Therapy Optimization Trial for the Treatment of Relapsed or Refractory Brain Tumors in Children

Inclusion Criteria

• •Disease Characteristics
• •Histologically confirmed Medulloblastoma, cerebral PNET or Ependymoma
• •Refractory or relapsed disease
• •Measurable disease by MRI or detection of tumor cells in cerebrospinal fluid Patients characteristics
• •Performance status ECOG ≥ 3 or Karnofsky Status ≥ 40%
• •Life expectancy ≥ 8 weeks
• •Hematological:
• •Absolute leukocyte count ≥ 2.0 x 10\^9 /l
• •Hemoglobin ≥ 10g/dl
• •Platelet count ≥ 70 x 10\^9/l
• •Renal:
• •Creatinine no greater than 1.5 times UNL
• •No overt renal disease
• •Hepatic:
• •Bilirubin less than 2.5 times UNL
• •AST and ALT less than 5 times UNL
• •No overt hepatic disease
• •Pulmonary:
• •No overt pulmonary disease
• •Cardiovascular:
• •No overt cardiovascular disease
• •Other:
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception
• •No uncontrolled infection Prior concurrent therapy
• •More than 2 weeks since prior systemic chemotherapy
• •More than 4 weeks since prior radiotherapy
• •No other concurrent anticancer or experimental drugs Examinations required
• •Examination of lumbar CSF
• •Cranial and spinal MRI within 14 days prior to start of treatment