About this trial
This study explores how safe it is to give melphalan injections directly into the eye, along with standard chemotherapy, to children with retinoblastoma. Retinoblastoma is a type of eye cancer that can be hereditary or occur randomly. It can be more challenging to treat if there are tumors in the eye fluid. The goal is to see if adding melphalan can help improve treatment outcomes for these patients.
The trial ID is NCT05504291. This is a Phase 2 trial, meaning it looks at how well the treatment works and its safety. It is FDA-regulated and plans to include about 26 participants.
Who can join
Children under 18 years old with newly diagnosed retinoblastoma can join if they have specific types of the disease, particularly with vitreous seeding. The trial is open to all genders. The team will check eligibility before enrollment.
Conditions
Bilateral Retinoblastoma, Childhood Intraocular Retinoblastoma, Group D Retinoblastoma, Stage I Retinoblastoma, Unilateral Retinoblastoma
The study team makes the final call on eligibility.
What happens in the study
Participants will receive a combination of chemotherapy drugs, including carboplatin, vincristine, and etoposide, along with melphalan. Everyone in the study will get this treatment. There will be tests and imaging done regularly to monitor progress.
Where
This trial is running at 17 locations in the United States. 16 of them are currently recruiting.
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas
C S Mott Children's Hospital
Ann Arbor, Michigan
Children's Healthcare of Atlanta - Arthur M Blank Hospital
Atlanta, Georgia
Children's Hospital Colorado
Aurora, Colorado
Children's Hospital Los Angeles
Los Angeles, California
Children's Hospital Medical Center of Akron
Akron, Ohio
Children's Hospital of Alabama
Birmingham, Alabama
Children's Hospital of Wisconsin
Milwaukee, Wisconsin
The first 8 of 17 sites are listed here. The registry record has the full list.