Imiquimod in Preventing Cervical Cancer in Women With Cervical Neoplasia

NCT00031759 | Completed Phase 2

• 3 other identifiers: NCCTG-989251CDR0000069223NCI-P02-0208
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 8

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.

Conditions

Cervical Cancer; Precancerous Condition

Keywords

cervical cancer; cervical intraepithelial neoplasia grade 1; cervical intraepithelial neoplasia grade 2; cervical intraepithelial neoplasia grade 3

Outcome Measures

Primary Outcomes (1)

• Overall survival

  Up to 7.5 years

Secondary Outcomes (1)

• Compare the quality of life of patients treated with these regimens

  Up to 7.5 years

Study Arms (2)

Ablative or excisional therapy

OTHER

Patients undergo ablative or excisional therapy. Quality of life is assessed at baseline, 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.

Procedure: Ablative or excisional therapy

Ablative or excisional therapy + imiquimod

EXPERIMENTAL

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, 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.

Drug: imiquimod; Procedure: Ablative or excisional therapy

Interventions

imiquimod DRUG

Ablative or excisional therapy + imiquimod

Ablative or excisional therapy PROCEDURE

Ablative or excisional therapy; Ablative or excisional therapy + imiquimod

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 Life expectancy: * At least 5 years 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: Other: * No concurrent immunosuppressive therapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Study Sites (8)

CCOP - Mayo Clinic Scottsdale Oncology Program

Scottsdale, Arizona, 85259-5404, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

MBCCOP - Hawaii

Honolulu, Hawaii, 96813, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214-3882, United States

Location

CCOP - Michigan Cancer Research Consortium

Ann Arbor, Michigan, 48106, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

CCOP - Sioux Community Cancer Consortium

Sioux Falls, South Dakota, 57104, United States

Location

Related Publications (1)

• Pachman DR, Barton DL, Clayton AC, McGovern RM, Jefferies JA, Novotny PJ, Sloan JA, Loprinzi CL, Gostout BS. Randomized clinical trial of imiquimod: an adjunct to treating cervical dysplasia. Am J Obstet Gynecol. 2012 Jan;206(1):42.e1-7. doi: 10.1016/j.ajog.2011.06.105. Epub 2011 Jul 13.

  PMID: 21907959 RESULT

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Precancerous Conditions; Uterine Cervical Dysplasia

Interventions

Imiquimod

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Bobbie S. Gostout, MD

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2002
• First Posted: January 27, 2003
• Study Start: June 1, 1999
• Primary Completion: July 1, 2004
• Study Completion: February 1, 2010
• Last Updated: July 13, 2016

Record last verified: 2016-07

Locations

US (8)