Vaccine Therapy in Treating Patients With Persistent or Recurrent Cervical Cancer

PRIMARY OBJECTIVES: I. To evaluate the tolerability, safety, and nature and degree of toxicity of ADXS11-001 (live-attenuated Listeria monocytogenes cancer vaccine ADXS11-001) by the numbers of patients with dose-limiting toxicities (DLTs) and adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0. II. To assess the activity of ADXS11-001 for patients with persistent or recurrent carcinoma of the cervix with the frequency of patients who survive for at least 12 months after initiating therapy. SECONDARY OBJECTIVES: I. To characterize the distribution of progression-free survival and overall survival. II. To examine the proportion of patients with objective tumor response. TERTIARY OBJECTIVES: I. To assess changes in clinical immunology based upon serum cytokines and to correlate any observed changes with clinical response including progression-free survival, overall survival, tumor response, DLTs, and adverse effects. II. To examine associations between presence and type of high-risk human papillomavirus (H-HPV) and measures of clinical response and serum cytokine levels. OUTLINE: Patients receive live-attenuated Listeria monocytogenes cancer vaccine ADXS11-001 intravenously (IV) over 30 minutes on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.