Radiation Therapy and Combination Chemotherapy in Treating Young Patients With Metastatic Medulloblastoma Who Have Undergone Surgery
- Conditions
- Brain and Central Nervous System Tumors
- Registration Number
- NCT00276666
- Lead Sponsor
- Children's Cancer and Leukaemia Group
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 29
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Toxicity
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (21)
Our Lady's Hospital for Sick Children Crumlin
🇮🇪Dublin, Ireland
Sir James Spence Institute of Child Health at Royal Victoria Infirmary
🇬🇧Newcastle-Upon-Tyne, England, United Kingdom
Great Ormond Street Hospital for Children
🇬🇧London, England, United Kingdom
Royal Belfast Hospital for Sick Children
🇬🇧Belfast, Northern Ireland, United Kingdom
Royal Hospital for Sick Children
🇬🇧Glasgow, Scotland, United Kingdom
Oxford Radcliffe Hospital
🇬🇧Oxford, England, United Kingdom
Addenbrooke's Hospital
🇬🇧Cambridge, England, United Kingdom
Leicester Royal Infirmary
🇬🇧Leicester, England, United Kingdom
Royal London Hospital
🇬🇧London, England, United Kingdom
Queen's Medical Centre
🇬🇧Nottingham, England, United Kingdom
Children's Hospital - Sheffield
🇬🇧Sheffield, England, United Kingdom
Royal Aberdeen Children's Hospital
🇬🇧Aberdeen, Scotland, United Kingdom
Childrens Hospital for Wales
🇬🇧Cardiff, Wales, United Kingdom
Royal Manchester Children's Hospital
🇬🇧Manchester, England, United Kingdom
Birmingham Children's Hospital
🇬🇧Birmingham, England, United Kingdom
Institute of Child Health at University of Bristol
🇬🇧Bristol, England, United Kingdom
Cookridge Hospital
🇬🇧Leeds, England, United Kingdom
Leeds Cancer Centre at St. James's University Hospital
🇬🇧Leeds, England, United Kingdom
Royal Liverpool Children's Hospital, Alder Hey
🇬🇧Liverpool, England, United Kingdom
Southampton General Hospital
🇬🇧Southampton, England, United Kingdom
Royal Marsden - Surrey
🇬🇧Sutton, England, United Kingdom