Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00077207
Status:
COMPLETED
Last Update Posted:
2018-05-16
First Post:
2004-02-10
Brief Title:
Carboplatin Vincristine and Temozolomide in Treating Children With Progressive andor Symptomatic Low-Grade Glioma
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
A Pilot Study Using Carboplatin Vincristine And Temozolomide For Children 10 Years With ProgressiveSymptomatic Low-Grade Gliomas
Status:
COMPLETED
Status Verified Date:
2018-04
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 carboplatin vincristine and temozolomide work in different ways to stop tumor cells from dividing so they stop growing or die Giving more than one drug may kill more tumor cells
PURPOSE This pilot study is studying giving carboplatin and vincristine together with temozolomide in treating children with progressive andor symptomatic low-grade glioma
PURPOSE This pilot study is studying giving carboplatin and vincristine together with temozolomide in treating children with progressive andor symptomatic low-grade glioma
Detailed Description:
OBJECTIVES
Primary
Determine the feasibility and toxicity of an induction and maintenance regimen comprising carboplatin vincristine and temozolomide in children with progressive andor symptomatic low-grade gliomas
Secondary
Determine response rate in patients treated with this regimen
Determine 3-year progression-free survival and overall survival of patients treated with this regimen
Correlate response and progression-free survival with the genomic profile of tumors in patients treated with this regimen
OUTLINE This is a pilot study
Induction therapy Patients receive carboplatin IV over 1 hour on days 1 8 15 and 22 vincristine IV on days 1 8 15 22 29 and 36 and oral temozolomide on days 43-47 Four weeks after the completion of induction therapy patients achieving stable or responding disease proceed to maintenance therapy
Maintenance therapy Patients receive carboplatin and temozolomide as in induction therapy and vincristine IV on days 1 8 and 15 Treatment repeats every 10 weeks for a total of 6 courses in the absence of disease progression
Patients are followed every 3 months for 1 year every 4 months for 1 year every 6 months for 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 30-50 patients will be accrued for this study within 2 years
Primary
Determine the feasibility and toxicity of an induction and maintenance regimen comprising carboplatin vincristine and temozolomide in children with progressive andor symptomatic low-grade gliomas
Secondary
Determine response rate in patients treated with this regimen
Determine 3-year progression-free survival and overall survival of patients treated with this regimen
Correlate response and progression-free survival with the genomic profile of tumors in patients treated with this regimen
OUTLINE This is a pilot study
Induction therapy Patients receive carboplatin IV over 1 hour on days 1 8 15 and 22 vincristine IV on days 1 8 15 22 29 and 36 and oral temozolomide on days 43-47 Four weeks after the completion of induction therapy patients achieving stable or responding disease proceed to maintenance therapy
Maintenance therapy Patients receive carboplatin and temozolomide as in induction therapy and vincristine IV on days 1 8 and 15 Treatment repeats every 10 weeks for a total of 6 courses in the absence of disease progression
Patients are followed every 3 months for 1 year every 4 months for 1 year every 6 months for 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 30-50 patients will be accrued for this study within 2 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2012-02572 | OTHER | NCI | None |
| CDR0000350005 | OTHER | None | None |
| COG-ACNS0223 | OTHER | None | None |