Ignite Creation Date:
2024-05-05 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00276679
Status:
COMPLETED
Last Update Posted:
2013-09-17
First Post:
2006-01-12
Brief Title:
Temozolomide in Treating Young Patients With High-Risk Relapsed or Refractory Neuroblastoma
Sponsor:
Childrens Cancer and Leukaemia Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study of Temozolomide Temodal in Children Over 1 Year of Age With Relapsed or Refractory High Risk Neuroblastoma
Status:
COMPLETED
Status Verified Date:
2006-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 expressionactivity changes in the tumor during initial presentation treatment and relapseprogression 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
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 expressionactivity changes in the tumor during initial presentation treatment and relapseprogression 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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CCLG-SFOP-NAG-2003-02 | None | None | None |
| CCLG-NAG-2003-02 | None | None | None |
| EU-20591 | None | None | None |