Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00079417
Status:
COMPLETED
Last Update Posted:
2023-03-13
First Post:
2004-03-08
Brief Title:
Neoadjuvant Carboplatin and Vincristine and Standard Local Ophthalmic Therapy in Treating Patients With Intraocular Retinoblastoma
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
Trial of Systemic Neoadjuvant Chemotherapy for Group B Intraocular Retinoblastoma
Status:
COMPLETED
Status Verified Date:
2023-01
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:
This phase III trial is studying how well giving carboplatin and vincristine together with standard local ophthalmic therapy works in treating children with intraocular retinoblastoma Drugs used in chemotherapy such as carboplatin and vincristine work in different ways to stop tumor from dividing so they stop growing or die It is not yet known whether neoadjuvant chemotherapy combined with standard local ophthalmic therapy is effective in treating intraocular retinoblastoma
Detailed Description:
PRIMARY OBJECTIVES
I Determine the 2-year event-free survival of patients with Group B intraocular retinoblastoma treated with neoadjuvant chemoreduction comprising carboplatin and vincristine and standardized local ophthalmic therapy
SECONDARY OBJECTIVES
I Determine the response rate after one course of chemoreduction before standardized local ophthalmic therapy in these patients
II Correlate response rate with event-free survival in patients treated with this regimen
III Determine the incidence of toxic effects in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive chemoreduction comprising carboplatin IV over 60 minutes followed by vincristine IV over 1-2 minutes on day 1 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity After the first course of chemoreduction patients undergo standardized local ophthalmic therapy comprising local laser therapy cryotherapy andor radioactive plaque comprising iodine I 125 or ruthenium Ru 106
Patients are followed every 3-4 weeks until there is no active tumor seen on a minimum of 3 ophthalmic exams under anesthesia every 6-8 weeks until 3 years of age every 4-6 months until 10 years of age and then annually thereafter
I Determine the 2-year event-free survival of patients with Group B intraocular retinoblastoma treated with neoadjuvant chemoreduction comprising carboplatin and vincristine and standardized local ophthalmic therapy
SECONDARY OBJECTIVES
I Determine the response rate after one course of chemoreduction before standardized local ophthalmic therapy in these patients
II Correlate response rate with event-free survival in patients treated with this regimen
III Determine the incidence of toxic effects in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive chemoreduction comprising carboplatin IV over 60 minutes followed by vincristine IV over 1-2 minutes on day 1 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity After the first course of chemoreduction patients undergo standardized local ophthalmic therapy comprising local laser therapy cryotherapy andor radioactive plaque comprising iodine I 125 or ruthenium Ru 106
Patients are followed every 3-4 weeks until there is no active tumor seen on a minimum of 3 ophthalmic exams under anesthesia every 6-8 weeks until 3 years of age every 4-6 months until 10 years of age and then annually thereafter
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-2009-00422 | REGISTRY | None | None |
| ARET0331 | None | None | None |
| CDR0000355721 | None | None | None |
| COG-ARET0331 | None | None | None |
| ARET0331 | OTHER | None | None |
| ARET0331 | OTHER | None | None |
| U10CA098543 | NIH | CTEP | httpsreporternihgovquickSearchU10CA098543 |