

Key Dates

Start date
Apr 30, 2006
Status verified
Feb 2013
Primary completion
Dec 31, 2006
Completion
Jul 31, 2009

Study Design

Enrollment
20 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Correlation of the acute permeability and blood flow response (24-48 hours) with progression-free survival (PFS) [ Time Frame: 1 year ]

Locations (1)

FacilityCityStateZIPSite coordinators
Duke Comprehensive Cancer CenterDurhamNorth Carolina27710-

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By research site
Duke Comprehensive Cancer Center· Durham, NC

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