Clinical Trials /

Intravaginal Artesunate for the Treatment of HPV+ High Grade Cervical Intraepithelial Neoplasia (CIN2/3)

NCT02354534

Description:

This phase I research protocol is designed to assess immunogenicity and clinical endpoints in patients with human papillomavirus (HPV) 16 cervical intraepithelial neoplasia (CIN)2/3. The protocol tests the use of artesunate in suppository formulation applied intravaginally in patients with cervical dysplasia (CIN2/3). The primary endpoint is to determine and evaluate the safety, tolerability, and feasibility of intravaginal administration of artesunate in health women with CIN2/3.

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

Completed

Phase:

Phase 1

URL:

https://clinicaltrials.gov/show/NCT02354534

Trial Eligibility

Document

Title

  • Brief Title: Intravaginal Artesunate for the Treatment of HPV+ High Grade Cervical Intraepithelial Neoplasia (CIN2/3)
  • Official Title: A Phase I Study of Intravaginally Administered Artesunate In Women With High Grade Cervical Intraepithelial Neoplasia (CIN2/3)

Clinical Trial IDs

  • ORG STUDY ID: J1498
  • SECONDARY ID: IRB00045376
  • NCT ID: NCT02354534

Conditions

  • Cervical Intraepithelial Neoplasia Grade 2/3
  • High-risk HPV (Any Strain)

Interventions

DrugSynonymsArms
Artesunate Suppositories200 mg Artesunate suppositories, 1 cycle

Purpose

This phase I research protocol is designed to assess immunogenicity and clinical endpoints in patients with human papillomavirus (HPV) 16 cervical intraepithelial neoplasia (CIN)2/3. The protocol tests the use of artesunate in suppository formulation applied intravaginally in patients with cervical dysplasia (CIN2/3). The primary endpoint is to determine and evaluate the safety, tolerability, and feasibility of intravaginal administration of artesunate in health women with CIN2/3.

Detailed Description

      Phase I open-label dose escalation study of intravaginal artesunate, formulated in
      suppositories, in adult females with biopsy-confirmed CIN2/3. Thirty (30) subjects will
      undergo up to a total of three cycles of intravaginal artesunate. The first cycle will be
      initiated on Day 0, the second at Week 4, and the third and final cycle at week 8.

Trial Arms

NameTypeDescriptionInterventions
50 mg Artesunate suppositories, 1 cycleExperimentalSubjects enrolled in this cohort will receive 1 five day cycle of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated).
  • Artesunate Suppositories
200 mg Artesunate suppositories, 1 cycleExperimentalSubjects enrolled in this cohort will receive 1 five day cycle of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated).
  • Artesunate Suppositories
200 mg Artesunate suppositories,2 cyclesExperimentalSubjects enrolled in this cohort will receive 2 five day cycles of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated).
  • Artesunate Suppositories
200 mg Artesunate suppositories,3 cyclesExperimentalSubjects enrolled in this cohort will receive 3 five day cycles of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated).
  • Artesunate Suppositories

Eligibility Criteria

        Inclusion Criteria:

          -  ≥ 18 years

          -  Capable of informed consent

          -  HPV-positive by DNA test

          -  Histologically confirmed CIN 2, CIN 3, or CIN 2/3

          -  Body weight ≥ 50 kg

          -  Immune competent

        Exclusion Criteria:

          -  Pregnant and nursing women

          -  HIV seropositive

          -  Active autoimmune disease

          -  Taking immunosuppressive medication

          -  Evidence of concurrent adenocarcinoma in situ

          -  Concurrent malignancy except for nonmelanoma skin lesions
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of Participants With Serious Adverse Events
Time Frame:41 weeks
Safety Issue:
Description:Number of participants with serious adverse events or dose limiting toxicities related to the study intervention assessed using Common Terminology Criteria for Adverse Events (CTCAE) 4.0 criteria.

Secondary Outcome Measures

Measure:Viral Clearance of HPV
Time Frame:41 weeks
Safety Issue:
Description:Number of participants whose human papillomavirus (HPV) genotypes present at study entry become undetectable without surgical intervention.
Measure:Histologic Regression of CIN2/3
Time Frame:41 weeks
Safety Issue:
Description:Number of participants with histologic regression from cervical intraepithelial neoplasia (CIN) 2/3 to CIN 1 or less, as assessed by colposcopically-directed biopsies.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Completed
Lead Sponsor:Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Trial Keywords

  • cervical dysplasia
  • HPV
  • Treatment
  • preinvasive
  • cervix
  • vaginal suppository
  • Cornelia Trimble
  • abnormal pap
  • CIN

Last Updated

April 2, 2021