Study 1: Melphalan or Melphalan + Topotecan for Retinoblastoma (RETINO2018 Trial)

Phase 2 & 3

Recruiting

Led By Livia LUMBROSO LE ROUIC, MD

Research Sponsored by Institut Curie

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up in the year patients turn 6 years of age and at least 24 months of treatment

Awards & highlights

No Placebo-Only Group

Summary

This protocol includes 2 independent studies. Both studies are multicenter studies, evaluating different therapeutic approaches in two different populations of patients: * Study 1, a randomized phase-II study evaluating the efficacy of Intra-Arterial Chemotherapy (IAC) with melphalan and topotecan versus melphalan alone, both in association with ophthalmologic treatments. * Study 2, a minimally invasive interventional study evaluating the results on visual function following reference treatment with intravenous (IV) chemotherapy in association with ophthalmologic or local ophthalmological treatment without IV chemotherapy.

Eligible Conditions

Retinoblastoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ in the year patients turn 6 years of age and at least 24 months of treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~in the year patients turn 6 years of age and at least 24 months of treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and in the year patients turn 6 years of age and at least 24 months of treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Study 1: Rate of eye preservation

Visual function

Secondary study objectives

Additional assessment of visual function

Integration at school

Ocular toxicity

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Study 2: Etoposide, carboplatin and vincristineExperimental Treatment6 Interventions

Neoadjuvant chemotherapy involves 2 to 6 cycles of combined etoposide, carboplatin and vincristine in association with ophthalmologic treatments.

Group II: Study 1: Melphalan or Melphalan + TopotecanExperimental Treatment5 Interventions

Randomized phase-II study evaluating the efficacy of Intra-Arterial Chemotherapy (IAC) with melphalan and topotecan versus melphalan alone, both in association with ophthalmologic treatments.

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