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

Cervical Intraepithelial Neoplasia Grade 2/3 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02354534
• Other study ID #: J1498
• Secondary ID: IRB00045376
• Status: Completed
• Phase: Phase 1
• Start date: February 2015
• Est. completion date: November 6, 2018

Study information

• Verified date: March 2021
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 6, 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma in Situ
• Cervical Intraepithelial Neoplasia
• Cervical Intraepithelial Neoplasia Grade 2/3
• High-risk HPV (Any Strain)
• Neoplasms

Intervention

Drug:
• Artesunate Suppositories

Locations

Country	Name	City	State
United States	Johns Hopkins Outpatient Center	Baltimore	Maryland
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland
United States	Greater Baltimore Medical Center	Towson	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Frantz Viral Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	41 weeks
Secondary	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.	41 weeks