Clinical Trials /

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

NCT02354534

Description:

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.

Related Conditions:
  • High Grade Cervical Intraepithelial Neoplasia
Recruiting Status:

Completed

Phase:

Phase 1

Trial Eligibility

Document

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

Title

  • Brief Title: Intravaginal Artesunate for the Treatment of HPV+ High Grade Cervical Intraepithelial Neoplasia (CIN2/3)
  • Official Title: A Phase I Study of Intravaginally Administered Artesunate In Women With High Grade Cervical Intraepithelial Neoplasia (CIN2/3)
  • Clinical Trial IDs

    NCT ID: NCT02354534

    ORG ID: J1498

    NCI ID: IRB00045376

    Trial Conditions

    Cervical Intraepithelial Neoplasia Grade 2/3

    High-risk HPV (Any Strain)

    Trial Interventions

    Drug Synonyms Arms
    Artesunate Suppositories 50 mg Artesunate suppositories, 1 cycle, 200 mg Artesunate suppositories, 1 cycle, 200 mg Artesunate suppositories,2 cycles, 200 mg Artesunate suppositories,3 cycles

    Trial Purpose

    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.

    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.

    Trial Arms

    Name Type Description Interventions
    50 mg Artesunate suppositories, 1 cycle Experimental Subjects enrolled in this cohort will receive 1 five day cycle of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories
    200 mg Artesunate suppositories, 1 cycle Experimental Subjects enrolled in this cohort will receive 1 five day cycle of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories
    200 mg Artesunate suppositories,2 cycles Experimental Subjects enrolled in this cohort will receive 2 five day cycles of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories
    200 mg Artesunate suppositories,3 cycles Experimental Subjects enrolled in this cohort will receive 3 five day cycles of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories

    Eligibility 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

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Female

    Primary Outcome Measures

    Histologic regression of CIN2/3 (Regression of CIN2/3 to CIN1 or less)

    Secondary Outcome Measures

    Clearance of HPV

    Trial Keywords

    cervical dysplasia

    HPV

    Treatment

    preinvasive

    cervix

    vaginal suppository

    Johns Hopkins

    Cornelia Trimble

    abnormal pap

    CIN