Intravitreal Injections of Melphalan for Retinoblastoma

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Brief Title

Intravitreal Injections of Melphalan for Retinoblastoma

Official Title

Intravitreal Injections of Melphalan for Retinoblastoma

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.

Study Type

Interventional

Primary Outcome

treatment response

Secondary Outcome

 complications

Condition

Retinoblastoma

Intervention

IVit Melphalan

Study Arms / Comparison Groups

 IVit Treatment group
Description:  Intravitreal injections of Melphalan

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

10

Start Date

March 2012

Completion Date

August 2015

Primary Completion Date

August 2015

Eligibility Criteria

        Inclusion Criteria:

          -  Retinoblastoma that has not responded to chemotherapy

          -  Retinoblastoma that has vitreal seeding

        Exclusion Criteria:

          -  previous failure of IVit Melphalan

Gender

All

Ages

N/A - 20 Years

Accepts Healthy Volunteers

No

Contacts

Shahar Frenkel, MD, PhD, ,

Location Countries

Israel

Location Countries

Israel

Administrative Informations

NCT ID

NCT01558960

Organization ID

RB-001-HMO-CTIL

Responsible Party

Sponsor

Study Sponsor

Hadassah Medical Organization

Study Sponsor

Shahar Frenkel, MD, PhD, Principal Investigator, Hadassah Medical Organization

Verification Date

March 2012