Intra-arterial Chemotherapy for Children With Retinoblastoma

NCT ID: NCT00906113

Last Updated: 2016-10-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2017-12-31

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.

Conditions

Retinoblastoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intra-arterial melphalan

The patients will be treated by injection of chemotherapy (melphalan) into the ophthalmic artery of an eye affected by retinoblastoma

Group Type: EXPERIMENTAL

Intra-arterial injection of melphalan

Intervention Type: DRUG

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

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Injection of melphalan into the ophthalmic artery

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• None

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hadassah Medical Organization

OTHER

Sponsor Role: lead

Responsible Party

Michael Weintraub

DIrector, Pediatric Hematology Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hadassah University Hospital

Jerusalem, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Michael Weintraub, MD

Role: CONTACT

michaelw@hadassah.org.il

972-2-6777408

Jacob Pe'er, MD

Role: CONTACT

972-26778431

Facility Contacts

Michael Weintraub, MD

Role: primary

michaelw@hadassah.org.il

Other Identifiers

0058-09-HMO

Identifier Type: -

Identifier Source: org_study_id