Overview

This trial is active, not recruiting.

Condition intraocular retinoblastoma
Treatments cryosurgery, infrared laser therapy, iodine i 125, ruthenium ru 106, carboplatin, vincristine sulfate, radiation therapy
Phase phase 3
Sponsor Children's Oncology Group
Collaborator National Cancer Institute (NCI)
Start date December 2005
End date January 2010
Trial size 28 participants
Trial identifier NCT00079417, ARET0331, CDR0000355721, COG-ARET0331, NCI-2009-00422, U10CA098543

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 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Patients receive chemoreduction comprising carboplatin IV (Pts < 36 months: 18.6 mg/kg Pts ≥ 36 months: 560 mg/m2) over 60 minutes followed by vincristine sulfate IV (Pts < 36 months: 0.05 mg/kg Pts ≥36 months: 1.5 mg/m2) over 1-2 minutes on day 1. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. After the first course of chemoreduction, patients undergo standardized local ophthalmic therapy comprising local infrared laser therapy, cryosurgery, and/or radiation therapy (radioactive) plaque comprising iodine I 125 or ruthenium Ru 106.
cryosurgery cryoablation
Application of extreme cold to destroy abnormal or diseased tissue.
infrared laser therapy
Laser therapy or "photobiomodulation" is the use of specific wavelength of light (red and near-infrared) to create therapeutic effects
iodine i 125 125-Iodine
Undergo radioactive therapy
ruthenium ru 106 Ru-106
Undergo radioactive therapy
carboplatin Carboplat
Given IV
vincristine sulfate leurocristine sulfate
Given IV
radiation therapy irradiation
Undergo radioactive therapy

Primary Outcomes

Measure
Event-free Survival
time frame: At 2 years

Secondary Outcomes

Measure
Use of Nonprotocol Chemotherapy
time frame: Up to 10 years
Response Rate (RR) at Patient and Eye Levels After the First Course
time frame: Up to 10 years
Event-free Survival Rate (EFSR) Defined as the Need for Non-protocol Chemotherapy, Enucleation, or EBRT at the Patient Level
time frame: Up to 10 years
Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0
time frame: From the beginning of treatment, assessed up to 10 years

Eligibility Criteria

Male or female participants up to 5 years old.

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

Additional Information

Official title Trial of Systemic Neoadjuvant Chemotherapy for Group B Intraocular Retinoblastoma
Principal investigator Debra Friedman, MD
Description PRIMARY OBJECTIVES: I. Determine the 2-year event-free survival of patients with Group B intraocular retinoblastoma treated with neoadjuvant chemoreduction comprising carboplatin and vincristine and standardized local ophthalmic therapy. SECONDARY OBJECTIVES: I. Determine the response rate after one course of chemoreduction (before standardized local ophthalmic therapy) in these patients. II. Correlate response rate with event-free survival in patients treated with this regimen. III. Determine the incidence of toxic effects in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive chemoreduction comprising carboplatin IV over 60 minutes followed by vincristine IV over 1-2 minutes on day 1. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. After the first course of chemoreduction, patients undergo standardized local ophthalmic therapy comprising local laser therapy, cryotherapy, and/or radioactive plaque comprising iodine I 125 or ruthenium Ru 106. Patients are followed every 3-4 weeks until there is no active tumor seen on a minimum of 3 ophthalmic exams under anesthesia, every 6-8 weeks until 3 years of age, every 4-6 months until 10 years of age, and then annually thereafter.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Children's Oncology Group.