An Open-Label Trial of SMK Treatment of Advanced Metastatic Cancer

The purpose of this study was to determine the safety, tolerability, and efficacy of SMK in patients with advanced metastatic breast cancer. SMK (Lumeria) is a unique therapy that creates alteration in defenses to oxidative stress and increases free radical exposure to the cancer cell. This was an IRB-approved study for metastatic cancer. No additional chemotherapy was allowed. The first 30 (14 with breast cancer) patients meeting entry criteria were consented. SMK was given orally and subcutaneously (SC), 5 days/week for 6 weeks (1 cycle). Subjects were allowed to continue with additional cycles based on their preferences. Before they entered the study, 4/14 (29%) had declined routine treatment, 10/14 (71%) had used many available treatments, and all were considered incurable in the end stage of progressive disease. The median number of cycles was 3 (range: 1-10). At the end of the study, 13/14 (93%) were alive with a median survival over 15 months; 11/14 (79%) had a 1 to 3 point improvement in ECOG rating; 10/14 (71%) had a 1 to 5 point improvement in EORTC (scale 1-7) rating. There was no treatment-associated toxicity except for cutaneous hyperpigmentation. In conclusion, SMK is a promising life extension treatment for metastatic breast cancer with no significant toxicity.