Trial intelligence / Profile preview

Oral Procarbazine in Recurrent High Grade Astrocytomas

NCT00004004Phase 2

Key facts

Status: Completed
Start: Jul 1999
Countries: 1
Sponsor: New Approaches to Brain Tumor Therapy Consortium
Modality: Small Molecules

Drugs: procarbazine
Conditions: malignant gliomaastrocytomaOligodendroglioma (OG)glioblastoma multiforme (GBM)

Overview

Phase 2, open-label trial of procarbazine in malignant glioma, astrocytoma, Oligodendroglioma (OG) and 1 more (2 arms), sponsored by New Approaches to Brain Tumor Therapy Consortium. Primary endpoints: Maximum Tolerated Dose and Pharmacokinetics. Started Jul 1999; status: completed.

Design

2 arms

Study design: Non-randomizedOpen-label

Procarbazine with EIAED
Patients receiving anticonvulsants metabolized by the P450 hepatic enzyme complex.
Procarbazine without EIAED
Patients not receiving anticonvulsants metabolized by the P450 hepatic enzyme complex.

Who it enrols

Adults with progressive or recurrent malignant glioma (anaplastic astrocytoma, anaplastic oligodendroglioma, or glioblastoma multiforme) after radiotherapy, with adequate organ function and no more than 1 prior chemotherapy regimen.

Endpoints

Primary

Maximum Tolerated Dose
Pharmacokinetics

Secondary

Objective Response Rate
Overall Survival
Disease Free Survival
Toxicity

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