Lonafarnib and Temozolomide in Treating Patients With Recurrent Primary Supratentorial Gliomas
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 mixed glioma, adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult glioblastoma, adult pilocytic astrocytoma, adult anaplastic ependymoma, adult subependymoma, adult myxopapillary ependymoma, adult oligodendroglioma, adult giant cell glioblastoma, adult gliosarcoma, adult diffuse astrocytoma, adult subependymal giant cell astrocytoma, adult pineal gland astrocytoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed primary supratentorial glioma Multifocal disease allowed Recurrent disease after prior surgery and/or radiotherapy Radiological evidence of increased and/or enhanced target lesion Amenable to temozolomide therapy PATIENT CHARACTERISTICS: Age Over 18 Performance status ECOG 0-2 OR WHO 0-2 Life expectancy Not specified Hematopoietic Neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 10.0 g/dL Hepatic Alkaline phosphatase < 2.5 times upper limit of normal (ULN) Transaminases < 2.5 times ULN Bilirubin < 1.5 times ULN Renal Creatinine < 1.7 mg/dL Cardiovascular Cardiac function clinically normal Normal 12-lead ECG QTc ≤ 440 msec on ECG No ischemic heart disease within the past 6 months Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study participation No unstable systemic disease No active uncontrolled infection No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up No other active or recurrent malignancy within the past 5 years except cone biopsied carcinoma of the cervix or adequately treated basal cell or squamous cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent anticancer biologic agents Chemotherapy At least 4 weeks since prior chemotherapy (6 weeks for temozolomide) Prior adjuvant chemotherapy allowed No more than 1 prior chemotherapy regimen for recurrent disease No other concurrent chemotherapy Endocrine therapy Concurrent corticosteroids allowed provided treatment remains at a stable or decreasing dose for at least 2 weeks Radiotherapy See Disease Characteristics No concurrent radiotherapy Surgery See Disease Characteristics At least 3 months since prior surgery for primary brain tumor Other Concurrent anticonvulsants allowed No other concurrent anticancer agents No other concurrent investigational therapy
Sites / Locations
- Centre de Lutte Contre le Cancer Georges-Francois Leclerc
- Centre Regional Rene Gauducheau
- Centre Hospitalier Universitaire Vaudois