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

Parts of the study:

P-HIT-REZ-2005: a trial for the treatment of relapsed PNETs (medulloblastomas,supratentorial PNETs)

E-HIT-REZ-2005: a trial for the treatment of relapsed ependymomas (Phase II-Study with temozolomide)

Phase II-Study: intraventricular therapy with etoposide in neoplastic meningitis in relapsed PNETs and ependymomas with subarachnoid tumor manifestation (window study)

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