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Phase II Trial to Assess the Radiosensitizing Effect of ZARNESTRA in Patients With Glioblastoma Multiforme

NCT00209989 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2011-11-24

No results posted yet for this study

Summary

The purpose of this study is to determine the efficacy by the determination of the Time To Progression (TTP) in patients with resectable GBM or non surgical GBM with a size less than 5 cm treated with the combination of ZARNESTRA plus Radiation therapy.

Conditions

Interventions

DRUG

Zarnestra

ZARNESTRA 100 bid (phase II recommended dose defined in phase I)will be administered continuously from one week prior to start of radiation therapy until the last day of radiation therapy.

PROCEDURE

standard Radiation therapy

Radiotherapy will be focused on the initial tumour volume with a reasonable margin of safety (2 cm). A total dose of 60 Gray (Gy) will be given to the Clinical Target Volume

Sponsors & Collaborators

  • Janssen-Cilag Ltd.

    collaborator INDUSTRY

  • Institut Claudius Regaud

    lead OTHER

Principal Investigators

  • Elizabeth MOYAL, Dr · Institut Claudius Regaud

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2011-06-30
Completion
2011-06-30

Countries

  • France

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 NCT00209989 on ClinicalTrials.gov