Intratumoral Injection Of Alpha-Gal Glycosphingolipids
|Metastatic Melanoma||Biological: Antimelanoma injection of GSL alpha-Gal||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Phase I Study To Evaluate The Toxicity And Feasibility Of Intratumoral Injection Of Alpha-Gal (Beta-galactosidase ) Glycosphingolipids In Patients With Advanced Melanoma|
- Grade 3/4 toxicity [ Time Frame: 11-12 weeks ]Grade 3/4 toxicity or adverse event during injection protocol or up to a month after
- Clinical response [ Time Frame: 2 years ]Injected tumor deposit regression (RECIST), regression of other known metastases (RECIST), progression of disease (new metastases)
- Immune response in injected lesion [ Time Frame: six weeks ]Evidence of immune cell infiltration of injected tumor: histologic comparison of biopsy of injected lesion with pre injection biopsy of same lesion
|Study Start Date:||March 2007|
|Study Completion Date:||March 2014|
|Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
Experimental: Antimelanoma injection-GSL alpha-Gal
Intervention consists of injection of a single melanoma metastasis with two injections of GSL alpha-Gal separated by four weeks. Both injections done with the same dose of GSL alpha-GAL each time. Phase 1 dose escalating scheme: 0.1mg, 1 mg, 10mg
Biological: Antimelanoma injection of GSL alpha-Gal
Single arm, phase 1 trial of escalating doses of GSL alpha-Gal (0.1mg, 1mg, 10mg)injected into a melanoma metastasis at day 0 and then again 4 weeks later.
Other Name: Alph-Gal Glycosphingolipids
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00668512
|United States, Wisconsin|
|Universiity of Wisconsin|
|Madison, Wisconsin, United States, 53792|
|Principal Investigator:||Giles Whalen, MD||University of Massachusetts, Worcester|