Atypical Squamous Cells of Undetermined SignificancePhase 2NCT00091130
SGN-00101 Vaccine in Treating Human Papillomavirus in Patients Who Have Abnormal Cervical Cells
A Phase 2 study testing HspE7 and laboratory biomarker analysis in people with Atypical Squamous Cells of Undetermined Significance and Cervical Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
This randomized phase II trial is studying how well SGN-00101 vaccine works compared to a placebo in treating human papillomavirus and preventing cervical cancer in patients with abnormal cervical cells. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Atypical Squamous Cells of Undetermined Significance, Cervical Cancer, High-grade Squamous Intraepithelial Lesion
- What is being tested?
- HspE7 and laboratory biomarker analysis
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 139 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Jun 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 54Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Medical Center At Irvine-Orange Campus
Orange, California, 92868
About this study
Official title: 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)
This randomized phase II trial is studying how well SGN-00101 vaccine works compared to a placebo in treating human papillomavirus and preventing cervical cancer in patients with abnormal cervical cells. Vaccines, such as SGN-00101, may make the body build an immune response to kill human papillomavirus and abnormal cervical cells and may be effective in preventing cervical cancer
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Atypical Squamous Cells of Undetermined Significance, Cervical Cancer, High-grade Squamous Intraepithelial Lesion, Low-grade Squamous Intraepithelial Lesion
- Being tested
- HspE7, placebo, laboratory biomarker analysis
- Medical subject headings
- Atypical Squamous Cells of the Cervix, Uterine Cervical Neoplasms, Squamous Intraepithelial Lesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HspE7Biological
Also called HPV 16 E7/HSP65 Vaccine, HPV E7 Peptide Epitope Vaccine, SGN-00101
Given SC
placeboOther
Also called PLCB
Given SC
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (SGN-00101) | Experimental | 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. Receives: Biological: HspE7; Other: laboratory biomarker analysis |
| Arm II (placebo) | Placebo comparator | 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. Receives: Other: placebo; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
HPV-16 viral load
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.
Measured: 6 months
Natural history of HPV 16 viral load
A repeated measures version of the zero-inflated log-normal model will be constructed.
Measured: Baseline
Natural history of HPV 16 viral load
A repeated measures version of the zero-inflated log-normal model will be constructed.
Measured: 3 months
Natural history of HPV 16 viral load
A repeated measures version of the zero-inflated log-normal model will be constructed.
Measured: 6 months
Regression or non-regression of the cellular atypia
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.
Measured: Up to 52 weeks
Secondary outcomes (3)
HPV-16 viral load
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.
Measured: 3 months
Time to infection resolution
Kaplan Meier curves will be constructed.
Measured: Up to 52 weeks
Time to disease resolution
Kaplan Meier curves will be constructed.
Measured: Up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2004 (estimated)
- Study startSep 2004
- Primary completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atypical Squamous Cells of Undetermined SignificanceStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Frank Meyskens, Principal investigator, University of California Medical Center At Irvine-Orange Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00091130
- Sponsor's protocol ID
- NCI-2012-02623
- Other IDs
- UCI#02-55, N01CN25139, CDR0000383786
- Status last verified
- Mar 2013
- First submitted
- 7 Sep 2004
- Last updated
- 3 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT00091130
- Acronym / sponsor ID
- NCI-2012-02623
- Conditions
- Atypical Squamous Cells of Undetermined Significance, Cervical Cancer, High-grade Squamous Intraepithelial Lesion, Low-grade Squamous Intraepithelial Lesion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Sep 2004
- Primary completion
- Jun 2007 (actual)
- First posted
- 8 Sep 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized phase II trial is studying how well SGN-00101 vaccine works compared to a placebo in treating human papillomavirus and preventing cervical cancer in patients with abnormal cervical cells. Vaccines, such as SGN-00101, may make the body build an immune response to kill human papillomavirus and abnormal cervical cells and may be effective in preventing cervical cancer
Detailed description
PRIMARY OBJECTIVES:
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (SGN-00101) | Experimental | Biological: HspE7, Other: laboratory biomarker analysisPatients 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. |
| Arm II (placebo) | Placebo comparator | Other: placebo, Other: laboratory biomarker analysisPatients 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (54 listed)
- Meets criteria for 1 of the following groups:
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HspE7Also: HPV 16 E7/HSP65 Vaccine, HPV E7 Peptide Epitope Vaccine, SGN-00101Given SC | Biological | Arm I (SGN-00101) |
| placeboAlso: PLCBGiven SC | Other | Arm II (placebo) |
| laboratory biomarker analysisCorrelative studies | Other | Arm I (SGN-00101), Arm II (placebo) |
Primary outcome
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.
Natural history of HPV 16 viral load
Time frame: Baseline
A repeated measures version of the zero-inflated log-normal model will be constructed.
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.
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.
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.
3 secondary outcomes
HPV-16 viral load
Time frame: 3 months
Time to infection resolution
Time frame: Up to 52 weeks
Time to disease resolution
Time frame: Up to 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank Meyskens principal investigator
University of California Medical Center At Irvine-Orange Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HspE7 and laboratory biomarker analysis in people with Atypical Squamous Cells of Undetermined Significance and Cervical Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 54 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HPV-16 viral load (time frame: 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2013.