Intravitreal Injections of Melphalan for Retinoblastoma

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01558960

Enrollment

Registered

2012-03-20

Start date

2012-03-31

Completion date

2015-08-31

Last updated

2015-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retinoblastoma

Keywords

Retinoblastoma

Brief summary

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

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

Interventions

DRUGIVit Melphalan

IVit injections of Melphalan

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 20 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* previous failure of IVit Melphalan

Design outcomes

Primary

Measure	Time frame	Description
treatment response	1 year	short term response to treatment and long term complications

Secondary

Measure	Time frame	Description
complications	1 year	short and long term complications

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026