A Vaccine (TA-CIN) as Adjuvant Therapy in Treating Patients with HPV16 Related Stage IB1-IV Cervical Cancer

Inclusion Criteria

• Diagnosis of HPV16 related stage IB1-IV cervical cancer; completed definitive treatment within the past 12 months
• No evidence of disease recurrence based on imaging and clinical assessments within 8 weeks of enrollment
• Documented to have HPV16 nucleic acid within the cervical tumor specimen as determined by in situ hybridization * NOTE: HPV16 nucleic acid testing may be done as part of a “pre-screening” consent at any time prior to enrollment on the primary study. To be eligible for HPV16 testing, patients must have stage IB1-IV cervical cancer and have completed definitive treatment such that enrollment within 12 months of diagnosis would be possible if testing is positive
• Fresh-frozen or paraffin-embedded material must be available for in situ hybridization testing for HPV16 nucleic acid for central confirmation
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• White blood cell count >= 3,000
• Lymphocyte number >= 500
• Absolute neutrophil count >= 1,000
• Platelets >= 90,000
• Hemoglobin >= 9
• Total bilirubin < 1.5 x upper limit of normal (ULN) (< 3 x ULN if Gilbert’s disease)
• Aspartate aminotransferases (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) < 3 x ULN
• Creatinine < 1.5 x ULN or estimated creatinine clearance >= 60 ml/min per modified Cockcroft-Gault Formula
• Ability to understand and the willingness to sign a written informed consent document
• Subject is able to adhere to the study visit schedule and other protocol requirements

Exclusion Criteria

• Patients with a diagnosis of immunosuppression or prolonged, active use of immunosuppressive medications such as systemic steroids
• Patients who have had chemotherapy, radiation, biological cancer therapy, or other investigational agents within 28 days prior to the first dose of study drug
• Patients who have had surgery within 28 days of dosing of investigational agent, excluding minor procedures (dental work, skin biopsy, etc)
• Patients with an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Patients who have an active autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus [SLE], ulcerative colitis, Crohn's disease, multiple sclerosis [MS], ankylosing spondylitis)
• Patients being chronically treated with immunosuppressive drugs such as cyclosporin, adrenocorticotropic hormone (ACTH), or systemic corticosteroids
• Patients with a recognized immunodeficiency disease including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia; patients who have acquired, hereditary, or congenital immunodeficiencies
• Women of child-bearing potential (i.e., those who have had fertility-sparing procedures for the management of cervical cancer) will be excluded
• Patient with active or chronic infection of human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV) (tested at baseline)
• Patients with non-healed wounds
• A history of current or recent concurrent malignancy (=< 5 years) except basal cell cancer
• Inability to understand or unwillingness to sign an informed consent document