A Prospective International Multicenter Clinical Trial for Eyes With Relapsed Retinoblastoma
NCT04455139 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2
Last updated 2023-10-03
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.
Conditions
- Eye Cancer, Retinoblastoma
Interventions
- DRUG
-
Topotecan
intravitreal or intra-arterial administration of topotecan
- DRUG
-
Melphalan
intravitreal or intra-arterial administration of topotecan
Sponsors & Collaborators
-
Prof. Beck Popovic Maja
lead OTHER
Principal Investigators
-
Maja Beck Popovic, Prof · University of Lausanne Hospitals
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 3 Months
- Max Age
- 11 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-11-15
- Primary Completion
- 2023-05-22
- Completion
- 2023-05-22
Countries
- Switzerland
Study Locations
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