• To determine the immunologic response to the treatment with MKC1106-PP regimen
  
• To determine the safety and adverse event profile of MKC1106-PP.
  

• Determine blood plasmid levels by PCR analysis
  
• Measure cytokine levels
  
• Describe any objective tumor responses to the treatment with MKC1106-PP
  

The multi-component active immunotherapy, MKC1106-PP, consists of 1 plasmid dose and 2 peptides doses of sterile aqueous solutions designed to stimulate an immune reaction to two tumor associated antigens (PRAME and PSMA). A prime-boost treatment strategy will be employed wherein the plasmid component will be administered on Days 1, 4, 15 and 18 of each treatment cycle followed by administration of peptides on Days 29 and 32 of the treatment cycle. All components will be administered separately into superficial inguinal lymph nodes under ultrasound guidance . Subjects will undergo immunologic evaluation on Day 39 of each treatment cycle, and will undergo an evaluation for extent of disease following every other treatment cycle. Subjects who do not have evidence of progressive neoplasia may remain in the clinical trial and receive up to 6 cycles of clinical trial treatment.

Two cohorts of subjects will be treated:

• first cohort of 12 subjects will receive a low-dose of the peptides;
• second cohort of 12 subjects will receive a high-dose of the peptides;

both cohorts will receive the same dose of plasmid.