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Vaccine Therapy in Treating Patients With Persistent or Recurrent Cervical Cancer

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ClinicalTrials.gov Identifier: NCT01266460
Recruitment Status : Completed
First Posted : December 24, 2010
Results First Posted : September 11, 2020
Last Update Posted : September 11, 2020
Sponsor:
Collaborators:
Advaxis, Inc.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
GOG Foundation ( Gynecologic Oncology Group )

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Cervical Adenocarcinoma
Cervical Adenosquamous Carcinoma
Cervical Squamous Cell Carcinoma, Not Otherwise Specified
Recurrent Cervical Carcinoma
Interventions Biological: Attenuated Live Listeria Encoding HPV 16 E7 Vaccine ADXS11-001
Other: Laboratory Biomarker Analysis
Enrollment 54
Recruitment Details GOG-0265 enrolled 54 patients from May 23, 2011 to September of 2015. Of the 54 patients enrolled, 50 patients received treatment.
Pre-assignment Details  
Arm/Group Title Treatment (ADXS11-001)
Hide Arm/Group Description

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.

Attenuated Live Listeria Encoding HPV 16 E7 Vaccine ADXS11-001: Given IV

Laboratory Biomarker Analysis: Correlative studies

Period Title: Overall Study
Started 50
Completed 16
Not Completed 34
Reason Not Completed
Adverse Event             3
Withdrawal by Subject             5
Disease Progression             18
Not otherwise specified             8
Arm/Group Title Treatment (ADXS11-001)
Hide Arm/Group Description

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.

Attenuated Live Listeria Encoding HPV 16 E7 Vaccine ADXS11-001: Given IV

Laboratory Biomarker Analysis: Correlative studies

Overall Number of Baseline Participants 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
20 - 29 years
25
  50.0%
30 - 39 years
11
  22.0%
40 - 49 years
17
  34.0%
50 - 59 years
9
  18.0%
60 - 69 years
10
  20.0%
70 - 79 years
1
   2.0%
>= 80 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
Female
50
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
Hispanic or Latino
3
   6.0%
Not Hispanic or Latino
45
  90.0%
Unknown or Not Reported
2
   4.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
American Indian or Alaska Native
1
   2.0%
Asian
4
   8.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
5
  10.0%
White
37
  74.0%
More than one race
1
   2.0%
Unknown or Not Reported
2
   4.0%
1.Primary Outcome
Title Number of Patients With Dose-limiting Toxicities, as Assessed by CTCAE v 4.0
Hide Description Number of patients with dose-limiting toxicities, as assessed by CTCAE v 4.0
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Only the first six patients were analyzed for Dose Limiting Toxicities.
Arm/Group Title Treatment (ADXS11-001)
Hide Arm/Group Description:

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.

Attenuated Live Listeria Encoding HPV 16 E7 Vaccine ADXS11-001: Given IV

Laboratory Biomarker Analysis: Correlative studies

Overall Number of Participants Analyzed 6
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
2.Primary Outcome
Title Incidence of Adverse Effects as Assessed by CTCAE v 4.0
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and evaluable.
Arm/Group Title Treatment (ADXS11-001)
Hide Arm/Group Description:

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.

Attenuated Live Listeria Encoding HPV 16 E7 Vaccine ADXS11-001: Given IV

Laboratory Biomarker Analysis: Correlative studies

Overall Number of Participants Analyzed 50
Measure Type: Count of Participants
Unit of Measure: Participants
29
  58.0%
3.Primary Outcome
Title Number of Patients Who Survive for at Least 12 Months
Hide Description The number of patients (and percentage) who survive for at least 12 months.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and evaluable
Arm/Group Title Treatment (ADXS11-001)
Hide Arm/Group Description:

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.

Attenuated Live Listeria Encoding HPV 16 E7 Vaccine ADXS11-001: Given IV

Laboratory Biomarker Analysis: Correlative studies

Overall Number of Participants Analyzed 50
Measure Type: Count of Participants
Unit of Measure: Participants
19
  38.0%
4.Secondary Outcome
Title Distribution of Overall Survival
Hide Description 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and evaluable.
Arm/Group Title Treatment (ADXS11-001)
Hide Arm/Group Description:

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.

Attenuated Live Listeria Encoding HPV 16 E7 Vaccine ADXS11-001: Given IV

Laboratory Biomarker Analysis: Correlative studies

Overall Number of Participants Analyzed 50
Median (95% Confidence Interval)
Unit of Measure: Months
6.1
(4.3 to 12.1)
5.Secondary Outcome
Title Distribution of Progression-free Survival
Hide Description 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and evaluable
Arm/Group Title Treatment (ADXS11-001)
Hide Arm/Group Description:

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.

