Back to resultsPhase II Cisplatin + Temozolomide in Malignant Glial Tumours in Children and Adolescents
Primary Purpose
Glioma
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Temozolomide, Cisplatinum
Sponsored by
About this trial
This is an interventional treatment trial for Glioma
Eligibility Criteria
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
Sites / Locations
- Institut Gustave-Roussy
- Bristol Royal Hospital for Children
Outcomes
Primary Outcome Measures
Radiological response after two courses of Temozolomide-Cisplatinum
Secondary Outcome Measures
Progression-free survival
Health status and quality of life
Toxicity
Full Information
NCT ID
NCT00147160
First Posted
September 6, 2005
Last Updated
April 10, 2012
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
1. Study Identification
Unique Protocol Identification Number
NCT00147160
Brief Title
Phase II Cisplatin + Temozolomide in Malignant Glial Tumours in Children and Adolescents
Official Title
Phase II Study of the Combination of Cisplatin + Temozolomide in Malignant Glial Tumours in Children and Adolescents at Diagnosis or in Relapse
Study Type
Interventional
2. Study Status
Record Verification Date
September 2006
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
4. Oversight
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
87 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Temozolomide, Cisplatinum
Primary Outcome Measure Information:
Title
Radiological response after two courses of Temozolomide-Cisplatinum
Secondary Outcome Measure Information:
Title
Progression-free survival
Title
Health status and quality of life
Title
Toxicity
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacques Grill, MD, PhD
Organizational Affiliation
Gustave Roussy, Cancer Campus, Grand Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Gustave-Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
Bristol Royal Hospital for Children
City
Bristol
ZIP/Postal Code
BS2 8BJ
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Phase II Cisplatin + Temozolomide in Malignant Glial Tumours in Children and Adolescents
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