Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2025-12-26 @ 2:28 AM
Study NCT ID:
NCT00031759
Status:
COMPLETED
Last Update Posted:
2016-07-13
First Post:
2002-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Imiquimod in Preventing Cervical Cancer in Women With Cervical Neoplasia
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Study Overview
Official Title:
Phase II Topical Immunomodulatory Therapy With Imiquimod for the Chemoprevention of Recurrent and High-Grade Cervical Intraepithelial Neoplasia (CIN)
Status:
COMPLETED
Status Verified Date:
2016-07
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 substances to try to prevent the development of cancer. Applying topical imiquimod before abnormal cervical cells are removed may be effective in preventing cervical cancer.
PURPOSE: Randomized phase II trial to study the effectiveness of applying topical imiquimod before abnormal cervical cells are removed in preventing cervical cancer in patients who have recurrent or persistent cervical neoplasia.
PURPOSE: Randomized phase II trial to study the effectiveness of applying topical imiquimod before abnormal cervical cells are removed in preventing cervical cancer in patients who have recurrent or persistent cervical neoplasia.
Detailed Description:
OBJECTIVES:
* Compare the chemopreventive efficacy of topical imiquimod followed by local ablative or excisional therapy vs ablative/excisional therapy alone in patients with recurrent or high-grade cervical intraepithelial neoplasia.
* Compare the toxicity of these regimens in these patients.
* Compare the quality of life of patients treated with these regimens.
* Determine the safety and tolerability of imiquimod in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, disease (primary vs recurrent or persistent), severity of dysplasia (grade I vs grade II vs grade III), current tobacco use (yes vs no), planned surgical procedure (excisional vs laser vs cryotherapy vs other), and time since first abnormal Pap smear, including pathology of ascus favor dysplasia (less than 1 year vs 1-3 years vs more than 3 years). Patients are randomized to one of two treatment arms.
* Arm I: Patients undergo ablative or excisional therapy.
* Arm II: Patients have topical imiquimod applied to the cervix for 6-10 hours twice weekly for a total of 5 doses. Within 3-4 weeks after the final application, patients undergo ablative or excisional therapy.
Quality of life is assessed at baseline, after last dose of study drug (arm II only), 3-5 days after ablation or excisional therapy, at 3 months, and then annually thereafter.
Patients are followed every 3-4 months until 2 consecutive normal Pap smears or colposcopic exams, every 6 months for 2 years, and then annually until 5 years after completion of study therapy.
PROJECTED ACCRUAL: A total of 66-152 (33-76 per treatment arm) will be accrued for this study within 18 months.
* Compare the chemopreventive efficacy of topical imiquimod followed by local ablative or excisional therapy vs ablative/excisional therapy alone in patients with recurrent or high-grade cervical intraepithelial neoplasia.
* Compare the toxicity of these regimens in these patients.
* Compare the quality of life of patients treated with these regimens.
* Determine the safety and tolerability of imiquimod in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, disease (primary vs recurrent or persistent), severity of dysplasia (grade I vs grade II vs grade III), current tobacco use (yes vs no), planned surgical procedure (excisional vs laser vs cryotherapy vs other), and time since first abnormal Pap smear, including pathology of ascus favor dysplasia (less than 1 year vs 1-3 years vs more than 3 years). Patients are randomized to one of two treatment arms.
* Arm I: Patients undergo ablative or excisional therapy.
* Arm II: Patients have topical imiquimod applied to the cervix for 6-10 hours twice weekly for a total of 5 doses. Within 3-4 weeks after the final application, patients undergo ablative or excisional therapy.
Quality of life is assessed at baseline, after last dose of study drug (arm II only), 3-5 days after ablation or excisional therapy, at 3 months, and then annually thereafter.
Patients are followed every 3-4 months until 2 consecutive normal Pap smears or colposcopic exams, every 6 months for 2 years, and then annually until 5 years after completion of study therapy.
PROJECTED ACCRUAL: A total of 66-152 (33-76 per treatment arm) will be accrued for this study within 18 months.
Study Oversight
Has Oversight DMC:
False
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?: