A Cancer Vaccine (Labvax 3(22)-23) and GM-CSF for the Treatment of Advanced Stage Adenocarcinoma

Open to people ages 18 years and up

• Ability to understand and willingness to sign an informed consent form
• Subjects of at least 18 years of age with histologically confirmed diagnosis of adenocarcinoma
• Subjects with advanced/metastatic or recurrent solid tumors, with measurable or non-measurable disease as determined by RECIST version 1.1 are eligible for participation
• Subjects can either have had no response to or progressed on prior cancer therapy. Patients must have recovered from all clinically significant treatment-related toxicities to grade 1 or less
• No limit on prior lines of therapy for metastatic disease. Prior chemotherapy, immunotherapy or molecularly targeted therapy must have been completed for at least 3 weeks prior to 1st vaccine injection. Prior palliative radiation must have been completed for at least 2 weeks prior to 1st vaccine injection
• Subjects with known untreated, active brain and/or leptomeningeal metastases are excluded. Subjects with treated brain metastasis who are neurologically stable and off steroids for at least one week is eligible
• Subjects must have documentation of positive delayed-type hypersensitivity (DTH) response to common recall antigens prior to 1st vaccine injection. As part of the prescreen evaluation, subjects will undergo DTH testing to at least one common recall antigen; selection will be at the discretion of the physician, based upon the history and physical (mumps, Trichophyton, Candida antigens, influenza [flu] matrix, and/or purified protein derivative [PPD], etc.). Skin tests will be read at or about 48 hours. A skin reaction will be considered positive if there is any measurable induration associated with erythema of 10 mm or greater. Erythema alone will not be regarded as a positive DTH response
• All subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
• All subjects must have a life expectancy of >= 6 months at the time of 1st vaccine injection
• All laboratory testing and all radiologic tests (e.g., computed tomography [CT], positron emission tomography [PET] or magnetic resonance imaging [MRI] scan) must be done within 4 weeks prior to 1st vaccine injection
• Absolute granulocyte count (AGC) >= 1,000 obtained within 4 weeks prior to 1st vaccine injection
• Pre-treatment platelet count of >= 75,000 obtained within 4 weeks prior to 1st vaccine injection
• A pre-treatment serum creatinine of =< 1.5 mg/dL is required. Measurements must be obtained within 4 weeks prior to 1st vaccine injection
• Serum bilirubin =< 1.5 obtained within 4 weeks prior to 1st vaccine injection
• Aspartate aminotransferase (AST) =< 2.5 x institutional upper limits of normal (=< 5x if with liver metastases) obtained within 4 weeks prior to 1st vaccine injection
• Because the effects of the vaccine on the unborn fetus or nursing infant are unknown, pregnant and nursing women are ineligible. Women of childbearing age must have a negative urine or serum pregnancy test (human chorionic gonadotropin [HCG]). Subjects must agree to follow strict contraceptive practices during the course of this trial

• Known active immunological disease, autoimmune disease, hereditary or congenital immunodeficiencies, underlying immunodeficiency, or altered immune function (e.g., active Grave's disease, acquired immunodeficiency virus [AIDS]/human immunodeficiency virus [HIV], Addison's disease, myasthenia gravis, severe atopic dermatitis, rheumatoid arthritis, eczema scleroderma, Goodpasture's syndrome, Sjogren's syndrome, ankylosing spondylitis, Hashimoto's thyroiditis, systemic lupus erythematosus, autoimmune neutropenia/thrombocytopenia, immune-mediated hemolytic anemia, or previous history of anaphylaxis requiring intensive care unit [ICU] care)
• Subjects who have had a prior splenectomy are ineligible
• Pregnant or nursing women
• Any medical condition including additional malignancies, laboratory abnormalities, or psychiatric illness that in the opinion of the investigator would prevent the subject from participating and adhering to study related procedures
• Uncontrolled concomitant disease that in the opinion of the investigator would interfere with the subject's safety or compliance on trial
• Severe infection that in the opinion of the investigator would interfere with subject safety or compliance on trial within 4 weeks prior to enrollment
• Subjects who have contraindications to GM-CSF injections according to the package insert (e.g., subjects with excessive leukemic myeloid blasts in the bone marrow or peripheral blood [>= 10%]; known hypersensitivity to GM-CSF, yeast-derived products or any component of the product)