A phase I trial to evaluate the safety and tolerability of ALS-357 when administered for four weeks as a topical ointment, in escalating doses, to patients with cutaneous metastatic melanoma and to evaluate the effect of escalating doses of topically applied ALS-357 on histological remission of cutaneous metastatic melanoma and induction of apoptotic biomarkers.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Topical application of ALS-357
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States
RECRUITINGEvaluate the safety and tolerability of ALS-357 when administered for four weeks as a topical ointment, in escalating doses, to patients with cutaneous metastatic melanoma.
Time frame: Day 8, 15, 22, 29 and 43
Evaluate the effect of escalating doses of topically applied ALS-357 on histological remission of cutaneous metastatic melanoma and induction of apoptotic biomarkers.
Time frame: Day 8, 15, 22, 29 and 43
Evaluate differences in induction of apoptosis in treated versus control lesions via TUNEL assay.
Time frame: Day 15, 29 and 43
Nucleic Acid will be isolated from portions of the biopsies to be utilized for gene expression profiling by various analytical platforms and correlated with other apoptotic in situ and surface protein expression pathways.
Time frame: Day 15, 29 and 43
Evaluate the plasma concentration of ALS-357 at each scheduled study visit.
Time frame: Day 1, 8, 15, 22, 29 and 43
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