Vaccine Therapy in Treating Patients With Persistent or Recurrent Cervical Cancer
RATIONALE: Vaccines may help the body build an effective immune response to kill tumor cells.
PURPOSE: This phase II clinical trial is studying the side effects and how well vaccine therapy works in treating patients with persistent or recurrent cervical cancer.
Biological: live-attenuated Listeria monocytogenes cancer vaccine ADXS11-001
Other: laboratory biomarker analysis
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Evaluation of ADXS11-001 (NSC 752718, BB-IND#13,712) in the Treatment of Persistent or Recurrent Squamous or Non-Squamous Cell Carcinoma of the Cervix|
- Number of patients with dose-limiting toxicities [ Designated as safety issue: Yes ]
- Frequency and severity of adverse effects as assessed by CTCAE v 4.0 [ Designated as safety issue: Yes ]
- Proportion of patients who survive for at least 12 months [ Designated as safety issue: No ]
- Distribution of overall survival [ Designated as safety issue: No ]
- Distribution of progression-free survival [ Designated as safety issue: No ]
- Proportion of patients who have objective tumor response (complete or partial) [ Designated as safety issue: No ]
|Study Start Date:||September 2011|
|Estimated Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
ADXS11-001 15 minute IV infusion of 1x10^9 cfu in 80ml normal saline
|Biological: live-attenuated Listeria monocytogenes cancer vaccine ADXS11-001 Other: laboratory biomarker analysis|
- To evaluate the tolerability, safety, and nature and degree of toxicity of ADX11-001 by the numbers of patients with dose-limiting toxicities (DLTs) and adverse events as assessed by the CTCAE v4.0.
- 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.
- To characterize the distribution of progression-free survival and overall survival.
- To examine the proportion of patients with objective tumor response.
- 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. (Exploratory)
- To examine associations between presence and type of high-risk human papillomavirus (H-HPV) and measures of clinical response and serum cytokine levels. (Exploratory)
OUTLINE: This is a multicenter study.
Patients receive live-attenuated Listeria monocytogenes cancer vaccine ADXS11-001 IV over 15 minutes on day 1. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.
Tumor tissue and serum samples may be collected periodically for translational research.
After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.
|United States, Alabama|
|UAB Comprehensive Cancer Center||Recruiting|
|Birmingham, Alabama, United States, 35294|
|Contact: Clinical Trials Office - UAB Comprehensive Cancer Center 205-934-0309|
|United States, Georgia|
|Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center||Recruiting|
|Savannah, Georgia, United States, 31403-3089|
|Contact: Clinical Trials Office - Curtis and Elizabeth Anderson Cancer 912-350-8568|
|United States, Oklahoma|
|Oklahoma University Cancer Institute||Recruiting|
|Oklahoma City, Oklahoma, United States, 73104|
|Contact: Robert S. Mannel, MD 405-271-8787|
|United States, Virginia|
|Virginia Commonwealth University Massey Cancer Center||Recruiting|
|Richmond, Virginia, United States, 23298-0037|
|Contact: Clinical Trials Office -Virginia Commonwealth University Masse 804-628-1939|
|Principal Investigator:||Warner Huh, MD||University of Alabama at Birmingham|