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Phase II

Treatment of High-Grade Pre-Neoplastic Cervical Lesions (CIN 2/3) Using a Novel "Prime and Pull" Strategy

  • Study HIC#:1603017415
  • Last Updated:06/19/2020

To determine treatment efficacy defined as histologic regression to CIN 1 or less at weeks 20-24 (4 to 8 weeks after the end of imiquimod treatment) in the HPV Vaccine + Imiquimod group compared to control

  • Age18 years and older
  • GenderFemale only
  • Start Date06/12/2016
  • End Date03/30/2021

Eligibility Criteria

Eligible Patients

1. Patients must have untreated cervical biopsy-proven, CIN 2/3 ectocervical lesion(s).
2. Patients must have satisfactory colposcopy with visualization of the entire transformation zone.
3. Patients must be high-risk HPV+ as determined by commercially available DNA hybridization test which tests for 13 high-risk HPV types.
4. All patients must have a histologic diagnosis of CIN 2,3 cervical lesion(s) confirmed by a study pathologist within past 4 weeks.
5. Patients must have signed an approved informed consent.
6. Patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to the study entry and be practicing an effective form of contraception.
7. Patients must be at least 18 years of age based on previous and current cervical cancer screening guidelines.
8. Patients must be fluent in speaking English or Spanish.

Ineligible Patients:

1. Patients with unsatisfactory colposcopy (unable to visualize entire transformation zone) or evidence of endocervical disease defined as CIN 2/3 diagnosed on endocervical curettage.
2. Patients known to have untreated cervical biopsy-proven CIN 2/3 present for more than 10 weeks.
3. Patients with a history of invasive cervical cancer
4. Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancers are excluded if there is any evidence of other malignancy being present within the last five years. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy.
5. Patients who have a significant history of cardiac disease, i.e., uncontrolled hypertension, unstable angina, uncontrolled congestive heart failure, or uncontrolled arrhythmias within 6 months of registration (NYHA classification III-IV).
6. Patients with any unstable medical issue (including cardiac issues as above,
active treatment for pulmonary embolism, CVA, renal or hepatic insufficiency, active infection/sepsis requiring IV antibiotics).
7. Patients who have received prior therapy with any irreversible human epidermal growth factor receptor tyrosine kinase inhibitor.
8. Patients who have an uncontrolled seizure disorder, or active neurological disease.
9. Patients known to be seropositive for HIV and active hepatitis, even if liver function studies are in the normal range. Patients otherwise immunocompromised will also be excluded (chronic steroid use, taking immunosuppressive medications).
10. Known hemorrhagic diathesis or active bleeding disorder.
11. Pregnant or breastfeeding patients.
12. Patients who have had a total hysterectomy (removal of uterus and cervix) or trachelectomy (removal of cervix).
13. Patients with a known hypersensitivity to imiquimod. Patients with a known hypersensitivity to any prophylactic HPV vaccine or severe allergic reactions to yeast (vaccine component).
14. Patients who have received their first dose of HPV vaccine < 4 weeks ago or their second dose < 12 weeks ago.
15. Known hypersensitivity or prior intravaginal treatment with Imiquimod