Radiation Therapy and Combination Chemotherapy in Treating Young Patients With Metastatic Medulloblastoma Who Have Undergone Surgery
NCT ID: NCT00276666
Last Updated: 2013-09-17
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
29 participants
INTERVENTIONAL
2001-11-30
Brief Summary
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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
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* 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.
Conditions
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Keywords
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Study Design
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TREATMENT
NONE
Interventions
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cisplatin
lomustine
vincristine sulfate
adjuvant therapy
radiation therapy
Eligibility Criteria
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Inclusion Criteria
* Medullomyoblastoma
* Melanotic medulloblastoma
* Metastatic disease, meeting at least 1 of the following criteria:
* Unequivocal evidence on pre- or post-operative MR scan of supratentorial (stage M2) metastases and/or spinal metastases (stage M3)
* Tumor cells seen on cytospin analysis of lumbar cerebral spinal fluid (CSF) (stage M1) performed between 15 days and 21 days after surgery
* Involvement of CSF pathways by tumor is defined as the unequivocal identification of primitive neuroectodermal cells, either on cytological grounds or with a combination of cytological and immunocytological features (e.g., reactivity for GFAP or a neuronal marker, such as synaptophysin)
* Underwent surgery to remove the tumor no more than 6 weeks ago
PATIENT CHARACTERISTICS:
* Hemoglobin ≥ 10 g/dL
* Absolute neutrophil count ≥ 1,000/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Neurologically stable (or improving) during the week before starting radiotherapy
* Lansky (1-16 years) or Karnofsky (\>16 years) performance status 30-100%
* No active infection
* No prior malignant disease
* Not pregnant or nursing
* No syndrome with recognized potential for increased sensitivity to radiotherapy and/or chromosomal fragility
* Not require anesthesia
* No hearing loss or renal impairment that would make the patient unable to comply with 'Packer' chemotherapy protocol
PRIOR CONCURRENT THERAPY:
* No steroids, if possible, at the start of radiotherapy OR on a stable or reducing dose of steroids during the week before starting radiotherapy
* No prior chemotherapy or radiotherapy
* Dexamethasone should not be used as an anti-emetic unless other therapies fail
3 Years
21 Years
ALL
No
Sponsors
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Children's Cancer and Leukaemia Group
OTHER
Principal Investigators
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Roger Taylor, MD
Role: STUDY_CHAIR
Cookridge Hospital
Frank Saran, MD
Role:
Royal Marsden NHS Foundation Trust
Barry Pizer, MD
Role:
Royal Liverpool Children's Hospital, Alder Hey
David Ellison, MD
Role:
Northern Centre for Cancer Treatment at Newcastle General Hospital
Susan V. Picton, MD
Role:
Leeds Cancer Centre at St. James's University Hospital
Locations
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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
Countries
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Other Identifiers
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CCLG-CNS-2001-06
Identifier Type: -
Identifier Source: secondary_id
EU-20577
Identifier Type: -
Identifier Source: secondary_id
CDR0000454549
Identifier Type: -
Identifier Source: org_study_id