Status:
COMPLETED
SGN-00101 Vaccine in Treating Human Papillomavirus in Patients Who Have Abnormal Cervical Cells
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Atypical Squamous Cells of Undetermined Significance
Cervical Cancer
Eligibility:
FEMALE
18-50 years
Phase:
PHASE2
Brief 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 cel...
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 sign...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
139 Patients enrolled
Trial Details
Trial ID
NCT00091130
Start Date
September 1 2004
Last Update
June 3 2013
Active Locations (1)
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1
University of California Medical Center At Irvine-Orange Campus
Orange, California, United States, 92868