Intra-arterial Chemotherapy for the Treatment of Intraocular Retinoblastoma

NCT01293539

Sponsor: Sidney Kimmel Comprehensive Cancer Center

Study team:

PI: Monica S. Pearl, MD, Interventional Neuroradiology
Alan Friedman, MD, Pediatric Oncology
James Handa, MD, Ophthalmology
Philippe Gailloud, MD, Interventional Neuroradiology
Amber Jones, BA, CCRP, Interventional Neuroradiology, Study Coordinator
Beatriz Kohler, RN, MBA, MPH, Interventional Neuroradiology, Study Nurse

Intra-arterial Chemotherapy for the Treatment of Intraocular Retinoblastoma:

This is a Phase II clinical trial administering melphalan hydrochloride through the ophthalmic artery to treat intraocular retinoblastoma.

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

How is intra-arterial chemotherapy different from systemic chemotherapy?

Systemic chemotherapy involves anti-cancer medications that are injected into a vein or given by mouth, exposing the entire body to significant doses of chemotherapy. Intra-arterial chemotherapy via the ophthalmic artery delivers the chemotherapeutic drug directly to the tumor, thereby transforming the treatment from systemic to local chemotherapy and limiting the complications and adverse events associated with toxicity from systemic chemotherapy.

Who is eligible?

We are now recruiting patients for this study. Patients considered for this study are those with unilateral or bilateral intraocular retinoblastoma who would otherwise be treated by systemic chemotherapy, external beam radiation, or enucleation.

Exclusion criteria include patients with small, localized intraocular retinoblastoma that is amenable to focal therapy (laser or crythotherapy), patients with extraocular disease on MRI, disorders of coagulation or vasculopathy, and abnormal renal function.

Patient Education: "My Diary for Intra-Arterial Retinoblastoma Treatment"

The Division of Interventional Neuroradiology has developed a treatment diary that addresses challenges in treating children enrolled in this study. The book engages the child and parent with “Jane’s Story,” which explains the importance of documenting how the child feels in the diary and the treatment. The story describes the procedure through characters that the child can relate to. The parent then guides the child through the diary and writes the entries with them, providing a chronological record for the physician. Stickers are supplied for recording pain intensity and to add interactivity to the story. The “Treatment Diary” was written by Dr. Monica Pearl, “Jane’s Story” was written and illustrated by Lydia Gregg, image © 2011 Johns Hopkins Division of Interventional Neuroradiology.

Contact Us:

For more information about this study, please contact:

Amber Jones:  Study Coordinator
Division of Interventional Neuroradiology
Phone: 410-502-0736; or 410-955-8525
Email: ajones78@jhmi.edu; inr@jhmi.edu