Attenuated Live Listeria Encoding HPV 16 E7 Vaccine ADXS11-001: Given IV

Laboratory Biomarker Analysis: Correlative studies

Overall Number of Participants Analyzed 50
Median (95% Confidence Interval)
Unit of Measure: Months
2.8
(2.6 to 3.0)
6.Secondary Outcome
Title Number of Patients Who Have Objective Tumor Response (Complete or Partial)
Hide Description 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and evaluable.
Arm/Group Title Treatment (ADXS11-001)
Hide Arm/Group Description:

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.

Attenuated Live Listeria Encoding HPV 16 E7 Vaccine ADXS11-001: Given IV

Laboratory Biomarker Analysis: Correlative studies

Overall Number of Participants Analyzed 50
Measure Type: Count of Participants
Unit of Measure: Participants
Complete Response
0
   0.0%
Partial Response
2
   4.0%
Stable Disease
5
  10.0%
Progressive Disease
32
  64.0%
Not Evaluable
11
  22.0%
7.Other Pre-specified Outcome
Title Changes in Clinical Immunology Based Upon Serum
Hide Description 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.
Time Frame Baseline to up to 24 hours after dose 3
Outcome Measure Data Not Reported
Time Frame For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (ADXS11-001)
Hide Arm/Group Description

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.

