Official title: A Prospective, Randomized, Blinded, Placebo-controlled, Phase IIb Trial of an Autologous Tumor Lysate (TL) + Yeast Cell Wall Particles (YCWP) + Dendritic Cells (DC) Vaccine vs Unloaded YCWP + DC in Stage III and Stage IV (Resected) Melanoma to Prevent Recurrence.
Purpose: The majority of melanoma vaccines tested to date have been antigen-specific vaccines targeting melanoma-specific or associated antigens and utilizing a variety of delivery systems and immune-adjuvants. As opposed to testing an "off the shelf" vaccine that might be able to treat a subset of patients, our approach has been personalized to the patient and applicable to all patients. Our vaccine approach consists of harnessing the most potent antigen presenting cell in the body – the dendritic cell (DC) – together with the full repertoire of tumor antigens from an individual's cancer. We have conducted phase I and II studies using an autologous DC-tumor cell fusion technique that has now been simplified into a DC-tumor cell lysate vaccine. The autologous tumor lysate (TL) is loaded into yeast cell wall particles (YCWP) that are naturally and efficiently taken up into the patient's DC. These autologous tumor lysate, particle-loaded, DC (TLPLDC) are injected intradermally (ID) monthly x 3 followed by boosters at 6, 12, and 18 months.
From ClinicalTrials.gov, https://clinicaltrials.gov/ct2/show/NCT02301611?term=Elios&rank=1
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I have further investigated this therapy. It is currently being offered in the Cayman Islands. The only trial cited is for 25 patients. The overall survival for the patients initially diagnosed with stage 2 to 4 disease was approximatey 12% at 30 months.Other data were just as dismal. Having a clinical trial accepted by the FDA does not necessarily mean that it has scientific or clinical validity. Please be careful of this trial. It could cost you your life.