Clinical Trial Details
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NCT01574092 : Irinotecan in Combination With Cisplatin in Pediatric Patients With Unfavorable Prognosis Gliomas
PhasePhase 2
AgesMin: 6 Months Max: 18 Years
Inclusion criteria:

1. Histological confirmation of neoplasia, except for intrinsic brain stem tumour and
optic pathway glioma in one patient with neurofibromatosis type 1 (NF1).

2. Pertaining to one of the diagnostic groups: Cohort 1: Recently diagnosed high grade
glioma. Cohort 2: Recurrent high grade glioma. Cohort 3: Intrinsic brain stem tumour.
Cohort 4: High risk low grade glioma.

3. Measurable primary or metastatic tumours with at least one 10 mm diameter lesion in
two MR dimensions.

4. Absence of prior treatment with cisplatin or irinotecan.

5. Aged between 6 months to 18 years.

6. Lansky/Karnofsky performance status ? 70% (Appendix 6.1). Neurological deficits
secondary to the tumour should be stable before entering the trial.

7. Patients receiving dexamethasone should be on a stable or decreasing regimen before

8. Life expectancy ? 3 months.

9. Adequate organic function, including haematological, renal and hepatic function.

10. Wash-out period of at least 3 weeks after chemotherapy and 6 weeks after nitrosoureas
or radiotherapy. Recovery from all toxic effects of previous treatments.

11. Subjects of fertile age should use an effective birth control method throughout the
entire study. Women of child-bearing age will be included after a negative pregnancy
test result.

12. Informed consent of the parents or legal representative, and informed consent of the
mature minor.

Exclusion criteria:

1. Concurrent administration of any other anti-cancer treatment.

2. Pre-existing, non-controlled diarrhoea

3. Pregnancy or lactation

4. Treatment in another clinical trial.

5. Serious concomitant disease that could compromise the completion of the trial. -
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