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Trial record 3 of 8 for:    artemisinin | cancer

Artesunate Vaginal Inserts for the Treatment of Cervical Intraepithelial Neoplasia (CIN2/3) (ART-CIN_IIB)

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ClinicalTrials.gov Identifier: NCT04098744
Recruitment Status : Recruiting
First Posted : September 23, 2019
Last Update Posted : March 16, 2021
Sponsor:
Collaborators:
Amarex Clinical Research
M.D. Anderson Cancer Center
Harris Health System (L.B.J. Hospital)
The Cleveland Clinic
Information provided by (Responsible Party):
Frantz Viral Therapeutics, LLC

Brief Summary:

This is a phase II double blind, placebo-controlled, randomized study of Artesunate vaginal inserts for the treatment of women who have cervical high grade intraepithelial neoplasia (CIN2/3).

Participants who receive placebo in this study have the option to receive active drug (artesunate) after their week 15 colposcopy visit.


Condition or disease Intervention/treatment Phase
CIN 2/3 HPV Infection Pre-Cancerous Dysplasia Cervical Dysplasia HPV Related Disease Drug: Artesunate vaginal insert Drug: Placebo vaginal insert Phase 2

Detailed Description:

Eligible participants in this study are randomized to receive either artesunate or placebo vaginal inserts for the treatment of CIN2/3. Both groups receive three 5-day cycles of the respective drug, at weeks 0, 2, and 4. Dosing visits can be done as telehealth visits (medication is mailed to the patient's home). Participants are followed closely with colposcopies at weeks 6, 15, and 28. After the week 15 colposcopy visit the investigator is unblinded. Participants in the placebo group who still have CIN2/3 have the option to start treatment with artesunate within 4 weeks. Participants in the artesunate treatment who still have CIN2/3 at the week 15 visit, will undergo standard of care surgical treatment (LEEP or cold knife conization) within 6 weeks.

Primary Objective: To evaluate the histopathologic regression after three 5-day cycles of artesunate vaginal inserts in adult females with biopsy-proven HPV-associated CIN 2/3.

Secondary Objectives:

  • To evaluate the safety of artesunate vaginal inserts for the treatment of CIN2/3
  • To evaluate the viral clearance after three 5-day cycles of artesunate vaginal inserts in adult females with biopsy-proven HPV-associated CIN 2/3.
  • To evaluate histopathologic regression after the week 15 time point

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase II Double Blind, Placebo-controlled, Randomized Trial of Artesunate Vaginal Inserts for the Treatment of Patients With Cervical Intraepithelial Neoplasia (CIN2/3)
Actual Study Start Date : September 9, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Artesunate vaginal insert
Participants will receive three 5-day cycles of artesunate vaginal inserts, 200mg/day, at week 0, week 2, week 4.
Drug: Artesunate vaginal insert
Artesunate formulated as vaginal inserts, 200mg
Other Names:
  • Artesunic acid
  • DHA
  • artemisinin

Placebo Comparator: Placebo vaginal inserts
Participants will receive three 5-day cycles of placebo vaginal inserts, at week 0, week 2, and week 4. Unblinding will take place at week 15. Participants who do not have histologic regression at week 15 will have the opportunity to cross over to the experimental arm, and start treatment with artesunate vaginal inserts within 4 weeks of the week 15 visit.
Drug: Placebo vaginal insert
Placebo for artesunate vaginal inserts




Primary Outcome Measures :
  1. Proportion of participants with histologic regression by week 15 [ Time Frame: 15 weeks ]
    Number of participants who undergo histologic regression to cervical intraepithelial neoplasia (CIN) 1 or less by week 15, following 3 cycles of artesunate vaginal inserts, as determined by biopsy histopathologic analysis


Secondary Outcome Measures :
  1. Number of participants who have achieved clearance of detectable human papilloma virus (HPV) by week 15 [ Time Frame: 15 weeks ]
    Number of participants who had HPV strains detected at study entry which become undetectable within the study window (15 weeks)

  2. Proportion of participants with histologic regression after week 15 [ Time Frame: 21 weeks ]
    Number of participants who undergo histologic regression to cervical intraepithelial neoplasia (CIN) 1 or less after week 15 following 3 cycles of artesunate vaginal inserts, as determined by biopsy histopathologic analysis


