Back to resultsIntravitreal Injections of Melphalan for Retinoblastoma
Primary Purpose
Retinoblastoma
Status
Terminated
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
IVit Melphalan
Sponsored by
About this trial
This is an interventional treatment trial for Retinoblastoma focused on measuring Retinoblastoma
Eligibility Criteria
Inclusion Criteria:
- Retinoblastoma that has not responded to chemotherapy
- Retinoblastoma that has vitreal seeding
Exclusion Criteria:
- previous failure of IVit Melphalan
Sites / Locations
- Hadassah-Hebrew University Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
IVit Treatment group
Arm Description
Intravitreal injections of Melphalan
Outcomes
Primary Outcome Measures
treatment response
short term response to treatment and long term complications
Secondary Outcome Measures
complications
short and long term complications
Full Information
NCT ID
NCT01558960
First Posted
March 1, 2012
Last Updated
August 19, 2015
Sponsor
Hadassah Medical Organization
1. Study Identification
Unique Protocol Identification Number
NCT01558960
Brief Title
Intravitreal Injections of Melphalan for Retinoblastoma
Official Title
Intravitreal Injections of Melphalan for Retinoblastoma
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Terminated
Why Stopped
Sufficient findings to draw conclusions
Study Start Date
March 2012 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hadassah Medical Organization
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinoblastoma
Keywords
Retinoblastoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
IVit Treatment group
Arm Type
Experimental
Arm Description
Intravitreal injections of Melphalan
Intervention Type
Drug
Intervention Name(s)
IVit Melphalan
Intervention Description
IVit injections of Melphalan
Primary Outcome Measure Information:
Title
treatment response
Description
short term response to treatment and long term complications
Time Frame
1 year
Secondary Outcome Measure Information:
Title
complications
Description
short and long term complications
Time Frame
1 year
10. Eligibility
Sex
All
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Retinoblastoma that has not responded to chemotherapy
Retinoblastoma that has vitreal seeding
Exclusion Criteria:
previous failure of IVit Melphalan
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shahar Frenkel, MD, PhD
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah-Hebrew University Medical Center
City
Jerusalem
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Intravitreal Injections of Melphalan for Retinoblastoma
We'll reach out to this number within 24 hrs