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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00906113
Other study ID # 0058-09-HMO
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received May 19, 2009
Last updated October 1, 2016
Start date June 2011
Est. completion date December 2017

Study information

Verified date October 2016
Source Hadassah Medical Organization
Contact Michael Weintraub, MD
Phone 972-2-6777408
Email michaelw@hadassah.org.il
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 10
Est. completion date December 2017
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender Both
Age group 6 Months to 10 Years
Eligibility Inclusion Criteria:

- Children with retinoblastoma in a single remaining eye with useful vision

Exclusion Criteria:

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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
Injection of melphalan into the ophthalmic artery
Injection of 5 milligrams of melphalan into the ophthalmic artery in an eye affected by retinoblastoma

Locations

Country Name City State
Israel Hadassah University Hospital Jerusalem

Sponsors (1)

Lead Sponsor Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Salvage of eye and vision Three years from intervention No
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