A Phase I Trial Of CC-8490 For The Treatment Of Patients With Recurrent/Refractory High-Grade Gliomas

Date de début de l'étude : 1 décembre 2003

DISEASE CHARACTERISTICS: * Histologically confirmed supratentorial malignant glioma, including any of the following: * Glioblastoma multiforme * Gliosarcoma * Anaplastic astrocytoma * Anaplastic oligodendroglioma * Anaplastic mixed oligoastrocytoma * Malignant glioma/astrocytoma not otherwise specified OR * Clinical and radiographic diagnosis of progressive low-grade glioma * Radiographically diagnosed infiltrating brain stem gliomas not amenable to biopsy allowed * Recurrent or progressive disease as determined by 1 of the following: * CT scan or MRI within the past 21 days * Biopsy within the past 12 weeks * Failed prior radiotherapy PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 60-100% Life expectancy * More than 8 weeks Hematopoietic * Granulocyte count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 (transfusion independent) * Hemoglobin at least 8 g/dL (transfusion allowed) Hepatic * Bilirubin no greater than 1.5 mg/dL * AST and ALT no greater than 2 times upper limit of normal * No significant active hepatic disease that would preclude study participation Renal * Creatinine no greater than 1.5 mg/dL OR * Creatinine clearance at least 60 mL/min * No significant active renal disease that would preclude study participation Cardiovascular * No significant active cardiac disease that would preclude study participation Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 2 months after study participation * No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix * No significant active psychiatric disease that would preclude study participation * No other condition or laboratory abnormality that would preclude study participation * Able to swallow capsules whole PRIOR CONCURRENT THERAPY: Biologic therapy * At least 2 weeks since prior interferon * No concurrent immunotherapy Chemotherapy * At least 2 weeks since prior vincristine * At least 3 weeks since prior procarbazine * At least 4 weeks since prior temozolomide or carboplatin * At least 6 weeks since prior nitrosoureas * No other concurrent anticancer chemotherapy Endocrine therapy * At least 2 weeks since prior tamoxifen * Concurrent steroids allowed provided dose has been stable for at least 5 days prior to study enrollment Radiotherapy * See Disease Characteristics * At least 2 weeks since prior radiotherapy * No concurrent radiotherapy Surgery * At least 2 weeks since prior resection of a recurrent or progressive tumor Other * At least 2 weeks since other prior non-cytotoxic therapy * At least 4 weeks since other prior cytotoxic therapies * More than 28 days since prior experimental study drugs * No other concurrent investigational agents