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Intra-arterial Chemotherapy for Children With Retinoblastoma

Primary Purpose

Retinoblastoma

Status

Unknown status

Phase

Phase 1

Locations

Israel

Study Type

Interventional

Intervention

Intra-arterial injection of melphalan

Injection of melphalan into the ophthalmic artery

About this trial

This is an interventional treatment trial for Retinoblastoma focused on measuring Retinoblastoma

Eligibility Criteria

6 Months - 10 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Children with retinoblastoma in a single remaining eye with useful vision

Exclusion Criteria:

None

Sites / Locations

Hadassah University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intra-arterial melphalan

Arm Description

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

Outcomes

Primary Outcome Measures

Salvage of eye and vision

Secondary Outcome Measures

Full Information

NCT ID

NCT00906113

First Posted

May 19, 2009

Last Updated

October 1, 2016

Sponsor

Hadassah Medical Organization

1. Study Identification

Unique Protocol Identification Number

NCT00906113

Brief Title

Intra-arterial Chemotherapy for Children With Retinoblastoma

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Unknown status

Study Start Date

June 2011 (undefined)

Primary Completion Date

December 2017 (Anticipated)

Study Completion Date

December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hadassah Medical Organization

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Retinoblastoma

Keywords

Retinoblastoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intra-arterial melphalan

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Intra-arterial injection of melphalan

Intervention Description

Injection of 5 milligrams of melphalan into the ophthalmic artery once every 3 weeks for a total of 6 courses

Intervention Type

Drug

Intervention Name(s)

Injection of melphalan into the ophthalmic artery

Intervention Description

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

Primary Outcome Measure Information:

Title

Salvage of eye and vision

Time Frame

Three years from intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

10 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Children with retinoblastoma in a single remaining eye with useful vision Exclusion Criteria: None

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Michael Weintraub, MD

Phone

972-2-6777408

michaelw@hadassah.org.il

First Name & Middle Initial & Last Name or Official Title & Degree

Jacob Pe'er, MD

Phone

972-26778431

Facility Information:

Facility Name

Hadassah University Hospital

City

Jerusalem

ZIP/Postal Code

91120

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Michael Weintraub, MD

michaelw@hadassah.org.il

First Name & Middle Initial & Last Name & Degree

Michael Weintraub, MD

12. IPD Sharing Statement

Plan to Share IPD

Yes

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Intra-arterial Chemotherapy for Children With Retinoblastoma

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