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Home > "I" Clinical Trials Conditions > Imiquimod in Preventing Cervical Cancer in Women With Cervical Neoplasia  Imiquimod in Preventing Cervical Cancer in Women With Cervical Neoplasia
Imiquimod in Preventing Cervical Cancer in Women With Cervical Neoplasia
For Condition: Cervical Cancer
Status: Recruiting
Sponsor(s): North Central Cancer Treatment Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Chemoprevention therapy is the use of certain substances to try to prevent the development of cancer. Applying topicalimiquimod before abnormal cervical cells are removed may be effective in preventing cervical cancer. PURPOSE: Randomizedphase 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.
Details: 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.
Eligibility:
Study Type: Interventional, Prevention
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed primary grade II or III cervical intraepithelial neoplasia (CIN) or persistent grade I-III CIN (dysplasia that is not new and requires treatment) - Squamous cell lesions not involving endocervix by colposcopy OR colposcopy with negative cytobrush or endocervical curettage - No untreated cervical or vaginal infection other than human papilloma virus - No desire for hysterectomy as ablative therapy PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Not specified Life expectancy: - At least 5 years Hematopoietic: - Not specified Hepatic: - Not specified Renal: - Not specified Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 3 months after study - HIV negative - No AIDS - No known hypersensitivity to imiquimod - No latex allergy PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - Not specified Endocrine therapy: - Not specified Radiotherapy: - Not specified Surgery: - See Disease Characteristics Other: - No concurrent immunosuppressive therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
BobbieGostout, Study Chair, Mayo Clinic Cancer Center
CCOP - Mayo Clinic Scottsdale Oncology Program *Recruiting*
Scottsdale, Arizona, 85259-5404
United States
Recruiting Tom Fitch 480-301-9875
Mayo Clinic Cancer Center *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting Bobbie Gostout 507-284-2511
Mayo Clinic *Recruiting*
Jacksonville, Florida, 32224
United States
Recruiting Edith Perez 904-953-0118
CCOP - Carle Cancer Center *Recruiting*
Urbana, Illinois, 61801
United States
Recruiting Kendrith Rowland 217-383-4083
CCOP - Michigan Cancer Research Consortium *Recruiting*
Ann Arbor, Michigan, 48106
United States
Recruiting Philip Stella 734-712-2000
MBCCOP - Hawaii *Recruiting*
Honolulu, Hawaii, 96813
United States
Recruiting Brian Issell 808-586-3013
CCOP - Wichita *Recruiting*
Wichita, Kansas, 67214-3882
United States
Recruiting Shaker Dakhil 316-268-5784
CCOP - Sioux Community Cancer Consortium *Recruiting*
Sioux Falls, South Dakota, 57104
United States
Recruiting Loren Tschetter 605-328-8044
Additional Information:
Study ID Numbers: CDR0000069223; NCCTG-989251,NCI-P02-0208
Study Start Date:
Record last reviewed: March 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00031759
Other Cervical Cancer Studies:
1. Celecoxib in Treating Patients With Cervical Intraepithelial Neoplasia
2. Whole Body Hyperthermia Combined With Chemotherapy in Treating Patients With Metastatic Breast, Ovarian, Endometrial, or Cervical Cancer
3. Imiquimod in Preventing Cervical Cancer in Women With Cervical Neoplasia
4. EF5 Prior to Surgery or Biopsy in Patients With Breast, Prostate, or Cervical Cancer or High Grade Soft Tissue Sarcoma
5. Radiation Therapy Plus Paclitaxel and Cisplatin in Treating Patients With Cervical Cancer
Related Studies:
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Imiquimod in Preventing Cervical Cancer in Women With Cervical Neoplasia
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