Intra-arterial Chemotherapy for Children With Retinoblastoma

Retinoblastoma Clinical Trial

Official title:

Phase 1-2 Study of Injection of Melphalan Into the Ophthalmic Artery in Children With Retinoblastoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00906113
• Other study ID #: 0058-09-HMO
• 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

• Retinoblastoma

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