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

Overview

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.

Full Title of Study: “A Phase I Study of Intravaginally Administered Artesunate In Women With High Grade Cervical Intraepithelial Neoplasia (CIN2/3)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2018

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.

Interventions

  • Drug: Artesunate Suppositories

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Number of Participants With Serious Adverse Events
    • Time Frame: 41 weeks
    • 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 Measures

  • Viral Clearance of HPV
    • Time Frame: 41 weeks
    • Number of participants whose human papillomavirus (HPV) genotypes present at study entry become undetectable without surgical intervention. HPV genotyping detects strains of HPV present at each timepoint. For this outcome, we evaluated whether strains of HPV detected at study entry became undetectable during the study participation.
  • Histologic Regression of CIN2/3
    • Time Frame: 41 weeks
    • Number of participants who had histologic regression from cervical intraepithelial neoplasia (CIN) 2/3 to CIN 1 or less, as assessed by colposcopically-directed biopsies. Histologic regression is defined as disappearance of the high grade lesion (CIN2/3) without surgical intervention.

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • Collaborator
    • Frantz Viral Therapeutics
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Cornelia L Trimble, MD, Principal Investigator, Johns Hopkins University

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