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
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Study Type | Interventional |
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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) |
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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) | |
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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 |
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Overall Number of Baseline Participants | 50 | |
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[Not Specified]
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Age, Customized
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 50 participants |
20 - 29 years |
25 50.0%
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30 - 39 years |
11 22.0%
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40 - 49 years |
17 34.0%
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50 - 59 years |
9 18.0%
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60 - 69 years |
10 20.0%
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70 - 79 years |
1 2.0%
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>= 80 years |
0 0.0%
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 50 participants | |
Female |
50 100.0%
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Male |
0 0.0%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 50 participants | |
Hispanic or Latino |
3 6.0%
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Not Hispanic or Latino |
45 90.0%
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Unknown or Not Reported |
2 4.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 50 participants | |
American Indian or Alaska Native |
1 2.0%
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Asian |
4 8.0%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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Black or African American |
5 10.0%
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White |
37 74.0%
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More than one race |
1 2.0%
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Unknown or Not Reported |
2 4.0%
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Name/Title: | Christopher Purdy on behalf of Austin Miller PhD |
Organization: | NRG Oncology |
Phone: | (716) 845-1300 ext 2296 |
EMail: | purdyc@nrgoncology.org |
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 |