Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT00110110 |
| Other study ID # |
1000005587 |
| Secondary ID |
HFSC-OCRN-RB-200 |
| Status |
Active, not recruiting |
| Phase |
Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
June 2004 |
| Est. completion date |
December 31, 2024 |
Study information
| Verified date |
April 2024 |
| Source |
The Hospital for Sick Children |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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 and/or
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 and/or laser therapy works in treating patients
with newly diagnosed retinoblastoma in both eyes.
Description:
OBJECTIVES:
Primary
- Compare the efficacy of neoadjuvant high-dose carboplatin and etoposide, vincristine,
and cyclosporine (CSA) followed by ophthalmic focal therapy comprising cryotherapy
and/or 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 and/or 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 and/or 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 2.4 years.
