Combination Chemotherapy With or Without Radiation Therapy in Treating Children With Brain Tumors
NCT ID: NCT00281905
Last Updated: 2013-09-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
50 participants
INTERVENTIONAL
1992-06-30
Brief Summary
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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.
Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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TREATMENT
NONE
Interventions
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carboplatin
cisplatin
cyclophosphamide
methotrexate
vincristine sulfate
radiation therapy
Eligibility Criteria
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Inclusion Criteria
* 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
3 Years
ALL
No
Sponsors
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Children's Cancer and Leukaemia Group
OTHER
Principal Investigators
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Richard Grundy, MD, PhD
Role: STUDY_CHAIR
Queen's Medical Center
Locations
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Our Lady's Hospital for Sick Children
Dublin, , Ireland
Birmingham Children's Hospital
Birmingham, England, United Kingdom
Institute of Child Health at University of Bristol
Bristol, England, United Kingdom
Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
Cambridge, England, United Kingdom
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom
Leicester Royal Infirmary
Leicester, England, United Kingdom
Royal Liverpool Children's Hospital, Alder Hey
Liverpool, England, United Kingdom
Royal London Hospital
London, England, United Kingdom
Great Ormond Street Hospital for Children NHS Trust
London, England, United Kingdom
Central Manchester and Manchester Children's University Hospitals NHS Trust
Manchester, England, United Kingdom
Sir James Spence Institute of Child Health
Newcastle upon Tyne, England, United Kingdom
Queen's Medical Centre
Nottingham, England, United Kingdom
Oxford Radcliffe Hospital
Oxford, England, United Kingdom
Children's Hospital - Sheffield
Sheffield, England, United Kingdom
Southampton General Hospital
Southampton, England, United Kingdom
Royal Marsden NHS Foundation Trust - Surrey
Sutton, England, United Kingdom
Royal Belfast Hospital for Sick Children
Belfast, Northern Ireland, United Kingdom
Royal Aberdeen Children's Hospital
Aberdeen, Scotland, United Kingdom
Royal Hospital for Sick Children
Edinburgh, Scotland, United Kingdom
Royal Hospital for Sick Children
Glasgow, Scotland, United Kingdom
Childrens Hospital for Wales
Cardiff, Wales, United Kingdom
Countries
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Other Identifiers
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CCLG-CNS-9204
Identifier Type: -
Identifier Source: secondary_id
EU-20574
Identifier Type: -
Identifier Source: secondary_id
CCLG-CNS-1992-04
Identifier Type: -
Identifier Source: secondary_id
CDR0000454575
Identifier Type: -
Identifier Source: org_study_id