Intravitreal Injections of Melphalan for Retinoblastoma
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|ClinicalTrials.gov Identifier: NCT01558960|
Recruitment Status : Terminated (Sufficient findings to draw conclusions)
First Posted : March 20, 2012
Last Update Posted : August 20, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Retinoblastoma||Drug: IVit Melphalan||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Intravitreal Injections of Melphalan for Retinoblastoma|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||August 2015|
Experimental: IVit Treatment group
Intravitreal injections of Melphalan
Drug: IVit Melphalan
IVit injections of Melphalan
- treatment response [ Time Frame: 1 year ]short term response to treatment and long term complications
- complications [ Time Frame: 1 year ]short and long term complications
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01558960
|Hadassah-Hebrew University Medical Center|
|Principal Investigator:||Shahar Frenkel, MD, PhD||Hadassah Medical Organization|