This pilot phase I trial studies the side effects of carboplatin in treating patients with retinoblastoma that has come back or does not respond to treatment. Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02792036.
PRIMARY OBJECTIVES:
I. 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:
I. To estimate the ocular salvage rate after treatment with intravitreal carboplatin in patients with recurrent or progressive intraocular retinoblastoma with vitreous seeding.
II. To evaluate the effects of intravitreal carboplatin therapy on the histopathology of eyes enucleated for progressive or recalcitrant disease while on therapy.
OUTLINE:
Patients receive carboplatin intravitreally once every 14-21 days in each eye for up to 8 injections per eye in the absence of disease progression or unacceptable toxicity. Patients with regression of stable seed may receive up to 8 additional injections per eye. Patients also undergo brachytherapy, cryotherapy, laser photocoagulation, or thermotherapy every 2-6 weeks.
After completion of study treatment, patients are followed up every 6-12 months for up to 5 years.
Lead OrganizationSaint Jude Children's Research Hospital
Principal InvestigatorRachel C. Brennan
