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

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ClinicalTrials.gov Identifier: NCT00147160
Recruitment Status : Completed
First Posted : September 7, 2005
Last Update Posted : April 11, 2012
Sponsor:
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris

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

Condition or disease Intervention/treatment Phase
Glioma Drug: Temozolomide, Cisplatinum Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 87 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2003
Actual Primary Completion Date : July 2006
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Radiological response after two courses of Temozolomide-Cisplatinum

Secondary Outcome Measures :
  1. Progression-free survival
  2. Health status and quality of life
  3. Toxicity


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Ages Eligible for Study:   4 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00147160


Locations
France
Institut Gustave-Roussy
Villejuif, France, 94805
United Kingdom
Bristol Royal Hospital for Children
Bristol, United Kingdom, BS2 8BJ
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Investigators
Principal Investigator: Jacques Grill, MD, PhD Gustave Roussy, Cancer Campus, Grand Paris

Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier: NCT00147160     History of Changes
Other Study ID Numbers: CISTEM2
CSET-2002/978
First Posted: September 7, 2005    Key Record Dates
Last Update Posted: April 11, 2012
Last Verified: September 2006

Additional relevant MeSH terms:
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Temozolomide
Cisplatin
Dacarbazine
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action