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Irinotecan, Radiation Therapy, and Temozolomide in Pediatric High-Grade Gliomas

NCT00004068Phase 2

Key facts

Status: Completed
Start: Mar 1999
Primary completion: Apr 2003
Countries: 1
Sponsor: St. Jude Children's Research Hospital
Modality: Small Molecules

Drugs: irinotecan
Conditions: gliomabrainstem gliomaastrocytoma

Overview

Phase 2, open-label, single-arm trial of irinotecan in glioma, brainstem glioma and astrocytoma, sponsored by St. Jude Children's Research Hospital. Primary endpoints: Objective Response Rate, Rate of Freedom from Recurrence and 3 more. Started Mar 1999; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-labelSingle group

Irinotecan + RT + Temozolomide
Single arm receiving sequential irinotecan, radiation therapy, and temozolomide.

Who it enrols

Patients aged 3 to 21 with newly diagnosed, histologically confirmed high-grade gliomas, brain stem gliomas, or high-risk grade II astrocytomas, with adequate organ function and no prior chemotherapy or radiotherapy.

Endpoints

Primary

Objective Response Ratepost-irinotecan window
Rate of Freedom from Recurrencepost-irinotecan window
Overall Survival3 years
Progression-Free Survival3 years
Hematopoietic Toxicity of Temozolomideduring temozolomide treatment

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