Histamine receptor agonists for cancer therapy in cancer patients unresponsive to cancer immunotherapy and with elevated myeloid derived suppressor cells

A method for treating a cancer or a tumor, the method comprising:

• selecting or identifying a subject having a population frequency of myeloid derived suppressor cells (MDSCs) greater than or equal to about 3%;
• and administering to the subject a pharmaceutical formulation comprising:
• a therapeutically effective amount of at least one active pharmaceutical ingredient (API), wherein the API comprises histamine, a histamine salt, a histamine derivative, a salt of a histamine derivative, and any combination of the foregoing, wherein the histamine derivative comprises a C1-6 alkyl histamine, and wherein the salt of the histamine derivative comprises a C1-6 alkyl histamine monocation or a C1-6 alkyl histamine polycation;
• and
• a pharmaceutically acceptable carrier, a pharmaceutically acceptable excipient, a pharmaceutically acceptable diluent, and any combination of the foregoing,
• wherein the pharmaceutical formulation comprises a dosage form selected from a coated tablet and a liquid form,
• wherein the cancer or the tumor is selected from a leukemia, a myeloma, a bone marrow cancer, a Hodgkin's lymphoma, a Non-Hodgkin's lymphoma, a follicular lymphoma, a lymphoid malignancy of T-cell or B-cell origin, a bladder cancer, a brain cancer, a cervical cancer, an esophageal cancer, a hepatocellular cancer, a head and neck cancer (including oral cancer), an ovarian cancer, a small cell lung cancer, a non-small cell lung cancer, a prostate cancer, a spleen cancer, a polycythemia vera, a thyroid cancer, an endometrial cancer, a stomach cancer, a gallbladder cancer, a bile duct cancer, a testicular cancer, a neuroblastoma, an osteosarcoma, a sarcoma, a carcinoma, an Ewing's tumor and a Wilms's tumor.