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

Primary Purpose

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

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Artesunate Suppositories
Sponsored by
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Intraepithelial Neoplasia Grade 2/3 focused on measuring cervical dysplasia, HPV, Treatment, preinvasive, cervix, vaginal suppository, Cornelia Trimble, abnormal pap, CIN

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Johns Hopkins Outpatient Center
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • Greater Baltimore Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

50 mg Artesunate suppositories, 1 cycle

200 mg Artesunate suppositories, 1 cycle

200 mg Artesunate suppositories,2 cycles

200 mg Artesunate suppositories,3 cycles

Arm Description

Subjects enrolled in this cohort will receive 1 five day cycle of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated).

Subjects enrolled in this cohort will receive 1 five day cycle of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated).

Subjects enrolled in this cohort will receive 2 five day cycles of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated).

Subjects enrolled in this cohort will receive 3 five day cycles of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated).

Outcomes

Primary Outcome Measures

Number of Participants With Serious Adverse Events
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

Viral Clearance of HPV
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
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.

Full Information

First Posted
January 13, 2015
Last Updated
April 6, 2021
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
Frantz Viral Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT02354534
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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
February 2015 (Actual)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
November 6, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
Frantz Viral Therapeutics

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Intraepithelial Neoplasia Grade 2/3, High-risk HPV (Any Strain)
Keywords
cervical dysplasia, HPV, Treatment, preinvasive, cervix, vaginal suppository, Cornelia Trimble, abnormal pap, CIN

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
50 mg Artesunate suppositories, 1 cycle
Arm Type
Experimental
Arm Description
Subjects enrolled in this cohort will receive 1 five day cycle of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated).
Arm Title
200 mg Artesunate suppositories, 1 cycle
Arm Type
Experimental
Arm Description
Subjects enrolled in this cohort will receive 1 five day cycle of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated).
Arm Title
200 mg Artesunate suppositories,2 cycles
Arm Type
Experimental
Arm Description
Subjects enrolled in this cohort will receive 2 five day cycles of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated).
Arm Title
200 mg Artesunate suppositories,3 cycles
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Artesunate Suppositories
Primary Outcome Measure Information:
Title
Number of Participants With Serious Adverse Events
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.
Time Frame
41 weeks
Secondary Outcome Measure Information:
Title
Viral Clearance of HPV
Description
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.
Time Frame
41 weeks
Title
Histologic Regression of CIN2/3
Description
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.
Time Frame
41 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cornelia L Trimble, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Outpatient Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231-2410
Country
United States
Facility Name
Greater Baltimore Medical Center
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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