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Sponsored by: |
Children's Cancer and Leukaemia Group |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00281905 |
RATIONALE: Drugs used in chemotherapy 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. Radiation therapy uses high-energy x-rays to kill tumor cells.
Giving radiation therapy after chemotherapy may kill any remaining tumor cells.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with or without radiation therapy works in treating children with brain tumors.
Condition | Intervention | Phase |
---|---|---|
Brain and Central Nervous System Tumors Neuroblastoma |
Drug: carboplatin Drug: cisplatin Drug: cyclophosphamide Drug: methotrexate Drug: vincristine sulfate Radiation: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Management of Children Aged Less Than 3 Years With Brain Tumors |
Estimated Enrollment: | 50 |
Study Start Date: | June 1992 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Quality of life is assessed periodically.
After completion of study treatment, patients are followed periodically for at least 2 years.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Ages Eligible for Study: | up to 3 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following:
Histologically confirmed primary intracranial brain tumor of 1 of the following histologies:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No concurrent steroids as anti-emetics
Ireland | |
Our Lady's Hospital for Sick Children | |
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 | |
Central Manchester and Manchester Children's University Hospitals NHS Trust | |
Manchester, England, United Kingdom, M27 4HA | |
Children's Hospital - Sheffield | |
Sheffield, England, United Kingdom, S10 2TH | |
Oxford Radcliffe Hospital | |
Oxford, England, United Kingdom, 0X3 9DU | |
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 | |
Leicester Royal Infirmary | |
Leicester, England, United Kingdom, LE1 5WW | |
Great Ormond Street Hospital for Children NHS Trust | |
London, England, United Kingdom, WC1N 3JH | |
Queen's Medical Centre | |
Nottingham, England, United Kingdom, NG7 2UH | |
Royal Liverpool Children's Hospital, Alder Hey | |
Liverpool, England, United Kingdom, L12 2AP | |
Royal London Hospital | |
London, England, United Kingdom, E1 1BB | |
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 General Hospital | |
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 |
Study Chair: | Richard Grundy, MD, PhD | Queen's Medical Centre |
Study ID Numbers: | CDR0000454575, CCLG-CNS-9204, EU-20574, CCLG-CNS-1992-04 |
Study First Received: | January 24, 2006 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00281905 History of Changes |
Health Authority: | United States: Federal Government |
untreated childhood brain stem glioma childhood high-grade cerebral astrocytoma childhood low-grade cerebral astrocytoma untreated childhood cerebellar astrocytoma childhood choroid plexus tumor childhood infratentorial ependymoma childhood supratentorial ependymoma newly diagnosed childhood ependymoma |
untreated childhood medulloblastoma childhood oligodendroglioma untreated childhood supratentorial primitive neuroectodermal tumor disseminated neuroblastoma localized resectable neuroblastoma localized unresectable neuroblastoma regional neuroblastoma stage 4S neuroblastoma |
Antimetabolites Choroid Plexus Neoplasms Neuroectodermal Tumors, Primitive Immunologic Factors Central Nervous System Neoplasms Cyclophosphamide Brain Diseases Ependymoma Neuroblastoma Cisplatin Neoplasms, Germ Cell and Embryonal Neuroepithelioma Methotrexate Glioma Alkylating Agents |
Nervous System Neoplasms Astrocytoma Central Nervous System Diseases Vincristine Antimitotic Agents Carboplatin Folic Acid Antagonists Immunosuppressive Agents Folic Acid Neuroectodermal Tumors Brain Neoplasms Brain Stem Glioma, Childhood Tubulin Modulators Medulloblastoma Oligodendroglioma |
Antimetabolites Antimetabolites, Antineoplastic Neuroectodermal Tumors, Primitive Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Reproductive Control Agents Central Nervous System Neoplasms Cyclophosphamide Brain Diseases Neuroblastoma Neoplasms by Site Therapeutic Uses |
Neoplasms, Germ Cell and Embryonal Abortifacient Agents Methotrexate Dermatologic Agents Alkylating Agents Nucleic Acid Synthesis Inhibitors Nervous System Neoplasms Neoplasms by Histologic Type Mitosis Modulators Nervous System Diseases Central Nervous System Diseases Vincristine Enzyme Inhibitors Antimitotic Agents Carboplatin |