Spots Global Cancer Trial Database for Radiation Therapy and Combination Chemotherapy in Treating Young Patients With Metastatic Medulloblastoma Who Have Undergone Surgery
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Trial Identification
Brief Title: Radiation Therapy and Combination Chemotherapy in Treating Young Patients With Metastatic Medulloblastoma Who Have Undergone Surgery
Official Title: Hyperfractionated Accelerated Radiotherapy (HART) With Chemotherapy (Cisplatin, CCNU, Vincristine) for Metastatic (M1-3) Medulloblastoma
Study ID: NCT00276666
Conditions
Study Description
Brief Summary: RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as lomustine, vincristine, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with combination chemotherapy after surgery may kill any tumor cells that remain. PURPOSE: This phase II trial is studying giving radiation therapy together with combination chemotherapy to see how well it works in treating young patients with metastatic medulloblastoma who have undergone surgery.
Detailed Description: OBJECTIVES: * Determine the toxicity of hyperfractionated accelerated radiotherapy (HART) in young patients with metastatic medulloblastoma. * Determine the toxicity of chemotherapy (vincristine during radiotherapy and 8 courses of lomustine, cisplatin, and vincristine after radiotherapy) in association with HART in these patients. OUTLINE: This is a multicenter study. * Radiotherapy and vincristine: Beginning 4-6 weeks after surgery, patients undergo hyperfractionated accelerated radiotherapy (HART) twice a day, 5 days a week, for 5 weeks. Patients also receive vincristine IV once weekly for 8 weeks beginning in week 1\*. Approximately 6-8 weeks after completion of radiotherapy, patients proceed to maintenance chemotherapy. NOTE: \*The first 7 patients undergo radiotherapy without receiving vincristine * Maintenance chemotherapy: Patients receive oral lomustine once on day 1 and cisplatin IV over 6 hours on day 1 and vincristine IV on days 1, 8, and 15. Treatment repeats every 6 weeks for 8 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically for 5 years. PROJECTED ACCRUAL: A total of 29 patients will be accrued for this study.
Eligibility
Minimum Age: 3 Years
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Our Lady's Hospital for Sick Children Crumlin, 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, Cambridge, England, United Kingdom
Cookridge Hospital, Leeds, 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, London, England, United Kingdom
Royal Manchester Children's Hospital, Manchester, England, United Kingdom
Sir James Spence Institute of Child Health at Royal Victoria Infirmary, 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 - 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
Contact Details
Name: Roger Taylor, MD
Affiliation: Cookridge Hospital
Role: STUDY_CHAIR
Name: Frank Saran, MD
Affiliation: Royal Marsden NHS Foundation Trust
Role:
Name: Barry Pizer, MD
Affiliation: Royal Liverpool Children's Hospital, Alder Hey
Role:
Name: David Ellison, MD
Affiliation: Northern Centre for Cancer Treatment at Newcastle General Hospital
Role:
Name: Susan V. Picton, MD
Affiliation: Leeds Cancer Centre at St. James's University Hospital
Role:
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