MedTrace Logo

A Study of Intra-Ophthalmic Artery Topotecan Infusion for the Treatment of Retinoblastoma

NCT01466855 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2020-09-14

No results posted yet for this study

Summary

This study will test if giving topotecan directly into the blood vessel of the eye will improve the treatment of retinoblastoma. This method is referred to as "selective intra-ophthalmic artery chemotherapy" (SIOAC).

The goals of this study are:

* To find out if topotecan is an effective treatment for retinoblastoma when delivered directly to the ophthalmic artery (SIOAC delivery)
* To find out what kind of effects (good and bad) can be expected when topotecan is given by SIOAC
* To assess visual pathway function before and after the study therapy
* To learn more about the pharmacology (how your body handles the drug) of topotecan when delivered directly to the ophthalmic artery

Conditions

  • Retinoblastoma

Interventions

DRUG

Intra-Ophthalmic Artery Topotecan Infusion

Topotecan via intra-ophthalmic artery delivery infused over 30 minutes on Day 1 of every 21-day cycle.

Sponsors & Collaborators

  • Children's Hospital Medical Center, Cincinnati

    lead OTHER

Principal Investigators

  • James Geller, MD · Children's Hospital Medical Center, Cincinnati

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2015-10-31
Completion
2015-10-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01466855 on ClinicalTrials.gov