Neoadjuvant Carboplatin and Vincristine and Standard Local Ophthalmic Therapy in Treating Patients With Intraocular Retinoblastoma
Condition: Intraocular Retinoblastoma
MeSH terms: Retinoblastoma
Intervention: Carboplatin; Cryosurgery; Infrared Laser Therapy; Iodine I-125; Radiation Therapy; Ruthenium Ru-106; Vincristine Sulfate
Intervention description: Given IV; Undergo radioactive therapy; Undergo radioactive therapy; Undergo radioactive therapy; Given IV
Intervention MeSH terms: Iodine; Cadexomer iodine; Carboplatin; Vincristine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Maximum age: 5 Years
Healthy volunteers: No

Summary:

      This phase III trial is studying how well giving carboplatin and vincristine together with
      standard local ophthalmic therapy works in treating children with intraocular retinoblastoma.
      Drugs used in chemotherapy, such as carboplatin and vincristine, work in different ways to
      stop tumor from dividing so they stop growing or die. It is not yet known whether neoadjuvant
      chemotherapy combined with standard local ophthalmic therapy is effective in treating
      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