Clinical Trial: Vaccine Therapy in Treating Patients With Persistent or Recurrent Cervical Cancer

Study Status: Suspended
Recruit Status: Suspended
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:

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,
Sponsor: Gynecologic Oncology Group

Current Primary Outcome:

  • Incidence of adverse effects as assessed by CTCAE v 4.0 [ Time Frame: Up to 5 years ]
  • Number of patients with dose-limiting toxicities, as assessed by CTCAE v 4.0 [ Time Frame: 28 days ]
  • Proportion of patients who survive for at least 12 months [ Time Frame: 12 months ]


Original Primary Outcome:

  • Number of patients with dose-limiting toxicities
  • Frequency and severity of adverse effects as assessed by CTCAE v 4.0
  • Proportion of patients who survive for at least 12 months


Current Secondary Outcome:

  • Distribution of overall survival [ Time Frame: Time from study entry to time of death or the date of last contact, assessed up to 5 years ]
    Characterized with Kaplan-Meier plots and estimates of the median time until death.
  • Distribution of progression-free survival [ Time Frame: Time from study entry to time of progression or death, whichever occurs first, assessed up to 5 years ]
    Characterized with Kaplan-Meier plots and estimates of the median time until progression.
  • Proportion of patients who have objective tumor response (complete or partial) [ Time Frame: Up to 5 years ]


Original Secondary Outcome:

  • Distribution of overall survival
  • Distribution of progression-free survival
  • Proportion of patients who have objective tumor response (complete or partial)


Information By: Gynecologic Oncology Group

Dates:
Date Received: December 23, 2010
Date Started: May 2011
Date Completion:
Last Updated: May 31, 2016
Last Verified: May 2016