Erlotinib in Treating Patients With Recurrent Malignant Glioma or Recurrent or Progressive Meningioma
Adult Anaplastic Astrocytoma, Adult Anaplastic Oligodendroglioma, Adult Giant Cell Glioblastoma
About this trial
This is an interventional treatment trial for Adult Anaplastic Astrocytoma
Eligibility Criteria
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
Sites / Locations
- University of California Los Angeles
- University of California San Francisco
- National Cancer Institute Neuro-Oncology Branch
- Memorial Sloan Kettering Cancer Center
- University of Pittsburgh
- University of Texas Southwestern Medical Center
- University of Wisconsin
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Phase 1 Dose Escalation
Phase 2 recurrent malignant gliomas and nonprogressive GBM
Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. erlotinib hydrochloride given orally Other: pharmacological study.
Phase II: Patients not concurrently receiving EIAEDs are treated with erlotinib as above at a predetermined dose (150mg/day. patients requiring surgery treated 7 days prior to tumor removal (150mg/day) PK analysis and effects of erlotinib on epidermal growth factor receptor (EGFR) erlotinib hydrochloride given orally Other: pharmacological study, laboratory biomarker analysis.