Clinical Trial: Intra-arterial Chemotherapy for the Treatment of Intraocular Retinoblastoma

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Intra-arterial Chemotherapy for the Treatment of Intraocular Retinoblastoma

Brief Summary: The purpose of this study is to show that chemotherapy delivered directly through the artery supplying the eye (ophthalmic artery) to patients with retinoblastoma is a safe and effective treatment alternative to conventional systemic chemotherapy, external beam radiation, and surgical removal of the eye.

Detailed Summary: Delivering the chemotherapeutic agent in the arterial system through the ophthalmic artery transforms the treatment of retinoblastoma from systemic chemotherapy to local chemotherapy. Administration of the drug directly to the targeted site thus avoids the complications and adverse events associated with toxicity from systemic, rather than local, chemotherapy.
Sponsor: Sidney Kimmel Comprehensive Cancer Center

Current Primary Outcome: Number of patients who complete therapy without the need for additional treatment including systemic chemotherapy, external beam radiation, or enucleation. [ Time Frame: Within the first six months after the initial treatment. ]

The primary objective of this study is to show that intra-arterial delivery of the chemotherapeutic agent is successful in treating intraocular retinoblastoma, defined as avoiding systemic chemotherapy, external beam radiation, and enucleation.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Sidney Kimmel Comprehensive Cancer Center

Dates:
Date Received: January 21, 2011
Date Started: March 2011
Date Completion: August 2021
Last Updated: August 24, 2016
Last Verified: August 2016