This phase II trial studies the side effects and how well vaccine therapy works in treating patients with cervical cancer that does not go to remission despite treatment (persistent) or has come back (recurrent). Vaccines therapy may help the body build an effective immune response to kill tumor cells.
A Phase II Evaluation of ADXS11-001 (NSC 752718) in the Treatment of Persistent or Recurrent Squamous or Non-squamous Cell Carcinoma of the Cervix
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.
I. To characterize the distribution of progression-free survival and overall survival.
II. To examine the proportion of patients with objective tumor response.
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.
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.
Cervical Adenocarcinoma Cervical Adenosquamous Carcinoma Cervical Squamous Cell Carcinoma Recurrent Cervical Carcinoma Vaccines
Open to females ages 18 years and up
We will not share your information with anyone other than the team in charge of this study. Submitting your contact information does not obligate you to participate in research.
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If you do not hear from the study team, please call 888-689-8273 and tell them you’re interested in study number NCT01266460.
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