Imiquimod in Preventing Cervical Cancer in Women With Cervical Neoplasia

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00031759
First received: March 8, 2002
Last updated: March 13, 2012
Last verified: April 2004
  Purpose

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.


Condition Intervention Phase
Cervical Cancer
Precancerous Condition
Drug: imiquimod
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Prevention
Official Title: Phase II Topical Immunomodulatory Therapy With Imiquimod for the Chemoprevention of Recurrent and High-Grade Cervical Intraepithelial Neoplasia (CIN)

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: June 1999
Primary Completion Date: July 2004 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00031759

Locations
United States, Arizona
CCOP - Mayo Clinic Scottsdale Oncology Program
Scottsdale, Arizona, United States, 85259-5404
United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
United States, Hawaii
MBCCOP - Hawaii
Honolulu, Hawaii, United States, 96813
United States, Illinois
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Kansas
CCOP - Wichita
Wichita, Kansas, United States, 67214-3882
United States, Michigan
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States, 48106
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, South Dakota
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, United States, 57104
Sponsors and Collaborators
North Central Cancer Treatment Group
Investigators
Study Chair: Bobbie S. Gostout, MD Mayo Clinic
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00031759     History of Changes
Other Study ID Numbers: CDR0000069223, NCCTG-989251, NCI-P02-0208
Study First Received: March 8, 2002
Last Updated: March 13, 2012
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
cervical cancer
cervical intraepithelial neoplasia grade 1
cervical intraepithelial neoplasia grade 2
cervical intraepithelial neoplasia grade 3

Additional relevant MeSH terms:
Carcinoma in Situ
Cervical Intraepithelial Neoplasia
Neoplasms
Precancerous Conditions
Uterine Cervical Neoplasms
Carcinoma
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Uterine Neoplasms
Imiquimod
Adjuvants, Immunologic
Antineoplastic Agents
Immunologic Factors
Interferon Inducers
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014