Other Outcome Measures:
  1. Number of participants with Treatment-Emergent Adverse Events (TEAE) [ Time Frame: 28 weeks ]
    Number of participants who had adverse events, as defined by CTCAE v5.0, related to the study intervention

  2. Number of participants who withdrew from the study due to TEAEs [ Time Frame: 28 weeks ]
    Number of participants who were withdrawn from the study due to adverse events related to the study drug



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   This study is for women only as it is a treatment for cervical intraepithelial neoplasia (CIN2/3)
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult females age ≥ 25 years
  • Capable of informed consent
  • Any HPV genotype detectable by DNA test/HPV genotyping
  • Colposcopically-directed, histologically confirmed tissue diagnosis of either CIN2, CIN3, or CIN2/3
  • Women of childbearing potential agree to use birth control through week 28 of the study.
  • Weight ≥ 50kg

Exclusion Criteria:

  • Pregnant and nursing women
  • Active autoimmune disease
  • Taking immunosuppressive medication
  • HIV seropositivity
  • Immunocompromised subjects
  • Evidence of concurrent cervical adenocarcinoma in situ
  • Concurrent malignancy except for nonmelanoma skin lesions, because treatment for other cancers have systemic effects

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): NCT04098744


Contacts
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Contact: Mihaela Plesa, BA, CCRP 440-255-1155 ext 100 mplesa@frantzgroup.com
Contact: Ahmad Bayat, MD (301) 956-2523 ahmadb@amarexcro.com

Locations
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United States, Ohio
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Donna White    216-445-8090    whited11@ccf.org   
Contact: Megan Park    216-445-8090    parkm2@ccf.org   
Principal Investigator: Chad Michener, MD         
Hillcrest Hospital Recruiting
Mayfield Heights, Ohio, United States, 44124
Contact: Donna White    216-445-8090    whited11@ccf.org   
Contact: Megan Park    216-445-8090    parkm2@ccf.org   
Principal Investigator: Chad Michener, MD         
United States, Texas
The Harris Health System (L.B.J Hospital) Recruiting
Houston, Texas, United States, 77026
Contact: Jessica Gallegos    713-563-4580    jrgalleg@mdanderson.org   
Contact: Cindy Melendez    713-563-4582    cvmelend@mdanderson.org   
Principal Investigator: Andrea Milbourne, MD         
Sub-Investigator: Kathleen Schmeler, MD         
University of Texas, M.D. Anderson Recruiting
Houston, Texas, United States, 77030
Contact: Jessica Gallegos    713-563-4580    jrgalleg@mdanderson.org   
Contact: Cindy Melendez    713-563-4582    cvmelend@mdanderson.org   
Principal Investigator: Andrea Milbourne, MD         
Sub-Investigator: Kathleen Schmeler, MD         
Sponsors and Collaborators
Frantz Viral Therapeutics, LLC
Amarex Clinical Research
M.D. Anderson Cancer Center
Harris Health System (L.B.J. Hospital)
The Cleveland Clinic
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Responsible Party: Frantz Viral Therapeutics, LLC
ClinicalTrials.gov Identifier: NCT04098744    
Other Study ID Numbers: ART-CIN IIB
2020 0237 ( Other Identifier: MD Anderson IRB )
20 1148 ( Other Identifier: CCF IRB )
First Posted: September 23, 2019    Key Record Dates
Last Update Posted: March 16, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Frantz Viral Therapeutics, LLC:
cancer prevention
artemisinin
treatment study
non-surgical
HPV related disease
CIN
topical treatment
vaginal inserts
artesunate
non-invasive
high risk HPV
vaginal suppository
Additional relevant MeSH terms:
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Cervical Intraepithelial Neoplasia
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Tumor Virus Infections
Artemisinins
Papillomavirus Infections
Uterine Cervical Dysplasia
Carcinoma in Situ
Carcinoma
Precancerous Conditions
Uterine Cervical Diseases
Uterine Diseases
DNA Virus Infections
Virus Diseases
Artesunate
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics