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Intra-arterial Chemotherapy(Chemosurgery) for Retinoblastoma


Phase 1/Phase 2
1 Month
N/A
Not Enrolling
Both
Retinoblastoma

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Trial Information

Intra-arterial Chemotherapy(Chemosurgery) for Retinoblastoma


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

tumor control

Outcome Time Frame:

6 month

Safety Issue:

No

Principal Investigator

David H Abramson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Weill Cornell Medical College and Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

RTB1

NCT ID:

NCT00901238

Start Date:

May 2006

Completion Date:

July 2009

Related Keywords:

  • Retinoblastoma
  • retinoblastoma
  • intra-arterial chemotherapy
  • chemosurgery
  • melphalan
  • topotecan
  • Retinoblastoma

Name

Location

Memorial Sloan Kettering Cancer Center New York, New York  10021
Weill Medical College of Cornell University New York, New York  10021