Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00075569
Status:
COMPLETED
Last Update Posted:
2018-05-21
First Post:
2004-01-09
Brief Title:
SGN-00101 Immunotherapy in Treating Patients With Grade III Cervical Intraepithelial Neoplasia
Sponsor:
Albert Einstein College of Medicine
Organization:
Albert Einstein College of Medicine
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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| AECOM-0309225 | OTHER | None | None |
| NCI-5850 | OTHER_GRANT | National Cancer Institute | None |