CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 30 enrolled
Drug / intervention
liposomal vincristine sulfate +5 moredrug
Likely dose
Liposomal vincristine (IV), carboplatin (IV), etoposide (IV), with filgrastim (subcutaneous) support; exact doses not specified in provided textAI-extracted
Key inclusion· 7
  • Bilateral retinoblastoma with at least one eye having Group C or D intraocular disease by International Classification System
  • Group C: localized disease with minimal subretinal/vitreous seeding (subretinal fluid ≤1/4 retina, local fine vitreous seeding, subretinal seeding <3 mm from tumor)
  • Group D: diffuse disease with significant vitreous/subretinal seeding (massive/diffuse tumors, subretinal fluid up to total retinal detachment, diffuse/massive vitreous disease)
  • Prior enucleation of one eye allowed if remaining eye is Group C or D
Key exclusion· 5
  • Prior chemotherapy
  • Concurrent chemotherapy (other than study drugs)
  • Prior radiotherapy
  • Concurrent radiotherapy (other than study protocol)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00072384
NCT00072384Phase 3Completed

A Single Arm Trial of Systemic And Subtenon Chemotherapy For Groups C And D Intraocular Retinoblastoma

Children's Oncology Group·interventional·Posted Nov 6, 2003·Updated Jul 30, 2021

In Brief

A Phase 3 clinical trial evaluating liposomal vincristine sulfate, cryosurgery, and 4 other interventions for Intraocular Retinoblastoma. Completed, enrolled 30 participants across 11 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 6, 2003
Enrollment StartApr 16, 2007
Primary CompletionFeb 1, 2013
Study CompletionJun 30, 2021
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 22.7 years ago

Interventions

liposomal vincristine sulfatedrug

Given IV

cryosurgeryprocedure

Application of extreme cold to destroy abnormal or diseased tissue.

laser surgeryprocedure

Surgery using a laser (instead of a scalpel) to cut tissue

carboplatindrug

Given IV

etoposidedrug

Given IV

filgrastimbiological

Given subcutaneously