CC-8490 in Treating Patients With Recurrent or Refractory High-Grade Gliomas

Inclusion Criteria

• •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