Vincristine, Carboplatin, and Etoposide or Observation Only in Treating Patients Who Have Undergone Surgery for Newly Diagnosed Retinoblastoma

Inclusion Criteria:

   - Newly diagnosed unilateral retinoblastoma

   - Underwent enucleation as primary therapy within the past 5 weeks

      - Must enroll and submit pathology slides within 21 days of enucleation

      - Adjuvant chemotherapy must begin within 35 days after enucleation

   - Disease with or without high-risk histopathologic features

      - High-risk features are defined as any of the following:

         - Posterior uveal invasion (includes choroidal invasion)

         - Any degree of concomitant choroid and/or optic nerve involvement

         - Tumor involving the optic nerve posterior to the lamina cribrosa as an
         independent finding

         - Scleral invasion

         - Anterior chamber seeding

         - Ciliary body infiltration

         - Iris infiltration

   - No evidence of extraocular retinoblastoma clinically, by CT scan, or by MRI of the
   brain and orbits with and without gadolinium

   - No tumor at the cut end of the optic nerve on any eye enucleated as evidenced by
   histologic examination prior to study entry

   - No systemic metastases as evidenced by bone marrow scan, bone scan, or any other
   additional test at study entry

   - Lansky performance status 50-100%

   - Hemoglobin > 8 g/dL

   - Absolute neutrophil count ≥ 1,000/mm³

   - Platelet count ≥ 100,000/mm³

   - Creatinine adjusted according to age as follows:

      - No greater than 0.4 mg/dL (≤ 5 months)

      - No greater than 0.5 mg/dL (6 months -11 months)

      - No greater than 0.6 mg/dL (1 year-23 months)

      - No greater than 0.8 mg/dL (2 years-5 years)

      - No greater than 1.0 mg/dL (6 years-9 years)

      - No greater than 1.2 mg/dL (10 years-12 years)

      - No greater than 1.4 mg/dL (13 years and over [female])

      - No greater than 1.5 mg/dL (13 years to 15 years [male])

      - No greater than 1.7 mg/dL (16 years and over [male])

   - Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min

   - Bilirubin ≤ 1.5 times upper limit of normal (ULN) for age

   - AST or ALT < 2.5 times ULN for age

   - No prior therapy other than enucleation

   - No prior chemotherapy