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.
Completed
Phase 1
NCT ID: NCT02354534
ORG ID: J1498
NCI ID: IRB00045376
Cervical Intraepithelial Neoplasia Grade 2/3
High-risk HPV (Any Strain)
| 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 |
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.
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.
| 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 |
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
Histologic regression of CIN2/3 (Regression of CIN2/3 to CIN1 or less)
Clearance of HPV
cervical dysplasia
HPV
Treatment
preinvasive
cervix
vaginal suppository
Johns Hopkins
Cornelia Trimble
abnormal pap
CIN
