Combination Chemotherapy + Cyclosporine and Focal Therapy for Retinoblastoma

Phase 2

Waitlist Available

Led By Elise Heon, MD

Research Sponsored by The Hospital for Sick Children

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 year follow-up per patient

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying a combination of chemotherapy drugs with or without cyclosporine followed by cryotherapy (freezing) and/or laser therapy in treating patients with newly diagnosed retinoblastoma in both eyes.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Chemotherapy can cause side effects like nausea, hair loss, fatigue and increased risk of infection. Cryotherapy might lead to local pain or swelling. Laser therapy could potentially cause discomfort or damage to surrounding healthy tissue.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 year follow-up per patient

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 year follow-up per patient

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 year follow-up per patient for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Comparing efficacy of study treatment with historic world data, in terms of increasing the proportion of eyes that remains relapse-free while avoiding external beam radiation and/or enucleation

Secondary study objectives

Toxicity during treatment

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

vincristine sulfate

1994

Completed Phase 3

~11270

Carboplatin

2014

Completed Phase 3

~6120