Retinoblastoma Clinical Trial
Official title:
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 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.
The eye(s) will be sterilized prior to injection. Aqueous fluid (0.1-0.15ml) will be
withdrawn and sent for pathology review. Carboplatin diluted in normal saline will be
administered via intravitreal injection under anesthesia once to each eligible eye
approximately every 14 days. Following the injection, triple freeze/thaw cryotherapy is
applied to the injection site and the eye is washed with water. The eye is gently "shaken" in
all directions to evenly distribute the drug.
This trial will use a traditional phase I design for dose de-escalation with two dose levels.
The first 6 patients will be enrolled at dose level 1 and will be observed for dose-limiting
toxicity (DLT) throughout the treatment period up to approximately 5 months after start of
therapy. If 0-2 (of the first 6) participants experience DLT, a second cohort of 6 patients
will be enrolled at the same dose level 1. Study accrual would be completed at 12.
However, if 3 or more of the first 6 patients experience DLT at dose level 1, the dose level
would be de-escalated to level -1 and 6 patients enrolled at this level (dose -1). If 0-2
patients experience DLT at dose level -1, a second cohort of 6 patients will be enrolled at
dose level -1, and the study accrual would be complete. If 3 or more patients experience DLT
at dose level -1, accrual would also be complete.
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