Clinical trial · Interventional
Intravitreal Carboplatin for the Treatment of Participants With Recurrent or Refractory Intraocular Retinoblastoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Retinoblastoma | Retinoblastoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Focal Therapy | Procedure | — | UNRESOLVED |
| Maxitrol® | Drug | Dexamethasone | ALIAS |
| Plaque Radiotherapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment
- description
- Participants with retinoblastoma that is refractory or has relapsed inside the eye. Interventions: Carboplatin, Maxitrol® , focal therapy, plaque radiotherapy.
- interventionNames
- Drug: Carboplatin
- Drug: Maxitrol®
- Procedure: Focal Therapy
- Procedure: Plaque Radiotherapy
Primary outcomes (1)
- measure
- Number of participants who develop dose-limiting toxicity (DLT)
- timeFrame
- From baseline through end of therapy (up to 5 months)
- description
- 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 will be replaced.
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 17 Years
Show eligibility criteria text
Inclusion Criteria: * Refractory or recurrent retinoblastoma with vitreous seeding meeting eligibility criteria by ultrasonic biomicroscopy performed during examination under anesthesia (EUA) by an ophthalmologist: * At least three consecutive clock hours of disease-free, attached peripheral retina through which the intraocular injection may be administered. * Absence of invasion in anterior and posterior chamber. * Absence of anterior hyaloid detachment. * Absence of retinal detachment at the entry site. * Absence of tumor at the entry site. * ECOG Performance Score must be ≤ 2 within two weeks prior to registration. * Participants must have an adequate liver function, as defined by bilirubin ≤3 x upper limit of normal (ULN), and SGOT and SGPT ≤3 x ULN. * Participants must have adequate renal function as defined by serum creatinine ≤3 x ULN for age. * Legal guardians must sign an informed consent indicating that they are aware of this study, the possible benefits, and toxic side effects. Legal guardians will be given a signed copy of the consent form. Exclusion Criteria: * Presence of metastatic disease or gross orbital involvement. * Participants must not have an invasive infection at time of protocol entry. * Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
References
Publications (0)
Data not yet available