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)
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 Phase
Phase 1
Study Type
Interventional
Primary Outcome
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
Secondary Outcome
Viral clearance of HPV
Condition
Cervical Intraepithelial Neoplasia Grade 2/3
Intervention
Artesunate Suppositories
Study Arms / Comparison Groups
50 mg Artesunate suppositories, 1 cycle
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).
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
29
Start Date
February 2015
Completion Date
November 6, 2018
Primary Completion Date
July 2018
Eligibility Criteria
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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Cornelia L Trimble, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02354534
Organization ID
J1498
Secondary IDs
IRB00045376
Responsible Party
Sponsor
Study Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
Frantz Viral Therapeutics
Study Sponsor
Cornelia L Trimble, MD, Principal Investigator, Johns Hopkins University
Verification Date
May 2019