Treatment of High-Grade Pre-Neoplastic Cervical Lesions (CIN 2/3)

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Brief Title

Treatment of High-Grade Pre-Neoplastic Cervical Lesions (CIN 2/3)

Official Title

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

Brief Summary

      This is a randomized Phase II, three arm control trial in patients with Cervical
      Intraepithelial Neoplasia (CIN) 2/3 high grade cervical dysplasia. Patients with CIN 2/3
      meeting eligibility criteria will have cervical biopsy specimens centrally reviewed by study
      pathologist to confirm diagnosis. HPV DNA test and HPV 16/18 genotyping will be performed
      from endocervical cytobrush samples to determine HPV status associated with the dysplasia.

      Patients who have CIN 2/3 with HPV+ disease will be enrolled in this study. Patients will be
      randomized to one of three arms: observation only (control), imiquimod only, imiquimod +
      9-valent HPV vaccine.
    

Detailed Description

      The primary objectives of this study are as follows:

        -  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,

        -  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 Imiquimod group
           compared to control.

      The secondary objectives of this study are as follows:

        -  To assess complete regression (i.e., histologic remission) at weeks 20-24 (4 to 8 weeks
           after the end of imiquimod treatment) in each group,

        -  To assess HPV clearance in each group,

        -  To assess treatment tolerability.

      In addition to the primary and secondary objectives of this study, there additional
      exploratory/correlative objectives. The exploratory/correlative objectives are as follows:

        -  To assess T cell infiltration in post-treatment cervical biopsies and endocervical
           cytobrush samples,

        -  To assess HPV16 E7 immunity in CD4/CD8 T cells.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Incidence of Objective Response

Secondary Outcome

 Incidence of HPV Clearance

Condition

Cervical Intraepithelial Neoplasia

Intervention

9-valent HPV vaccine

Study Arms / Comparison Groups

 imiquimod + 9-valent HPV vaccine
Description:  Participants randomized to the imiquimod + 9-valent HPV vaccine group will receive instruction on imiquimod self application (16 week course) at the baseline visit. In addition, all women (regardless of age) will be administered a dose of the HPV vaccine on day of enrollment (regardless of previous HPV vaccination history). Women previously unvaccinated will receive an additional booster dose at 8 weeks.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

138

Start Date

July 2016

Completion Date

November 2021

Primary Completion Date

May 2021

Eligibility Criteria

        Inclusion Criteria

          -  Patients must have untreated cervical biopsy-proven, CIN 2/3 ectocervical lesion(s).

          -  Patients must have satisfactory colposcopy with visualization of the entire
             transformation zone or a negative endocervical curettage if colposcopy is
             unsatisfactory.

          -  Patients must be high-risk HPV+ as determined by commercially available DNA
             hybridization test which tests for 13 high-risk HPV types.

          -  All Patients must have a histologic diagnosis of CIN 2,3 cervical lesion(s) confirmed
             by a study pathologist within past 10 weeks.

          -  Patients must have signed an approved informed consent.

          -  Patients of childbearing potential must have a negative urine pregnancy test within 7
             days prior to the study entry and be practicing an effective form of contraception.

          -  Patients must be at least 18 years of age based on previous and current cervical
             cancer screening guidelines.

          -  Patients must be fluent in speaking English or Spanish.

        Exclusion Criteria

          -  Patients with unsatisfactory colposcopy* (unable to visualize entire transformation
             zone) or evidence of endocervical disease defined as CIN 2/3 diagnosed on endocervical
             curettage.

             *Patients with unsatisfactory colposcopy but negative endocervical curettage are
             eligible

          -  Patients with a history of invasive cervical cancer

          -  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.

          -  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).

          -  Patients who have an uncontrolled seizure disorder, or active neurological disease.

          -  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).

          -  Pregnant or breastfeeding patients.

          -  Patients who have had a total hysterectomy (removal of uterus and cervix) or
             trachelectomy (removal of cervix).

          -  Patients with a known hypersensitivity to imiquimod. Patients with a known
             hypersensitivity to any prophylactic HPV vaccine or severe allergic reactions yeast
             (vaccine component).

          -  Patients who have received their first dose of HPV vaccine < 4 weeks ago or their
             second dose < 12 weeks ago.

          -  Known hypersensitivity or prior intravaginal treatment with Imiquimod
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Alessandro D Santin, MD, 203-737-4450, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02864147

Organization ID

1603017415


Responsible Party

Sponsor

Study Sponsor

Yale University


Study Sponsor

Alessandro D Santin, MD, Principal Investigator, Yale University School of Medicine Department of Obstetrics, Gynecology & Reproductive Sciences, Division of Gynecologic Oncology


Verification Date

February 2021