Intra-arterial Chemotherapy(Chemosurgery) for Retinoblastoma
Chemosurgery
1 other identifier
interventional
100
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2006
Typical duration for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 12, 2009
CompletedFirst Posted
Study publicly available on registry
May 13, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedDecember 17, 2009
December 1, 2009
3.2 years
May 12, 2009
December 16, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
tumor control
6 month
Secondary Outcomes (1)
tumor control with vision
6 month
Interventions
selective catheterization of the ophthalmic artery and injection of melphalan and topotecan
Eligibility Criteria
You may qualify if:
- advanced retinoblastoma in one or both eyes
- recurrent retinoblastoma after failure of conventional methods
You may not qualify if:
- retinoblastoma judged curable by conventional methods
- patient judged unable to undergo the procedure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Weill Medical College of Cornell University
New York, New York, 10065, United States
Related Publications (2)
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.
PMID: 19169884BACKGROUNDAbramson 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.
PMID: 18342944RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David H Abramson, MD
Weill Cornell Medical College and Memorial Sloan-Kettering Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 12, 2009
First Posted
May 13, 2009
Study Start
May 1, 2006
Primary Completion
July 1, 2009
Study Completion
July 1, 2009
Last Updated
December 17, 2009
Record last verified: 2009-12