Intravitreal Injections of Melphalan for Retinoblastoma

August 19, 2015 updated by: Hadassah Medical Organization

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Intravitreal injections of Melphalan will be given to cases unresponsive to chemotherapy or with vitreal seeding of the disease.

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel
        • Hadassah-Hebrew University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 20 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Retinoblastoma that has not responded to chemotherapy
  • Retinoblastoma that has vitreal seeding

Exclusion Criteria:

  • previous failure of IVit Melphalan

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: IVit Treatment group
Intravitreal injections of Melphalan
Drug: IVit Melphalan
IVit injections of Melphalan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
treatment response
Time Frame: 1 year
short term response to treatment and long term complications
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
complications
Time Frame: 1 year
short and long term complications
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (ACTUAL)

August 1, 2015

Study Completion (ACTUAL)

August 1, 2015

Study Registration Dates

First Submitted

March 1, 2012

First Submitted That Met QC Criteria

March 18, 2012

First Posted (ESTIMATE)

March 20, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

August 20, 2015

Last Update Submitted That Met QC Criteria

August 19, 2015

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RB-001-HMO-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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