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Bevacizumab and Irinotecan in Treating Patients With Recurrent or Refractory Gliomas

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 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.

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:

  • - 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

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.

 NCT00268359
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.

  • - 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.

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

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