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Sponsored by: |
Children's Cancer and Leukaemia Group |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00360945 |
RATIONALE: Drugs used in chemotherapy, such as cisplatin and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving cisplatin together with temozolomide works in treating young patients with malignant glioma.
Condition | Intervention | Phase |
---|---|---|
Brain and Central Nervous System Tumors |
Drug: cisplatin Drug: temozolomide Procedure: fluorescence in situ hybridization Procedure: immunohistochemistry staining method Procedure: laboratory biomarker analysis Procedure: loss of heterozygosity analysis Procedure: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label |
Official Title: | Phase II Study of the Combination of Cisplatin + Temozolomide in Malignant Glial Tumours in Children and Adolescents at Diagnosis or in Relapse |
Estimated Enrollment: | 87 |
Study Start Date: | April 2004 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, open-label, nonrandomized, parallel-group study. Patients are stratified according to disease status (newly diagnosed vs relapsed). Patients with newly diagnosed disease are further stratified according to spread of disease (localized and measurable vs diffuse unmeasurable).
Tissue and blood samples are obtained at baseline and examined by immunohistochemistry, fluorescent in situ hybridization (FISH), and loss of heterozygosity. The tumor tissue is analyzed for p53, MSH2, MLH1, and MGMT.
After completion of study treatment, patients are followed periodically for 2 years.
PROJECTED ACCRUAL: A total of 87 patients will be accrued for this study.
Ages Eligible for Study: | 4 Years to 20 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed diagnosis of 1 of the following grade III or grade IV malignant glial tumors*:
Anaplastic mixed tumor
Incompletely resected tumors
PATIENT CHARACTERISTICS:
Creatinine normal for age
PRIOR CONCURRENT THERAPY:
France | |
Institut Gustave Roussy | |
Villejuif, France, F-94805 | |
Ireland | |
Our Lady's Hospital for Sick Children Crumlin | |
Dublin, Ireland, 12 | |
United Kingdom, England | |
Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust | |
Cambridge, England, United Kingdom, CB2 2QQ | |
Birmingham Children's Hospital | |
Birmingham, England, United Kingdom, B4 6NH | |
Bristol Royal Hospital for Children | |
Bristol, England, United Kingdom, BS2 8BJ | |
Leicester Royal Infirmary | |
Leicester, England, United Kingdom, LE1 5WW | |
Children's Hospital - Sheffield | |
Sheffield, England, United Kingdom, S10 2TH | |
Great Ormond Street Hospital for Children NHS Trust | |
London, England, United Kingdom, WC1N 3JH | |
Institute of Child Health at University of Bristol | |
Bristol, England, United Kingdom, BS2 8AE | |
Leeds Cancer Centre at St. James's University Hospital | |
Leeds, England, United Kingdom, LS9 7TF | |
Central Manchester and Manchester Children's University Hospitals NHS Trust | |
Manchester, England, United Kingdom, M27 4HA | |
Middlesex Hospital | |
London, England, United Kingdom, W1T 3AA | |
Oxford Radcliffe Hospital | |
Oxford, England, United Kingdom, 0X3 9DU | |
Queen's Medical Centre | |
Nottingham, England, United Kingdom, NG7 2UH | |
Royal Liverpool Children's Hospital, Alder Hey | |
Liverpool, England, United Kingdom, L12 2AP | |
Royal Marsden NHS Foundation Trust - Surrey | |
Sutton, England, United Kingdom, SM2 5PT | |
Sir James Spence Institute of Child Health | |
Newcastle-Upon-Tyne, England, United Kingdom, NE1 4LP | |
Southampton University Hospital NHS Trust | |
Southampton, England, United Kingdom, SO16 6YD | |
United Kingdom, Northern Ireland | |
Royal Belfast Hospital for Sick Children | |
Belfast, Northern Ireland, United Kingdom, BT12 6BE | |
United Kingdom, Scotland | |
Royal Aberdeen Children's Hospital | |
Aberdeen, Scotland, United Kingdom, AB25 2ZG | |
Royal Hospital for Sick Children | |
Glasgow, Scotland, United Kingdom, G3 8SJ | |
Royal Hospital for Sick Children | |
Edinburgh, Scotland, United Kingdom, EH9 1LF | |
United Kingdom, Wales | |
Childrens Hospital for Wales | |
Cardiff, Wales, United Kingdom, CF14 4XW |
Investigator: | Steve Lowis, MD, PhD, BA, MRCP, MRCPCH | Bristol Royal Hospital for Children |
Investigator: | Jacques Grill, MD, PhD | Institut Gustave Roussy |
Investigator: | Anthony Michalski, MD | Great Ormond Street Hospital for Children |
Investigator: | David A. Walker | Queen's Medical Centre |
Study ID Numbers: | CDR0000482280, CCLG-CNS-2004-02, EU-20622 |
Study First Received: | August 3, 2006 |
Last Updated: | May 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00360945 |
Health Authority: | United States: Federal Government |
childhood oligodendroglioma untreated childhood cerebellar astrocytoma childhood high-grade cerebral astrocytoma childhood low-grade cerebral astrocytoma |
recurrent childhood cerebellar astrocytoma recurrent childhood cerebral astrocytoma recurrent childhood brain tumor |
Brain Neoplasms Cisplatin Astrocytoma Oligodendroglioma Glioma |
Central Nervous System Neoplasms Temozolomide Recurrence Nervous System Neoplasms |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Radiation-Sensitizing Agents Antineoplastic Agents Therapeutic Uses |
Physiological Effects of Drugs Nervous System Diseases Antineoplastic Agents, Alkylating Alkylating Agents Pharmacologic Actions |