Cervical Adenocarcinoma Clinical Trial
Official title:
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
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.
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.
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