NCT00276679

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Children's Cancer and Leukaemia Group · Academic / Other
• Sex: All
• Age: 1 Year – 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neuroblastoma

Interventions

Type	Name	Description
DRUG	temozolomide

Timeline

• Start date: 2003-04-01
• Completion: 2006-11-01
• First posted: 2006-01-13
• Last updated: 2013-09-17

Locations

22 sites across 3 countries: France, Ireland, United Kingdom