Erlotinib in Treating Patients With Recurrent Malignant Glioma or Recurrent or Progressive Meningioma

Inclusion Criteria:

• One of the following diagnoses:

  • Histologically confirmed intracranial malignant glioma

    • Glioblastoma multiforme (GBM), anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed oligoastrocytoma, or malignant astrocytoma not otherwise specified
    • Original histology of low-grade glioma allowed provided a subsequent histology of malignant glioma is confirmed
  • Histologically or radiographically confirmed recurrent or progressive benign or malignant meningioma

• Progressive disease or tumor recurrence on MRI or CT scan

  • Phase I: No more than 3 prior relapses and no more than 2 prior chemotherapy* or biologic therapy regimens
  • Phase II: No more than 2 prior relapses and no more than 2 prior chemotherapy* or biologic therapy regimens

• Patients with progressive disease must have failed prior radiotherapy* that was completed at least 4 weeks ago

  • Patients with progressive disease between 4 and 12 weeks after completion of external beam radiotherapy must have clear evidence of progression on MRI
  • Patients with GBM who have completed external beam radiotherapy and do not show progression are eligible
  • Patients with progressive disease after interstitial brachytherapy or stereotactic radiosurgery must have confirmed true progression rather than radiation necrosis based upon positron-emission tomography, thallium scanning, MRI, or surgical documentation
• Measurable or evaluable disease
• Performance status - Karnofsky 60-100%
• More than 8 weeks
• WBC at least 3,000/mm^3
• Absolute neutrophil count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3
• Hemoglobin at least 10 mg/dL (transfusion allowed)
• Bilirubin less than 1.5 times upper limit of normal (ULN)
• SGOT less than 1.5 times ULN
• Creatinine less than 1.5 mg/dL

• None of the following ophthalmic abnormalities:

  • Abnormalities of the cornea (e.g., dry eye syndrome or Sjögren's syndrome)
  • Congenital abnormality (e.g., Fuch's dystrophy)
  • Abnormal slit-lamp examination using a vital dye (e.g., fluorescein or Bengal-Rose)
  • Abnormal corneal sensitivity test (Schirmer test or similar tear production test)
• Patients found to have dry eyes on examination but have an otherwise normal examination allowed
• No active infection
• No other serious concurrent medical illness
• No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
• No other disease that would obscure toxicity or dangerously alter drug metabolism
• No significant medical illness that would preclude study participation
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective barrier contraception during and for 12 weeks after study participation
• See Disease Characteristics
• At least 1 week since prior thalidomide
• At least 1 week since prior interferon
• At least 4 weeks since prior SU5416 or other experimental biologic agents
• See Disease Characteristics
• No prior chemotherapy (including polifeprosan 20 with carmustine implant [Gliadel wafers]) for patients with stable GBM
• At least 2 weeks since prior vincristine
• At least 3 weeks since prior procarbazine
• At least 6 weeks since prior nitrosoureas
• At least 1 week since prior tamoxifen
• See Disease Characteristics
• Recovered from prior radiotherapy
• No more than 6 weeks since prior external beam radiotherapy for patients with GBM without evidence of progression
• Recovered from prior surgery
• Recovered from prior therapy
• At least 1 week since prior noncytotoxic agents (e.g., isotretinoin) except radiosensitizers
• At least 4 weeks since prior cytotoxic therapy
• At least 4 weeks since prior tipifarnib or imatinib mesylate
• No prior erlotinib or other epidermal growth factor receptor inhibitors
• No concurrent combination antiretroviral therapy for HIV-positive patients