Intravitreal Injections of Melphalan for Retinoblastoma
Retinoblastoma treatment has become more and more focused in the last years. New treatments developed by Dr. Kaneko from Japan in 1995 are now being tested in clinical trials.
Intra-arterial chemotherapy with Melphalan has shown success in some patients but with limited response when there is marked vitreal seeding. For these cases Intravitreal injections of Melphalan have been successful in Japan.
In this study the same chemotherapy (melphalan) will be administered intravitreally (directly through the eye wall) and the response (short and long term) will be monitored.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Intravitreal Injections of Melphalan for Retinoblastoma|
- treatment response [ Time Frame: 1 year ] [ Designated as safety issue: No ]short term response to treatment and long term complications
- complications [ Time Frame: 1 year ] [ Designated as safety issue: No ]short and long term complications
|Study Start Date:||March 2012|
|Study Completion Date:||August 2015|
|Primary Completion Date:||August 2015 (Final data collection date for primary outcome measure)|
Experimental: IVit Treatment group
Intravitreal injections of Melphalan
Drug: IVit Melphalan
IVit injections of Melphalan
Other Name: IVit Melphalan
Intravitreal injections of Melphalan will be given to cases unresponsive to chemotherapy or with vitreal seeding of the disease.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01558960
|Hadassah-Hebrew University Medical Center|
|Principal Investigator:||Shahar Frenkel, MD, PhD||Hadassah Medical Organization|