- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00091130
SGN-00101 Vaccine in Treating Human Papillomavirus in Patients Who Have Abnormal Cervical Cells
An Exploratory Study to Evaluate the Effect of HPV 16 Vaccine on the Reduction of Viral Load in HPV 16 Positive Women With Persistent Viral Infection, But Low Grade Disease (ASCUS/LSIL)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. Compare the effectiveness of SGN-00101 vaccine vs placebo in reducing the human papillomavirus (HPV)-16 viral load in patients with atypical squamous cells of undetermined significance (ASCUS) or low-grade squamous intraepithelial lesions (LSIL) of the cervix with persistent HPV-16 infection who are at increased risk for developing a high-grade squamous intraepithelial lesion or invasive cervical cancer.
II. Compare the natural history of HPV-16 viral load in patients treated with these regimens.
III. Compare the effect of HPV-16 variants on viral load response in patients treated with these regimens.
IV. Compare the relative effectiveness of these regimens on the regression of cervical cellular atypias (based on Pap test results), in terms of the regression of cytologic findings of LSIL and ASCUS to normal findings and resolution or regression of colposcopically defined cervicovaginal lesions, in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive SGN-00101 vaccine subcutaneously (SC) on day 1 of weeks 1, 4, and 8 for a maximum of 3 injections in the absence of unacceptable toxicity or the development of an invasive malignancy or serious illness.
ARM II: Patients receive placebo vaccine SC on day 1 of weeks 1, 4, and 8 for a maximum of 3 injections in the absence of unacceptable toxicity or the development of an invasive malignancy or serious illness.
Patients are followed at 12, 24, and 52 weeks after the last vaccination.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
California
-
Orange, California, United States, 92868
- University of California Medical Center At Irvine-Orange Campus
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Meets criteria for 1 of the following groups:
Prospective group, meeting the following criteria:
- Evidence of atypical squamous cells of undetermined significance (ASCUS) or low-grade squamous intraepithelial lesions (LSIL) by Pap test
- Human papillomavirus (HPV)-16-positive by polymerase chain reaction (PCR) and PGMY09/PGMY11 oligonucleotide primers viral load assay
Medical records-based group, meeting the following criteria:
- Medical-record evidence of ASCUS or LSIL by Pap test within the past 6-12 months
Meets 1 of the following criteria:
- Liquid-cytology findings of ASCUS or LSIL
- Colposcopic evidence of a LSIL by the Reid Index score of 1-5
- Historically persistent HPV-16-infection by PCR and HPV reverse transcription (RT)-PCR
- No evidence of high-grade squamous intraepithelial lesions (HSIL) by colposcopy (Reid Index ≥ 6)
- Reports no sex partner change since last index Pap screening test
Specimen-based group, meeting the following criteria:
Medical-record evidence of ASCUS or LSIL by Pap test within the past 6-12 months
- Liquid-based cytology specimen available
Meets 1 of the following criteria:
- Liquid-cytology findings of ASCUS or LSIL
- Colposcopic evidence of a LSIL by the Reid Index score of 1-5
- Historically persistent HPV-16-infection by PCR and, where measurable, HPV RT-PCR showing no greater than 3-fold reduction over the index liquid-cytology specimen
- No evidence of HSIL by colposcopy (Reid Index ≥ 6)
- Menstrual period occurred at least once within the past 52 weeks
- No HSIL by Pap test within the past year
- Performance status - ECOG 0
- No severe or unstable coagulation
- Hepatitis B surface antigen negative
- Hepatitis C antibody negative
- No angina
- No heart failure
- No other cardiac condition
- No respiratory condition
- No asthma
- No immunological disorders (e.g., lupus, diabetes, multiple sclerosis, or myasthenia gravis)
- Not immunocompromised, suggestive of severe immune deficiency
- HIV negative
- No AIDS
- No active infection, defined as fever > 100° F
- No syphilis
- No severe allergic reactions (anaphylactic response) to drugs or any other allergen
- No history of allergy to any vaccine constituents, including cell- or tissue-system elements used to prepare the vaccine (e.g., bread products, yeast, or recombinant DNA technology using yeast systems)
- Must agree to use effective form of contraception throughout vaccination period
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during vaccination period and for 5 months after study treatment
- No sexual intercourse within 48 hours of virus specimen collection during study visits
- No objects (e.g., tampons, douche, suppositories, fingers, or toes) within the vagina or rectum within 48 hours of virus specimen collection during study visits
- No prior malignancy except nonmelanoma skin cancer
- No medical or psychiatric illness than would preclude study participation or compliance
- No other disorders requiring medical intervention that would preclude study participation
- No prior HPV vaccine
- More than 30 days since prior investigational vaccine
- More than 30 days since prior systemic steroid therapy
- No prior splenectomy
- More than 30 days since prior investigational drug
- More than 72 hours since prior antibiotic therapy for active infection
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm I (SGN-00101)
Patients receive SGN-00101 vaccine SC on day 1 of weeks 1, 4, and 8 for a maximum of 3 injections in the absence of unacceptable toxicity or the development of an invasive malignancy or serious illness.
|
Correlative studies
Given SC
Other Names:
|
Placebo Comparator: Arm II (placebo)
Patients receive placebo vaccine SC on day 1 of weeks 1, 4, and 8 for a maximum of 3 injections in the absence of unacceptable toxicity or the development of an invasive malignancy or serious illness.
|
Correlative studies
Given SC
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HPV-16 viral load
Time Frame: 6 months
|
Following the univariate modeling, multivariate logistic regression models will be constructed by adding the demographic factors, baseline viral load, and type of cellular atypia to the model.
