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|NCT01535183 : Irinotecan Combination Chemotherapy for Refractory or Relapsed Brain Tumor in Children and Adolescents|
|Ages||Min: N/A Max: 19 Years|
- 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.
- 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.
|Links||Permanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT01535183
| Link to official Clinicaltrials.gov listing