Intra-arterial Chemotherapy for Children With Retinoblastoma

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ClinicalTrials.gov Identifier: NCT00906113

Recruitment Status : Unknown

Verified October 2016 by Michael Weintraub, Hadassah Medical Organization.
Recruitment status was: Recruiting

First Posted : May 21, 2009

Last Update Posted : October 4, 2016

Sponsor:

Information provided by (Responsible Party):

Michael Weintraub, Hadassah Medical Organization

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Retinoblastoma	Drug: Intra-arterial injection of melphalan Drug: Injection of melphalan into the ophthalmic artery	Phase 1 Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	10 participants
Allocation:	N/A
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Phase 1-2 Study of Injection of Melphalan Into the Ophthalmic Artery in Children With Retinoblastoma
Study Start Date :	June 2011
Estimated Primary Completion Date :	December 2017
Estimated Study Completion Date :	December 2017

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Retinoblastoma

Drug Information available for: Melphalan Melphalan hydrochloride

Genetic and Rare Diseases Information Center resources: Retinoblastoma Neuroepithelioma

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

Salvage of eye and vision [ Time Frame: Three years from intervention ]

Eligibility Criteria

Information from the National Library of Medicine

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

Criteria

Inclusion Criteria:

Children with retinoblastoma in a single remaining eye with useful vision

Exclusion Criteria:

None

Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00906113

Contacts

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

Locations

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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

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Responsible Party:	Michael Weintraub, DIrector, Pediatric Hematology Oncology, Hadassah Medical Organization
ClinicalTrials.gov Identifier:	NCT00906113
Other Study ID Numbers:	0058-09-HMO
First Posted:	May 21, 2009 Key Record Dates
Last Update Posted:	October 4, 2016
Last Verified:	October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes

Keywords provided by Michael Weintraub, Hadassah Medical Organization:


Retinoblastoma

Additional relevant MeSH terms:

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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, Hereditary	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

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