Intravitreal Injections of Melphalan for Retinoblastoma
- Conditions
- Retinoblastoma
- Interventions
- Drug: IVit Melphalan
- Registration Number
- NCT01558960
- Lead Sponsor
- Hadassah Medical Organization
- Brief Summary
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.
- Detailed Description
Intravitreal injections of Melphalan will be given to cases unresponsive to chemotherapy or with vitreal seeding of the disease.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 10
- Retinoblastoma that has not responded to chemotherapy
- Retinoblastoma that has vitreal seeding
- previous failure of IVit Melphalan
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description IVit Treatment group IVit Melphalan Intravitreal injections of Melphalan
- Primary Outcome Measures
Name Time Method treatment response 1 year short term response to treatment and long term complications
- Secondary Outcome Measures
Name Time Method complications 1 year short and long term complications
Trial Locations
- Locations (1)
Hadassah-Hebrew University Medical Center
🇮🇱Jerusalem, Israel