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Title
Status

 

ARET2121 - Intravitreal Melphalan for Intraocular Retinoblastoma

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ARET2121 - Intravitreal Melphalan for Intraocular Retinoblastoma

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DiagnosisBilateral Retinoblastoma, Childhood Intraocular Retinoblastoma, Group D Retinoblastoma, Stage I Retinoblastoma, Unilateral RetinoblastomaStudy StatusOpen
PhaseII
Ageup to 18 YearsRandomisationNO
Line of treatmentFirst line treatment
Routes of Treatment AdministrationCVE (Carboplatin/Vincristine/Etoposide - given intravenous (IV) Melphalan - intravitreal (injection in eye)
Last Posted Update2024-09-19
ClinicalTrials.gov #NCT05504291
International Sponsor
Children's Oncology Group
Principal Investigators for Canadian Sites
CHU Ste. Justine - Dr. Monia Marzouki
Centres
Medical contact
Dr. Henrique Bittencourt
Dr. Monia Marzouki
Dr. Sebastien Perreault (neuro-onc)
 
Social worker/patient navigator contact
Marie-Claude Charrette
 
Clinical research contact
Marie Saint-Jacques
 

 

 

Study Description

This trial is looking at whether adding a medicine called melphalan (which is injected into the eye) to regular chemotherapy can help treat children with retinoblastoma, a type of eye cancer. Retinoblastoma can sometimes be harder to treat when there are tiny bits of the tumor floating in the jelly-like part of the eye - called vitreous seeds. Melphalan, along with other chemotherapy drugs, works by stopping cancer cells from growing and dividing. The goal of this study is to see if adding melphalan early in treatment can better target those floating tumor bits and improve treatment for retinoblastoma.

Inclusion Criteria
  • Must be under 18 years old
  • The child must have a new diagnosis of retinoblastoma (a type of eye cancer) that is still in the eye 
  • Participant must meet one of the following conditions: 
    • Retinoblastoma in one eye (Group D) with tumor pieces floating in the eye fluid.
    • Retinoblastoma in both eyes, with one eye in Group D (with tumor pieces in the fluid) and the other eye less severe (Group A-C).
    • Retinoblastoma in both eyes, with at least one eye in Group D (with tumor pieces in the fluid).
    • Retinoblastoma in both eyes, with one eye in Group D (with tumor pieces in the fluid) and the other eye in Group E (most severe), where the Group E eye was removed before any treatment.
    • Retinoblastoma in both eyes, with one eye in Group D (with tumor pieces in the fluid) and one Group E eye that hasn't been removed yet (depending on the doctor's decision).
  • The child must be in good enough health to handle treatment, based on performance scores for their age.
  • Blood counts and kidney function must meet certain safety levels before treatment.

Other inclusion and exclusion criteria may apply and will be discussed with you by the study team.