Retinoblastoma Clinical Trial
— ChemosurgeryOfficial title:
Intra-arterial Chemotherapy(Chemosurgery) for Retinoblastoma
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | July 2009 |
Est. primary completion date | July 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 1 Month and older |
Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Memorial Sloan Kettering Cancer Center | New York | New York |
United States | Weill Medical College of Cornell University | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Weill Medical College of Cornell University | Memorial Sloan Kettering Cancer Center |
United States,
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/ — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | tumor control | 6 month | No | |
Secondary | tumor control with vision | 6 month | No |
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