drugset / Trial / NCT02792036

Intravitreal Carboplatin for the Treatment of Participants With Recurrent or Refractory Intraocular Retinoblastoma

NCT02792036

Phase 1 Completed 8 enrolled St. Jude Children's Research Hospital
NaSingle-groupOpen-labelTreatment

Summary

Retinoblastoma (RB) is the most common intraocular tumor of childhood. Recurrent or refractory disease following therapy most often occurs due to persistence of vitreous disease and/or retinal reactivation of the main tumor mass. With this treatment protocol, investigators seek to identify a less invasive method of local drug delivery that does not disrupt the eye's integrity. PRIMARY OBJECTIVE: * To determine the safety and toxicity profile associated with intravitreal carboplatin for the treatment of recurrent or progressive intraocular retinoblastoma with vitreous seeding. SECONDARY OBJECTIVES: * To estimate the ocular salvage rate after treatment with intravitreal carboplatin in patients with recurrent or progressive intraocular retinoblastoma with vitreous seeding. * To evaluate the effects of intravitreal carboplatin therapy on the histopathology of eyes enucleated for progressive or recalcitrant disease while on therapy.

Timeline

Start
2016-11-01
Primary completion
2019-10-04
Completion
2019-10-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Carboplatin Small molecule Intravitreal
Background Maxitrol Unknown Topical

Indications