Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00392340
Status:
UNKNOWN
Last Update Posted:
2013-09-17
First Post:
2006-10-25
Brief Title:
Topotecan Vincristine and Doxorubicin in Treating Young Patients With Refractory Stage 4 Neuroblastoma
Sponsor:
Childrens Cancer and Leukaemia Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
An Open-Label Multicentre Phase II Study of TVD as Treatment for Children With Stage 4 Neuroblastoma Failing to Respond to First-Line Treatment According to HR-NBL-01 E-SIOP Topotecan-Vincristine-Doxorubicin in Children With Stage 4 Neuroblastoma Failing to Respond to COJEC TVD
Status:
UNKNOWN
Status Verified Date:
2009-06
Last Known Status:
ACTIVE_NOT_RECRUITING
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 topotecan vincristine and doxorubicin work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving more than one drug combination chemotherapy may kill more tumor cells
PURPOSE This phase II trial is studying how well giving topotecan together with vincristine and doxorubicin works in treating young patients with refractory stage 4 neuroblastoma
PURPOSE This phase II trial is studying how well giving topotecan together with vincristine and doxorubicin works in treating young patients with refractory stage 4 neuroblastoma
Detailed Description:
OBJECTIVES
Primary
Assess whether treatment with topotecan hydrochloride vincristine and doxorubicin hydrochloride can achieve a satisfactory response rate in pediatric patients with stage 4 neuroblastoma that failed to respond to rapid first-line treatment
Secondary
Determine time to progression in these patients
Determine the toxicity of this regimen in these patients
OUTLINE This is a multicenter open-label study
Patients receive topotecan hydrochloride IV over 30 minutes on days 1-5 and vincristine IV continuously and doxorubicin hydrochloride IV continuously over 48 hours on days 5 and 6 Patients also receive filgrastim G-CSF subcutaneously beginning on day 9 and continuing until blood counts recover Treatment repeats every 21-28 days for 2 courses in the absence of disease progression or unacceptable toxicity Patients who achieve partial response PR after two courses of treatment receive an additional two courses Patients who achieve complete response or very good PR are treated according to the standard therapy in protocol SIOP-EUROPE- HR-NBL-1 Patients who fail to achieve PR after 2 courses receive further treatment at the physicians discretion
Patients are followed periodically for at least 3 years
PROJECTED ACCRUAL A total of 63 patients will be accrued for this study
Primary
Assess whether treatment with topotecan hydrochloride vincristine and doxorubicin hydrochloride can achieve a satisfactory response rate in pediatric patients with stage 4 neuroblastoma that failed to respond to rapid first-line treatment
Secondary
Determine time to progression in these patients
Determine the toxicity of this regimen in these patients
OUTLINE This is a multicenter open-label study
Patients receive topotecan hydrochloride IV over 30 minutes on days 1-5 and vincristine IV continuously and doxorubicin hydrochloride IV continuously over 48 hours on days 5 and 6 Patients also receive filgrastim G-CSF subcutaneously beginning on day 9 and continuing until blood counts recover Treatment repeats every 21-28 days for 2 courses in the absence of disease progression or unacceptable toxicity Patients who achieve partial response PR after two courses of treatment receive an additional two courses Patients who achieve complete response or very good PR are treated according to the standard therapy in protocol SIOP-EUROPE- HR-NBL-1 Patients who fail to achieve PR after 2 courses receive further treatment at the physicians discretion
Patients are followed periodically for at least 3 years
PROJECTED ACCRUAL A total of 63 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 |
|---|---|---|---|
| EU-20641 | None | None | None |
| CCLG-NB-2006-05 | None | None | None |
| EUDRACT-2005-000915-80 | None | None | None |