Combination of Irinotecan and Temozolomide in Children With Brain Tumors.

Phase 2 Single-Arm, Open Label Study Of Irinotecan In Combination With Temozolomide In Children With Recurrent Or Refractory Medulloblastoma And In Children With Newly Diagnosed High-Grade Glioma.

This study will assess the rate of objective confirmed tumor response of irinotecan in combination with temozolomide in children with recurrent or refractory medulloblastoma and in children with newly diagnosed high-grade glioma.

Inclusion Criteria:

• Cohort 1: Recurrent or refractory medulloblastoma in which current standard treatment approaches have failed; biopsy is not required for recurrent disease.
• Cohort 2: Newly-diagnosed high-grade glioma (World Health Organization [WHO] grade 3 or 4)
• Life expectancy ≥ 3 months

Exclusion Criteria:

• Diagnosis of brainstem glioma
• Concurrent administration of any other anti-tumor therapy
• Pre-existing uncontrolled diarrhea