Radiation Therapy and Combination Chemotherapy in Treating Young Patients With Metastatic Medulloblastoma Who Have Undergone Surgery

Phase 2

• 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.

Study Timeline

• Study Start: 2001-11
• Study First Submitted: 2006-01-12
• Study First Submitted QC: 2006-01-12
• Study First Posted: 2006-01-13
• Status Verified: 2009-06
• Primary Completion: 2010-03
• Last Update Submitted: 2013-09-16
• Last Update Posted: 2013-09-17

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Toxicity

Trial Locations

Locations (21)

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

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