Clinical Trials /

Artesunate Vaginal Inserts for the Treatment of CIN2/3

NCT04098744

Description:

This is a phase II double blind, placebo-controlled, randomized study of Artesunate vaginal inserts for the treatment of women who have cervical high grade intraepithelial neoplasia (CIN2/3). Participants who receive placebo in this study have the option to receive active drug (artesunate) after their week 15 colposcopy visit.

Related Conditions:
  • High Grade Cervical Intraepithelial Neoplasia
Recruiting Status:

Not yet recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Phase II Study of Artesunate Vaginal Inserts for the Treatment of CIN2/3
  • Official Title: A Phase II Double Blind, Placebo-controlled, Randomized Trial of Artesunate Vaginal Inserts for the Treatment of Patients With Cervical Intraepithelial Neoplasia (CIN2/3)

Clinical Trial IDs

  • ORG STUDY ID: J1991
  • SECONDARY ID: IRB00219993
  • NCT ID: NCT04098744

Conditions

  • CIN 2/3
  • HPV Infection
  • Pre-Cancerous Dysplasia
  • Cervical Dysplasia

Interventions

DrugSynonymsArms
Artesunate vaginal insertArtesunic acid, DHA, artemisininArtesunate vaginal insert
Placebo vaginal insertPlacebo vaginal inserts

Purpose

This is a phase II double blind, placebo-controlled, randomized study of Artesunate vaginal inserts for the treatment of women who have cervical high grade intraepithelial neoplasia (CIN2/3). Participants who receive placebo in this study have the option to receive active drug (artesunate) after their week 15 colposcopy visit.

Detailed Description

      Eligible participants in this study are randomized to receive either artesunate or placebo
      vaginal inserts for the treatment of CIN2/3. Both groups receive three 5-day cycles of the
      respective drug, at weeks 0, 2, and 4. Participants are followed closely with colposcopies at
      weeks 6, 15, and 28. After the week 15 colposcopy visit the investigator is unblinded.
      Participants in the placebo group who still have CIN2/3 have the option to start treatment
      with artesunate within 4 weeks. Participants in the artesunate treatment who still have
      CIN2/3 at the week 15 visit, will undergo standard of care surgical treatment (LEEP or cold
      knife conization) within 6 weeks.

      Primary Objective: To evaluate the histopathologic response to three 5-day cycles of
      artesunate vaginal inserts in adult females with biopsy-proven HPV-associated CIN 2/3.

      Secondary Objectives:

        -  To evaluate the safety of artesunate vaginal inserts for the treatment of CIN2/3

        -  To evaluate the viral clearance after three 5-day cycles of artesunate vaginal inserts
           in adult females with biopsy-proven HPV-associated CIN 2/3.

        -  To evaluate histopathologic regression after the week 15 time point
    

Trial Arms

NameTypeDescriptionInterventions
Artesunate vaginal insertExperimentalParticipants will receive three 5-day cycles of artesunate vaginal inserts, 200mg/day, at week 0, week 2, week 4.
  • Artesunate vaginal insert
Placebo vaginal insertsPlacebo ComparatorParticipants will receive three 5-day cycles of placebo vaginal inserts, at week 0, week 2, and week 4. Unblinding will take place at week 15. Participants who do not have histologic regression at week 15 will have the opportunity to cross over to the experimental arm, and start treatment with artesunate vaginal inserts within 4 weeks of the week 15 visit.
  • Placebo vaginal insert

Eligibility Criteria

        Inclusion Criteria:

          -  Adult females age ≥ 18 years

          -  Capable of informed consent

          -  HPV-detectable by DNA test

          -  Colposcopically-directed, histologically confirmed tissue diagnosis of either CIN2,
             CIN3, or CIN2/3

          -  If HIV+, CD4 count ≥200

          -  Women of childbearing potential agree to use birth control through week 28 of the
             study.

          -  Weight ≥ 50kg

        Exclusion Criteria:

          -  Pregnant and nursing women

          -  Active autoimmune disease

          -  Taking immunosuppressive medication

          -  Evidence of concurrent cervical adenocarcinoma in situ

          -  Concurrent malignancy except for nonmelanoma skin lesions, because treatment for other
             cancers have systemic effects

          -  Patients who take efavirenz as HIV antiretroviral therapy
      
Maximum Eligible Age:100 Years
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Proportion of subjects with histologic regression to cervical intraepithelial neoplasia (CIN) 1 or less by week 15
Time Frame:15 weeks
Safety Issue:
Description:Number of participants who have histologic regression of CIN2/3 to CIN1 within the study window (15 weeks)

Secondary Outcome Measures

Measure:Number of participants who have achieved clearance of detectable human papilloma virus (HPV) by week 15
Time Frame:15 weeks
Safety Issue:
Description:Number of participants who had HPV strains detected at study entry which become undetectable within the study window (15 weeks)

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Trial Keywords

  • treatment study
  • cancer prevention
  • non-surgical
  • HPV disease
  • CIN
  • topical treatment
  • vaginal inserts
  • artesunate
  • artemisinin
  • non-invasive
  • high risk HPV

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