Treatment of cancer with immune stimulators

Abstract

The present invention provides compositions and methods for treating cancer or a metastasis thereof in a subject. In some embodiments, the methods involve administering a composition comprising therapeutically effective amount of at least one immune stimulator to the subject. In some embodiments, a combination of at least two immune stimulators is used for the treatment. In some embodiments, the combination includes an alpha thymosin peptide and an additional immune stimulator, and/or optionally one or more additional anti-cancer agents.

1 . A method of treating cancer or a metastasis thereof in a subject comprising administering a composition comprising therapeutically effective amount of a first immune stimulator and a second immune stimulator, wherein the first immune stimulator is an alpha thymosin peptide, and the second immune stimulator is a compound other than IL-2, interferon-α, or IRX-2. 
     
     
         2 .- 4 . (canceled) 
     
     
         5 . The method of  claim 1 , wherein the second immune stimulator is an immunostimulant that is effective in treating sepsis. 
     
     
         6 . (canceled) 
     
     
         7 . The method of  claim 1 , wherein the composition further comprises an additional anti-cancer agent. 
     
     
         8 .- 10 . (canceled) 
     
     
         11 . The method of  claim 1 , wherein the alpha thymosin peptide is thymosin alpha 1 (TA1). 
     
     
         12 .- 14 . (canceled) 
     
     
         15 . The method of  claim 1 , wherein the combination further comprises a kinase inhibitor. 
     
     
         16 .- 17 . (canceled) 
     
     
         18 . The method of  claim 1 , wherein the composition further comprises an antineoplastic heat shock apoptosis activator (HSAA). 
     
     
         19 .- 20 . (canceled) 
     
     
         21 . The method of  claim 1 , wherein said combination further includes administration of an antibody against cytotoxic T lymphocyte-associated antigen 4 (CTLA4). 
     
     
         22 .- 23 . (canceled) 
     
     
         24 . The method of  claim 1 , wherein said combination further includes administration of an alkylating antineoplastic agent (AlkAA). 
     
     
         25 .- 26 . (canceled) 
     
     
         27 . The method of  claim 1 , wherein the method further comprising administering a chemotherapeutic agent to the subject. 
     
     
         28 .- 29 . (canceled) 
     
     
         30 . A method of treating cancer or a metastasis thereof in a subject comprising administering a composition comprising therapeutically effective amount of an immune stimulator, wherein the immune stimulator is effective in treating sepsis. 
     
     
         31 . (canceled) 
     
     
         32 . The method of  claim 30 , wherein the immunostimulant comprises granulocyte macrophage colony stimulating factor (GM-CSF), programmed cell death-1 (PD-1) inhibitors and/or interleukin-7 (IL-7). 
     
     
         33 . The method of  claim 30 , wherein the composition further comprises an additional anti-cancer agent. 
     
     
         34 . The method of  claim 33 , wherein the additional anti-cancer agent is an alpha thymosin peptide. 
     
     
         35 . The method of  claim 34 , wherein the alpha thymosin peptide is thymosin alpha 1 (TA1). 
     
     
         36 . The method of  claim 34 , wherein the method further comprising administering a chemotherapeutic agent to the subject. 
     
     
         37 .- 38 . (canceled) 
     
     
         39 . A method for determining the responsiveness of a human subject to cancer treatment comprising determining the level of activity of one or more biomarkers in a biological sample from a human subject, wherein the biomarkers are selected from the group consisting of IL-1β, IL-4, IL-6, and IL-10. 
     
     
         40 . (canceled) 
     
     
         41 . The method of  claim 39 , wherein a higher than normal level of IL-1β activity is indicative that the human subject is responsive to the treatment. 
     
     
         42 . The method of  claim 39 , wherein a lower than normal level of IL-4 activity is indicative that the human subject is responsive to the treatment. 
     
     
         43 . The method of  claim 39 , wherein a higher than normal level of IL-6 activity is indicative that the human subject is responsive to the treatment. 
     
     
         44 . The method of  claim 39 , wherein a higher than normal level of IL-10 activity is indicative that the human subject is responsive to the treatment. 
     
     
         45 . (canceled)