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

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ClinicalTrials.gov Identifier: NCT02354534
Recruitment Status : Completed
First Posted : February 3, 2015
Last Update Posted : May 29, 2019
Sponsor:
Collaborator:
Frantz Viral Therapeutics
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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.


Condition or disease Intervention/treatment Phase
Cervical Intraepithelial Neoplasia Grade 2/3 High-risk HPV (Any Strain) Drug: Artesunate Suppositories Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of Intravaginally Administered Artesunate In Women With High Grade Cervical Intraepithelial Neoplasia (CIN2/3)
Actual Study Start Date : February 2015
Actual Primary Completion Date : July 2018
Actual Study Completion Date : November 6, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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).
Drug: Artesunate Suppositories
Experimental: 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).
Drug: Artesunate Suppositories
Experimental: 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).
Drug: Artesunate Suppositories
Experimental: 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).
Drug: Artesunate Suppositories



Primary Outcome Measures :
  1. 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 [ Time Frame: 15 weeks ]
    Number of participants with related serious adverse events or dose limiting toxicities assessed using CTCAE4.0 criteria


Secondary Outcome Measures :
  1. Viral clearance of HPV [ Time Frame: 41 weeks ]
    Number of participants whose HPV genotypes present at study entry become undetectable without surgical intervention

  2. Histologic regression of CIN2/3 [ Time Frame: 41 weeks ]
    Number of participants with histologic regression from CIN2/3 to CIN1 or less, as assessed by colposcopically-directed biopsies



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02354534


Locations
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United States, Maryland
Johns Hopkins Outpatient Center
Baltimore, Maryland, United States, 21205
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
Greater Baltimore Medical Center
Towson, Maryland, United States, 21204
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Frantz Viral Therapeutics
Investigators
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Principal Investigator: Cornelia L Trimble, MD Johns Hopkins University

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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT02354534     History of Changes
Other Study ID Numbers: J1498
IRB00045376 ( Other Identifier: JHM IRB )
First Posted: February 3, 2015    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
cervical dysplasia
HPV
Treatment
preinvasive
cervix
vaginal suppository
Cornelia Trimble
abnormal pap
CIN
Additional relevant MeSH terms:
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Carcinoma in Situ
Cervical Intraepithelial Neoplasia
Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Artesunate
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics