drugset / Trial / NCT04455139

A Prospective International Multicenter Clinical Trial for Eyes With Relapsed Retinoblastoma

NCT04455139 ↗

Phase 2 Terminated 2 enrolled Prof. Beck Popovic Maja
RandomizedParallel-groupOpen-labelTreatment

Summary

While 95% of patients with retinoblastoma can be cured nowadays, treatment of relapse remains challenging, ending often in enucleation and/or radiotherapy. In the last 10 years, new treatment modalities have been developed to give the chance of cure also in relapse, avoiding enucleation which results in esthetic sequelae and orbital growth problems, and radiotherapy which significantly increases the risk of secondary cancers in hereditary retinoblastoma. The current protocol aims at covering all types of relapses in retinoblastoma, with treatments adapted to the site of relapse, at harmonizing the new eye- and vision-preserving treatment procedures, and evaluating their efficacy and toxicity.

Timeline

Start
2021-11-15
Primary completion
2023-05-22
Completion
2023-05-22

Outcome

Outcome not reported

Stopped (Enrollment): “Difficulties in recruiting patients due to changing in treatment standards for the target population”

Drugs

EvaluationDrugModalityDoseRoute
Subject Melphalan Small molecule — Intravitreal
Subject Topotecan Small molecule — Intravitreal

Indications