Trial of Systemic Neoadjuvant Chemotherapy for Group B Intraocular Retinoblastoma

Fecha de inicio: 26 de diciembre de 2005

Inclusion Criteria: * Newly diagnosed Group B intraocular retinoblastoma meeting 1 of the following criteria: * Group B tumor(s) in 1 eye * Group B tumor(s) in both eyes * Group A tumor in 1 eye and Group B tumor(s) in the other eye * Group E tumor in 1 eye that has been enucleated and Group B tumor(s) in the remaining eye at the time of enucleation of the Group E tumor * Defined by the International Classification System for Intraocular Retinoblastoma as follows: * Group A: Small tumors (≤ 3 mm in greatest dimension) confined to the retina, away from foveola and disc meeting the following criteria: * More than 3 mm from fovea * More than 1.5 mm from optic disk * Group B: Tumors more than 3 mm meeting the following criteria: * Confined to the retina in any location not in Group A * Tumor associated subretinal fluid \< 3 mm from the tumor margin with no subretinal seeding * Group E: Must have ≥ 1 of the following present: * Tumor touching the lens * Tumor anterior to anterior vitreous face involving ciliary body or anterior segment * Diffuse infiltrating retinoblastoma * Neovascular glaucoma * Opaque media from hemorrhage * Tumor necrosis with aseptic orbital cellulites * Phthisis bulbi * Confirmation of diagnosis by CT scan or MRI of the brain and orbits AND an ophthalmologic evaluation under anesthesia within the past 3 weeks * No choroidal and/or optic nerve invasion past the lamina cribosa * No evidence of extraocular retinoblastoma clinically or by head and orbital MRI and/or CT scan * No tumor present on histological exam at the cut end of the optic nerve for any Group E eye enucleated before study entry * Performance status - ECOG 0-2 * Bilirubin ≤ 1.5 times upper limit of normal (ULN) for age * AST or ALT \< 2.5 times ULN for age * Creatinine clearance (based on Schwartz formula) or radioisotope glomerular filtration rate ≥ 70mL/min/1.73 m\^2 * No prior chemotherapy * No other concurrent chemotherapy * No prior radiotherapy * No other concurrent radiotherapy, including intensity-modulated stereotactic, or proton beam radiotherapy * Prior enucleation of one eye allowed provided the remaining eye is Group B * No concurrent enucleation * No prior local ophthalmic therapy for retinoblastoma * No other prior therapy for retinoblastoma * No local therapy during chemotherapy course 1