Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002794
Status:
COMPLETED
Last Update Posted:
2011-10-04
First Post:
1999-11-01
Brief Title:
Carboplatin Plus Vincristine in Treating Children With Retinoblastoma
Sponsor:
St Jude Childrens Research Hospital
Organization:
St Jude Childrens Research Hospital
Study Overview
Official Title:
Evaluation of Chemotherapy as Initial Treatment for Retinoblastoma
Status:
COMPLETED
Status Verified Date:
2011-10
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 use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of carboplatin plus vincristine in treating children with retinoblastoma
PURPOSE Phase II trial to study the effectiveness of carboplatin plus vincristine in treating children with retinoblastoma
Detailed Description:
OBJECTIVES I Estimate the objective response rate in infants and children with retinoblastoma when treated with carboplatin CBDCA and vincristine VCR every 3 weeks for 24 weeks II Assess the success of this regimen in delaying radiotherapy and eliminating the need for surgery by estimating the cumulative incidence function of treatment failure III Estimate the cumulative incidence of failure of this regimen as measured by subsequent treatment with radiotherapy or surgery
OUTLINE All patients receive carboplatin and vincristine every 3 weeks for a maximum of 8 courses Patients with disease progression after at least 2 courses are removed from study and considered for alternative therapy Patients are followed every 6 weeks for 1 year every 2 months for 1 year every 3-4 months for 3 years and yearly for 12 years
PROJECTED ACCRUAL A total of 25 patients will be accrued for this study within 45 years
OUTLINE All patients receive carboplatin and vincristine every 3 weeks for a maximum of 8 courses Patients with disease progression after at least 2 courses are removed from study and considered for alternative therapy Patients are followed every 6 weeks for 1 year every 2 months for 1 year every 3-4 months for 3 years and yearly for 12 years
PROJECTED ACCRUAL A total of 25 patients will be accrued for this study within 45 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-H96-0935 | US NIH GrantContract | None | httpsreporternihgovquickSearchP01CA023099 |
| P30CA021765 | NIH | None | None |
| P01CA023099 | NIH | None | None |
| SJCRH RET3 | None | None | None |