Intravitreal Injections of Melphalan for Retinoblastoma

Retinoblastoma Clinical Trial

Official title:

Intravitreal Injections of Melphalan for Retinoblastoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01558960
• Other study ID #: RB-001-HMO-CTIL
• Status: Terminated
• Phase: N/A
• First received: March 1, 2012
• Last updated: August 19, 2015
• Start date: March 2012
• Est. completion date: August 2015

Study information

• Verified date: March 2012
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 20 Years

Eligibility

Inclusion Criteria:

• Retinoblastoma that has not responded to chemotherapy

• Retinoblastoma that has vitreal seeding

Exclusion Criteria:

• previous failure of IVit Melphalan

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Retinoblastoma

Intervention

Drug:
• IVit Melphalan
IVit injections of Melphalan

Locations

Country	Name	City	State
Israel	Hadassah-Hebrew University Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	treatment response	short term response to treatment and long term complications	1 year	No
Secondary	complications	short and long term complications	1 year	No