Clinical Trial Details
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NCT01535183 : Irinotecan Combination Chemotherapy for Refractory or Relapsed Brain Tumor in Children and Adolescents
PhasePhase 2
AgesMin: N/A Max: 19 Years
Inclusion Criteria:

- Diagnosis of brain tumor : embryonal brain tumor (medulloblastoma, CNS PNET, ATRT,
etc), intracranial germ cell tumor

- Relapse or refractory state

- Prior therapy : Patients must have fully recovered from the acute toxic effects of
all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study.
Patients are eligible 8 weeks from the day of stem cell infusion for autologous stem
cell transplant, if hematological and all other eligibility criteria are met.

- Performance status: ECOG 0-2.

- Patients must be free of significant functional deficits in major organs, but the
following eligibility criteria may be modified in individual cases.

1. Heart: a shortening fraction ? 28%

2. Liver: total bilirubin < 2 × upper limit of normal; ALT < 3 × upper limit of

3. Kidney: creatinine <2 × normal

- Patients must lack any active viral infections or active fungal infection.

- Patients (or one of parents if patients age < 20) should sign informed consent.

Exclusion Criteria:

- Pregnant or nursing women.

- Malignant (except brain tumor) or nonmalignant illness that is uncontrolled or whose
control may be jeopardized by complications of study therapy.

- Psychiatric disorder that would preclude compliance.

- Patients who, in the opinion of the investigator, may not be able to comply with the
safety monitoring requirements of the study.
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