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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
54
Given IV
Correlative studies
Number of Patients With Dose-limiting Toxicities, as Assessed by CTCAE v 4.0
Number of patients with dose-limiting toxicities, as assessed by CTCAE v 4.0
Time frame: 28 days
Incidence of Adverse Effects as Assessed by CTCAE v 4.0
Incidence of adverse effects as assessed by CTCAE v 4.0 (i.e. the number of patients experiencing at least one grade 3 adverse event)
Time frame: Adverse events were collected an average of 4 years 7 months
Number of Patients Who Survive for at Least 12 Months
The number of patients (and percentage) who survive for at least 12 months.
Time frame: 12 months
Distribution of Overall Survival
Characterized with Kaplan-Meier plots and estimates of the median time until death.
Time frame: Patients will be followed (physical exams and histories) every three months for the first three years, then every six months for the next two years. Patients will be monitored for delayed toxicity and survival for 5-year period, unless consent withdrawn.
Distribution of Progression-free Survival
Characterized with Kaplan-Meier plots and estimates of the median time until progression. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time frame: Patients will be followed (physical exams and histories) every three months for the first three years, then every six months for the next two years. Patients will be monitored for delayed toxicity and survival for 5-year period, unless consent withdrawn.
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University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States
Saint Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
UC San Diego Moores Cancer Center
La Jolla, California, United States
Los Angeles County-USC Medical Center
Los Angeles, California, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
UCSF Medical Center-Mount Zion
San Francisco, California, United States
UCSF Medical Center-Mission Bay
San Francisco, California, United States
Memorial Health University Medical Center
Savannah, Georgia, United States
University of Kansas Cancer Center
Kansas City, Kansas, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, United States
...and 14 more locations
Number of Patients Who Have Objective Tumor Response (Complete or Partial)
The number of patients who have objective tumor response (complete response or partial response). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time frame: Patients will be followed (physical exams and histories) every three months for the first three years, then every six months for the next two years. Patients will be monitored for delayed toxicity and survival for 5-year period, unless consent withdrawn.