Tipifarnib in Treating Patients With Recurrent or Progressive Malignant Glioma
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 glioblastoma, adult giant cell glioblastoma, adult gliosarcoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed intracranial primary malignant glioma Glioblastoma multiforme Anaplastic astrocytoma* Anaplastic oligodendroglioma* Anaplastic mixed oligodendroglioma* Malignant astrocytoma (not otherwise specified)* NOTE: *Closed to accrual effective 5/28/2002 Progressive or recurrent disease confirmed by MRI or CT scan within the past 14 days Stable steroid dose for at least 5-7 days Confirmation of true progressive disease by PET scan, thallium scan, MR spectroscopy, or surgery if prior therapy included interstitial brachytherapy or stereotactic radiosurgery Failed prior radiotherapy Phase I (phase I completed effective 10/2/2001): No more than 2 prior chemotherapy or cytotoxic regimens, including 1 prior adjuvant therapy and 1 prior regimen for progressive or recurrent disease, or 2 prior regimens for progressive disease Phase II (phase II open only to patients requiring resection and who provide surgical tissue samples [effective 3/13/2003]): No more than 2 prior chemotherapy or cytotoxic regimens for relapsed disease following initial therapy (radiotherapy with or without chemotherapy) Prior surgical resection for relapsed disease with no anticancer therapy for up to 12 weeks followed by another surgical resection is considered 1 relapse Patients who received prior therapy for a low-grade glioma with a surgical diagnosis of a high-grade glioma are considered to be in first relapse 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 2,000/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 10 g/dL (transfusion allowed) Hepatic: Bilirubin no greater than 2.5 times upper limit of normal (ULN) SGOT no greater than 2.5 times ULN Renal: Creatinine less than 1.5 mg/dL Cardiovascular: No uncontrolled high blood pressure No unstable angina No symptomatic congestive heart failure No myocardial infarction within the past 6 months No serious uncontrolled cardiac arrhythmia Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No severe nonmalignant systemic diseases or active infections No other severe concurrent disease that would preclude study therapy No allergy to azoles (e.g., ketoconazole, itraconazole, or voriconazole) HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: At least 1 week since prior interferon No concurrent anticancer immunotherapy No concurrent routine prophylactic filgrastim (G-CSF) during first course of study No concurrent sargramostim (GM-CSF) Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas, suramin, or mitomycin) At least 3 weeks since prior procarbazine At least 2 weeks since prior vincristine No other concurrent anticancer chemotherapy Endocrine therapy: See Disease Characteristics At least 1 week since prior tamoxifen Concurrent corticosteroids allowed No concurrent anticancer hormonal therapy Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy and recovered No concurrent anticancer radiotherapy Surgery: See Disease Characteristics At least 3 weeks since prior resection and recovered Prior recent resection of recurrent or progressive tumor allowed Other: Recovered from all prior therapy (excluding neurotoxicity or alopecia) Prior radiosensitizers allowed Concurrent H2 blockers and antacids allowed provided taken at least 2 hours before and after tipifarnib No concurrent proton pump inhibitors (e.g., omeprazole or lansoprazole) No other concurrent medication that would preclude study therapy (e.g., immunosuppressive agents) No other concurrent anticancer therapy No other concurrent investigational drugs No concurrent participation in any other clinical study No other concurrent medications except analgesics, chronic treatments for concurrent medical conditions, or agents for life-threatening medical problems
Sites / Locations
- Jonsson Comprehensive Cancer Center, UCLA
- UCSF Comprehensive Cancer Center
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
- 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
- University of Texas - MD Anderson Cancer Center
- University of Texas Health Science Center at San Antonio
- University of Wisconsin Comprehensive Cancer Center