Intravaginal Artesunate for the Treatment of HPV+ High Grade Cervical Intraepithelial Neoplasia (CIN2/3)
| Status: | Active, not recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/13/2018 |
| Start Date: | February 2015 |
| End Date: | February 2019 |
A Phase I Study of Intravaginally Administered Artesunate In Women With High Grade Cervical Intraepithelial Neoplasia (CIN2/3)
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.
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.
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.
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
We found this trial at
3
sites
Baltimore, Maryland 21231
410-955-6190
Phone: 410-955-8804
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins The name Johns Hopkins has become synonymous...
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Baltimore, Maryland 21287
Principal Investigator: Cornelia L Trimble, MD
Phone: 410-502-0512
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Towson, Maryland 21204
Principal Investigator: Kimberly Levinson, MD, MPH
Phone: 443-849-2765
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