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

Neuroblastoma Clinical Trial

Official title:

Phase II Study of Temozolomide (Temodal) in Children Over 1 Year of Age With Relapsed or Refractory High Risk Neuroblastoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00276679
• Other study ID #: CDR0000454577
• Secondary ID: CCLG-NAG-2003-02
• Status: Completed
• Phase: Phase 2
• First received: January 12, 2006
• Last updated: September 16, 2013
• Start date: April 2003
• Est. completion date: November 2006

Study information

• Verified date: January 2006
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 16 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuroblastoma

Intervention

Drug:
• temozolomide

Locations

Country	Name	City	State
France	Centre Hospitalier Regional de Purpan	Toulouse
Ireland	Our Lady's Hospital for Sick Children	Dublin
United Kingdom	Royal Aberdeen Children's Hospital	Aberdeen	Scotland
United Kingdom	Royal Belfast Hospital for Sick Children	Belfast	Northern Ireland
United Kingdom	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	Childrens Hospital for Wales	Cardiff	Wales
United Kingdom	Royal Hospital for Sick Children	Edinburgh	Scotland
United Kingdom	Royal Hospital for Sick Children	Glasgow	Scotland
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	Great Ormond Street Hospital for Children NHS Trust	London	England
United Kingdom	Royal London Hospital	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

Sponsors (1)

Lead Sponsor	Collaborator
Children's Cancer and Leukaemia Group

Countries where clinical trial is conducted

France,  Ireland,  United Kingdom, 

References & 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; Société Françaisedes Can — View Citation