SGN-00101 Immunotherapy in Treating Patients With Grade III Cervical Intraepithelial Neoplasia
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.
|Study Design:||Masking: Open Label
Primary Purpose: Prevention
|Official Title:||SGN-00101 (HspE7) Immunotherapy Of CIN III|
- Rate of regression at 4-7 months after completion of treatment [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
|Study Start Date:||March 2004|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00075569
|United States, New York|
|Albert Einstein Cancer Center at Albert Einstein College of Medicine|
|Bronx, New York, United States, 10461|
|New York Weill Cornell Cancer Center at Cornell University|
|New York, New York, United States, 10021|
|Study Chair:||Carolyn D. Runowicz, MD||University of Connecticut Health Center|
|Investigator:||Mark H. Einstein, MD, MS||Albert Einstein College of Medicine of Yeshiva University|