Combination of Irinotecan and Temozolomide in Children With Brain Tumors.

Pfizer

Status and phase: Completed; Phase 2

Conditions: Glioma; Medulloblastoma

Treatments: Drug: Temozolomide; Drug: Irinotecan

Study type: Interventional

Funder types: Industry

Identifiers

NCT00404495

A5961166

Details and patient eligibility

About

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.

Enrollment: 83 patients

Sex: All

Ages: 6 months to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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83 participants in 1 patient group

Temozolomide + Irinotecan

Experimental group

Treatment:

Drug: Temozolomide

Drug: Irinotecan