Intravitreal Injections of Melphalan for Retinoblastoma

Hadassah Medical Center

Status: Terminated

Conditions: Retinoblastoma

Treatments: Drug: IVit Melphalan

Study type: Interventional

Funder types: Other

Identifiers

NCT01558960

RB-001-HMO-CTIL

Details and patient eligibility

About

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.

Full description

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

Enrollment: 10 estimated patients

Sex: All

Ages: Under 20 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• previous failure of IVit Melphalan

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

IVit Treatment group

Experimental group

Description:

Intravitreal injections of Melphalan

Treatment:

Drug: IVit Melphalan