Phase II Cisplatin + Temozolomide in Malignant Glial Tumours in Children and Adolescents

April 10, 2012 updated by: Gustave Roussy, Cancer Campus, Grand Paris

Phase II Study of the Combination of Cisplatin + Temozolomide in Malignant Glial Tumours in Children and Adolescents at Diagnosis or in Relapse

The purpose of this study is to determine whether the combination of Temozolomide and Cisplatinum is effective in the treatment of malignant glial tumours of children and adolescents

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

87

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Villejuif, France, 94805
        • Institut Gustave-Roussy
  • United Kingdom
      • Bristol, United Kingdom, BS2 8BJ
        • Bristol Royal Hospital for Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 21 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age from 4th birthday and younger than 21st birthday
  • Histologically documented malignant glial tumour (WHO classification grade III and IV) : astrocytoma, oligodendroglioma, oligoastrocytoma and mixed tumours
  • Measurable and evaluable disease by the imaging criteria (MRI)
  • Patient not previously treated by either of the two drugs

Exclusion Criteria:

  • Malignant brain stem tumours are excluded

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Radiological response after two courses of Temozolomide-Cisplatinum

Secondary Outcome Measures

Outcome Measure
Toxicity
Progression-free survival
Health status and quality of life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Investigators

  • Principal Investigator: Jacques Grill, MD, PhD, Gustave Roussy, Cancer Campus, Grand Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2003

Primary Completion (ACTUAL)

July 1, 2006

Study Completion (ACTUAL)

December 1, 2007

Study Registration Dates

First Submitted

September 6, 2005

First Submitted That Met QC Criteria

September 6, 2005

First Posted (ESTIMATE)

September 7, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

April 11, 2012

Last Update Submitted That Met QC Criteria

April 10, 2012

Last Verified

September 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CISTEM2
  • CSET-2002/978

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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