A Vaccine (pING-hHER3FL) for the Treatment of Patients with Tumors that Have Been Resected

Inclusion Criteria

• Documented history of solid tumor where HER3 expression is expected (this includes breast, colon, lung, prostate, ovarian, cervical, endometrial, gastric, pancreatic, bladder, head and neck, liver, and esophageal cancer, but other tumors will be considered based on emerging HER3 expression data in the literature). Demonstration of HER3 expression is not required for enrollment
• Has undergone surgical resection of malignancy and has completed intended standard course of chemotherapy and HER2 targeted therapy (if indicated) and radiotherapy (if indicated) under the direction of their physician. Subjects may continue on adjuvant hormonal therapy (for example, adjuvant aromatase inhibitors as adjuvant therapy for estrogen receptor [ER]/progesterone receptor [PR] positive [+] breast cancer.)
• Has no evidence of disease by standard imaging studies (performed at the direction of their physician) within 60 days prior to initiating study treatment
• Between 3 weeks and 2 years since prior cytotoxic chemotherapy, HER2-targeted therapy or radiotherapy to the start of study treatment (based on the most recently completed therapy for their cancer)
• Eastern Cooperative Oncology Group (ECOG) 0 or 1
• Estimated life expectancy > 3 months
• Age >= 18 years
• Absolute neutrophil count (ANC) > 1500/uL
• Hemoglobin >= 9 g/dL
• Platelets >= 75,000/uL
• Serum creatinine < 1.5 mg/dL
• Bilirubin < 1.5 mg/dL (except for Gilbert's syndrome which will allow bilirubin =< 2.0 mg/dL)
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 x upper limit of normal (ULN) or if liver metastases are present =< 5 x ULN
• Female patients must be of non-child-bearing potential or use effective contraception, e.g., use of oral contraceptives with an additional barrier method (since the study drug may impair the effectiveness of oral contraceptives), double barrier methods (diaphragm with spermicidal gel or condoms with contraceptive foam), Depo-Provera, partner vasectomy, total abstinence, and willing to continue the effective contraception method for 30 days after the last dose of study treatment
• Labs performed as standard of care prior to signing consent can be used to fulfill eligibility requirements if they were performed within 4 weeks of the start of study treatment
• Ability to understand and provide signed informed consent
• Ability to return to the study site for adequate follow-up, as required by this protocol
• Negative serum pregnancy test within 7 days prior to the start of study treatment, for women of childbearing potential only

Exclusion Criteria

• Patients must have recovered to grade 1 toxicities from any prior treatment(s) (except grade 2 alopecia or fatigue)
• Known central nervous system (CNS)/brain metastases (treated metastases permitted, provided the patient is asymptomatic and off all steroids at least 4 weeks prior to the start of study treatment.) * No brain imaging will be performed as part of this study
• History of auto-immune disease requiring immunosuppressive therapy such as, but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis. Prior history of autoimmune thyroiditis or vitiligo is not an exclusion
• Serious chronic or acute illness considered by the principal investigator to constitute an unwarranted high risk for investigational treatment
• Medical or psychological impediment to probable compliance with the protocol
• Concurrent or prior second malignancy (within the past 5 years) other than non-melanoma skin cancer, carcinoma in situ of the bladder and cervix
• Presence of active infection or systemic use of antimicrobials within 48 hours prior to the start of study treatment
• Patients on continuous steroid therapy for at least 72 hours (or other continuous immunosuppressives such as azathioprine or cyclosporine A) are excluded on the basis of potential immune suppression. Patients must have had 4 weeks of discontinuation of any continuous steroid therapy (taken for at least 72 hours duration) prior to start of study treatment (except steroids used for allergic reactions or as anti-emetics for systemic chemotherapy which are permitted)
• Presence of a known active acute or chronic infection including human immunodeficiency virus (HIV) or viral hepatitis (hepatitis B and C)
• Pregnant or nursing women
• Prior immunotherapy