NCT02354534

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2015

Typical duration for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2015

Completed
19 days until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 3, 2015

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 6, 2018

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

April 2, 2021

Completed
Last Updated

April 28, 2021

Status Verified

March 1, 2021

Enrollment Period

3.4 years

First QC Date

January 13, 2015

Results QC Date

March 8, 2021

Last Update Submit

April 6, 2021

Conditions

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

Keywords

cervical dysplasiaHPVTreatmentpreinvasivecervixvaginal suppositoryCornelia Trimbleabnormal papCIN

Outcome Measures

Primary Outcomes (1)

  • 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.

    41 weeks

Secondary Outcomes (2)

  • Viral Clearance of HPV

    41 weeks

  • Histologic Regression of CIN2/3

    41 weeks

Study Arms (4)

50 mg Artesunate suppositories, 1 cycle

EXPERIMENTAL

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

Drug: Artesunate Suppositories

200 mg Artesunate suppositories, 1 cycle

EXPERIMENTAL

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

Drug: Artesunate Suppositories

200 mg Artesunate suppositories,2 cycles

EXPERIMENTAL

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

Drug: Artesunate Suppositories

200 mg Artesunate suppositories,3 cycles

EXPERIMENTAL

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

Drug: Artesunate Suppositories

Interventions

Artesunate SuppositoriesDRUG
200 mg Artesunate suppositories, 1 cycle200 mg Artesunate suppositories,2 cycles200 mg Artesunate suppositories,3 cycles50 mg Artesunate suppositories, 1 cycle

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Johns Hopkins Outpatient Center

Baltimore, Maryland, 21205, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

Greater Baltimore Medical Center

Towson, Maryland, 21204, United States

Location

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Results Point of Contact

Title
Cornelia L. Trimble, MD
Organization
Johns Hopkins University
CervixDoctor@jhmi.edu
410-502-0512

Study Officials

  • Cornelia L Trimble, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2015

First Posted

February 3, 2015

Study Start

February 1, 2015

Primary Completion

July 1, 2018

Study Completion

November 6, 2018

Last Updated

April 28, 2021

Results First Posted

April 2, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

US(3)