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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT00352521
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Duke University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

James J. Vredenburgh, MD
Principal Investigator Affiliation Duke Cancer Institute
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, NIH
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Brain and Central Nervous System Tumors
Additional Details

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 & Interventions

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Duke Comprehensive Cancer Center, Durham, North Carolina

Status

Address

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710