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NCT02792036 · ClinicalTrials.gov registry record · Phase 1
Intravitreal Carboplatin for the Treatment of Participants With Recurrent or Refractory Intraocular Retinoblastoma
A Phase 1 study, sponsored by St. Jude Children's Research Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT02792036: Completed Phase 1 study, sponsored by St. Jude Children's Research Hospital.
NCT02792036 is a Phase 1 study that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 8 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02792036, a Phase 1 study, has completed, sponsored by St. Jude Children's Research Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study 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.
Primary Outcome
DLTs are defined as any of the following: uveitis, sterile or infectious endophthalmitis, retinopathy or rhegmatogenous retinal detachment, massive vitreous hemorrhage that obscures direct visualization of the retina/tumor, and/or cataract that threatens the visual axis or view by treating physician. Grade 3 or 4 allergic reactions should lead to discontinuation of intravitreal carboplatin injections. Patients who have grade 3 or 4 allergic reactions will not be evaluable for this objective and
Interventions
- DRUG Carboplatin
- PROCEDURE Focal Therapy
- DRUG Maxitrol®
- PROCEDURE Plaque Radiotherapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2016-11-01 |
| Est. Completion | 2019-10-04 |
| Phase | Phase 1 |
What the finished NCT02792036 record still lists
NCT02792036 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 4 interventions - of which Carboplatin is the first listed.
NCT02792036 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02792036 about?
NCT02792036 is a clinical study titled "Intravitreal Carboplatin for the Treatment of Participants With Recurrent or Refractory Intraocular Retinoblastoma". 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 in...
What is the current status of trial NCT02792036?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2016-11-01. Estimated completion is 2019-10-04.
What interventions are being tested in trial NCT02792036?
The interventions under investigation include: Carboplatin (DRUG), Focal Therapy (PROCEDURE), Maxitrol® (DRUG), Plaque Radiotherapy (PROCEDURE).
Who is sponsoring clinical trial NCT02792036?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02792036's enrollment target sits among peer trials
8 1959th of 2000 higher than 29 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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