Thalidomide and Temozolomide in Relapsed or Progressive CNS Disease or Neuroblastoma
Central Nervous System Tumor, Pediatric, Neuroblastoma
About this trial
This is an interventional treatment trial for Central Nervous System Tumor, Pediatric
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed* diagnosis of 1 of the following: Poor prognosis brain tumor Relapsed or progressive disease No curative therapy exists Neuroblastoma Recurrent disease NOTE: *Histologic confirmation not required for brain stem glioma; patients with brain stem glioma must have clinical and radiographic evidence of disease Patients with brain stem glioma must have symptoms lasting < 3 months comprising cranial nerve deficits (often VI or VII) and/or ataxia and/or long tract signs PATIENT CHARACTERISTICS: Age 21 and under Performance status Karnofsky 50-100% OR Lansky 50-100% Life expectancy More than 2 months Hematopoietic Hemoglobin ≥ 9.0 g/dL Platelet count > 75,000/mm^3 WBC > 2,000/mm^3 Absolute neutrophil count > 1,000/mm^3 Hepatic Bilirubin ≤ 1.5 mg/dL SGOT and SGPT ≤ 2 times normal (SGOT ≤ 4 times normal for patients taking Zantac) Alkaline phosphatase ≤ 2 times normal No active hepatic disease ≥ grade 3 Renal Creatinine < 1.5 mg/dL OR Creatinine clearance ≥ 70 mL/min No active renal disease ≥ grade 3 Cardiovascular No active cardiac disease ≥ grade 3 Pulmonary No active pulmonary disease ≥ grade 3 Other Not pregnant or nursing Fertile patients must use effective contraception during and for 4 weeks after study participation Willing and able to participate in the System for Thalidomide Education and Prescription Safety (S.T.E.P.S.^®) program No active psychiatric disease ≥ grade 3 PRIOR CONCURRENT THERAPY: Biologic therapy Prior biologic therapy allowed No prior thalidomide Chemotherapy Prior chemotherapy allowed No prior temozolomide Endocrine therapy Concurrent steroids allowed Radiotherapy Prior radiotherapy allowed Surgery Prior surgery allowed Other Concurrent antiseizure medications allowed No other concurrent investigational agents
Sites / Locations
- Dana Farber Cancer Institute
Arms of the Study
Arm 1
Experimental
Thalidomide and Temozolomide
Thalidomide: Oral thalidomide on days 1-28 of a 28 day cycle initiated at 3 mg/kg and increased to maximum dose of 24 mg/kg or 1000 mg as tolerated. Temozolomide: Oral temozolomide on days 1-5 of 28 day cycle given at 200 mg/m2 or 150 mg/m2 for patients who had previously received significant therapy to the bone marrow (chemotherapy or radiation) or cranial spinal radiation. Patients were treated for 6 cycles unless disease progression or excessive toxicity. Treatment could continue beyond 6 cycles if absent disease progression