A Study of the Effectiveness of a Local Injection of Chemotherapy for Retinoblastoma

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Brief Title

A Study of the Effectiveness of a Local Injection of Chemotherapy for Retinoblastoma

Official Title

Intra-arterial (Ophthalmic Artery) Chemotherapy for Retinoblastoma

Brief Summary

      Over the past 15 years, intravenous chemotherapy has become the most popular conservative
      (eye-saving) method for retinoblastoma treatment because it is often effective and usually
      safe. In recent years, there has been much interest in providing highly focused (focal)
      chemotherapy to a diseased organ including the liver, brain, and eye. With focused
      chemotherapy, the chemotherapy drugs are injected directly into the ophthalmic artery (the
      artery that supplies blood to the eye). A benefit of focal chemotherapy delivery is that it
      decreases the chance of toxicity to other organs such as bone marrow suppression (causing low
      blood counts) and the development of other cancers in the future.
    

Detailed Description

      The management of retinoblastoma includes systemic chemotherapy (carboplatin, etoposide, and
      vincristine), thermotherapy, cryotherapy (freezing treatment), laser photocoagulation, plaque
      radiotherapy, external beam radiotherapy, and enucleation. The treatment is tailored to each
      individual case. Over the past 15 years, intravenous chemotherapy has risen as the most
      popular conservative (eye-saving) method for retinoblastoma management because it is
      effective and safe. In recent years, there has been keen interest in providing chemotherapy
      more focally to a diseased organ including the liver, brain, and eye. The benefit of focal
      chemotherapy delivery is to avoid toxicity to other organs and this toxicity includes the
      risk of future cancers.
    


Study Type

Interventional


Primary Outcome

Tumor control


Condition

Retinoblastoma

Intervention

Melphalan, Carboplatin

Study Arms / Comparison Groups

 Chemotherapy
Description:  Chemotherapy using Melphalan, Carboplatin.

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

January 2009

Completion Date

April 2014

Primary Completion Date

March 2014

Eligibility Criteria

        Inclusion Criteria:

          -  Advanced retinoblastoma in one or both eyes

          -  Recurrent retinoblastoma after failure of previous treatment

          -  No age limit (usually kids presenting with retinoblastoma present in the 1st two
             decades of life)

          -  Judged by principal investigator to be medically and physically able to undergo the
             procedure

        Exclusion Criteria:

          -  Recurrent retinoblastoma which is treatable with other conservative measures

          -  Invasive retinoblastoma (retinoblastoma that has grown locally outside of the eye, for
             example, into the bone around the eye)
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Carol L Shields, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00857519

Organization ID

08-885


Responsible Party

Principal Investigator

Study Sponsor

Wills Eye

Collaborators

 Thomas Jefferson University

Study Sponsor

Carol L Shields, MD, Principal Investigator, Oncology Service, Wills Eye Institute


Verification Date

December 2016