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

NCT00091130 | Completed Phase 2

• 4 other identifiers: NCI-2012-02623UCI#02-55N01CN25139CDR0000383786
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 1

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 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

Conditions

Atypical Squamous Cells of Undetermined Significance; Cervical Cancer; High-grade Squamous Intraepithelial Lesion; Low-grade Squamous Intraepithelial Lesion

Outcome Measures

Primary Outcomes (5)

• 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.

  6 months

• Natural history of HPV 16 viral load

  A repeated measures version of the zero-inflated log-normal model will be constructed.

  Baseline

• Natural history of HPV 16 viral load

  A repeated measures version of the zero-inflated log-normal model will be constructed.

  3 months

• Natural history of HPV 16 viral load

  A repeated measures version of the zero-inflated log-normal model will be constructed.

  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.

  Up to 52 weeks

Secondary Outcomes (3)

• HPV-16 viral load

  3 months

• Time to infection resolution

  Up to 52 weeks

• Time to disease resolution

  Up to 52 weeks

Study Arms (2)

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.

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.

Other: placebo; Other: laboratory biomarker analysis

Interventions

HspE7 BIOLOGICAL

Given SC

Also known as: HPV 16 E7/HSP65 Vaccine, HPV E7 Peptide Epitope Vaccine, SGN-00101

Arm I (SGN-00101)

placebo OTHER

Given SC

Also known as: PLCB

Arm II (placebo)

laboratory biomarker analysis OTHER

Correlative studies

Arm I (SGN-00101); Arm II (placebo)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

University of California Medical Center At Irvine-Orange Campus

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Atypical Squamous Cells of the Cervix; Uterine Cervical Neoplasms; Squamous Intraepithelial Lesions

Condition Hierarchy (Ancestors)

Uterine Cervical Dysplasia; Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site

Study Officials

• Frank Meyskens

  University of California Medical Center At Irvine-Orange Campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2004
• First Posted: September 8, 2004
• Study Start: September 1, 2004
• Primary Completion: June 1, 2007
• Last Updated: June 3, 2013

Record last verified: 2013-03

Locations

US (1)