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

NCT ID: NCT02354534

Last Updated: 2021-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2018-11-06

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

50 mg Artesunate suppositories, 1 cycle

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

Group Type: EXPERIMENTAL

Artesunate Suppositories

Intervention Type: DRUG

200 mg Artesunate suppositories, 1 cycle

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

Group Type: EXPERIMENTAL

Artesunate Suppositories

Intervention Type: DRUG

200 mg Artesunate suppositories,2 cycles

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

Group Type: EXPERIMENTAL

Artesunate Suppositories

Intervention Type: DRUG

200 mg Artesunate suppositories,3 cycles

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

Group Type: EXPERIMENTAL

Artesunate Suppositories

Intervention Type: DRUG

Interventions

Artesunate Suppositories

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Frantz Viral Therapeutics, LLC

INDUSTRY

Sponsor Role: collaborator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cornelia L Trimble, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB00045376

Identifier Type: OTHER

Identifier Source: secondary_id

J1498

Identifier Type: -

Identifier Source: org_study_id