Combination Chemotherapy + Cyclosporine and Focal Therapy for Retinoblastoma

Recruiting in Palo Alto (17 mi)

+5 other locations

Overseen byElise Heon, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: The Hospital for Sick Children

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for patients with bilateral retinoblastoma, a type of eye cancer, specifically those with IIRC Group B, C, or D disease in at least one eye. Suitable participants are over 30 days old and have normal liver and kidney function tests. Those with unilateral retinoblastoma, metastatic disease, or very young infants under 30 days old cannot join.

Inclusion Criteria

IIRC Group E disease in 1 eye allowed provided the eye was enucleated at diagnosis AND there is no extraocular RB in the enucleated eye by histologic confirmation AND there is IIRC Group B, C, or D disease in the remaining eye

Age over 30 days

AST and ALT < 2 times upper limit of normal (ULN)

+6 more

Exclusion Criteria

You have a type of eye cancer called retinoblastoma that has spread outside of the eye.

IIRC Group A disease in 1 or both eyes

Unilateral RB

+2 more

Participant Groups

The study is testing if combining chemotherapy (carboplatin, etoposide, vincristine) with cyclosporine followed by cryotherapy or laser therapy can effectively treat retinoblastoma. Cyclosporine may help reduce the tumor's resistance to chemotherapy.

1Treatment groups

Experimental Treatment

Group I: CEV Chemo + Cyclosporine & Focal TherapyExperimental Treatment7 Interventions

Systemic carboplatin (28 mg/kg/dose), etoposide (12 mg/kg/dose) and vincristine sulfate (0.025 mg/kg/dose for the first cycle and 0.05 mg/kg/dose for subsequent cycles if first cycle well-tolerated) chemotherapy given with cyclosporin A (33 mg/kg/dose). Following 4-6 cycles CEV chemotherapy (depending on tumor stage) given every 3 weeks, focal laser therapy and/or cryosurgery are applied for tumor consolidation. Filgrastim is given after each chemotherapy cycle to prevent severe neutropenia.

Carboplatin is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Paraplatin for: