Bevacizumab in Treating Patients With Recurrent or Progressive Glioma
Brain and Central Nervous System Tumors
About this trial
This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring adult glioblastoma, adult gliosarcoma, recurrent adult brain tumor, adult anaplastic astrocytoma, adult giant cell glioblastoma
Eligibility 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
Sites / Locations
- Hematology-Oncology Associates of Illinois
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Arms of the Study
Arm 1
Experimental
Avastin