Intra-arterial Chemotherapy for Children With Retinoblastoma

The recruitment status of this study is unknown because the information has not been verified recently.

Verified May 2009 by Hadassah Medical Organization.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Hadassah Medical Organization

ClinicalTrials.gov Identifier:

NCT00906113

First received: May 19, 2009

Last updated: June 22, 2011

Last verified: May 2009

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

MedlinePlus related topics: Cancer

Drug Information available for: Melphalan Melphalan hydrochloride

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 Primary Completion Date:	December 2012 (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
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:

None

Contacts and Locations

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

No publications provided

Responsible Party:	Michael Weintraub M.D., Hadassah University Hospital, Jerusalem, Israel
ClinicalTrials.gov Identifier:	NCT00906113 History of Changes
Other Study ID Numbers:	0058-09-HMO
Study First Received:	May 19, 2009
Last Updated:	June 22, 2011
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
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013

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