Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00091130
Status:
COMPLETED
Last Update Posted:
2013-06-03
First Post:
2004-09-07
Brief Title:
SGN-00101 Vaccine in Treating Human Papillomavirus in Patients Who Have Abnormal Cervical Cells
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
An Exploratory Study to Evaluate the Effect of HPV 16 Vaccine on the Reduction of Viral Load in HPV 16 Positive Women With Persistent Viral Infection But Low Grade Disease ASCUSLSIL
Status:
COMPLETED
Status Verified Date:
2013-03
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:
This randomized phase II trial is studying how well SGN-00101 vaccine works compared to a placebo in treating human papillomavirus and preventing cervical cancer in patients with abnormal cervical cells Vaccines such as SGN-00101 may make the body build an immune response to kill human papillomavirus and abnormal cervical cells and may be effective in preventing cervical cancer
Detailed Description:
PRIMARY OBJECTIVES
I Compare the effectiveness of SGN-00101 vaccine vs placebo in reducing the human papillomavirus HPV-16 viral load in patients with atypical squamous cells of undetermined significance ASCUS or low-grade squamous intraepithelial lesions LSIL of the cervix with persistent HPV-16 infection who are at increased risk for developing a high-grade squamous intraepithelial lesion or invasive cervical cancer
II Compare the natural history of HPV-16 viral load in patients treated with these regimens
III Compare the effect of HPV-16 variants on viral load response in patients treated with these regimens
IV Compare the relative effectiveness of these regimens on the regression of cervical cellular atypias based on Pap test results in terms of the regression of cytologic findings of LSIL and ASCUS to normal findings and resolution or regression of colposcopically defined cervicovaginal lesions in these patients
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are randomized to 1 of 2 treatment arms
ARM I Patients receive SGN-00101 vaccine subcutaneously SC on day 1 of weeks 1 4 and 8 for a maximum of 3 injections in the absence of unacceptable toxicity or the development of an invasive malignancy or serious illness
ARM II Patients receive placebo vaccine SC on day 1 of weeks 1 4 and 8 for a maximum of 3 injections in the absence of unacceptable toxicity or the development of an invasive malignancy or serious illness
Patients are followed at 12 24 and 52 weeks after the last vaccination
I Compare the effectiveness of SGN-00101 vaccine vs placebo in reducing the human papillomavirus HPV-16 viral load in patients with atypical squamous cells of undetermined significance ASCUS or low-grade squamous intraepithelial lesions LSIL of the cervix with persistent HPV-16 infection who are at increased risk for developing a high-grade squamous intraepithelial lesion or invasive cervical cancer
II Compare the natural history of HPV-16 viral load in patients treated with these regimens
III Compare the effect of HPV-16 variants on viral load response in patients treated with these regimens
IV Compare the relative effectiveness of these regimens on the regression of cervical cellular atypias based on Pap test results in terms of the regression of cytologic findings of LSIL and ASCUS to normal findings and resolution or regression of colposcopically defined cervicovaginal lesions in these patients
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are randomized to 1 of 2 treatment arms
ARM I Patients receive SGN-00101 vaccine subcutaneously SC on day 1 of weeks 1 4 and 8 for a maximum of 3 injections in the absence of unacceptable toxicity or the development of an invasive malignancy or serious illness
ARM II Patients receive placebo vaccine SC on day 1 of weeks 1 4 and 8 for a maximum of 3 injections in the absence of unacceptable toxicity or the development of an invasive malignancy or serious illness
Patients are followed at 12 24 and 52 weeks after the last vaccination
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 |
|---|---|---|---|
| CDR0000383786 | REGISTRY | PDQ Physician Data Query | None |
| UCI02-55 | None | None | None |
| N01CN25139 | OTHER_GRANT | None | None |