Intra-arterial Chemotherapy for Children With Retinoblastoma

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Brief Title

Intra-arterial Chemotherapy for Children With Retinoblastoma

Official Title

Phase 1-2 Study of Injection of Melphalan Into the Ophthalmic Artery in Children With Retinoblastoma

Brief Summary

      Retinoblastoma is a cancer of the eye that occurs exclusively in children. The treatment for
      retinoblastoma may include surgery, chemotherapy, radiation and local treatments to the eye
      such as freezing (cryotherapy) and local radiation (brachytherapy). In some cases, a child
      with retinoblastoma will have active cancer in a single remaining eye with useful vision. In
      such cases, it is sometimes necessary to remove this eye. In such cases, the injection of
      chemotherapy directly into the artery that supplies the eye and the tumor may lead to
      regression of the tumor without the need to remove the eye.

      This form of treatment was pioneered by a group in New York (Abramson et al). In this study
      the investigators will assess the efficacy and safety of the technique in a group of children
      with retinoblastoma.
    


Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

Salvage of eye and vision


Condition

Retinoblastoma

Intervention

Intra-arterial injection of melphalan

Study Arms / Comparison Groups

 Intra-arterial melphalan
Description:  The patients will be treated by injection of chemotherapy (melphalan) into the ophthalmic artery of an eye affected by retinoblastoma

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

10

Start Date

June 2011

Completion Date

December 2017

Primary Completion Date

December 2017

Eligibility Criteria

        Inclusion Criteria:

          -  Children with retinoblastoma in a single remaining eye with useful vision

        Exclusion Criteria:

          -  None
      

Gender

All

Ages

6 Months - 10 Years

Accepts Healthy Volunteers

No

Contacts

, 972-2-6777408, [email protected]

Location Countries

Israel

Location Countries

Israel

Administrative Informations


NCT ID

NCT00906113

Organization ID

0058-09-HMO


Responsible Party

Principal Investigator

Study Sponsor

Hadassah Medical Organization


Study Sponsor

, , 


Verification Date

October 2016