Intravitreal Injections of Melphalan for Retinoblastoma

NCT ID: NCT01558960

Last Updated: 2015-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2015-08-31

Brief Summary

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Retinoblastoma treatment has become more and more focused in the last years. New treatments developed by Dr. Kaneko from Japan in 1995 are now being tested in clinical trials.

Intra-arterial chemotherapy with Melphalan has shown success in some patients but with limited response when there is marked vitreal seeding. For these cases Intravitreal injections of Melphalan have been successful in Japan.

In this study the same chemotherapy (melphalan) will be administered intravitreally (directly through the eye wall) and the response (short and long term) will be monitored.

Detailed Description

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Intravitreal injections of Melphalan will be given to cases unresponsive to chemotherapy or with vitreal seeding of the disease.

Conditions

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Retinoblastoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IVit Treatment group

Intravitreal injections of Melphalan

Group Type EXPERIMENTAL

IVit Melphalan

Intervention Type DRUG

IVit injections of Melphalan

Interventions

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IVit Melphalan

IVit injections of Melphalan

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Retinoblastoma that has not responded to chemotherapy
* Retinoblastoma that has vitreal seeding

Exclusion Criteria

* previous failure of IVit Melphalan
Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shahar Frenkel, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Locations

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Hadassah-Hebrew University Medical Center

Jerusalem, , Israel

Site Status

Countries

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Israel

Other Identifiers

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RB-001-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id

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