Intra-arterial Chemotherapy(Chemosurgery) for Retinoblastoma

This study has been completed.
Sponsor:
Collaborator:
Memorial Sloan-Kettering Cancer Center
Information provided by:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00901238
First received: May 12, 2009
Last updated: December 16, 2009
Last verified: December 2009
  Purpose

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.


Condition Intervention Phase
Retinoblastoma
Procedure: Intra-arterial Chemotherapy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intra-arterial Chemotherapy(Chemosurgery) for Retinoblastoma

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • tumor control [ Time Frame: 6 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • tumor control with vision [ Time Frame: 6 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: May 2006
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Intra-arterial Chemotherapy
    selective catheterization of the ophthalmic artery and injection of melphalan and topotecan
    Other Name: chemosurgery
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.

  Eligibility

Ages Eligible for Study:   1 Month and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00901238

Locations
United States, New York
Weill Medical College of Cornell University
New York, New York, United States, 10065
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Weill Medical College of Cornell University
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: David H Abramson, MD Weill Cornell Medical College and Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
Publications:
Responsible Party: David Abramson,MD, Weill Cornell Medical Center
ClinicalTrials.gov Identifier: NCT00901238     History of Changes
Other Study ID Numbers: RTB1
Study First Received: May 12, 2009
Last Updated: December 16, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:
retinoblastoma
intra-arterial chemotherapy
chemosurgery
melphalan
topotecan

Additional relevant MeSH terms:
Retinoblastoma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Retinal Neoplasms
Eye Neoplasms
Neoplasms by Site
Eye Diseases
Retinal Diseases

ClinicalTrials.gov processed this record on July 20, 2014