Phase II Study of Intravitreal Melphalan with Systemic Chemotherapy for Treating Group D Retinoblastoma with Vitreous Seeds in Children

What this Trial Is About

Researchers are studying retinoblastoma RB, a cancer of the retina, focusing on cases with vitreous seeds, which are tumors in the eyes jelly-like fluid and increase treatment difficulty and risk. This phase II trial aims to evaluate the safety and side effects of adding melphalan, injected directly into the eye, to standard chemotherapy. The trial also explores the effectiveness and long-term visual outcomes of this combined treatment approach for Group D retinoblastoma with vitreous seeding. Participants receive systemic chemotherapy with carboplatin, vincristine, and etoposide over cycles lasting 28 days each. During the first two cycles, patients undergo imaging and urine sample collection without melphalan injections. From cycle 3 onwards, eligibility for melphalan injections is assessed before each cycle, and eligible patients receive one injection of melphalan into the eye per cycle, for up to six injections. Imaging, tissue sampling, and magnetic resonance imaging are conducted throughout the trial. Participants are monitored with eye imaging under anesthesia, ultrasound biomicroscopy, and blood and urine tests at regular intervals during treatment. After treatment, follow-ups occur at 4 weeks, then every 3 months for one year, and every 3 to 6 months for up to five years. Researchers measure the success of melphalan administration combined with chemotherapy, track serious side effects, and evaluate long-term event-free survival and visual outcomes.

A Study to Give Treatment Inside the Eye to Treat Retinoblastoma