Intra-arterial Chemotherapy for the Treatment of Intraocular Retinoblastoma
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Intra-arterial Chemotherapy for the Treatment of Intraocular Retinoblastoma|
- 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. ] [ Designated as safety issue: No ]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.
|Study Start Date:||March 2011|
|Estimated Study Completion Date:||August 2021|
|Estimated Primary Completion Date:||August 2015 (Final data collection date for primary outcome measure)|
Drug: Melphalan hydrochloride
Drug administered intra-arterially (injection in the artery).
2.5mg (3-6 month old) 3.0 mg (6-12 month old) 4.0 mg (1-3 year old) 5.0 mg (>3 years old)
Dose modification: decrease standard dose by 25% if there are signs of toxicity. Increase the dose by 25% if there is inadequate tumor response.
Frequency: 2 treatment cycles at 3-4 week intervals, with a third treatment cycle administered if the tumor requires it.
Dose not to exceed 0.5mg/kg, per treatment cycle.
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.
|Contact: Monica Pearl, M.D.||firstname.lastname@example.org|
|Contact: Amber Jones, B.A., CCRPemail@example.com|
|United States, Maryland|
|The Johns Hopkins Hospital||Recruiting|
|Baltimore, Maryland, United States, 21287|
|Sub-Investigator: James Handa, M.D.|
|Sub-Investigator: Alan Friedman, M.D.|
|Sub-Investigator: Philippe Gailloud, M.D.|
|Principal Investigator:||Monica Pearl, M.D.||The Johns Hopkins Hospital|