Combination Chemotherapy, Surgery or Radiation Therapy, and Peripheral Stem Cell Transplant in Treating Patients With Recurrent Medulloblastoma or Primitive Neuroectodermal and Pineal Tumors
NCT ID: NCT00025077
Last Updated: 2013-08-02
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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COMPLETED
PHASE2
50 participants
INTERVENTIONAL
2000-01-31
2011-04-30
Brief Summary
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PURPOSE: This phase II trial is studying how well combination chemotherapy followed by surgery or radiation therapy and peripheral stem cell transplant work in treating patients with recurrent medulloblastoma or primitive neuroectodermal and pineal tumors.
Detailed Description
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* Determine the feasibility of cyclophosphamide and surgical resection or radiotherapy followed by thiotepa, carboplatin, and autologous peripheral blood stem cell rescue in patients with recurrent medulloblastoma or supratentorial neuroectodermal and pineal tumors.
* Determine the acute and chronic toxicity of this regimen in these patients.
* Determine progression-free and overall survival of patients treated with this regimen.
OUTLINE: This is a multicenter study.
* Cytoreductive Phase: Patients receive cyclophosphamide IV over 1 hour on days 1 and 2 and filgrastim (G-CSF) subcutaneously (SC) once daily beginning on day 7 and continuing until blood counts recover. Treatment repeats after discontinuation of G-CSF for 2-4 courses. Peripheral blood stem cells (PBSC) are harvested after each course of cyclophosphamide. Patients undergo surgical resection or radiotherapy after the completion of chemotherapy. Patients achieving complete response proceed to myeloablative therapy.
* Myeloablative Phase: Patients receive thiotepa IV over 3 hours on days 1-3. Autologous PBSC are reinfused on day 5 and patients receive G-CSF SC once daily beginning on day 10 and continuing until blood counts recover. Beginning 2 days after the completion of G-CSF, patients receive carboplatin IV over 1 hour on days 1-3. Autologous PBSC are reinfused on day 5 and patients receive G-CSF SC once daily beginning on day 10 and continuing until blood counts recover.
Patients are followed at 1, 3, 6, and 12 months.
PROJECTED ACCRUAL: Approximately 50 patients will be accrued for this study within 5 years.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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filgrastim
carboplatin
cyclophosphamide
thiotepa
conventional surgery
peripheral blood stem cell transplantation
radiation therapy
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed recurrent medulloblastoma or supratentorial primitive neuroectodermal and pineal tumor
* Nodular/desmoplastic medulloblastoma
* Medullomyoblastoma
* Melanotic medulloblastoma
* Ependymoblastoma
* Pinealoblastoma
* Received prior craniospinal radiotherapy OR
* Relapse in site of prior localized radiotherapy (e.g., relapse after "baby brain" protocol)
PATIENT CHARACTERISTICS:
Age:
* Under 21
Performance status:
* Lansky 40-100% for ages 1-16 years
* Karnofsky 40-100% for ages over 16 years
Life expectancy:
* At least 8 weeks
Hematopoietic:
* Neutrophil count at least 1,000/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin less than upper limit of normal (ULN)
* AST less than 2 times ULN
Renal:
* Glomerular filtration rate at least 60 mL/min
Other:
* Not pregnant or nursing
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* Not specified
Endocrine therapy
* Not specified
Radiotherapy
* See Disease Characteristics
Surgery
* Not specified
20 Years
ALL
No
Sponsors
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Children's Cancer and Leukaemia Group
OTHER
Principal Investigators
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Barry Pizer, MD
Role: STUDY_CHAIR
Royal Liverpool Children's Hospital, Alder Hey
Locations
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Our Lady's Hospital for Sick Children Crumlin
Dublin, , Ireland
Birmingham Children's Hospital
Birmingham, England, United Kingdom
Bristol Royal Hospital for Children
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
Saint Bartholomew's Hospital
London, England, United Kingdom
Great Ormond Street Hospital for Children NHS Trust
London, England, United Kingdom
University College of London Hospitals
London, England, United Kingdom
Central Manchester and Manchester Children's University Hospitals NHS Trust
Manchester, England, United Kingdom
Newcastle Upon Tyne Hospitals NHS Trust
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 University Hospital NHS Trust
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
Aberdeen Royal Infirmary
Aberdeen, Scotland, United Kingdom
Royal Hospital for Sick Children
Edinburgh, Scotland, United Kingdom
Royal Hospital for Sick Children
Glasgow, Scotland, United Kingdom
Countries
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Other Identifiers
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CDR0000068910
Identifier Type: REGISTRY
Identifier Source: secondary_id
EU-20105
Identifier Type: -
Identifier Source: secondary_id
CCLG-CNS-2000-01
Identifier Type: -
Identifier Source: org_study_id