Intravitreal Injections of Melphalan for Retinoblastoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01558960
Recruitment Status : Terminated (Sufficient findings to draw conclusions)
First Posted : March 20, 2012
Last Update Posted : August 20, 2015
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Retinoblastoma Drug: IVit Melphalan Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Experimental: IVit Treatment group
Intravitreal injections of Melphalan
Drug: IVit Melphalan
IVit injections of Melphalan

Primary Outcome Measures :
  1. treatment response [ Time Frame: 1 year ]
    short term response to treatment and long term complications

Secondary Outcome Measures :
  1. complications [ Time Frame: 1 year ]
    short and long term complications

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Ages Eligible for Study:   up to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • previous failure of IVit Melphalan

Information from the National Library of Medicine

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 identifier (NCT number): NCT01558960

Hadassah-Hebrew University Medical Center
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization
Principal Investigator: Shahar Frenkel, MD, PhD Hadassah Medical Organization

Responsible Party: Hadassah Medical Organization Identifier: NCT01558960     History of Changes
Other Study ID Numbers: RB-001-HMO-CTIL
First Posted: March 20, 2012    Key Record Dates
Last Update Posted: August 20, 2015
Last Verified: March 2012

Keywords provided by Hadassah Medical Organization:

Additional relevant MeSH terms:
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Retinal Neoplasms
Eye Neoplasms
Neoplasms by Site
Eye Diseases
Retinal Diseases
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs