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The PRECISE Trial: Study of IL13-PE38QQR Compared to GLIADEL Wafer in Patients With Recurrent Glioblastoma Multiforme

NCT00076986 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2011-06-06

No results posted yet for this study

Summary

The purpose of the PRECISE trial is to determine whether overall survival duration, safety, and quality of life are improved for patients treated with IL13-PE38QQR compared to patients treated with GLIADEL® Wafer following surgical tumor removal in the treatment of first recurrence of glioblastoma multiforme.

Conditions

Interventions

DRUG

IL13-PE38QQR

PROCEDURE

surgery and catheter placement (2 procedures)

DRUG

prolifespan 20 with carmustine implant (GLIADEL® Wafer)

PROCEDURE

surgery and wafer placement (1 procedure)

Sponsors & Collaborators

  • INSYS Therapeutics Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-02-29
Primary Completion
2007-03-31
Completion
2007-03-31

Countries

  • United States
  • Canada
  • Germany
  • Israel
  • Netherlands
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00076986 on ClinicalTrials.gov