Phase I Trial Of Escalating Oral Doses Of SCH 66336 In Pediatric Patients With Refractory Or Recurrent Brain Tumors

Fecha de inicio: 1 de enero de 2002

DISEASE CHARACTERISTICS: * Histologically confirmed recurrent or progressive (refractory) brain tumors * Histologic confirmation waived for brainstem gliomas * Bone marrow involvement allowed if transfusion independent PATIENT CHARACTERISTICS: Age: * 21 and under Performance status: * Lansky 60-100% OR * Karnofsky 60-100% Life expectancy: * More than 8 weeks Hematopoietic: * See Disease Characteristics * Absolute neutrophil count greater than 1,000/mm\^3 * Platelet count greater than 75,000/mm\^3 * Hemoglobin greater than 9 g/dL Hepatic: * Bilirubin no greater than upper limit of normal * SGPT and SGOT less than 2.5 times normal * Albumin greater than 3 g/dL * PT/PTT no greater than 120% upper limit of normal * No overt hepatic disease Renal: * Creatinine no greater than 1.5 times normal OR * Glomerular filtration rate greater than 70 mL/min * No overt renal disease Cardiovascular: * No overt cardiac disease Pulmonary: * No overt pulmonary disease Other: * Neurologic deficits allowed if stable for at least 1 week prior to study * More than 3rd percentile weight for height * Able to swallow pills * No uncontrolled infection * No known or suspected allergy to poloxamer 188, croscarmellose sodium, silicon dioxide, or magnesium stearate I * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for up to 10 weeks after study PRIOR CONCURRENT THERAPY: Biologic therapy: * More than 6 months since prior bone marrow transplantation * More than 1 week since prior growth factors Chemotherapy: * At least 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas) and recovered Endocrine therapy: * Concurrent dexamethasone allowed if on stable dose for at least 1 week prior to study * Concurrent oral contraceptives or other hormonal contraceptive methods allowed Radiotherapy: * More than 6 weeks since prior substantial bone marrow radiotherapy * More than 3 months since prior craniospinal radiotherapy (more than 24 Gy) or total body irradiation * More than 2 weeks since prior focal radiotherapy for symptomatic metastatic sites Surgery: * Not specified Other: * No concurrent enzyme-inducing anticonvulsant drugs * No other concurrent anticancer or experimental drug therapy