Intra-arterial Chemotherapy(Chemosurgery) for Retinoblastoma (Chemosurgery)
Primary Purpose
Retinoblastoma
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Intra-arterial Chemotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Retinoblastoma focused on measuring retinoblastoma, intra-arterial chemotherapy, chemosurgery, melphalan, topotecan
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
Sites / Locations
- Memorial Sloan Kettering Cancer Center
- Weill Medical College of Cornell University
Outcomes
Primary Outcome Measures
tumor control
Secondary Outcome Measures
tumor control with vision
Full Information
NCT ID
NCT00901238
First Posted
May 12, 2009
Last Updated
December 16, 2009
Sponsor
Weill Medical College of Cornell University
Collaborators
Memorial Sloan Kettering Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT00901238
Brief Title
Intra-arterial Chemotherapy(Chemosurgery) for Retinoblastoma
Acronym
Chemosurgery
Official Title
Intra-arterial Chemotherapy(Chemosurgery) for Retinoblastoma
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
Memorial Sloan Kettering Cancer Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinoblastoma
Keywords
retinoblastoma, intra-arterial chemotherapy, chemosurgery, melphalan, topotecan
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Intra-arterial Chemotherapy
Other Intervention Name(s)
chemosurgery
Intervention Description
selective catheterization of the ophthalmic artery and injection of melphalan and topotecan
Primary Outcome Measure Information:
Title
tumor control
Time Frame
6 month
Secondary Outcome Measure Information:
Title
tumor control with vision
Time Frame
6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David H Abramson, MD
Organizational Affiliation
Weill Cornell Medical College and Memorial Sloan-Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Weill Medical College of Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19169884
Citation
Brodie SE, Pierre Gobin Y, Dunkel IJ, Kim JW, Abramson DH. Persistence of retinal function after selective ophthalmic artery chemotherapy infusion for retinoblastoma. Doc Ophthalmol. 2009 Aug;119(1):13-22. doi: 10.1007/s10633-008-9164-3. Epub 2009 Jan 25.
Results Reference
background
PubMed Identifier
18342944
Citation
Abramson DH, Dunkel IJ, Brodie SE, Kim JW, Gobin YP. A phase I/II study of direct intraarterial (ophthalmic artery) chemotherapy with melphalan for intraocular retinoblastoma initial results. Ophthalmology. 2008 Aug;115(8):1398-404, 1404.e1. doi: 10.1016/j.ophtha.2007.12.014. Epub 2008 Mar 14.
Results Reference
result
Links:
URL
http://www.cornellneurosurgery.com
Description
Related Info
URL
http://mskcc.org
Description
Retinoblastoma
Learn more about this trial
Intra-arterial Chemotherapy(Chemosurgery) for Retinoblastoma
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