Intravitreal Injections of Melphalan for Retinoblastoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Hadassah Medical Organization.
Recruitment status was  Not yet recruiting
Information provided by (Responsible Party):
Hadassah Medical Organization Identifier:
First received: March 1, 2012
Last updated: March 18, 2012
Last verified: March 2012

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 Intervention
Drug: IVit Melphalan

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intravitreal Injections of Melphalan for Retinoblastoma

Resource links provided by NLM:

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • treatment response [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    short term response to treatment and long term complications

Secondary Outcome Measures:
  • complications [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    short and long term complications

Estimated Enrollment: 10
Study Start Date: March 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IVit Treatment group
Intravitreal injections of Melphalan
Drug: IVit Melphalan
IVit injections of Melphalan
Other Name: IVit Melphalan

Detailed Description:

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


Ages Eligible for Study:   up to 20 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01558960

Contact: Shahar Frenkel, MD, PhD +972-2-677-7111

Hadassah-Hebrew University Medical Center Not yet recruiting
Jerusalem, Israel
Contact: Shahar Frenkel, MD, PhD    +972-2-677-7111   
Principal Investigator: Shahar Frenkel, MD, PhD         
Sponsors and Collaborators
Hadassah Medical Organization
Principal Investigator: Shahar Frenkel, MD, PhD Hadassah Medical Organization
  More Information

No publications provided

Responsible Party: Hadassah Medical Organization Identifier: NCT01558960     History of Changes
Other Study ID Numbers: RB-001-HMO-CTIL
Study First Received: March 1, 2012
Last Updated: March 18, 2012
Health Authority: Israel: Ministry of Health

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
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on October 19, 2014