SGN-00101 Immunotherapy in Treating Patients With Grade III Cervical Intraepithelial Neoplasia
Condition: Cervical Cancer; Precancerous Condition
MeSH terms: Uterine Cervical Neoplasms; Uterine Cervical Dysplasia; Precancerous Conditions
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): HspE7
Intervention type(s): Biological
Intervention description(s): 500 micrograms of SGN-00101 (HspE7, Nventa, San Diego, CA) is a novel therapeutic vaccine consisting of a fusion protein containing an M. bovis BCG heat shock protein (Hsp65) covalently linked to the entire sequence of HPV 16 E7.
Other intervention name(s): SGN-00101
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel design
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: cervical cancer; cervical intraepithelial neoplasia grade 3