Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002675
Status:
COMPLETED
Last Update Posted:
2013-06-28
First Post:
1999-11-01
Brief Title:
Chemotherapy in Treating Patients With Retinoblastoma
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A TRIAL OF ADJUVANT CHEMOTHERAPY IN PATIENTS WITH INTRAOCULAR RETINOBLASTOMA
Status:
COMPLETED
Status Verified Date:
2013-06
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 combination chemotherapy in treating patients with retinoblastoma
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy in treating patients with retinoblastoma
Detailed Description:
OBJECTIVES I Estimate the response rate to adjuvant carboplatin CBDCA alone in children with intraocular retinoblastoma II Assess the overall survival disease-free survival and time to treatment failure in these patients III Attempt to maintain a 90 disease-free survival rate with this treatment IV Estimate the percentage of disease-free survivors who do not require the use of radiotherapy after adjuvant CBDCA V Assess the toxicity of this treatment VI Estimate the percentage of functional eyes salvaged using this radiation-sparing protocol and compare these results in a nonrandomized manner with historical treatment results in this population
OUTLINE Patients are stratified according to vitreous disease yes vs no Patients receive carboplatin IV over 1 hour on day 0 Treatment repeats every 2-3 weeks for 2 courses Patients achieving complete response CR proceed to local control measures consisting of cryotherapy laser photocoagulation etc except brachytherapy Patients not achieving CR continue with carboplatin until local control measures feasible Patients with vitreous disease achieving CR receive 2 additional courses and then receive local control measures Patients with vitreous disease not achieving CR receive intensive chemotherapy Patients receive intensive chemotherapy consisting of vincristine IV on days 0 7 and 14 cisplatin IV over 6 hours on day 0 etoposide IV on days 1 and 2 followed by cyclophosphamide IV over 60 minutes on days 1 and 2 Patients receive filgrastim G-CSF subcutaneously beginning on day 3 and until blood counts recover Treatment repeats every 2-4 weeks for 2 courses beyond CR Patients are followed for 3 years
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study over 5-6 years
OUTLINE Patients are stratified according to vitreous disease yes vs no Patients receive carboplatin IV over 1 hour on day 0 Treatment repeats every 2-3 weeks for 2 courses Patients achieving complete response CR proceed to local control measures consisting of cryotherapy laser photocoagulation etc except brachytherapy Patients not achieving CR continue with carboplatin until local control measures feasible Patients with vitreous disease achieving CR receive 2 additional courses and then receive local control measures Patients with vitreous disease not achieving CR receive intensive chemotherapy Patients receive intensive chemotherapy consisting of vincristine IV on days 0 7 and 14 cisplatin IV over 6 hours on day 0 etoposide IV on days 1 and 2 followed by cyclophosphamide IV over 60 minutes on days 1 and 2 Patients receive filgrastim G-CSF subcutaneously beginning on day 3 and until blood counts recover Treatment repeats every 2-4 weeks for 2 courses beyond CR Patients are followed for 3 years
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study over 5-6 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-V95-0710 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000064317 | REGISTRY | None | None |