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Bevacizumab in Treating Patients With Recurrent or Progressive 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 stop the growth of tumor cells by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well bevacizumab works in treating patients with recurrent or progressive glioma.

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 malignant glioma, including the following: - Glioblastoma multiforme.
  • - Gliosarcoma.
  • - Anaplastic astrocytoma or anaplastic glioma.
  • - Malignant glioma not otherwise specified.
  • - Evidence of tumor recurrence or progression by MRI or CT scan with contrast.
  • - CT scan or MRI must be performed ≤ 96 hours post-operatively (≤ 2 weeks prior to study registration) or 4-6 weeks post-operatively to assess residual disease in patients who have undergone recent resection of recurrent or progressive tumor.
  • - Steroid dosage must have been stable for ≥ 5 days.
  • - Failed ≥ 1 prior systemic treatment with chemotherapy or biologic agents (excluding polifeprosan 20 with carmustine implant [Gliadel wafers]) - Failed prior external-beam radiotherapy.
  • - If received prior interstitial brachytherapy or stereotactic radiosurgery, true progressive disease (rather than radiation necrosis) must be confirmed by positron emission tomography, single-photon emission computer tomography with thallium, magnetic resonance (MR) spectroscopy, MR perfusion, or surgical documentation.
PATIENT CHARACTERISTICS:
  • - Karnofsky performance status 70-100% - Life expectancy > 8 weeks.
  • - WBC > 3,000/mm³ - Absolute neutrophil count > 1,500/mm³ - Platelet count > 100,000/mm³ - Hemoglobin > 10 g/dL (transfusion allowed) - SGOT and SGPT < 1.5 times upper limit of normal (ULN) - Bilirubin < 1.5 times ULN.
  • - Creatinine < 1.5 mg/dL.
  • - Blood pressure ≤ 150/100 mm Hg.
  • - No unstable angina.
  • - No New York Heart Association class II-IV congestive heart failure.
  • - No stroke or myocardial infarction within the past 6 months.
  • - No clinically significant peripheral vascular disease.
  • - No evidence of bleeding diathesis or coagulopathy.
  • - Urine protein:creatinine ratio < 1.0.
  • - No significant medical illness that would preclude study participation or cannot be adequately controlled with appropriate therapy.
  • - No other serious medical illness or infection.
  • - No disease that would obscure toxicity or dangerously alter drug metabolism.
  • - No significant traumatic injury within the past 28 days.
  • - No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months.
  • - No serious, nonhealing wound, ulcer, or bone fracture.
  • - No history of any other cancer (except nonmelanoma skin cancer or carcinoma in situ of the cervix) unless cancer is in complete remission and patient is off all therapy for that cancer for ≥ 3 years.
  • - Not pregnant or nursing.
  • - Negative pregnancy test.
  • - Fertile patients must use effective contraception.
PRIOR CONCURRENT THERAPY:
  • - See Disease Characteristics.
  • - More than 4 weeks since prior surgery for recurrent or progressive disease and recovered.
  • - More than 28 days since prior major surgical procedure or open biopsy.
  • - At least 4 weeks since prior cytotoxic therapy (6 weeks for nitrosoureas) - At least 2 weeks since prior vincristine.
  • - At least 3 weeks since prior procarbazine hydrochloride.
  • - At least 1 week since prior noncytotoxic agents (e.g., interferon, tamoxifen, thalidomide, or isotretinoin) - Radiosensitizer does not count.
  • - At least 4 weeks since prior experimental biologic agents (e.g., epidermal growth factor receptor [EGFR] inhibitors) - More than 7 days since prior minor surgery, such as fine-needle aspirations or core biopsies.
  • - No concurrent combination anti-retroviral therapy for HIV-positive patients.
- No concurrent enzyme-inducing anticonvulsants (EIACs) - Patients on EIACs must switch to nonenzyme-inducing convulsants ≥ 2 weeks prior to study enrollment

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.

NCT00337207
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.

Northwestern University
Principal Investigator

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

Jeffrey J. Raizer, MD
Principal Investigator Affiliation Robert H. Lurie Cancer Center
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:

  • - Determine the safety of single-agent bevacizumab in the treatment of patients with recurrent or progressive malignant glioma.
  • - Determine the efficacy of bevacizumab, in terms of progression-free survival at 6 months, in these patients.
  • - Assess changes in tumoral blood flow based on magnetic resonance (MR) perfusion and tissue changes by MR spectroscopy.
OUTLINE: This is a pilot study. Patients receive bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically. PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study.

Arms & Interventions

Arms

Experimental: Avastin

Interventions

Biological: - bevacizumab

Bevacizumab 15 mg/kg every 3 weeks over 30 to 90 minutes. One cycle = 3 weeks. Treatment continues until progressive disease or unacceptable toxicity.

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.

Chicago, Illinois

Status

Address

Hematology-Oncology Associates of Illinois

Chicago, Illinois, 60611-2998

Chicago, Illinois

Status

Address

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611-3013