SGN-00101 Immunotherapy in Treating Patients With Grade III Cervical Intraepithelial Neoplasia
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|ClinicalTrials.gov Identifier: NCT00075569|
Recruitment Status : Completed
First Posted : January 12, 2004
Last Update Posted : January 28, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer Precancerous Condition||Biological: HspE7||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Masking:||None (Open Label)|
|Official Title:||SGN-00101 (HspE7) Immunotherapy Of CIN III|
|Study Start Date :||March 2004|
- Rate of regression at 4-7 months after completion of treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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||UConn Health|
|OverallOfficial:||Mark H. Einstein, MD, MS||Albert Einstein College of Medicine, Inc.|