Intra-arterial Chemotherapy for Children With Retinoblastoma

This study is currently recruiting participants. (see Contacts and Locations)

Verified March 2015 by Hadassah Medical Organization

Sponsor:

Information provided by (Responsible Party):

Michael Weintraub, Hadassah Medical Organization

ClinicalTrials.gov Identifier:

NCT00906113

First received: May 19, 2009

Last updated: March 17, 2015

Last verified: March 2015

History of Changes

Purpose

Retinoblastoma is a cancer of the eye that occurs exclusively in children. The treatment for retinoblastoma may include surgery, chemotherapy, radiation and local treatments to the eye such as freezing (cryotherapy) and local radiation (brachytherapy). In some cases, a child with retinoblastoma will have active cancer in a single remaining eye with useful vision. In such cases, it is sometimes necessary to remove this eye. In such cases, the injection of chemotherapy directly into the artery that supplies the eye and the tumor may lead to regression of the tumor without the need to remove the eye.

This form of treatment was pioneered by a group in New York (Abramson et al). In this study the investigators will assess the efficacy and safety of the technique in a group of children with retinoblastoma.

Condition	Intervention	Phase
Retinoblastoma	Drug: Intra-arterial injection of melphalan Drug: Injection of melphalan into the ophthalmic artery	Phase 1 Phase 2


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase 1-2 Study of Injection of Melphalan Into the Ophthalmic Artery in Children With Retinoblastoma

Resource links provided by NLM:

Genetics Home Reference related topics: retinoblastoma

Drug Information available for: Melphalan Melphalan hydrochloride

Genetic and Rare Diseases Information Center resources: Retinoblastoma Neuroepithelioma

U.S. FDA Resources

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:

Salvage of eye and vision [ Time Frame: Three years from intervention ] [ Designated as safety issue: No ]


Estimated Enrollment:	10
Study Start Date:	June 2011
Estimated Study Completion Date:	December 2015
Estimated Primary Completion Date:	December 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Intra-arterial melphalan The patients will be treated by injection of chemotherapy (melphalan) into the ophthalmic artery of an eye affected by retinoblastoma	Drug: Intra-arterial injection of melphalan Injection of 5 milligrams of melphalan into the ophthalmic artery once every 3 weeks for a total of 6 courses Drug: Injection of melphalan into the ophthalmic artery Injection of 5 milligrams of melphalan into the ophthalmic artery in an eye affected by retinoblastoma

Eligibility


Ages Eligible for Study:	6 Months to 10 Years (Child)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Children with retinoblastoma in a single remaining eye with useful vision

Exclusion Criteria:

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: NCT00906113

Contacts


Contact: Michael Weintraub, MD	972-2-6777408	michaelw@hadassah.org.il
Contact: Jacob Pe'er, MD	972-26778431

Locations


Israel
Hadassah University Hospital	Recruiting
Jerusalem, Israel, 91120
Contact: Michael Weintraub, MD michaelw@hadassah.org.il
Principal Investigator: Michael Weintraub, MD

Sponsors and Collaborators

Hadassah Medical Organization

More Information


Responsible Party:	Michael Weintraub, DIrector, Pediatric Hematology Oncology, Hadassah Medical Organization
ClinicalTrials.gov Identifier:	NCT00906113 History of Changes
Other Study ID Numbers:	0058-09-HMO
Study First Received:	May 19, 2009
Last Updated:	March 17, 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 September 30, 2016

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