This pilot clinical trial studies whether unilateral group D retinoblastoma, or retinoblastoma affecting one eye that has spread to the inner jelly like part of the eye, can be treated with a new technique for delivering chemotherapy directly into the blood vessel that supplies the affected eye. This new technique is called intra-arterial injection. This may give children with unilateral retinoblastoma a lower chance of needing surgery to remove the eye and reduce the amount of treatment side effects.
A Multi-institutional Feasibility Study of Intra-arterial Chemotherapy Given in the Ophthalmic Artery of Children With Retinoblastoma
PRIMARY OBJECTIVES:
- To study the feasibility of delivering melphalan directly into the ophthalmic artery in children with newly diagnosed unilateral group D retinoblastoma, who would otherwise be considered for enucleation.
SECONDARY OBJECTIVES:
- To estimate the ocular salvage rate after treatment with intra-arterial melphalan in children with newly diagnosed unilateral retinoblastoma with group D disease.
II. To evaluate the toxicities and adverse events associated with delivering multiple doses of intra-arterial chemotherapy.
III. To evaluate vision outcomes in children treated with intra-arterial chemotherapy.
IV. To monitor the rate of the development of metastatic disease while on protocol therapy.
TERTIARY OBJECTIVES:
- To evaluate the effects of intra-arterial therapy on the histopathology of eyes enucleated for progression.
OUTLINE:
Patients receive melphalan intra-arterially (IA) on day 1. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then periodically for 2 years.