This is a Phase I pilot study to evaluate the toxicity of two intra-tumoral injections of GSL alpha-GAL in patients with advanced or metastatic cutaneous melanoma. Patients who have failed standard therapies or are not eligible for standard treatment will be eligible for this study.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
Enrollment
12
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.
Universiity of Wisconsin
Madison, Wisconsin, United States
Grade 3/4 toxicity
Grade 3/4 toxicity or adverse event during injection protocol or up to a month after
Time frame: 11-12 weeks
Clinical response
Injected tumor deposit regression (RECIST), regression of other known metastases (RECIST), progression of disease (new metastases)
Time frame: 2 years
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