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

Sponsored by:	Children's Cancer and Leukaemia Group
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00276679

Purpose

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.

Condition	Intervention	Phase
Neuroblastoma	Drug: temozolomide	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label
Official Title:	Phase II Study of Temozolomide (Temodal) in Children Over 1 Year of Age With Relapsed or Refractory High Risk Neuroblastoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Neuroblastoma

Drug Information available for: Temozolomide

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

April 2003

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

Ages Eligible for Study:	1 Year to 16 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00276679

Locations

France
Centre Hospitalier Regional de Purpan
Toulouse, France, 31026
Ireland
Our Lady's Hospital for Sick Children
Dublin, Ireland, 12
United Kingdom, England
Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
Cambridge, England, United Kingdom, CB2 2QQ
Birmingham Children's Hospital
Birmingham, England, United Kingdom, B4 6NH
Central Manchester and Manchester Children's University Hospitals NHS Trust
Manchester, England, United Kingdom, M27 4HA
Oxford Radcliffe Hospital
Oxford, England, United Kingdom, 0X3 9DU
Great Ormond Street Hospital for Children NHS Trust
London, England, United Kingdom, WC1N 3JH
Institute of Child Health at University of Bristol
Bristol, England, United Kingdom, BS2 8AE
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom, LS9 7TF
Leicester Royal Infirmary
Leicester, England, United Kingdom, LE1 5WW
Children's Hospital - Sheffield
Sheffield, England, United Kingdom, S10 2TH
Queen's Medical Centre
Nottingham, England, United Kingdom, NG7 2UH
Royal Liverpool Children's Hospital, Alder Hey
Liverpool, England, United Kingdom, L12 2AP
Royal London Hospital
London, England, United Kingdom, E1 1BB
Royal Marsden NHS Foundation Trust - Surrey
Sutton, England, United Kingdom, SM2 5PT
Sir James Spence Institute of Child Health
Newcastle-Upon-Tyne, England, United Kingdom, NE1 4LP
Southampton General Hospital
Southampton, England, United Kingdom, SO16 6YD
United Kingdom, Northern Ireland
Royal Belfast Hospital for Sick Children
Belfast, Northern Ireland, United Kingdom, BT12 6BE
United Kingdom, Scotland
Royal Aberdeen Children's Hospital
Aberdeen, Scotland, United Kingdom, AB25 2ZG
Royal Hospital for Sick Children
Glasgow, Scotland, United Kingdom, G3 8SJ
Royal Hospital for Sick Children
Edinburgh, Scotland, United Kingdom, EH9 1LF
United Kingdom, Wales
Childrens Hospital for Wales
Cardiff, Wales, United Kingdom, CF14 4XW

Sponsors and Collaborators

Children's Cancer and Leukaemia Group

Investigators

Study Chair:	Herve Rubie, MD	Centre Hospitalier Regional de Purpan
Investigator:	Andrew David J. Pearson, MD, FRCP, DCh	University of Newcastle Upon-Tyne
Investigator:	Julia Chisholm, MD	Great Ormond Street Hospital for Children

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

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.

Study ID Numbers:	CDR0000454577, CCLG-NAG-2003-02, EU-20591, CCLG-SFOP-NAG-2003-02
Study First Received:	January 12, 2006
Last Updated:	March 7, 2009
ClinicalTrials.gov Identifier:	NCT00276679 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

recurrent neuroblastoma
disseminated neuroblastoma
localized unresectable neuroblastoma

Study placed in the following topic categories:

Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Antineoplastic Agents, Alkylating
Alkylating Agents

Temozolomide
Neuroectodermal Tumors, Primitive, Peripheral
Recurrence
Neuroblastoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neuroectodermal Tumors, Primitive
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Neoplasms, Nerve Tissue
Temozolomide
Pharmacologic Actions
Neuroblastoma
Neuroectodermal Tumors

Neoplasms
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Antineoplastic Agents, Alkylating
Neoplasms, Neuroepithelial
Alkylating Agents
Neuroectodermal Tumors, Primitive, Peripheral
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 11, 2009