The investigators are testing subtenon carboplatin in combination with vincristine and topotecan given by vein in the hopes of finding a drug combination that may be effective against retinoblastoma that has come back (recurrent) or is resistant to other treatment (refractory). The goals of this study are: * To decide if the drug combination is a useful treatment for recurrent or refractory retinoblastoma * To test the safety of the drug combination and to see what kind of effects (good and bad) can be expected from the drug combination * To measure visual changes before and after the study therapy * To use a special MRI scan to measure brain function involved in vision processing, both before and after the study therapy In this study, the investigators are also testing a new experimental way of giving carboplatin "subtenon carboplatin". The carboplatin will be given directly in the eye through a needle placed under the covering of the eye. This is to try to get more carboplatin to the retinoblastoma inside the eye.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Available in 50mg, 150mg, 450 mg, 600mg vials. It is provided as a premixed aqueous solution or lyophilized powder for injection given on day 1/week 10 (cycles 1-3).
Each vial contains topotecan hydrochloride equivalent to 4 mg of topotecan as free base. Given intravenously on days 1-5 of each week (cycles 1-6).
Each vial contains vincristine sulfate, 1 mg; mannitol, 100 mg; sterile water for injection; Acetic acid and sodium acetate are added for pH control. Given intravenously on day 1/week 1 (cycles 1-6).
Supplied as a clear solution in 300 mcg/ml 1 ml or 1.6 ml vials and prefilled syringes containing 300mcg/0.5mL or 480mcg/0.8mL. Given intravenously on day 6 of each week (cycles 1-6).
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
To estimate the event-free survival, where an event is defined at the ocular level as the need for non-protocol therapy defined as additional non-protocol chemotherapy, external beam radiation, or enucleation.
Time frame: at 1 year
To estimate the patterns of response, and response rate of locally refractory retinoblastoma to combination intravenous and peri-ocular chemotherapy.
Time frame: at 1 yr
To describe the toxicities associated with the proposed regimen.
Time frame: at 1 yr
To describe the histologic findings in the eyes ultimately requiring enucleation.
Time frame: at 1 yr
To describe the visual acuity of patients with advanced intraocular retinoblastoma before and after the proposed therapy.
Time frame: at 1 yr
To describe primary visual cortex function in patients with retinoblastoma via functional Magnetic Resonance Imaging (fMRI) technique both before and after the proposed therapy.
Time frame: at 1 yr
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