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Status:

COMPLETED

Bevacizumab in Treating Patients With Recurrent or Progressive Glioma

Lead Sponsor:

Northwestern University

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Brain and Central Nervous System Tumors

Eligibility:

All Genders

18+ years

Phase:

PHASE2

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...

Detailed Description

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 progre...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    March 1 2006

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    May 1 2009

    Estimated Enrollment :

    55 Patients enrolled

    Trial Details

    Trial ID

    NCT00337207

    Start Date

    March 1 2006

    End Date

    May 1 2009

    Last Update

    February 7 2020

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    1

    Hematology-Oncology Associates of Illinois

    Chicago, Illinois, United States, 60611-2998

    2

    Robert H. Lurie Comprehensive Cancer Center at Northwestern University

    Chicago, Illinois, United States, 60611-3013