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

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.

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Key information

Conditions

Retinoblastoma Eye Diseases Eye Diseases, Hereditary Eye Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors Retinal Diseases Retinal Neoplasms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oncology Service, Wills Eye Institute

Philadelphia, Pennsylvania, 19107, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Melphalan, Carboplatin

Drug

Intra-arterial chemotherapy.

Other names: ALKERAN,PARAPLATIN

Primary outcomes

Tumor control

Time frame: after 5 cycles of chemotherapy

Sponsors and collaborators

Lead sponsor

Wills Eye

Other

Collaborators

Thomas Jefferson University

Registry information

Official study title

Intra-arterial (Ophthalmic Artery) Chemotherapy for Retinoblastoma

Acronym: IAC-RB

Important dates

Study start: 2009
Primary completion: 2014
Study completion: 2014
First posted: Mar 6, 2009
Registry last updated: Dec 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed