Phase 3 N=30 Treatment

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

Intraocular Retinoblastoma

Bottom Line

View on ClinicalTrials.gov: NCT00072384 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2018

Primary outcome: Primary: Group D Eyes - Treatment Failure Within One Year — 0.52 Probability of treatment failure

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: liposomal vincristine sulfate (Drug); cryosurgery (Procedure); laser surgery (Procedure); carboplatin (Drug); etoposide (Drug); filgrastim (Biological)
Age: Pediatric
Sex: All
Sponsor: Children's Oncology Group
Primary completion: Feb 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Group D Eyes - Treatment Failure Within One Year	0.52	—
PRIMARY Group C Eyes - Treatment Failure Within One Year	0.25	—
SECONDARY Event-free Survival (EFS)	45.45	—
SECONDARY Toxicity Associated With Chemotherapy	10	—
SECONDARY Patterns of Failure for Group C and Group D in Terms of Vitreous vs Patterns of Failure for Group C and Group D in Terms of Vitreous vs Retinal vs Both as Sites of Recurrence	0; 1; 1; 7; 0; 1	—
SECONDARY Patterns of Treatment Failure vs. no Treatment Failure for Group C Eyes and Group D Eyes According to Initial Sites of Involvement	0; 3; 0; 0; 0; 3	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00072384). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.