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

• Status: Completed
• Trial end date: 2019-10-04
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Jude Children's Research Hospital
• Treatments: Carboplatin; Dexamethasone, neomycin, polymyxin B drug combination

Criteria

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.