Phase 3 N=28 Treatment

Neoadjuvant Carboplatin and Vincristine and Standard Local Ophthalmic Therapy in Treating Patients With Intraocular Retinoblastoma

Intraocular Retinoblastoma

Bottom Line

View on ClinicalTrials.gov: NCT00079417 ↗

Enrolled (actual)

Serious AEs

47.6%

Results posted

Feb 2014

Primary outcome: Primary: Event-free Survival — 0.65 Proportion of participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Carboplatin (Drug); Cryosurgery (Procedure); Infrared Laser Therapy (Procedure); Iodine I-125 (Radiation); Radiation Therapy (Radiation); Ruthenium Ru-106 (Radiation); Vincristine Sulfate (Drug)
Age: Pediatric
Sex: All
Sponsor: Children's Oncology Group
Primary completion: Jan 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Event-free Survival	0.65	—
SECONDARY Response Rate (RR) at Patient Level After the First Course of Therapy	0.71	—
SECONDARY Response Rate (RR) at Eye Levels After the First Course of Therapy	0.71	—
SECONDARY Event-free Survival Rate (EFSR) Defined as the Need for Non-protocol Chemotherapy, Enucleation, or EBRT at the Patient Level	0.60	—
SECONDARY Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0	1; 1; 1; 1; 6	—

Summary

This phase III trial is studying how well giving carboplatin and vincristine together with standard local ophthalmic therapy works in treating children with intraocular retinoblastoma. Drugs used in chemotherapy, such as carboplatin and vincristine, work in different ways to stop tumor from dividing so they stop growing or die. It is not yet known whether neoadjuvant chemotherapy combined with standard local ophthalmic therapy is effective in treating intraocular retinoblastoma.

Eligibility Criteria

Inclusion Criteria

Newly diagnosed Group B intraocular retinoblastoma meeting 1 of the following criteria:
Group B tumor(s) in 1 eye
Group B tumor(s) in both eyes
Group A tumor in 1 eye and Group B tumor(s) in the other eye
Group E tumor in 1 eye that has been enucleated and Group B tumor(s) in the remaining eye at the time of enucleation of the Group E tumor
Defined by the International Classification System for Intraocular Retinoblastoma as follows:
Group A: Small tumors (≤ 3 mm in greatest dimension) confined to the retina, away from foveola and disc meeting the following criteria:
More than 3 mm from fovea
More than 1.5 mm from optic disk
Group B: Tumors more than 3 mm meeting the following criteria:
Confined to the retina in any location not in Group A
Tumor associated subretinal fluid < 3 mm from the tumor margin with no subretinal seeding
Group E: Must have ≥ 1 of the following present:
Tumor touching the lens
Tumor anterior to anterior vitreous face involving ciliary body or anterior segment
Diffuse infiltrating retinoblastoma
Neovascular glaucoma
Opaque media from hemorrhage
Tumor necrosis with aseptic orbital cellulites
Phthisis bulbi
Confirmation of diagnosis by CT scan or MRI of the brain and orbits AND an ophthalmologic evaluation under anesthesia within the past 3 weeks
No choroidal and/or optic nerve invasion past the lamina cribosa
No evidence of extraocular retinoblastoma clinically or by head and orbital MRI and/or CT scan
No tumor present on histological exam at the cut end of the optic nerve for any Group E eye enucleated before study entry
Performance status - ECOG 0-2
Bilirubin ≤ 1.5 times upper limit of normal (ULN) for age
AST or ALT < 2.5 times ULN for age
Creatinine clearance (based on Schwartz formula) or radioisotope glomerular filtration rate ≥ 70mL/min/1.73 m^2
No prior chemotherapy
No other concurrent chemotherapy
No prior radiotherapy
No other concurrent radiotherapy, including intensity-modulated stereotactic, or proton beam radiotherapy
Prior enucleation of one eye allowed provided the remaining eye is Group B
No concurrent enucleation
No prior local ophthalmic therapy for retinoblastoma
No other prior therapy for retinoblastoma
No local therapy during chemotherapy course 1

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00079417). 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.