Phase I Study To Evaluate The Toxicity And Feasibility Of Intratumoral Injection Of Alpha-Gal (Beta-galactosidase ) Glycosphingolipids In Patients With Advanced Melanoma
A standard Phase I dose escalation model will be used to define the maximum tolerated dose
(MTD) of GSL alpha-GAL that can be administered directly into the tumor lesion on two
separate injections separated by 4-weeks. This trial will serve as the basis for future
Phase II trials utilizing multiple injections of GSL alpha-GAL in refractory solid tumors.
Additionally, in this study we will look for histologic evidence of an immune response
against the injected melanoma lesions which matches that seen in mice. Our hypothesis for
this study is that a second injection of GSL alpha-GAL into a melanoma lesion will not
precipitate an allergic or autoimmune reaction, but will cause a histologically evident
immune response to the tumor.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
Grade 3/4 toxicity
Grade 3/4 toxicity or adverse event during injection protocol or up to a month after
11-12 weeks
Yes
Giles Whalen, MD
Principal Investigator
University of Massachusetts, Worcester
United States: Food and Drug Administration
UM200701
NCT00668512
March 2007
March 2014
Name | Location |
---|---|
Universiity of Wisconsin | Madison, Wisconsin 53792 |