NCT02354534 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE1
Status at capture: COMPLETED
Registry last update: 2021-04-28

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Participants With Serious Adverse Events

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outcome · POSTED

Viral Clearance of HPV

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outcome · POSTED

Histologic Regression of CIN2/3

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility 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
healthy Volunteers: false
minimum Age: 18 Years
sex: FEMALE
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Subjects enrolled in this cohort will receive 1 five day cycle of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated).
intervention Names
Drug: Artesunate Suppositories
label
50 mg Artesunate suppositories, 1 cycle
type
EXPERIMENTAL
description
Subjects enrolled in this cohort will receive 1 five day cycle of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated).
intervention Names
Drug: Artesunate Suppositories
label
200 mg Artesunate suppositories, 1 cycle
type
EXPERIMENTAL
description
Subjects enrolled in this cohort will receive 2 five day cycles of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated).
intervention Names
Drug: Artesunate Suppositories
label
200 mg Artesunate suppositories,2 cycles
type
EXPERIMENTAL
description
Subjects enrolled in this cohort will receive 3 five day cycles of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated).
intervention Names
Drug: Artesunate Suppositories
label
200 mg Artesunate suppositories,3 cycles
type
EXPERIMENTAL

interventions

arm Group Labels
200 mg Artesunate suppositories, 1 cycle
200 mg Artesunate suppositories,2 cycles
200 mg Artesunate suppositories,3 cycles
50 mg Artesunate suppositories, 1 cycle
name
Artesunate Suppositories
type
DRUG

Study design

allocation

NON_RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 30
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
measure
Number of Participants With Serious Adverse Events
time Frame
41 weeks

secondary Outcomes

description
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.
measure
Viral Clearance of HPV
time Frame
41 weeks
description
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.
measure
Histologic Regression of CIN2/3
time Frame
41 weeks

Full study description

brief 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.
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.

Source references

Source notices and limitations

Discovery and provenance

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start
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offset unit
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query cond
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query disease state id
ds-vaginal-cancer
source file
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source kind
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source url
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Preserved source evidence · Not medical advice