Vaccine Therapy in Treating Patients With Persistent or Recurrent Cervical Cancer
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|ClinicalTrials.gov Identifier: NCT01266460|
Recruitment Status : Active, not recruiting
First Posted : December 24, 2010
Last Update Posted : March 13, 2020
|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|
|Actual 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
Other: Laboratory Biomarker Analysis
- 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 [ Time Frame: Up to 5 years ]
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01266460
|Principal Investigator:||Warner K Huh||NRG Oncology|