Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00072384
Status:
COMPLETED
Last Update Posted:
2021-07-30
First Post:
2003-11-04
Brief Title:
Systemic Chemotherapy and Subtenon Carboplatin and Local Ophthalmic Therapy in Children With Intraocular Retinoblastoma
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
A Single Arm Trial of Systemic And Subtenon Chemotherapy For Groups C And D Intraocular Retinoblastoma
Status:
COMPLETED
Status Verified Date:
2021-07
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:
Phase III trial to determine the effectiveness of combining systemic chemotherapy and subtenon carboplatin with ophthalmic therapy in treating children who have intraocular retinoblastoma Drugs used in chemotherapy such as vincristine carboplatin and etoposide work in different ways to stop tumor cells from dividing so they stop growing or die It is not yet known whether systemic chemotherapy and subtenon under the conjunctiva of the eye carboplatin combined with ophthalmic therapy is effective in treating intraocular within the eyeball retinoblastoma
Detailed Description:
PRIMARY OBJECTIVES
I Determine the event-free survival at 12 months of pediatric patients eyes with group D intraocular retinoblastoma treated with systemic chemotherapy comprising vincristine carboplatin and etoposide subtenon carboplatin and local ophthalmic therapy Event defined for each eye individually as needed for nonprotocol therapy including nonprotocol chemotherapy enucleation or any external-beam radiation
SECONDARY OBJECTIVES
I Determine the event-free survival at 12 months of pediatric patients eyes with group C retinoblastoma treated with systemic chemotherapy comprising carboplatin etoposide vincristine subtenon carboplatin and local ophthalmic therapy
II Determine the acute and long-term toxic effects of these regimens in these patients including visual outcome and incidence of secondary malignancies
III Determine the patterns of failure in patients treated with these regimens in terms of vitreous vs retinal vs both as sites of recurrence
IV Determine predictors of failure including findings at the on study examination under anesthesia and response status after six courses of chemotherapy
V Determine the percentage of group C and D eyes separately that can be preserved without enucleation after failing protocol therapy
OUTLINE This is a multicenter study
Patients receive vincristine IV over 1 minute on day 1 and carboplatin IV over 1 hour and etoposide IV over 1 hour on days 1 and 2 Patients also receive filgrastim G-CSF subcutaneously daily beginning on day 3 and continuing until blood counts recover Patients receive subtenon carboplatin to each group C or D eye on day 0 or 1 prior of courses 2-4 only Treatment repeats every 28 days for 6 courses in the absence of occurrence of extraocular retinoblastoma or a second malignancy Beginning with course 3 of systemic chemotherapy patients undergo local ophthalmic therapy comprising local laser andor cryotherapy on day 1
Patients are followed with ophthalmology exams every 4-12 weeks until 3 years of age every 6 months until 5 years of age and then annually for up to 10 years
I Determine the event-free survival at 12 months of pediatric patients eyes with group D intraocular retinoblastoma treated with systemic chemotherapy comprising vincristine carboplatin and etoposide subtenon carboplatin and local ophthalmic therapy Event defined for each eye individually as needed for nonprotocol therapy including nonprotocol chemotherapy enucleation or any external-beam radiation
SECONDARY OBJECTIVES
I Determine the event-free survival at 12 months of pediatric patients eyes with group C retinoblastoma treated with systemic chemotherapy comprising carboplatin etoposide vincristine subtenon carboplatin and local ophthalmic therapy
II Determine the acute and long-term toxic effects of these regimens in these patients including visual outcome and incidence of secondary malignancies
III Determine the patterns of failure in patients treated with these regimens in terms of vitreous vs retinal vs both as sites of recurrence
IV Determine predictors of failure including findings at the on study examination under anesthesia and response status after six courses of chemotherapy
V Determine the percentage of group C and D eyes separately that can be preserved without enucleation after failing protocol therapy
OUTLINE This is a multicenter study
Patients receive vincristine IV over 1 minute on day 1 and carboplatin IV over 1 hour and etoposide IV over 1 hour on days 1 and 2 Patients also receive filgrastim G-CSF subcutaneously daily beginning on day 3 and continuing until blood counts recover Patients receive subtenon carboplatin to each group C or D eye on day 0 or 1 prior of courses 2-4 only Treatment repeats every 28 days for 6 courses in the absence of occurrence of extraocular retinoblastoma or a second malignancy Beginning with course 3 of systemic chemotherapy patients undergo local ophthalmic therapy comprising local laser andor cryotherapy on day 1
Patients are followed with ophthalmology exams every 4-12 weeks until 3 years of age every 6 months until 5 years of age and then annually for up to 10 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-2009-00420 | REGISTRY | None | None |
| CDR0000339627 | OTHER | None | None |
| COG-ARET0231 | OTHER | None | None |
| U10CA098543 | NIH | Childrens Oncology Group | httpsreporternihgovquickSearchU10CA098543 |