Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00110110
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-17
First Post:
2005-05-03
Brief Title:
Combination Chemotherapy and Cyclosporine Followed by Focal Therapy for Bilateral Retinoblastoma
Sponsor:
The Hospital for Sick Children
Organization:
The Hospital for Sick Children
Study Overview
Official Title:
Multicenter Phase II Study for International Intraocular Retinoblastoma Classification Groups B C D Tumors Treated With Carboplatin-Etoposide-Vincristine-Cyclosporine-Focal Therapy Multimodality Protocol OCRN Multicenter RB 2003
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
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 etoposide and vincristine work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Sometimes when chemotherapy is given it does not stop the growth of tumor cells The tumor is said to be resistant to chemotherapy Giving cyclosporine together with chemotherapy may reduce drug resistance and allow the tumor cells to be killed Cryotherapy kills tumor cells by freezing them Laser therapy uses light to kill tumor cells Giving combination chemotherapy together with cyclosporine followed by cryotherapy andor laser therapy may be an effective treatment for retinoblastoma
PURPOSE This phase II trial is studying how well giving combination chemotherapy together with cyclosporine followed by cryotherapy andor laser therapy works in treating patients with newly diagnosed retinoblastoma in both eyes
PURPOSE This phase II trial is studying how well giving combination chemotherapy together with cyclosporine followed by cryotherapy andor laser therapy works in treating patients with newly diagnosed retinoblastoma in both eyes
Detailed Description:
OBJECTIVES
Primary
Compare the efficacy of neoadjuvant high-dose carboplatin and etoposide vincristine and cyclosporine CSA followed by ophthalmic focal therapy comprising cryotherapy andor laser therapy to historical world data of chemotherapy treatment without CSA in terms of increasing the proportion of eyes that remain relapse free and do not require external beam radiotherapy andor enucleation in patients with newly diagnosed Group B C or D bilateral intraocular retinoblastoma
Secondary
Determine the toxicity of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive high-dose carboplatin IV over 30 minutes on day 1 vincristine IV over 5 minutes and high-dose etoposide IV over 25 minutes on day 2 cyclosporine IV over 1 hour before chemotherapy and then over 2 hours after chemotherapy on days 1 and 2 and filgrastim G-CSF subcutaneously once daily beginning on day 3 and continuing until day 16 or until blood counts recover Treatment repeats every 21 days for a total of 3 courses for patients with Group B disease and a total of 6 courses for patients with Group C or D disease
Patients undergo eye examination under anesthesia EUA at initial staging and then before each course of chemotherapy Patients with small peripheral tumors in eyes without retinal detachment undergo minimal focal therapy mainly cryotherapy during EUA at initial staging and then after chemotherapy courses 1 and 2 At EUA after the third and subsequent courses of chemotherapy patients with tumors that have sufficiently reduced in size undergo additional cryotherapy or laser therapy After completion of chemotherapy patients with any suspicious active or reactivated tumor undergo additional cryotherapy andor laser therapy during EUA approximately every 4-8 weeks or at longer intervals for up to 5 years as needed
After completion of study chemotherapy patients are followed every 3 months for 2 years every 6 months for 2 years and then annually for 1 year
PROJECTED ACCRUAL A total of 71 patients will be accrued for this study within 24 years
Primary
Compare the efficacy of neoadjuvant high-dose carboplatin and etoposide vincristine and cyclosporine CSA followed by ophthalmic focal therapy comprising cryotherapy andor laser therapy to historical world data of chemotherapy treatment without CSA in terms of increasing the proportion of eyes that remain relapse free and do not require external beam radiotherapy andor enucleation in patients with newly diagnosed Group B C or D bilateral intraocular retinoblastoma
Secondary
Determine the toxicity of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive high-dose carboplatin IV over 30 minutes on day 1 vincristine IV over 5 minutes and high-dose etoposide IV over 25 minutes on day 2 cyclosporine IV over 1 hour before chemotherapy and then over 2 hours after chemotherapy on days 1 and 2 and filgrastim G-CSF subcutaneously once daily beginning on day 3 and continuing until day 16 or until blood counts recover Treatment repeats every 21 days for a total of 3 courses for patients with Group B disease and a total of 6 courses for patients with Group C or D disease
Patients undergo eye examination under anesthesia EUA at initial staging and then before each course of chemotherapy Patients with small peripheral tumors in eyes without retinal detachment undergo minimal focal therapy mainly cryotherapy during EUA at initial staging and then after chemotherapy courses 1 and 2 At EUA after the third and subsequent courses of chemotherapy patients with tumors that have sufficiently reduced in size undergo additional cryotherapy or laser therapy After completion of chemotherapy patients with any suspicious active or reactivated tumor undergo additional cryotherapy andor laser therapy during EUA approximately every 4-8 weeks or at longer intervals for up to 5 years as needed
After completion of study chemotherapy patients are followed every 3 months for 2 years every 6 months for 2 years and then annually for 1 year
PROJECTED ACCRUAL A total of 71 patients will be accrued for this study within 24 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 |
|---|---|---|---|
| CDR0000422340 | OTHER | The Hospital for Sick Children | None |
| HFSC-OCRN-RB-2003 | OTHER | None | None |