NCT01558960

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2012

Completed
Same day until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 20, 2012

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

August 20, 2015

Status Verified

March 1, 2012

Enrollment Period

3.4 years

First QC Date

March 1, 2012

Last Update Submit

August 19, 2015

Conditions

Retinoblastoma

Keywords

Retinoblastoma

Outcome Measures

Primary Outcomes (1)

  • treatment response

    short term response to treatment and long term complications

    1 year

Secondary Outcomes (1)

  • complications

    1 year

Study Arms (1)

IVit Treatment group

EXPERIMENTAL

Intravitreal injections of Melphalan

Drug: IVit Melphalan

Interventions

IVit MelphalanDRUG

IVit injections of Melphalan

IVit Treatment group

Eligibility Criteria

AgeUp to 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • previous failure of IVit Melphalan

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah-Hebrew University Medical Center

Jerusalem, Israel

Location

MeSH Terms

Conditions

Retinoblastoma

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueRetinal NeoplasmsEye NeoplasmsNeoplasms by SiteEye Diseases, HereditaryEye DiseasesRetinal Diseases

Study Officials

  • Shahar Frenkel, MD, PhD

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2012

First Posted

March 20, 2012

Study Start

March 1, 2012

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

August 20, 2015

Record last verified: 2012-03

Locations

IL(1)