Vaccine Therapy in Treating Patients With Persistent or Recurrent Cervical Cancer
|ClinicalTrials.gov Identifier: NCT01266460|
Recruitment Status : Active, not recruiting
First Posted : December 24, 2010
Last Update Posted : August 24, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cervical Adenocarcinoma Cervical Adenosquamous Carcinoma Cervical Squamous Cell Carcinoma, Not Otherwise Specified Recurrent Cervical Carcinoma||Biological: Attenuated Live Listeria Encoding HPV 16 E7 Vaccine ADXS11-001 Other: Laboratory Biomarker Analysis||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||67 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||May 23, 2011|
|Estimated Primary Completion Date :||October 2, 2018|
Experimental: Treatment (ADXS11-001)
Patients receive live-attenuated Listeria monocytogenes cancer vaccine ADXS11-001 IV over 30 minutes on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Biological: Attenuated Live Listeria Encoding HPV 16 E7 Vaccine ADXS11-001
Given IVOther: Laboratory Biomarker Analysis
- 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 ]
- 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 ]
- Changes in clinical immunology based upon serum [ Time Frame: Baseline to up to 24 hours after dose 3 ]Examined with descriptive statistics and graphics, and their relationship with survival and tumor response will be examined with proportional hazards and logistic regression models, as appropriate.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01266460
|United States, Alabama|
|University of Alabama at Birmingham Cancer Center|
|Birmingham, Alabama, United States, 35233|
|United States, Arizona|
|Saint Joseph's Hospital and Medical Center|
|Phoenix, Arizona, United States, 85013|
|United States, California|
|UC San Diego Moores Cancer Center|
|La Jolla, California, United States, 92093|
|UCSF Medical Center-Mount Zion|
|San Francisco, California, United States, 94115|
|UCSF Medical Center-Mission Bay|
|San Francisco, California, United States, 94158|
|United States, Kansas|
|University of Kansas Cancer Center|
|Kansas City, Kansas, United States, 66160|
|United States, Maryland|
|Sinai Hospital of Baltimore|
|Baltimore, Maryland, United States, 21215|
|Johns Hopkins University/Sidney Kimmel Cancer Center|
|Baltimore, Maryland, United States, 21287|
|United States, Michigan|
|University of Michigan Comprehensive Cancer Center|
|Ann Arbor, Michigan, United States, 48109|
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|United States, New York|
|Montefiore Medical Center-Einstein Campus|
|The Bronx, New York, United States, 10461|
|United States, North Carolina|
|Carolinas Medical Center/Levine Cancer Institute|
|Charlotte, North Carolina, United States, 28203|
|United States, Ohio|
|Case Western Reserve University|
|Cleveland, Ohio, United States, 44106|
|Ohio State University Comprehensive Cancer Center|
|Columbus, Ohio, United States, 43210|
|Lake University Ireland Cancer Center|
|Mentor, Ohio, United States, 44060|
|United States, Oklahoma|
|University of Oklahoma Health Sciences Center|
|Oklahoma City, Oklahoma, United States, 73104|
|Oklahoma Cancer Specialists and Research Institute-Tulsa|
|Tulsa, Oklahoma, United States, 74146|
|United States, Texas|
|UT Southwestern/Simmons Cancer Center-Dallas|
|Dallas, Texas, United States, 75390|
|University of Texas Medical Branch|
|Galveston, Texas, United States, 77555-0565|
|United States, Virginia|
|Virginia Commonwealth University/Massey Cancer Center|
|Richmond, Virginia, United States, 23298|
|United States, Wisconsin|
|Froedtert and the Medical College of Wisconsin|
|Milwaukee, Wisconsin, United States, 53226|
|Principal Investigator:||Warner Huh||NRG Oncology|