Gefitinib in Treating Patients With Recurrent or Progressive CNS Tumors
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 recurrent adult brain tumor, adult meningioma, adult glioblastoma, adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult pilocytic astrocytoma, adult subependymoma, adult mixed glioma, adult meningeal hemangiopericytoma, adult grade III meningioma, adult giant cell glioblastoma, adult gliosarcoma, adult grade I meningioma, adult grade II meningioma
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of 1 of the following: Histologically confirmed supratentorial malignant primary glioma Glioblastoma multiforme Anaplastic astrocytoma Anaplastic oligodendroglioma Anaplastic mixed oligoastrocytoma Malignant astrocytoma not otherwise specified Histologically confirmed or radiographically defined recurrent or progressive brain or spinal meningioma, including base of skull or cavernous sinus meningiomas Benign, malignant, or atypical May include neurofibromatosis type I or II Hemangiopericytoma allowed Recurrent or progressive disease by MRI or CT scan Evidence of true progressive disease by PET or thallium scan, MR spectroscopy, or surgical documentation required if patient received prior interstitial brachytherapy or stereotactic radiosurgery (to the target lesion for meningioma and hemangiopericytoma) Steroid dosage must be stable for at least 5 days prior to scan No limitations on the number of prior surgeries, radiotherapy or chemotherapy regimens, or radiosurgery treatments for patients with meningioma or hemangiopericytoma and may include standard external beam radiotherapy, interstitial brachytherapy, or gamma-knife radiosurgery in any combination Patients with glioma must have failed prior radiotherapy Original histology of low-grade glioma allowed if subsequent confirmation of malignant glioma is made at time of recurrence Phase I (closed to accrual as of 09/19/2003): Prior treatment for no more than 3 prior relapses in patients with glioma Phase II: Measurable disease after prior surgical resection of recurrent or progressive disease Prior treatment for no more than 2 prior relapses in patients with glioma PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: More than 8 weeks Hematopoietic: WBC at least 3,000/mm^3 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 120,000/mm^3 Hemoglobin at least 10 g/dL (transfusion allowed) Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN) SGOT less than 1.5 times ULN Renal: Creatinine less than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No significant cardiac risk factors within the past 6 months Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No gastrointestinal risk factors (e.g., active ulcerative colitis) within the past 6 months No active infection No concurrent disease that would obscure toxicity or dangerously alter drug metabolism No other significant medical illness that would preclude study No other malignancy within the past 3 years except non-melanoma skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: At least 1 week since prior interferon or thalidomide No concurrent filgrastim (G-CSF) Chemotherapy: See Disease Characteristics At least 2 weeks since prior vincristine At least 6 weeks since prior nitrosoureas At least 3 weeks since prior procarbazine Endocrine therapy: At least 1 week since prior tamoxifen Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy Surgery: See Disease Characteristics At least 7 days since prior surgery for recurrent or progressive tumor and recovered Other: Recovered from prior therapy No prior gefitinib or other epidermal growth factor receptor inhibitor At least 1 week since prior isotretinoin At least 1 week since other prior noncytotoxic agents (except radiosensitizers) At least 4 weeks since prior investigational agents Concurrent low-molecular weight heparin or warfarin for deep vein thrombosis or pulmonary embolism allowed
Sites / Locations
- Jonsson Comprehensive Cancer Center at UCLA
- UCSF Comprehensive Cancer Center
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
- NCI - Neuro-Oncology Branch
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
- University of Michigan Comprehensive Cancer Center
- Memorial Sloan-Kettering Cancer Center
- Hillman Cancer Center at University of Pittsburgh Cancer Institute
- Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
- M.D. Anderson Cancer Center at University of Texas
- University of Texas Health Science Center at San Antonio
- University of Wisconsin Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
p450
nonp450
p450 inhibitor
not on p450 inhibitor