Combined Vaccine Therapy in Treating Patients with Metastatic Solid Tumors

Inclusion Criteria

• For the dose escalation phase, patients must have histologically confirmed metastatic solid tumor (metastatic or unresectable, locally advanced gastrointestinal [GI] cancers [e.g., esophageal, colorectal, pancreatic and others]), ovarian and breast cancers; the malignancy should be considered incurable using standard treatment; for the extension cohort (N=12) and for the expansion phase (N=45), patients with advanced breast cancer (N=15), advanced gastrointestinal cancer (N=15) and advanced ovarian (N=15) will be enrolled; all patients enrolled on the extension and expansion phase will be required to have measurable disease
• For both the extension and expansion cohorts, patients must have received or refused first line standard systemic therapy for their metastases (if applicable) and patients (pancreatic and esophageal cancers) must have received no more than two prior cytotoxic chemotherapy regimens in the last two years after standard therapy; patients (breast, ovarian and gastrointestinal cancers) must have received no more than three prior cytotoxic chemotherapy regimens in the last two years after standard therapy
• Patients are required to have HER-2 (immunohistochemistry [IHC] 1+, 2+ and 3+) or EGFR over-expression to be enrolled on this study at the dose escalation cohort; patients will also be required to have HER-2 overexpression and/or EGFR overexpression for the extension and expansion cohorts * If the patient has had HER-2 expression measured prior to enrollment, the report alone will be accepted on the dose escalation phase of the study * If the patient has had EGFR expression measured prior to enrollment, the report alone will be accepted on the dose escalation phase of the study. *If the patient has not had HER-2 or EGFR expression measured prior to enrollment on this study, it would be obligatory for the patient to have the tests performed to justify their status; HER-2 status can be performed by a variety of tests; either immunohistochemistry (IHC) or fluorescent in situ hybridization (FISH) assay are acceptable if breast tumor tissues (previously frozen) are available; the test can be done at Ohio State University (OSU) or elsewhere if the patient is from out of town
• Patients with prior history of treated brain metastases who are off steroids and have stable metastatic brain disease for at least 3 months are eligible
• Patients must be ambulatory with an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
• Absolute neutrophil count (ANC) >= 1,000/mm^3
• Platelet count > 100,000/mm^3
• Serum bilirubin < 1.5 mg%, regardless of whether patients have liver involvement secondary to tumor
• Alanine aminotransferase (ALT) must be < 2 times upper limit of normal
• Creatinine < 1.5 mg/dL or calculated creatinine clearance > 60 mL/min
• Patients must be at least 3 weeks past any prior surgery, cytotoxic, chemotherapy, other immunotherapy, hormonal therapy, or radiation therapy; patients having been treated with monoclonal antibodies may enter the trial after a specified period of time (2 times the mean half-life of the agent); patients must have recovered from any toxicity of prior therapy prior to enrolling on study except for neuropathy where patients need to recover to less than grade 2 * Patients with hormone receptor positive breast cancer who are on stable endocrine therapy are eligible
• Women of child-bearing potential must not be pregnant and must have a negative pregnancy test; men and women must agree to practice effective contraception while on this study
• Patients must obtain a base line echocardiogram or multi gated acquisition scan (MUGA) and require the left ventricular ejection fraction to be within normal limits (or 50% or higher)
• Ability to understand and the willingness to sign a written informed consent document; the patient must be aware that his/her disease is neoplastic in nature and willingly consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks, and discomforts

Exclusion Criteria

• Patients with IHC of 0
• Patients on targeted therapies, such as cycline dependent kinase (CDK) 4/6 or mammalian target of rapamycin (mTOR) inhibitors in combination with endocrine therapy
• Patients who are (MVF-HER-2[266-296] and MVF-HER-2 [597-626]) immediate hypersensitivity skin test positive
• Patients who have evidence of active infection that requires antibiotic therapy; patients must have been off antibiotic treatment for at least 3 weeks prior to initiating treatment and must be confirmed to be clear of the infection; if patient develops an infection requiring antibiotic treatment while on the treatment portion of the study patients will be treated for the active infection with antibiotics and will resume vaccine treatment when the infection is healed
• Patients with known active human immunodeficiency virus (HIV), hepatitis A, hepatitis B, or hepatitis C infection
• Patients with serious uncontrolled cardiopulmonary disorders, including congestive heart failure, symptomatic coronary artery disease, serious cardiac arrhythmia, and symptomatic chronic obstructive pulmonary disease or patients with other serious uncontrolled medical diseases; at the discretion of the treating physician, patients who show disease control for at least 6 months may be enrolled
• Patients who require or likely to require corticosteroids or other immunosuppressives for intercurrent disease are NOT eligible
• Splenectomized patients
• Patients with active autoimmune diseases including rheumatoid arthritis, systemic lupus erythematosus, scleroderma, polymyositis dermato-myositis, or a vasculitic syndrome; at the discretion of the treating physician patients who show disease control for at least 6 months may be enrolled
• Patients who have developed anaphylactic responses to other vaccines
• Patients who have a history of congestive heart failure, coronary artery disease and myocardial infarction; active or unstable cardiovascular disease or cardiac disease requiring drug or device intervention