Spots Global Cancer Trial Database for Temozolomide in Treating Young Patients With High-Risk Relapsed or Refractory Neuroblastoma
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Trial Identification
Brief Title: Temozolomide in Treating Young Patients With High-Risk Relapsed or Refractory Neuroblastoma
Official Title: Phase II Study of Temozolomide (Temodal) in Children Over 1 Year of Age With Relapsed or Refractory High Risk Neuroblastoma
Study ID: NCT00276679
Conditions
Interventions
Study Description
Brief Summary: RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well temozolomide works in treating patients with high-risk relapsed or refractory neuroblastoma.
Detailed Description: OBJECTIVES: Primary * Determine the anti-tumor activity of temozolomide in young patients with high-risk relapsed or refractory neuroblastoma. Secondary * Determine the duration of response in patients treated with this drug. * Determine tolerability of this drug in these patients * Determine the tumor expression of the cellular repair mechanisms which repair DNA damage (O6-methylguanine-DNA methyltransferase \[MGMT\] and mismatch repair \[MMR\] systems) in patients treated with this drug. * Correlate MGMT and MMR expression with outcomes in patients treated with this drug. * Determine if MGMT and MMR expression/activity changes in the tumor during initial presentation, treatment, and relapse/progression in patients treated with this drug. * Determine the activity of MGMT in bone marrow taken at relapse, in terms of hematological toxicity, in patients treated with this drug. OUTLINE: This is a multicenter, open label, nonrandomized study. Patients receive oral temozolomide once daily for 5 days. Treatment repeats every 28 days for 2 courses. Patients achieving stable or responding disease after completion of the 2 courses may receive up to 10 additional courses of treatment in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.
Eligibility
Minimum Age: 1 Year
Eligible Ages: CHILD
Sex: ALL
Healthy Volunteers: No
Locations
Centre Hospitalier Regional de Purpan, Toulouse, , France
Our Lady's Hospital for Sick Children, 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 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
Royal London Hospital, London, England, United Kingdom
Great Ormond Street Hospital for Children NHS Trust, London, England, United Kingdom
Central Manchester and Manchester Children's University Hospitals NHS Trust, Manchester, England, United Kingdom
Sir James Spence Institute of Child Health, 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 NHS Foundation Trust - 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: Herve Rubie, MD
Affiliation: Centre Hospitalier Regional de Purpan
Role: STUDY_CHAIR
Name: Andrew David J. Pearson, MD, FRCP, DCh
Affiliation: University of Newcastle Upon-Tyne
Role:
Name: Julia Chisholm, MD
Affiliation: Great Ormond Street Hospital for Children NHS Foundation Trust
Role:
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