Attenuated Live Listeria Encoding HPV 16 E7 Vaccine ADXS11-001: Given IV

Laboratory Biomarker Analysis: Correlative studies

All-Cause Mortality
Treatment (ADXS11-001)
Affected / at Risk (%)
Total   43/50 (86.00%) 
Hide Serious Adverse Events
Treatment (ADXS11-001)
Affected / at Risk (%)
Total   27/50 (54.00%) 
Cardiac disorders   
Sinus tachycardia * 1  1/50 (2.00%) 
Gastrointestinal disorders   
Abdominal pain * 1  1/50 (2.00%) 
Ascites * 1  1/50 (2.00%) 
Constipation * 1  2/50 (4.00%) 
Rectal hemorrhage * 1  1/50 (2.00%) 
Vomiting * 1  3/50 (6.00%) 
General disorders   
Chills * 1  3/50 (6.00%) 
Fatigue * 1  1/50 (2.00%) 
Fever * 1  3/50 (6.00%) 
General disorders and administration site conditions - Other, specify * 1  1/50 (2.00%) 
Malaise * 1  1/50 (2.00%) 
Pain * 1  2/50 (4.00%) 
Hepatobiliary disorders   
Hepatic failure * 1  1/50 (2.00%) 
Immune system disorders   
Cytokine release syndrome * 1  6/50 (12.00%) 
Infections and infestations   
Infections and infestations - Other, specify * 1  1/50 (2.00%) 
Lung infection * 1  1/50 (2.00%) 
Sepsis * 1  1/50 (2.00%) 
Urinary tract infection * 1  2/50 (4.00%) 
Injury, poisoning and procedural complications   
Fracture * 1  1/50 (2.00%) 
Investigations   
Alkaline phosphatase increased * 1  1/50 (2.00%) 
Blood bilirubin increased * 1  1/50 (2.00%) 
Creatinine increased * 1  4/50 (8.00%) 
GGT increased * 1  1/50 (2.00%) 
INR increased * 1  1/50 (2.00%) 
Urine output decreased * 1  1/50 (2.00%) 
Metabolism and nutrition disorders   
Dehydration * 1  1/50 (2.00%) 
Hypercalcemia * 1  1/50 (2.00%) 
Hyperglycemia * 1  2/50 (4.00%) 
Hyperkalemia * 1  1/50 (2.00%) 
Hypoalbuminemia * 1  1/50 (2.00%) 
Hypocalcemia * 1  1/50 (2.00%) 
Hyponatremia * 1  1/50 (2.00%) 
Musculoskeletal and connective tissue disorders   
Back pain * 1  2/50 (4.00%) 
Pain in extremity * 1  2/50 (4.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify * 1  1/50 (2.00%) 
Nervous system disorders   
Lethargy * 1  1/50 (2.00%) 
Psychiatric disorders   
Confusion * 1  1/50 (2.00%) 
Delirium * 1  1/50 (2.00%) 
Renal and urinary disorders   
Acute kidney injury * 1  3/50 (6.00%) 
Chronic kidney disease * 1  1/50 (2.00%) 
Renal and urinary disorders - Other, specify * 1  1/50 (2.00%) 
Urinary tract obstruction * 1  3/50 (6.00%) 
Reproductive system and breast disorders   
Vaginal fistula * 1  1/50 (2.00%) 
Vaginal hemorrhage * 1  1/50 (2.00%) 
Vaginal pain * 1  1/50 (2.00%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea * 1  1/50 (2.00%) 
Hypoxia * 1  1/50 (2.00%) 
Pleural effusion * 1  2/50 (4.00%) 
Vascular disorders   
Flushing * 1  1/50 (2.00%) 
Hypotension * 1  6/50 (12.00%) 
Thromboembolic event * 1  2/50 (4.00%) 
1
Term from vocabulary, CTCAE (4.0)
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment (ADXS11-001)
Affected / at Risk (%)
Total   50/50 (100.00%) 
Blood and lymphatic system disorders   
Lymph node pain * 1  1/50 (2.00%) 
Cardiac disorders   
Chest pain - cardiac * 1  1/50 (2.00%) 
Sinus tachycardia * 1  11/50 (22.00%) 
Ventricular tachycardia * 1  1/50 (2.00%) 
Ear and labyrinth disorders   
Tinnitus * 1  2/50 (4.00%) 
Eye disorders   
Blurred vision * 1  1/50 (2.00%) 
Eye disorders - Other, specify * 1  1/50 (2.00%) 
Photophobia * 1  1/50 (2.00%) 
Gastrointestinal disorders   
Abdominal distension * 1  2/50 (4.00%) 
Abdominal pain * 1  14/50 (28.00%) 
Anal pain * 1  1/50 (2.00%) 
Ascites * 1  2/50 (4.00%) 
Bloating * 1  2/50 (4.00%) 
Constipation * 1  18/50 (36.00%) 
Diarrhea * 1  3/50 (6.00%) 
Dry mouth * 1  1/50 (2.00%) 
Duodenal stenosis * 1  1/50 (2.00%) 
Dysphagia * 1  2/50 (4.00%) 
Gastroesophageal reflux disease * 1  3/50 (6.00%) 
Hemorrhoidal hemorrhage * 1  1/50 (2.00%) 
Hemorrhoids * 1  1/50 (2.00%) 
Mucositis oral * 1  1/50 (2.00%) 
Nausea * 1  20/50 (40.00%) 
Vomiting * 1  15/50 (30.00%) 
General disorders   
Chills * 1  29/50 (58.00%) 
Edema limbs * 1  13/50 (26.00%) 
Edema trunk * 1  1/50 (2.00%) 
Fatigue * 1  37/50 (74.00%) 
Fever * 1  20/50 (40.00%) 
Flu like symptoms * 1  8/50 (16.00%) 
General disorders and administration site conditions - Other, specify * 1  1/50 (2.00%) 
Infusion related reaction * 1  1/50 (2.00%) 
Localized edema * 1  1/50 (2.00%) 
Malaise * 1  4/50 (8.00%) 
Non-cardiac chest pain * 1  2/50 (4.00%) 
Pain * 1  9/50 (18.00%) 
Hepatobiliary disorders   
Cholecystitis * 1  1/50 (2.00%) 
Gallbladder pain * 1  1/50 (2.00%) 
Hepatobiliary disorders - Other, specify * 1  1/50 (2.00%) 
Immune system disorders   
Cytokine release syndrome * 1  8/50 (16.00%) 
Infections and infestations   
Infections and infestations - Other, specify * 1  1/50 (2.00%) 
Peripheral nerve infection * 1  1/50 (2.00%) 
