Spots Global Cancer Trial Database for SGN-00101 Immunotherapy in Treating Patients With Grade III Cervical Intraepithelial Neoplasia

Study Description

Brief Summary: RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer or to treat early cancer. SGN-00101 may be effective in preventing the development of cervical cancer in patients who have cervical intraepithelial neoplasia. PURPOSE: This phase II trial is studying how well SGN-00101 immunotherapy works in preventing cervical cancer in patients with grade III cervical intraepithelial neoplasia.

Detailed Description: OBJECTIVES: Primary * Determine the rate of regression at 4-7 months in patients with grade III cervical intraepithelial neoplasia (CIN III) treated with SGN-00101 immunotherapy. * Compare the rate of regression at 4-7 months with expected outcome in patients immunized with this vaccine. * Determine the toxic effects and recovery from possible toxic effects of this vaccine in these patients. Secondary * Determine induction of cell-mediated immune responses against human papillomavirus (HPV) E7 peptides before and after treatment in patients immunized with this vaccine * Correlate regression of disease with enhanced immunologic responses in patients immunized with this vaccine. * Correlate seropositivity of HPV-16 virus-like particles (VLP16) with vaccine-induced regression of CIN III in patients immunized with this vaccine. * Determine the efficacy of this vaccine in patients whose CIN III is associated with HPV-16 infection vs other HPV types. OUTLINE: This is a multicenter study. Patients are assigned to 1 of 2 treatment groups. All patients receive SGN-00101 subcutaneously once monthly on months 1-3 (for a total of 3 vaccinations) in the absence of disease progression or unacceptable toxicity. * Group 1: Four months after the first vaccination, patients undergo therapeutic and diagnostic loop electrosurgical excision procedure (LEEP) or core biopsy. * Group 2: Six months after the first vaccination, patients undergo therapeutic and diagnostic LEEP or core biopsy. Patients in group 1 are followed at 12 months and patients in group 2 are followed at 14 months after the first vaccination. PROJECTED ACCRUAL: A total of 66 patients (36 for group 1 and 30 for group 2) will be accrued for this study.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Contact Details

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