Bevacizumab in Treating Patients With Recurrent or Progressive Glioma
Condition: Brain and Central Nervous System Tumors
MeSH terms: Nervous System Neoplasms; Central Nervous System Neoplasms
Intervention: bevacizumab
Intervention description: Bevacizumab 15 mg/kg every 3 weeks over 30 to 90 minutes. One cycle = 3 weeks. Treatment continues until progressive disease or unacceptable toxicity.
Intervention MeSH terms: Bevacizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 55.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: adult glioblastoma; adult gliosarcoma; recurrent adult brain tumor; adult anaplastic astrocytoma; adult giant cell glioblastoma

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 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.
    

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