Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00054041
Status:
COMPLETED
Last Update Posted:
2013-01-24
First Post:
2003-02-05
Brief Title:
Vaccine Therapy in Preventing Cervical Cancer in Patients With Cervical Intraepithelial Neoplasia
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Evaluation Of SGN-00101 HSP-E7 Fusion Protein In Women With Cervical Intraepithelial Neoplasia 3 CIN 3
Status:
COMPLETED
Status Verified Date:
2013-01
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:
Vaccines made from antigens may make the body build an immune response to kill abnormal cervical cells and may be effective in preventing cervical cancer Randomized phase II trial to study the effectiveness of vaccine therapy in preventing cervical cancer in patients who have cervical intraepithelial neoplasia
Detailed Description:
PRIMARY OBJECTIVES
I Determine the efficacy of SGN-00101 in terms of complete histologic regression in patients with grade III cervical intraepithelial neoplasia
II Determine the toxicity of this drug in these patients
SECONDARY OBJECTIVES
I Determine change in lesion size in these patients after treatment with this drug
II Compare histologic response before and after treatment with this drug in these patients
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive SGN-00101 subcutaneously once on weeks 1 4 and 8 in the absence of disease progression
Arm II Patients receive standard care
At week 15 all patients undergo large loop excision of the transformation zone under colposcopy
Patients are followed at 19 weeks every 3 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 28-84 patients 14-42 per treatment arm will be accrued for this study within 12-48 months
I Determine the efficacy of SGN-00101 in terms of complete histologic regression in patients with grade III cervical intraepithelial neoplasia
II Determine the toxicity of this drug in these patients
SECONDARY OBJECTIVES
I Determine change in lesion size in these patients after treatment with this drug
II Compare histologic response before and after treatment with this drug in these patients
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive SGN-00101 subcutaneously once on weeks 1 4 and 8 in the absence of disease progression
Arm II Patients receive standard care
At week 15 all patients undergo large loop excision of the transformation zone under colposcopy
Patients are followed at 19 weeks every 3 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 28-84 patients 14-42 per treatment arm will be accrued for this study within 12-48 months
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 |
|---|---|---|---|
| CDR0000269709 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU10CA027469 |
| GOG-0197 | None | None | None |
| U10CA027469 | NIH | None | None |