Systemic Chemotherapy and Subtenon Carboplatin, and Local Ophthalmic Therapy in Children With Intraocular Retinoblastoma

• Status: Completed
• Trial end date: 2021-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Carboplatin; Etoposide; Etoposide phosphate; Lenograstim; Vincristine

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