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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages N/A - 3 Years
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT00281905
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Children's Cancer and Leukaemia Group
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Richard Grundy, MD, PhD
Principal Investigator Affiliation Queen's Medical Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Unknown status
Countries Ireland, United Kingdom
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Brain and Central Nervous System Tumors, Neuroblastoma
Additional Details

OBJECTIVES:

  • - Determine the response rate in children under 36 months of age with primary brain or brain stem tumors treated with vincristine, methotrexate, carboplatin, cyclophosphamide, and cisplatin with or without radiotherapy.
  • - Determine the event-free survival and overall survival in children treated with this regimen.
  • - Determine the pattern of local recurrence or occurrence of CNS metastases in children treated with this regimen.
  • - Determine the quality of life in children treated with this regimen.
  • - Determine the tolerability and long-term toxicity of this regimen in these children.
  • - Determine the proportion of children who require radiotherapy after treatment with this regimen.
  • - Determine the prognosis of children who receive both chemotherapy and radiotherapy.
  • - Determine the nature and behavior of brain tumors in very young children.
OUTLINE: This is a multicenter study.
  • - Chemotherapy: Patients receive vincristine IV on days 0, 14, and 28; carboplatin IV over 4 hours on day 0; methotrexate IV continuously over 24 hours on day 14; cyclophosphamide IV over 4 hours on day 28; and cisplatin IV continuously over 48 hours on days 42 and 43.
Courses repeat every 56 days (8 weeks) for up to 12 months. Patients who achieve a complete response proceed to observation, as do those achieving a partial response with no tumor present on biopsy. Patients with biopsy proven residual tumors after 12 months of chemotherapy or recurrent tumors that don't have the potential to spread through the cerebrospinal fluid (CSF) proceed to local radiotherapy. Patients with unresponsive disease or progressive disease that has the potential to spread through the CSF proceed to craniospinal radiotherapy.
  • - Local radiotherapy: Patients undergo local radiotherapy 5 days a week for 5-5½ weeks.
  • - Craniospinal radiotherapy: Patients undergo craniospinal radiotherapy 5 days a week for 4 weeks.
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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Our Lady's Hospital for Sick Children, Dublin, Ireland

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Our Lady's Hospital for Sick Children

Dublin, , 12

Birmingham Children's Hospital, Birmingham, England, United Kingdom

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Birmingham Children's Hospital

Birmingham, England, B4 6NH

Bristol, England, United Kingdom

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Institute of Child Health at University of Bristol

Bristol, England, BS2 8AE

Cambridge, England, United Kingdom

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Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust

Cambridge, England, CB2 2QQ

Leeds, England, United Kingdom

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Leeds Cancer Centre at St. James's University Hospital

Leeds, England, LS9 7TF

Leicester Royal Infirmary, Leicester, England, United Kingdom

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Leicester Royal Infirmary

Leicester, England, LE1 5WW

Liverpool, England, United Kingdom

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Royal Liverpool Children's Hospital, Alder Hey

Liverpool, England, L12 2AP

Royal London Hospital, London, England, United Kingdom

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Royal London Hospital

London, England, E1 1BB

London, England, United Kingdom

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Great Ormond Street Hospital for Children NHS Trust

London, England, WC1N 3JH

Manchester, England, United Kingdom

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Central Manchester and Manchester Children's University Hospitals NHS Trust

Manchester, England, M27 4HA

Newcastle-Upon-Tyne, England, United Kingdom

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Sir James Spence Institute of Child Health

Newcastle-Upon-Tyne, England, NE1 4LP

Queen's Medical Centre, Nottingham, England, United Kingdom

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Queen's Medical Centre

Nottingham, England, NG7 2UH

Oxford Radcliffe Hospital, Oxford, England, United Kingdom

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Oxford Radcliffe Hospital

Oxford, England, 0X3 9DU

Children's Hospital - Sheffield, Sheffield, England, United Kingdom

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Children's Hospital - Sheffield

Sheffield, England, S10 2TH

Southampton General Hospital, Southampton, England, United Kingdom

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Southampton General Hospital

Southampton, England, SO16 6YD

Sutton, England, United Kingdom

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Royal Marsden NHS Foundation Trust - Surrey

Sutton, England, SM2 5PT

Royal Belfast Hospital for Sick Children, Belfast, Northern Ireland, United Kingdom

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Royal Belfast Hospital for Sick Children

Belfast, Northern Ireland, BT12 6BE

Royal Aberdeen Children's Hospital, Aberdeen, Scotland, United Kingdom

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Royal Aberdeen Children's Hospital

Aberdeen, Scotland, AB25 2ZG

Royal Hospital for Sick Children, Edinburgh, Scotland, United Kingdom

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Royal Hospital for Sick Children

Edinburgh, Scotland, EH9 1LF

Royal Hospital for Sick Children, Glasgow, Scotland, United Kingdom

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Royal Hospital for Sick Children

Glasgow, Scotland, G3 8SJ

Childrens Hospital for Wales, Cardiff, Wales, United Kingdom

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Childrens Hospital for Wales

Cardiff, Wales, CF14 4XW