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.
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
Trial Keywords
cervical dysplasia
HPV
Treatment
preinvasive
cervix
vaginal suppository
Johns Hopkins
Cornelia Trimble
abnormal pap
CIN