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

Completed · Phase 1

Conditions studied: Retinoblastoma

In brief

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.

Key facts

Study ID

NCT02792036

Run by

St. Jude Children's Research Hospital

People needed

8

Starts

2016-11-01

Expected to finish

2019-10-04

Last updated by the study team

2020-02-20

Who can join

Age: any, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• St. Jude Children's Research Hospital — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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