Rhinitis infective * 1  1/50 (2.00%) 
Urinary tract infection * 1  5/50 (10.00%) 
Vaginal infection * 1  1/50 (2.00%) 
Injury, poisoning and procedural complications   
Fracture * 1  1/50 (2.00%) 
Investigations   
Alanine aminotransferase increased * 1  11/50 (22.00%) 
Alkaline phosphatase increased * 1  12/50 (24.00%) 
Aspartate aminotransferase increased * 1  13/50 (26.00%) 
Cardiac troponin I increased * 1  1/50 (2.00%) 
Cholesterol high * 1  1/50 (2.00%) 
Creatinine increased * 1  5/50 (10.00%) 
GGT increased * 1  14/50 (28.00%) 
INR increased * 1  1/50 (2.00%) 
Lymphocyte count decreased * 1  5/50 (10.00%) 
Weight loss * 1  4/50 (8.00%) 
Metabolism and nutrition disorders   
Anorexia * 1  13/50 (26.00%) 
Hypercalcemia * 1  5/50 (10.00%) 
Hyperglycemia * 1  10/50 (20.00%) 
Hyperkalemia * 1  2/50 (4.00%) 
Hypertriglyceridemia * 1  1/50 (2.00%) 
Hypoalbuminemia * 1  11/50 (22.00%) 
Hypocalcemia * 1  7/50 (14.00%) 
Hypoglycemia * 1  2/50 (4.00%) 
Hypokalemia * 1  7/50 (14.00%) 
Hypomagnesemia * 1  10/50 (20.00%) 
Hyponatremia * 1  8/50 (16.00%) 
Hypophosphatemia * 1  4/50 (8.00%) 
Metabolism and nutrition disorders - Other, specify * 1  1/50 (2.00%) 
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  4/50 (8.00%) 
Back pain * 1  17/50 (34.00%) 
Bone pain * 1  1/50 (2.00%) 
Buttock pain * 1  1/50 (2.00%) 
Flank pain * 1  2/50 (4.00%) 
Generalized muscle weakness * 1  5/50 (10.00%) 
Muscle weakness lower limb * 1  1/50 (2.00%) 
Musculoskeletal and connective tissue disorder - Other, specify * 1  1/50 (2.00%) 
Myalgia * 1  12/50 (24.00%) 
Pain in extremity * 1  5/50 (10.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Tumor pain * 1  1/50 (2.00%) 
Nervous system disorders   
Dizziness * 1  7/50 (14.00%) 
Headache * 1  18/50 (36.00%) 
Memory impairment * 1  2/50 (4.00%) 
Nervous system disorders - Other, specify * 1  1/50 (2.00%) 
Paresthesia * 1  1/50 (2.00%) 
Peripheral motor neuropathy * 1  1/50 (2.00%) 
Peripheral sensory neuropathy * 1  7/50 (14.00%) 
Somnolence * 1  1/50 (2.00%) 
Psychiatric disorders   
Anxiety * 1  7/50 (14.00%) 
Depression * 1  8/50 (16.00%) 
Insomnia * 1  8/50 (16.00%) 
Renal and urinary disorders   
Acute kidney injury * 1  4/50 (8.00%) 
Bladder perforation * 1  1/50 (2.00%) 
Bladder spasm * 1  1/50 (2.00%) 
Cystitis noninfective * 1  1/50 (2.00%) 
Hematuria * 1  4/50 (8.00%) 
Urinary frequency * 1  5/50 (10.00%) 
Urinary incontinence * 1  1/50 (2.00%) 
Urinary retention * 1  1/50 (2.00%) 
Urinary tract obstruction * 1  1/50 (2.00%) 
Urinary tract pain * 1  3/50 (6.00%) 
Urinary urgency * 1  1/50 (2.00%) 
Reproductive system and breast disorders   
Menorrhagia * 1  1/50 (2.00%) 
Pelvic pain * 1  5/50 (10.00%) 
Vaginal discharge * 1  2/50 (4.00%) 
Vaginal fistula * 1  1/50 (2.00%) 
Vaginal hemorrhage * 1  3/50 (6.00%) 
Vaginal pain * 1  2/50 (4.00%) 
Respiratory, thoracic and mediastinal disorders   
Cough * 1  6/50 (12.00%) 
Dyspnea * 1  12/50 (24.00%) 
Hiccups * 1  1/50 (2.00%) 
Hoarseness * 1  1/50 (2.00%) 
Hypoxia * 1  1/50 (2.00%) 
Nasal congestion * 1  3/50 (6.00%) 
Pleural effusion * 1  1/50 (2.00%) 
Productive cough * 1  1/50 (2.00%) 
Respiratory, thoracic and mediastinal disorders - Other, specify * 1  1/50 (2.00%) 
Sore throat * 1  3/50 (6.00%) 
Skin and subcutaneous tissue disorders   
Alopecia * 1  2/50 (4.00%) 
Dry skin * 1  1/50 (2.00%) 
Hyperhidrosis * 1  2/50 (4.00%) 
Pruritus * 1  1/50 (2.00%) 
Rash maculo-papular * 1  2/50 (4.00%) 
Skin and subcutaneous tissue disorders - Other, specify * 1  2/50 (4.00%) 
Skin ulceration * 1  1/50 (2.00%) 
Vascular disorders   
Flushing * 1  1/50 (2.00%) 
Hot flashes * 1  4/50 (8.00%) 
Hypertension * 1  4/50 (8.00%) 
Hypotension * 1  16/50 (32.00%) 
Lymphedema * 1  3/50 (6.00%) 
Thromboembolic event * 1  1/50 (2.00%) 
1
Term from vocabulary, CTCAE (4.0)
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Christopher Purdy on behalf of Austin Miller PhD
Organization: NRG Oncology
Phone: (716) 845-1300 ext 2296
EMail: purdyc@nrgoncology.org
Layout table for additonal information
Responsible Party: GOG Foundation ( Gynecologic Oncology Group )
ClinicalTrials.gov Identifier: NCT01266460    
Other Study ID Numbers: GOG-0265
NCI-2011-02671 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
GOG-0265
CDR0000691288
GOG-0265 ( Other Identifier: NRG Oncology )
GOG-0265 ( Other Identifier: CTEP )
U10CA180830 ( U.S. NIH Grant/Contract )
U10CA180868 ( U.S. NIH Grant/Contract )
U10CA027469 ( U.S. NIH Grant/Contract )
First Submitted: December 23, 2010
First Posted: December 24, 2010
Results First Submitted: April 23, 2020
Results First Posted: September 11, 2020
Last Update Posted: September 11, 2020