Temozolomide in Treating Young Patients With High-Risk Relapsed or Refractory Neuroblastoma
NCT ID: NCT00276679
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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COMPLETED
PHASE2
INTERVENTIONAL
2003-04-30
2006-11-30
Brief Summary
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PURPOSE: This phase II trial is studying how well temozolomide works in treating patients with high-risk relapsed or refractory neuroblastoma.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
TREATMENT
NONE
Interventions
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temozolomide
Eligibility Criteria
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Inclusion Criteria
* Histologically proven neuroblastoma
* High-risk relapsed or refractory disease, defined as 1 of the following:
* Metastatic disease
* Localized MYC-N amplified disease
* Localized non MYC-N amplified disease at second relapse
* Measurable primary or metastatic disease by cross-sectional imaging or MIBG scan
PATIENT CHARACTERISTICS:
* Lansky performance status 40-100%
* Life expectancy \> 2 months
* Not pregnant or nursing
* Fertile patients must use effective contraception during the course of this study and for 6 months after study completion
* Organ toxicity \< grade 2
* Platelets ≥ 100,000/mm\^3 (50,000/mm\^3 after stem cell transplant or in case of marrow involvement)
* Neutrophil count ≥ 500/mm\^3
* Bilirubin \< 1.5 times normal
* AST and ALT ≤ 2.5 times normal
* No known HIV positivity
PRIOR CONCURRENT THERAPY:
* More than 21 days since prior chemotherapy treatment (isotretinoin is counted as chemotherapy for this purpose)
* More than 30 days since prior radiotherapy except local palliative treatment for pain control
* No more than 2 prior treatments for neuroblastoma
* No other concurrent investigative treatment for neuroblastoma
1 Year
16 Years
ALL
No
Sponsors
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Children's Cancer and Leukaemia Group
OTHER
Principal Investigators
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Herve Rubie, MD
Role: STUDY_CHAIR
Centre Hospitalier Regional de Purpan
Andrew David J. Pearson, MD, FRCP, DCh
Role:
University of Newcastle Upon-Tyne
Julia Chisholm, MD
Role:
Great Ormond Street Hospital for Children NHS Foundation Trust
Locations
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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
Countries
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References
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Rubie H, Chisholm J, Defachelles AS, Morland B, Munzer C, Valteau-Couanet D, Mosseri V, Bergeron C, Weston C, Coze C, Auvrignon A, Djafari L, Hobson R, Baunin C, Dickinson F, Brisse H, McHugh K, Biassoni L, Giammarile F, Vassal G; Societe Francaisedes Cancers de l'Enfant; United Kingdom Children Cancer Study Group-New Agents Group Study. Phase II study of temozolomide in relapsed or refractory high-risk neuroblastoma: a joint Societe Francaise des Cancers de l'Enfant and United Kingdom Children Cancer Study Group-New Agents Group Study. J Clin Oncol. 2006 Nov 20;24(33):5259-64. doi: 10.1200/JCO.2006.06.1572.
Other Identifiers
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CCLG-NAG-2003-02
Identifier Type: -
Identifier Source: secondary_id
EU-20591
Identifier Type: -
Identifier Source: secondary_id
CCLG-SFOP-NAG-2003-02
Identifier Type: -
Identifier Source: secondary_id
CDR0000454577
Identifier Type: -
Identifier Source: org_study_id