Cervical Cancer Clinical Trial
Official title:
SGN-00101 (HspE7) Immunotherapy Of CIN III
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.
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.
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