Combination Chemotherapy With or Without Radiation Therapy in Treating Children With Brain Tumors

NCT00281905 | Unknown Phase 2

• 4 other identifiers: CDR0000454575CCLG-CNS-9204EU-20574CCLG-CNS-1992-04
• Study Type: interventional
• Target: 50
• Locations: 2 countries
• Sites: 21

Brief Summary

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.

Conditions

Brain and Central Nervous System Tumors; Neuroblastoma

Keywords

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

Outcome Measures

Primary Outcomes (9)

• Response rate

• Event-free survival

• Local recurrence or occurrence of CNS metastases

• Quality of survival

• Tolerance

• Long-term toxicity

• Proportion of patients requiring radiotherapy

• Prognosis of children who receive both chemotherapy and radiotherapy

• Nature and behavior of brain tumors

Interventions

carboplatin DRUG

cisplatin DRUG

cyclophosphamide DRUG

methotrexate DRUG

vincristine sulfate DRUG

radiation therapy RADIATION

Eligibility Criteria

• Age: Up to 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

DISEASE CHARACTERISTICS: * Diagnosis of 1 of the following: * Brain stem tumor (histological confirmation not required) * Histologically confirmed primary intracranial brain tumor of 1 of the following histologies: * Anaplastic (malignant) astrocytoma * Glioblastoma * Anaplastic (malignant) oligodendroglioma * Ependymoma * Anaplastic (malignant) ependymoma * Anaplastic (malignant) oligoastrocytoma * Choroid plexus carcinoma * Astroblastoma * Polar spongioblastoma * Gliomatosis cerebri * Anaplastic (malignant) ganglioglioma * Pineoblastoma * Mixed pineocytoma or pineoblastoma * Medulloepithelioma * Neuroblastoma * Ependymoblastoma * Primitive neuroectodermal tumors (PNETs), including medulloblastoma or cerebral or spinal PNETs * Has undergone surgery or biopsy of the tumor within the past 2-4 weeks PATIENT CHARACTERISTICS: * No concurrent unrelated disease, including hematological or renal disease, that would preclude study treatment PRIOR CONCURRENT THERAPY: * No prior chemotherapy or radiotherapy * Prior steroids allowed * No concurrent steroids as anti-emetics * Concurrent steroids allowed for control of tumor-related symptoms

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Children's Cancer and Leukaemia Group: lead

Study Sites (21)

Our Lady's Hospital for Sick Children

Dublin, 12, Ireland

Location

Birmingham Children's Hospital

Birmingham, England, B4 6NH, United Kingdom

Location

Institute of Child Health at University of Bristol

Bristol, England, BS2 8AE, United Kingdom

Location

Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust

Cambridge, England, CB2 2QQ, United Kingdom

Location

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, LS9 7TF, United Kingdom

Location

Leicester Royal Infirmary

Leicester, England, LE1 5WW, United Kingdom

Location

Royal Liverpool Children's Hospital, Alder Hey

Liverpool, England, L12 2AP, United Kingdom

Location

Royal London Hospital

London, England, E1 1BB, United Kingdom

Location

Great Ormond Street Hospital for Children NHS Trust

London, England, WC1N 3JH, United Kingdom

Location

Central Manchester and Manchester Children's University Hospitals NHS Trust

Manchester, England, M27 4HA, United Kingdom

Location

Sir James Spence Institute of Child Health

Newcastle upon Tyne, England, NE1 4LP, United Kingdom

Location

Queen's Medical Centre

Nottingham, England, NG7 2UH, United Kingdom

Location

Oxford Radcliffe Hospital

Oxford, England, 0X3 9DU, United Kingdom

Location

Children's Hospital - Sheffield

Sheffield, England, S10 2TH, United Kingdom

Location

Southampton General Hospital

Southampton, England, SO16 6YD, United Kingdom

Location

Royal Marsden NHS Foundation Trust - Surrey

Sutton, England, SM2 5PT, United Kingdom

Location

Royal Belfast Hospital for Sick Children

Belfast, Northern Ireland, BT12 6BE, United Kingdom

Location

Royal Aberdeen Children's Hospital

Aberdeen, Scotland, AB25 2ZG, United Kingdom

Location

Royal Hospital for Sick Children

Edinburgh, Scotland, EH9 1LF, United Kingdom

Location

Royal Hospital for Sick Children

Glasgow, Scotland, G3 8SJ, United Kingdom

Location

Childrens Hospital for Wales

Cardiff, Wales, CF14 4XW, United Kingdom

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms; Neuroblastoma; Astrocytoma; Choroid Plexus Neoplasms; Oligodendroglioma

Interventions

Carboplatin; Cisplatin; Cyclophosphamide; Methotrexate; Vincristine; Radiotherapy

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Glioma; Cerebral Ventricle Neoplasms; Brain Neoplasms; Brain Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines; Therapeutics

Study Officials

• Richard Grundy, MD, PhD

  Queen's Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 24, 2006
• First Posted: January 25, 2006
• Study Start: June 1, 1992
• Last Updated: September 20, 2013

Record last verified: 2007-06

Locations

IE (1); GB (20)