A Phase I Study of Intravaginally Administered Artesunate In Women With High Grade Cervical Intraepithelial Neoplasia (CIN2/3)
Overview
- Phase
- Phase 1
- Intervention
- Artesunate Suppositories
- Conditions
- Cervical Intraepithelial Neoplasia Grade 2/3
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Enrollment
- 30
- Locations
- 3
- Primary Endpoint
- Number of Participants With Serious Adverse Events
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
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
Arms & Interventions
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).
Intervention: Artesunate Suppositories
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).
Intervention: Artesunate Suppositories
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).
Intervention: Artesunate Suppositories
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).
Intervention: Artesunate Suppositories
Outcomes
Primary Outcomes
Number of Participants With Serious Adverse Events
Time Frame: 41 weeks
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.
Secondary Outcomes
- Viral Clearance of HPV(41 weeks)
- Histologic Regression of CIN2/3(41 weeks)