Title
Intravaginal Artesunate for the Treatment of HPV+ High Grade Cervical Intraepithelial Neoplasia (CIN2/3)
A Phase I Study of Intravaginally Administered Artesunate In Women With High Grade Cervical Intraepithelial Neoplasia (CIN2/3)
Phase
Phase 1Lead Sponsor
Johns Hopkins UniversityStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Cervical Intraepithelial Neoplasia Grade 2/3 High-risk HPV (Any Strain)Intervention/Treatment
artesunate ...Study Participants
30This 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.
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.
Subjects enrolled in this cohort will receive 1 five day cycle of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated).
Subjects enrolled in this cohort will receive 1 five day cycle of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated).
Subjects enrolled in this cohort will receive 2 five day cycles of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated).
Subjects enrolled in this cohort will receive 3 five day cycles of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated).
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
| Event Type | Organ System | Event Term | 50 mg Artesunate Suppositories, 1 Cycle | 200 mg Artesunate Suppositories, 1 Cycle | 200 mg Artesunate Suppositories,2 Cycles | 200 mg Artesunate Suppositories,3 Cycles |
|---|
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.
Number of participants whose human papillomavirus (HPV) genotypes present at study entry become undetectable without surgical intervention. HPV genotyping detects strains of HPV present at each timepoint. For this outcome, we evaluated whether strains of HPV detected at study entry became undetectable during the study participation.
Number of participants who had histologic regression from cervical intraepithelial neoplasia (CIN) 2/3 to CIN 1 or less, as assessed by colposcopically-directed biopsies. Histologic regression is defined as disappearance of the high grade lesion (CIN2/3) without surgical intervention.
