Temozolomide in Treating Young Patients With High-Risk Relapsed or Refractory Neuroblastoma

NCT00276679 | Completed Phase 2

• 4 other identifiers: CDR0000454577CCLG-NAG-2003-02EU-20591CCLG-SFOP-NAG-2003-02
• Study Type: interventional
• Target: N/A
• Locations: 3 countries
• Sites: 22

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.

Conditions

Neuroblastoma

Keywords

recurrent neuroblastoma; disseminated neuroblastoma; localized unresectable neuroblastoma

Interventions

temozolomide DRUG

Eligibility Criteria

• Age: 1 Year - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

DISEASE CHARACTERISTICS: * 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Children's Cancer and Leukaemia Group: lead

Study Sites (22)

Centre Hospitalier Regional de Purpan

Toulouse, 31026, France

Location

Our Lady's Hospital for Sick Children

Dublin, 12, Ireland

Location

Birmingham Children's Hospital

Birmingham, England, B4 6NH, United Kingdom

Location

Institute of Child Health at University of Bristol

Bristol, England, BS2 8AE, United Kingdom

Location

Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust

Cambridge, England, CB2 2QQ, United Kingdom

Location

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, LS9 7TF, United Kingdom

Location

Leicester Royal Infirmary

Leicester, England, LE1 5WW, United Kingdom

Location

Royal Liverpool Children's Hospital, Alder Hey

Liverpool, England, L12 2AP, United Kingdom

Location

Royal London Hospital

London, England, E1 1BB, United Kingdom

Location

Great Ormond Street Hospital for Children NHS Trust

London, England, WC1N 3JH, United Kingdom

Location

Central Manchester and Manchester Children's University Hospitals NHS Trust

Manchester, England, M27 4HA, United Kingdom

Location

Sir James Spence Institute of Child Health

Newcastle upon Tyne, England, NE1 4LP, United Kingdom

Location

Queen's Medical Centre

Nottingham, England, NG7 2UH, United Kingdom

Location

Oxford Radcliffe Hospital

Oxford, England, 0X3 9DU, United Kingdom

Location

Children's Hospital - Sheffield

Sheffield, England, S10 2TH, United Kingdom

Location

Southampton General Hospital

Southampton, England, SO16 6YD, United Kingdom

Location

Royal Marsden NHS Foundation Trust - Surrey

Sutton, England, SM2 5PT, United Kingdom

Location

Royal Belfast Hospital for Sick Children

Belfast, Northern Ireland, BT12 6BE, United Kingdom

Location

Royal Aberdeen Children's Hospital

Aberdeen, Scotland, AB25 2ZG, United Kingdom

Location

Royal Hospital for Sick Children

Edinburgh, Scotland, EH9 1LF, United Kingdom

Location

Royal Hospital for Sick Children

Glasgow, Scotland, G3 8SJ, United Kingdom

Location

Childrens Hospital for Wales

Cardiff, Wales, CF14 4XW, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 17114659 RESULT

MeSH Terms

Conditions

Neuroblastoma

Interventions

Temozolomide

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Herve Rubie, MD

  Centre Hospitalier Regional de Purpan

  STUDY CHAIR

• Andrew David J. Pearson, MD, FRCP, DCh

  University of Newcastle Upon-Tyne

• Julia Chisholm, MD

  Great Ormond Street Hospital for Children NHS Foundation Trust

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 12, 2006
• First Posted: January 13, 2006
• Study Start: April 1, 2003
• Study Completion: November 1, 2006
• Last Updated: September 17, 2013

Record last verified: 2006-01

Locations

FR (1); GB (20); IE (1)