Intra-arterial Chemotherapy(Chemosurgery) for Retinoblastoma

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Brief Title

Intra-arterial Chemotherapy(Chemosurgery) for Retinoblastoma

Official Title

Intra-arterial Chemotherapy(Chemosurgery) for Retinoblastoma

Brief Summary

      Conventional treatments of retinoblastoma involves laser photocoagulation, cryotherapy
      (freezing of the tumor), plaque radiotherapy,external beam radiotherapy, and intravenous
      chemotherapy. Enucleation (removing of the eye)is the last option when the tumor cannot be
      controlled otherwise. However,many children with retinoblastoma present with advanced
      intraocular disease for which enucleation is the only option. Intra-arterial chemotherapy
      (Chemosurgery)delivers anti-tumor drug directly into the ophthalmic artery (the artery
      feeding the eye) in order to increase the dose of drug reaching the tumor while minimizing
      toxicity to the rest of the body.
    

Detailed Description

      Present treatments for intraocular retinoblastoma cure 99% of children but have significant
      toxicity. Enucleation of the eye is effective but blinds the eye and leaves a lifelong
      cosmetic deformity. Radiation is associated with the subsequent development of fatal cancers.
      Systemic (intravenous)chemotherapy is used worldwide but experience with it has shown that
      the majority of eyes initially treated with chemotherapy still require additional treatments,
      such as radiation, laser, cryotherapy or even enucleation. In addition blood transfusions,
      secondary infections, insertion of ports and permanent hearing loss are now well reported.
      Three years ago we developed this technique of Chemosurgery for significantly increasing the
      dose of drug to the cancer while decreasing the dose of drug administered to children. This
      approach has decreased the need for enucleation in advanced eyes scheduled for enucleation
      with minimal systemic toxicity. We now offer treatment of both eyes simultaneously (in
      bilateral cases) and to eyes with less advanced disease and normal vision as an alternative
      to toxic systemic chemotherapy. In cases of very advanced ocular disease we will be using
      multiple drugs infused at the same session to increase tumor kill.

      Chemosurgery interventions are performed under general anesthesia. The femoral artery (artery
      at the groin) is punctured and a catheter (a small plastic tube)is advanced into the
      opthalmic artery (the artery of the eye)using fluoroscopic (X-ray) guidance. The drugs are
      injected directly into the opthalmic artery over a period of 30-45 min.The catheter is then
      removed, manual compression exerted to the femoral artery, the child is awaken and goes to
      recovery for 6 hours. The procedure is repeated every 3-4 weeks for a total of 2 to 6
      sessions according to tumor response. Since April 2006, our center has treated by
      chemosurgery 60 eyes in 52 patients with advanced intra-ocular retinoblastoma for which
      enucleation was considered.
    

Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

tumor control

Secondary Outcome

 tumor control with vision

Condition

Retinoblastoma

Intervention

Intra-arterial Chemotherapy


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

Procedure

Estimated Enrollment

100

Start Date

May 2006

Completion Date

July 2009

Primary Completion Date

July 2009

Eligibility Criteria

        Inclusion Criteria:

          -  advanced retinoblastoma in one or both eyes

          -  recurrent retinoblastoma after failure of conventional methods

        Exclusion Criteria:

          -  retinoblastoma judged curable by conventional methods

          -  patient judged unable to undergo the procedure
      

Gender

All

Ages

1 Month - N/A

Accepts Healthy Volunteers

No

Contacts

David H Abramson, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00901238

Organization ID

RTB1



Study Sponsor

Weill Medical College of Cornell University

Collaborators

 Memorial Sloan Kettering Cancer Center

Study Sponsor

David H Abramson, MD, Principal Investigator, Weill Cornell Medical College and Memorial Sloan-Kettering Cancer Center


Verification Date

December 2009