A Phase I/II Trial Of OSI-774 In Patients With Recurrent Malignant Gliomas And Malignant Gliomas Post Radiation Therapy

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