Trial intelligence / Profile preview

IL13-PE38QQR in Pediatric Recurrent Malignant Glioma

NCT00378235Phase 2

Key facts

Status: Withdrawn
Countries: 1
Sponsor: Insys Therapeutics
Modality: Immunotoxins, Fc-Fusion Proteins

Drugs: cintredekin besudotox
Conditions: malignant glioma

Overview

Phase 2, open-label, single-arm trial of cintredekin besudotox in malignant glioma, sponsored by Insys Therapeutics. Primary endpoints: Toxicities and Adverse Events, Maximum Safe Flow Rate and 1 more. Status: withdrawn.

Design

1 arm

Study design: Non-randomizedOpen-label

IL13-PE38QQR Infusion
Intracerebral infusion of Cintredekin besudotox via stereotactically placed catheters

Who it enrols

Pediatric patients (3-21 years) with recurrent or progressive supratentorial malignant glioma amenable to gross total resection, having failed prior radiotherapy.

Endpoints

Primary

Toxicities and Adverse EventsStart of infusion through DLT observation period
Maximum Safe Flow RateStart of infusion through DLT observation period
Maximum Tolerated Infusion ConcentrationStart of infusion through DLT observation period

Secondary

Overall SurvivalPost initial progression
Progression-Free SurvivalPost initial progression or recurrence
Serum Levels of IL13-PE38QQR

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