A Study of the Effectiveness of a Local Injection of Chemotherapy for Retinoblastoma

Not Applicable

Completed

• Conditions: Retinoblastoma
• Interventions: Drug: Melphalan, Carboplatin

• Registration Number: NCT00857519
• Lead Sponsor: Wills Eye

Brief Summary

Over the past 15 years, intravenous chemotherapy has become the most popular conservative (eye-saving) method for retinoblastoma treatment because it is often effective and usually safe. In recent years, there has been much interest in providing highly focused (focal) chemotherapy to a diseased organ including the liver, brain, and eye. With focused chemotherapy, the chemotherapy drugs are injected directly into the ophthalmic artery (the artery that supplies blood to the eye). A benefit of focal chemotherapy delivery is that it decreases the chance of toxicity to other organs such as bone marrow suppression (causing low blood counts) and the development of other cancers in the future.

Detailed Description

The management of retinoblastoma includes systemic chemotherapy (carboplatin, etoposide, and vincristine), thermotherapy, cryotherapy (freezing treatment), laser photocoagulation, plaque radiotherapy, external beam radiotherapy, and enucleation. The treatment is tailored to each individual case. Over the past 15 years, intravenous chemotherapy has risen as the most popular conservative (eye-saving) method for retinoblastoma management because it is effective and safe. In recent years, there has been keen interest in providing chemotherapy more focally to a diseased organ including the liver, brain, and eye. The benefit of focal chemotherapy delivery is to avoid toxicity to other organs and this toxicity includes the risk of future cancers.

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-03-04
• Study First Submitted QC: 2009-03-04
• Study First Posted: 2009-03-06
• Primary Completion: 2014-03
• Study Completion: 2014-04
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-09
• Last Update Posted: 2016-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Advanced retinoblastoma in one or both eyes
• Recurrent retinoblastoma after failure of previous treatment
• No age limit (usually kids presenting with retinoblastoma present in the 1st two decades of life)
• Judged by principal investigator to be medically and physically able to undergo the procedure

Exclusion Criteria

• Recurrent retinoblastoma which is treatable with other conservative measures
• Invasive retinoblastoma (retinoblastoma that has grown locally outside of the eye, for example, into the bone around the eye)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Chemotherapy	Melphalan, Carboplatin	Chemotherapy using Melphalan, Carboplatin.

Primary Outcome Measures

Name	Time	Method
Tumor control	after 5 cycles of chemotherapy

Trial Locations

Locations (1)

Oncology Service, Wills Eye Institute; 🇺🇸 Philadelphia, Pennsylvania, United States