Systemic Chemotherapy and Subtenon Carboplatin, and Local Ophthalmic Therapy in Children With Intraocular Retinoblastoma
Condition: Intraocular Retinoblastoma
MeSH terms: Retinoblastoma
Intervention: liposomal vincristine sulfate; cryosurgery; laser surgery; carboplatin; etoposide; filgrastim
Intervention description: Given IV; Application of extreme cold to destroy abnormal or diseased tissue.; Surgery using a laser (instead of a scalpel) to cut tissue; Given IV; Given IV; Given subcutaneously
Intervention MeSH terms: Carboplatin; Etoposide; Vincristine; Etoposide phosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      Phase III trial to determine the effectiveness of combining systemic chemotherapy and
      subtenon carboplatin with ophthalmic therapy in treating children who have intraocular
      retinoblastoma. Drugs used in chemotherapy, such as vincristine, carboplatin, and etoposide,
      work in different ways to stop tumor cells from dividing so they stop growing or die. It is
      not yet known whether systemic chemotherapy and subtenon (under the conjunctiva of the eye)
      carboplatin combined with ophthalmic therapy is effective in treating intraocular (within the
      eyeball) retinoblastoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of bilateral retinoblastoma with at least 1 eye group C or D intraocular
             retinoblastoma by ophthalmologic examination, defined by the International
             Classification System for Intraocular Retinoblastoma as the following:

               -  Group C: Discrete localized disease with minimal subretinal and/or vitreous
                  seeding

                    -  Subretinal fluid, without prior or concurrent seeding, involving ≤ one
                       quarter of the retina

                    -  Local fine vitreous seeding may be present close to discrete tumor

                    -  Local subretinal seeding < 3 mm from tumor

               -  Group D: Diffuse disease with significant vitreous and/or subretinal seeding

                    -  Tumor(s) may be massive or diffuse

                    -  Subretinal fluid, without prior or concurrent seeding, involving up to total
                       retinal detachment

                    -  Diffuse or massive vitreous disease may include "greasy" seeds or avascular
                       tumor masses

                    -  Diffuse subretinal seeding may include subretinal plaques or tumor nodules

          -  Prior enucleation of 1 eye allowed provided the remaining eye is group C or D

          -  No tumor present on histologic examination at the cut end of the optic nerve on any
             eye enucleated prior to study entry

               -  Evidence of choroidal and/or optic nerve invasion past the lumina cribrosa is
                  allowed

          -  No extraocular retinoblastoma clinically or by MRI of brain and orbits with and
             without gadolinium or CT scan with and without contrast of brain and orbits

          -  No evidence of systemic metastases by bone marrow, lumbar puncture, bone scan, and/or
             any other additional test

          -  Performance status - Karnofsky 50-100% (over 16 years of age)

          -  Performance status - Lansky 50-100% (16 and under)

          -  Bilirubin ≤ 1.5 times upper limit of normal (ULN) for age

          -  AST and ALT < 2.5 times ULN for age

          -  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/1.73m^2

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception

          -  Negative pregnancy test in postmenarchal females

          -  No prior chemotherapy

          -  No other concurrent chemotherapy

          -  No prior radiotherapy

          -  No other concurrent radiotherapy