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