Intra-arterial Chemotherapy for Children With Retinoblastoma

Phase 1

• Conditions: Retinoblastoma
• Interventions: Drug: Intra-arterial injection of melphalan; Drug: Injection of melphalan into the ophthalmic artery

• Registration Number: NCT00906113
• Lead Sponsor: Hadassah Medical Organization

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-05-19
• Study First Submitted QC: 2009-05-20
• Study First Posted: 2009-05-21
• Study Start: 2011-06
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-01
• Last Update Posted: 2016-10-04
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intra-arterial melphalan	Injection of melphalan into the ophthalmic artery	The patients will be treated by injection of chemotherapy (melphalan) into the ophthalmic artery of an eye affected by retinoblastoma
Intra-arterial melphalan	Intra-arterial injection of melphalan	The patients will be treated by injection of chemotherapy (melphalan) into the ophthalmic artery of an eye affected by retinoblastoma

Primary Outcome Measures

Name	Time	Method
Salvage of eye and vision	Three years from intervention

Trial Locations

Locations (1)

Hadassah University Hospital; 🇮🇱 Jerusalem, Israel