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

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins30 enrolled

Overview

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.

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

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Interventions

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

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, United States

Outcomes

Primary Outcomes

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.

Time frame: 41 weeks

Secondary Outcomes

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.

Time frame: 41 weeks

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.

Time frame: 41 weeks