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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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)

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

Detailed Summary:

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, a
Sponsor: National Cancer Institute (NCI)

Current 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.

Original Primary Outcome:

Current Secondary Outcome:

• 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.
• Time to infection resolution [ Time Frame: Up to 52 weeks ]
  Kaplan Meier curves will be constructed.
• Time to disease resolution [ Time Frame: Up to 52 weeks ]
  Kaplan Meier curves will be constructed.

Original Secondary Outcome:

Information By: National Cancer Institute (NCI)

Dates:
Date Received: September 7, 2004
Date Started: September 2004
Date Completion:
Last Updated: May 31, 2013
Last Verified: March 2013