Vincristine, Carboplatin, and Etoposide or Observation Only in Treating Patients Who Have Undergone Surgery for Newly Diagnosed Retinoblastoma
Condition: Intraocular Retinoblastoma
MeSH terms: Retinoblastoma
Intervention: liposomal vincristine sulfate; carboplatin; etoposide
Intervention description: Given IV; Given IV; Given IV
Intervention MeSH terms: Carboplatin; Etoposide; Vincristine; Etoposide phosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 331.0
Sex: All
Maximum age: 6 Years
Healthy volunteers: No

Summary:

      This phase III trial is studying vincristine, carboplatin, and etoposide to see how well they
      work compared to observation only in treating patients who have undergone surgery for newly
      diagnosed retinoblastoma. Drugs used in chemotherapy, such as vincristine, carboplatin, and
      etoposide, work in different ways to stop the growth of tumor cells, either by killing the
      cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy)
      after surgery may kill any tumor cells that remain after surgery. Sometimes, after surgery,
      no additional treatment is needed for the tumor until it progresses. In this case,
      observation may be sufficient.
    

Eligibility criteria:

        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