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Intravitreal Injections of Melphalan for Retinoblastoma

This study has been terminated.
(Sufficient findings to draw conclusions)
Sponsor:
Information provided by (Responsible Party):
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01558960
First received: March 1, 2012
Last updated: August 19, 2015
Last verified: March 2012
  Purpose

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
Retinoblastoma
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
Study Completion Date: August 2015
Primary Completion Date: August 2015 (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

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

Ages Eligible for Study:   up to 20 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01558960

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

Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01558960     History of Changes
Other Study ID Numbers: RB-001-HMO-CTIL 
Study First Received: March 1, 2012
Last Updated: August 19, 2015
Health Authority: Israel: Ministry of Health

Keywords provided by Hadassah Medical Organization:
Retinoblastoma

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

ClinicalTrials.gov processed this record on December 09, 2016