Neoadjuvant Carboplatin and Vincristine and Standard Local Ophthalmic Therapy in Treating Patients With Intraocular Retinoblastoma
Intraocular Retinoblastoma
About this trial
This is an interventional treatment trial for Intraocular Retinoblastoma
Eligibility Criteria
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
Sites / Locations
- Children's Hospital Los Angeles
- Lurie Children's Hospital-Chicago
- Dana-Farber Cancer Institute
- Wayne State University/Karmanos Cancer Institute
- Duke University Medical Center
- Cincinnati Children's Hospital Medical Center
- Children's Hospital of Philadelphia
- Children's Oncology Group
- Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
- Fred Hutchinson Cancer Research Center
Arms of the Study
Arm 1
Experimental
Treatment (chemotherapy, surgery)
Patients receive chemoreduction comprising carboplatin IV over 60 minutes followed by vincristine IV over 1-2 minutes on day 1. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. After the first course of chemoreduction, patients undergo standardized local ophthalmic therapy comprising local laser therapy, cryotherapy, and/or radioactive plaque comprising iodine I 125 or ruthenium Ru 106.