Retinoblastoma Clinical Trial
Official title:
Intra-arterial Chemotherapy(Chemosurgery) for Retinoblastoma
Conventional treatments of retinoblastoma involves laser photocoagulation, cryotherapy (freezing of the tumor), plaque radiotherapy,external beam radiotherapy, and intravenous chemotherapy. Enucleation (removing of the eye)is the last option when the tumor cannot be controlled otherwise. However,many children with retinoblastoma present with advanced intraocular disease for which enucleation is the only option. Intra-arterial chemotherapy (Chemosurgery)delivers anti-tumor drug directly into the ophthalmic artery (the artery feeding the eye) in order to increase the dose of drug reaching the tumor while minimizing toxicity to the rest of the body.
Present treatments for intraocular retinoblastoma cure 99% of children but have significant
toxicity. Enucleation of the eye is effective but blinds the eye and leaves a lifelong
cosmetic deformity. Radiation is associated with the subsequent development of fatal
cancers. Systemic (intravenous)chemotherapy is used worldwide but experience with it has
shown that the majority of eyes initially treated with chemotherapy still require additional
treatments, such as radiation, laser, cryotherapy or even enucleation. In addition blood
transfusions, secondary infections, insertion of ports and permanent hearing loss are now
well reported. Three years ago we developed this technique of Chemosurgery for significantly
increasing the dose of drug to the cancer while decreasing the dose of drug administered to
children. This approach has decreased the need for enucleation in advanced eyes scheduled
for enucleation with minimal systemic toxicity. We now offer treatment of both eyes
simultaneously (in bilateral cases) and to eyes with less advanced disease and normal vision
as an alternative to toxic systemic chemotherapy. In cases of very advanced ocular disease
we will be using multiple drugs infused at the same session to increase tumor kill.
Chemosurgery interventions are performed under general anesthesia. The femoral artery
(artery at the groin) is punctured and a catheter (a small plastic tube)is advanced into the
opthalmic artery (the artery of the eye)using fluoroscopic (X-ray) guidance. The drugs are
injected directly into the opthalmic artery over a period of 30-45 min.The catheter is then
removed, manual compression exerted to the femoral artery, the child is awaken and goes to
recovery for 6 hours. The procedure is repeated every 3-4 weeks for a total of 2 to 6
sessions according to tumor response. Since April 2006, our center has treated by
chemosurgery 60 eyes in 52 patients with advanced intra-ocular retinoblastoma for which
enucleation was considered.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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