SGN-00101 Vaccine in Treating Human Papillomavirus in Patients Who Have Abnormal Cervical Cells

Completed · Phase 2 · Has a placebo group

Conditions studied: Atypical Squamous Cells of Undetermined Significance, Cervical Cancer, High-grade Squamous Intraepithelial Lesion, Low-grade Squamous Intraepithelial Lesion

In brief

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

Key facts

Study ID

NCT00091130

Run by

National Cancer Institute (NCI)

People needed

139

Starts

2004-09-01

Last updated by the study team

2013-06-03

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• University of California Medical Center At Irvine-Orange Campus — Orange, California, United States

Full record on ClinicalTrials.gov

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