Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00060099
Status:
UNKNOWN
Last Update Posted:
2013-11-06
First Post:
2003-05-06
Brief Title:
SGN-00101 in Treating Patients With Cervical Intraepithelial Neoplasia
Sponsor:
Dana-FarberBrigham and Womens Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Randomized Double-Blinded Trial Of SGN-00101 HSP-E7 For Treatment Of CIN IIIII
Status:
UNKNOWN
Status Verified Date:
2005-03
Last Known Status:
ACTIVE_NOT_RECRUITING
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 or treat early cancer SGN-00101 may be effective in preventing the development of cervical cancer in patients with cervical intraepithelial neoplasia
PURPOSE This randomized phase II trial is studying how well SGN-00101 works in preventing cervical cancer in patients with cervical intraepithelial neoplasia and human papillomavirus
PURPOSE This randomized phase II trial is studying how well SGN-00101 works in preventing cervical cancer in patients with cervical intraepithelial neoplasia and human papillomavirus
Detailed Description:
OBJECTIVES
Compare the efficacy of SGN-00101 vs placebo in patients with grade II or III cervical intraepithelial neoplasia
Correlate clinical response as defined by histologic demonstration of lesion regression with potential surrogate markers of vaccine efficacy eg spectroscopic changes in the epithelium development of human papilloma virus HPV-specific mucosal and systemic T-cell responses and levels of HPV-specific antibody in cervical secretions in patients treated with this drug
OUTLINE This is a randomized double-blind study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive SGN-00101 subcutaneously SC once a month for 3 consecutive months in the absence of disease progression or unacceptable toxicity
Arm II Patients receive placebo SC as in arm I Patients are followed monthly for 3 months after the last injection and then undergo large loop excision of the transformation zone under colposcopy at the fourth month Patients with disease progression undergo immediate large loop excision
PROJECTED ACCRUAL A maximum of 80 patients 40 per treatment arm will be accrued for this study
Compare the efficacy of SGN-00101 vs placebo in patients with grade II or III cervical intraepithelial neoplasia
Correlate clinical response as defined by histologic demonstration of lesion regression with potential surrogate markers of vaccine efficacy eg spectroscopic changes in the epithelium development of human papilloma virus HPV-specific mucosal and systemic T-cell responses and levels of HPV-specific antibody in cervical secretions in patients treated with this drug
OUTLINE This is a randomized double-blind study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive SGN-00101 subcutaneously SC once a month for 3 consecutive months in the absence of disease progression or unacceptable toxicity
Arm II Patients receive placebo SC as in arm I Patients are followed monthly for 3 months after the last injection and then undergo large loop excision of the transformation zone under colposcopy at the fourth month Patients with disease progression undergo immediate large loop excision
PROJECTED ACCRUAL A maximum of 80 patients 40 per treatment arm 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?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-3074 | None | None | None |
| BWH-000-P-CONS01 | None | None | None |