The univariate logistic regression model for infection resolution is equivalent to a chi-square test.
|
6 months
|
Natural history of HPV 16 viral load
Time Frame: Baseline
|
A repeated measures version of the zero-inflated log-normal model will be constructed.
|
Baseline
|
Natural history of HPV 16 viral load
Time Frame: 3 months
|
A repeated measures version of the zero-inflated log-normal model will be constructed.
|
3 months
|
Natural history of HPV 16 viral load
Time Frame: 6 months
|
A repeated measures version of the zero-inflated log-normal model will be constructed.
|
6 months
|
Regression or non-regression of the cellular atypia
Time Frame: Up to 52 weeks
|
The analysis for this will employ logistic regression models.
A multivariate logistic regression model will be constructed. .
A two group continuity corrected chi squared test with a 0.050 two-sided significance level will be used.
|
Up to 52 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HPV-16 viral load
Time Frame: 3 months
|
Following the univariate modeling, multivariate logistic regression models will be constructed by adding the demographic factors, baseline viral load, and type of cellular atypia to the model.
The univariate logistic regression model for infection resolution is equivalent to a chi-square test.
|
3 months
|
Time to infection resolution
Time Frame: Up to 52 weeks
|
Kaplan Meier curves will be constructed.
|
Up to 52 weeks
|
Time to disease resolution
Time Frame: Up to 52 weeks
|
Kaplan Meier curves will be constructed.
|
Up to 52 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Frank Meyskens, University of California Medical Center At Irvine-Orange Campus
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCI-2012-02623
- UCI#02-55
- N01CN25139 (Other Grant/Funding Number: US NIH Grant/Contract Award Number)
- CDR0000383786 (Registry Identifier: PDQ (Physician Data Query))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cervical Cancer
-
University of California, San DiegoWithdrawnCervical Cancer | Cervical Cancer Stage | Cervical Cancer Stage IB2 | Cervical Cancer Stage IB1 | Cervical Cancer Stage I | Cervical Cancer Stage IB | Cervical Cancer Stage II | Cervical Cancer Stage IIa | Cervical Cancer, Stage IIB | Cervical Cancer, Stage III | Cervical Cancer Stage IIIB | Cervical Cancer... and other conditionsUnited States
-
M.D. Anderson Cancer CenterWithdrawnStage IB3 Cervical Cancer FIGO 2018 | Stage II Cervical Cancer FIGO 2018 | Stage IIA Cervical Cancer FIGO 2018 | Stage IIA1 Cervical Cancer FIGO 2018 | Stage IIA2 Cervical Cancer FIGO 2018 | Stage IIB Cervical Cancer FIGO 2018 | Stage III Cervical Cancer FIGO 2018 | Stage IIIA Cervical Cancer FIGO... and other conditions
-
Abramson Cancer Center of the University of PennsylvaniaWithdrawnCervical Cancer | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical Cancer
-
National Cancer Institute (NCI)CompletedCervical Adenocarcinoma | Cervical Squamous Cell Carcinoma | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical Cancer | Stage IVB Cervical CancerUnited States
-
Mayo ClinicNational Cancer Institute (NCI)RecruitingCervical Adenosquamous Carcinoma | Cervical Squamous Cell Carcinoma, Not Otherwise Specified | Recurrent Cervical Carcinoma | Stage IB3 Cervical Cancer FIGO 2018 | Stage II Cervical Cancer FIGO 2018 | Stage IIA Cervical Cancer FIGO 2018 | Stage IIA1 Cervical Cancer FIGO 2018 | Stage IIA2 Cervical... and other conditionsUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingStage IA Cervical Cancer | Stage IB Cervical Cancer | Stage IA1 Cervical Cancer | Stage IA2 Cervical Cancer | Stage IB1 Cervical Cancer | Stage IB2 Cervical Cancer | Stage IB3 Cervical CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)CompletedRecurrent Cervical Cancer | Stage IVA Cervical Cancer | Stage IVB Cervical Cancer | Stage IIIA Cervical Cancer | Stage IIIB Cervical CancerUnited States
-
Shanghai First Maternity and Infant HospitalNot yet recruitingCervical Cancer, Stage IIB | Cervical Cancer Stage IIIB | Cervical Cancer Stage IIIA | Cervical Cancer, Stage IVA
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedCervical Adenocarcinoma | Cervical Squamous Cell Carcinoma | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical CancerUnited States
-
Institut de Cancérologie de LorraineCompletedCervical Adenocarcinoma | Stage IB Cervical Cancer | Stage III Cervical Cancer | Stage II Cervical CancerFrance
Clinical Trials on laboratory biomarker analysis
-
ECOG-ACRIN Cancer Research GroupNational Cancer Institute (NCI)CompletedProstate Cancer
-
National Cancer Institute (NCI)Recruiting
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)Not yet recruitingLynch Syndrome | Recurrent Uterine Corpus Carcinoma | Stage I Uterine Corpus Cancer | Stage II Uterine Corpus Cancer | Stage III Uterine Corpus Cancer | Stage IV Uterine Corpus CancerUnited States
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)Not yet recruitingRecurrent Uterine Corpus Carcinoma | Stage III Uterine Corpus Cancer | Stage IV Uterine Corpus CancerUnited States
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)RecruitingStage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian CancerUnited States
-
Ohio State University Comprehensive Cancer CenterActive, not recruitingLung Cancer | Radiation Toxicity | Adult Brain TumorUnited States
-
National Cancer Institute (NCI)Active, not recruitingMalignant NeoplasmUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedRecurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor | Metastatic Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor | Localized Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor | Askin TumorUnited States, Canada, Puerto Rico, Australia, New Zealand, Switzerland
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)Completed
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedRecurrent Osteosarcoma | Metastatic Osteosarcoma | Localized OsteosarcomaUnited States