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

• Status: Completed
• Trial end date: 2018-11-06
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: Frantz Viral Therapeutics
• Treatments: Artemisinins; Artesunate

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