Intravitreal Injections of Melphalan for Retinoblastoma | NCT01558960

Studies
Intravitreal Injections of Melphalan for Retinoblastoma

NCT01558960

Sponsor

Hadassah Medical Organization

Status

Terminated

Last Update Posted

Aug 20, 2015Estimated

Enrollment

10Estimated

Phase

Not Applicable

Conditions

Retinoblastoma

Interventions

IVit Melphalan

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2012

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Sufficient findings to draw conclusions

Expanded Access Info

Start Date

Mar 2012

Primary Completion Date

Aug 2015Actual

Completion Date

Aug 2015Actual

First Submitted Date

Mar 1, 2012

First Submission Date that Met QC Criteria

Mar 18, 2012

First Posted Date

Mar 20, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 19, 2015

Last Update Posted Date

Aug 20, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
IVit Treatment group	Experimental	Intravitreal injections of Melphalan	Drug: IVit Melphalan

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IVit Melphalan	Drug	IVit injections of Melphalan	IVit Treatment group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

previous failure of IVit Melphalan

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

20 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Shahar Frenkel, MD, PhD	Hadassah Medical Organization	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hadassah-Hebrew University Medical Center		Jerusalem			Israel

Condition Browse Module

MeSH Terms

ID	Term
D012175	Retinoblastoma

Ancestor Terms

ID	Term
D018302	Neoplasms, Neuroepithelial
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided