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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02354534
Recruitment Status : Completed
First Posted : February 3, 2015
Last Update Posted : May 29, 2019
Sponsor:
Collaborator:
Frantz Viral Therapeutics
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Tracking Information
First Submitted Date  ICMJE January 13, 2015
First Posted Date  ICMJE February 3, 2015
Last Update Posted Date May 29, 2019
Actual Study Start Date  ICMJE February 2015
Actual Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 22, 2018)
Safety and tolerability of Artesunate vaginal suppositories in women with cervical intraepithelial neoplasia (CIN2/3) as determined by number of participants with serious adverse events [ Time Frame: 15 weeks ]
Number of participants with related serious adverse events or dose limiting toxicities assessed using CTCAE4.0 criteria
Original Primary Outcome Measures  ICMJE
 (submitted: February 2, 2015)
Histologic regression of CIN2/3 (Regression of CIN2/3 to CIN1 or less) [ Time Frame: 28 weeks ]
Regression of CIN2/3 to CIN1 or less
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 22, 2018)
  • Viral clearance of HPV [ Time Frame: 41 weeks ]
    Number of participants whose HPV genotypes present at study entry become undetectable without surgical intervention
  • Histologic regression of CIN2/3 [ Time Frame: 41 weeks ]
    Number of participants with histologic regression from CIN2/3 to CIN1 or less, as assessed by colposcopically-directed biopsies
Original Secondary Outcome Measures  ICMJE
 (submitted: February 2, 2015)
Clearance of HPV [ Time Frame: 41 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intravaginal Artesunate for the Treatment of HPV+ High Grade Cervical Intraepithelial Neoplasia (CIN2/3)
Official Title  ICMJE A Phase I Study of Intravaginally Administered Artesunate In Women With High Grade Cervical Intraepithelial Neoplasia (CIN2/3)
Brief Summary

This phase I research protocol is designed to assess immunogenicity and clinical endpoints in patients with HPV16 CIN2/3. 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cervical Intraepithelial Neoplasia Grade 2/3
  • High-risk HPV (Any Strain)
Intervention  ICMJE Drug: Artesunate Suppositories
Study Arms  ICMJE
  • 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).
    Intervention: Drug: Artesunate Suppositories
  • 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).
    Intervention: Drug: Artesunate Suppositories
  • 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).
    Intervention: Drug: Artesunate Suppositories
  • 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).
    Intervention: Drug: Artesunate Suppositories
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 27, 2018)
29
Original Estimated Enrollment  ICMJE
 (submitted: February 2, 2015)
30
Actual Study Completion Date  ICMJE November 6, 2018
Actual Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • ≥ 18 years
  • Capable of informed consent
  • HPV-positive by DNA test
  • Histologically confirmed CIN2, CIN3, or CIN2/3
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02354534
Other Study ID Numbers  ICMJE J1498
IRB00045376 ( Other Identifier: JHM IRB )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Sponsor  ICMJE Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators  ICMJE Frantz Viral Therapeutics
Investigators  ICMJE
Principal Investigator: Cornelia L Trimble, MD Johns Hopkins University
PRS Account Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP