NCT00906113

Intra-arterial Chemotherapy for Children With Retinoblastoma

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Hadassah Medical Organization · Academic / Other
• Sex: All
• Age: 6 Months – 10 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Retinoblastoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2011-06-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2009-05-21
• Last updated: 2016-10-04

Locations

1 site across 1 country: Israel