Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2025-12-25 @ 8:39 PM
Study NCT ID:
NCT00075569
Status:
COMPLETED
Last Update Posted:
2018-05-21
First Post:
2004-01-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
SGN-00101 Immunotherapy in Treating Patients With Grade III Cervical Intraepithelial Neoplasia
Sponsor:
Albert Einstein College of Medicine
Organization:
Study Overview
Official Title:
SGN-00101 (HspE7) Immunotherapy Of CIN III
Status:
COMPLETED
Status Verified Date:
2006-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: