Artesunate Ointment for Vulvar Precancer (ART-VIN IIB Trial)
Palo Alto (17 mi)Age: 18+
Sex: Female
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Frantz Viral Therapeutics, LLC
Prior Safety Data
Breakthrough Therapy
Approved in 2 jurisdictions
Trial Summary
What is the purpose of this trial?This is a phase II double-blind, placebo-controlled study of artesunate ointment for the treatment of HPV-associated vulvar HSIL (usual type vulvar intraepithelial neoplasia 2/3).
What data supports the idea that Artesunate Ointment for Vulvar Precancer is an effective treatment?The available research does not provide any data on Artesunate Ointment for Vulvar Precancer. Instead, the studies focus on treatments for mycosis fungoides and other skin conditions, using different drugs and therapies. Therefore, there is no information here to support the effectiveness of Artesunate Ointment for Vulvar Precancer.2451012
Is Artesunate ointment a promising treatment for vulvar precancer?Yes, Artesunate ointment is a promising treatment for vulvar precancer. It has shown potential in treating HPV-associated vulvar intraepithelial neoplasia, a type of precancerous condition. Artesunate, originally an antimalarial drug, has also been noted for its ability to inhibit cancer cell growth, making it a versatile option for various medical applications.1791115
What safety data exists for Artesunate ointment for vulvar precancer?The provided research does not contain specific safety data for Artesunate ointment or its related names. The articles focus on other drugs and their side effects, such as lichenoid drug eruptions, desonide safety, sorafenib-induced skin cancers, vemurafenib-related side effects, and treatments for taxane-resistant cutaneous angiosarcoma. None of these studies mention Artesunate or its related compounds.3681314
Do I have to stop taking my current medications for the trial?You may need to stop certain medications. The trial excludes participants using Efavirenz for HIV, strong UGT inhibitors, imiquimod, cidofovir, 5-fluorouracil, and systemic corticosteroids. If you're on these, you might need to stop them to participate.
Eligibility Criteria
This trial is for adult women over 18 with a positive HPV test and biopsy-confirmed high-grade vulvar dysplasia (VIN2/3, HSIL). They must be able to consent, follow the study plan, not be pregnant or nursing, have no severe liver or kidney issues, weigh at least 50kg, and agree to use birth control. Excluded are those with low CD4 counts if HIV-positive, on certain HIV treatments or strong UGT inhibitors, using systemic corticosteroids or other cancer treatments.Inclusion Criteria
I weigh at least 50kg.
I tested positive for HPV.
I am a woman aged 18 or older.
Exclusion Criteria
I am not taking any strong UGT inhibitors.
I do not have anal, vulvar, or cervical cancer.
I am HIV-positive with a CD4 count below 200.
I am not willing to have surgery at week 18 to remove or check the progress of a lesion.
I am not currently undergoing chemotherapy or radiation for another cancer.
I am currently taking Efavirenz for HIV.
I am currently taking corticosteroids.
I have skin conditions affecting my vulva, like herpes or eczema.
I am not using imiquimod, cidofovir, or 5-FU during the study.
Treatment Details
The study tests artesunate ointment versus placebo in treating HPV-associated vulvar HSIL. It's a phase II trial where participants don't know which treatment they're getting (double-blind) and neither do the researchers (placebo-controlled). The goal is to see if artesunate can effectively treat these lesions.
2Treatment groups
Active Control
Placebo Group
Group I: Artesunate ointmentActive Control1 Intervention
Artesunate formulated as topical ointment, 40% Four 5-day cycles of artesunate ointment every 2 weeks
Group II: Placebo ointmentPlacebo Group1 Intervention
Placebo ointment Four 5-day cycles of placebo ointment every 2 weeks
Artesunate ointment is already approved in United States, European Union for the following indications:
๐บ๐ธ Approved in United States as Artesunate for:
- Severe malaria
๐ช๐บ Approved in European Union as Artesunate for:
- Malaria
Find a clinic near you
Research locations nearbySelect from list below to view details:
Ascension St. VincentIndianapolis, IN
Florida Gynecologic OncologyFort Myers, FL
Cleveland Clinic FoundationCleveland, OH
Cleveland Clinic Fairview HospitalCleveland, OH
More Trial Locations
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Who is running the clinical trial?
Frantz Viral Therapeutics, LLCLead Sponsor
The Cleveland ClinicCollaborator
References
Pharmacokinetics of artesunate after single oral administration to rats. [2019]Artesunate is a commonly used antimalarial drug derived from artemisinin. It is rapidly converted to dihydroartemisinin. Little is known on this conversion in the GI tract and blood, and how this influences absorption. In order to study the absorption phase of the kinetics of artesunate following oral administration in rats, samples were collected at baseline, and then 0.5, 2, 5, 10, 15, 30, 45, 60 and 120 minutes after a single dose of 150 mg.
Phase II trial of interferon-alpha-2a plus psolaren with ultraviolet light A in patients with cutaneous T-cell lymphoma. [2018]To evaluate the efficacy and side effects of psolaren with ultraviolet light A (PUVA) and interferon-alpha-2a (IFN-alpha-2a) in patients with mycosis fungoides (MF) and Sรฉzary syndrome (SS).
Overview on desonide 0.05%: a clinical safety profile. [2013]Desonide (as a cream, ointment, or lotion formulation) is widely used for the treatment of steroid-responsive dermatoses. This paper provides information on its safety record, as determined from adverse event reports and published trial results. A pharmacovigilance program, initiated in 1992 for all countries where desonide is available, collected reports of adverse events associated with topical desonide over nine years. Published accounts of randomized, controlled trials of desonide in comparison with hydrocortisone were reviewed. Sixty-two reports have been collected; most were from consumers and were not medically substantiated. There were no serious reactions directly attributable to desonide treatment and the majority of events reported were classified as expected local reactions, generally mild in nature. This level of reporting is against a background of extensive prescribing of desonide; almost one million packs are dispensed per annum in the US alone. The excellent safety profile of desonide revealed by this pharmacovigilance program is supported by a review of published clinical trial results.
PUVA-gel vs. PUVA-bath therapy for severe recalcitrant palmoplantar dermatoses. A randomized, single-blinded prospective study. [2013]In order to avoid unwanted effects of systemic psoralen and ultraviolet A (PUVA) therapy, various topical PUVA treatment modalities have been developed and are being increasingly used. However, up to now very few controlled studies comparing the therapeutic efficacy of different topical photochemotherapy modalities are available. Thus, the aim of our study was to compare the clinical efficacy of conventional PUVA-bath therapy to topical PUVA-gel therapy in patients with recalcitrant dermatoses of the palms and soles.
Treatment of early-stage mycosis fungoides with twice-weekly applications of mechlorethamine and topical corticosteroids: a prospective study. [2015]To determine if a therapeutic regimen of twice-weekly applications of mechlorethamine hydrochloride and betamethasone dipropionate cream is effective in the treatment of early-stage mycosis fungoides while increasing cutaneous tolerance.
Eruptive squamous cell carcinomas with keratoacanthoma-like features in a patient treated with sorafenib. [2018]Sorafenib is a multikinase inhibitor that displays antiproliferative and antiangiogenic properties in the treatment of solid tumors. Commonly administered for the treatment of metastatic or unresectable hepatocellular carcinoma and advanced renal cell carcinoma, sorafenib has demonstrated remarkable survival benefits for those where curative surgery is not an option. Although generally having a mild side effect profile, sorafenib has been linked to a variety of dermatologic disorders, including most commonly acneiform rash, hand-foot-skin reactions, facial erythema, splinter subungual hemorrhages, alopecia or pruritus. The authors describe a case of sorafenib-induced eruptive squamous cell carcinomas with keratoacanthoma-like features in a patient with hepatocellular carcinoma. This case adds to the growing literature suggesting a strong correlation between sorafenib and non-melanoma skin cancers including keratoacanthoma and squamous cell carcinoma. Routine dermatologic monitoring of these patients to ensure early detection is highly recommended. J Drugs Dermatol. 2011;10(3):308-310.
Stability and antiviral activity against human cytomegalovirus of artemisinin derivatives. [2018]Artesunate, a derivative of dihydroartemisinin, itself a product of artemisinin, inhibits the replication of cytomegalovirus in vitro. In vivo, artesunate undergoes rapid conversion into the active metabolite dihydroartemisinin. The in vitro stability of the compounds and the antiviral activity of dihydroartemisinin are of great concern for the interpretation of in vitro testing. The aim of the study was to measure artesunate conversion into dihydroartemisinin in culture medium and to evaluate the stability and antiviral activity of artemisinin derivatives, according to culture conditions.
Vemurafenib-related cutaneous side effects ameliorated by acitretin. [2018]Vemurafenib is a BRAF kinase inhibitor that improves the survival of patients with metastatic melanoma, who have the V600E BRAF mutation. The development of cutaneous neoplasms, including squamous cell carcinomas (SCCs), keratoacanthomas (KAs), and hyperkeratotic papules is one of the most common adverse effects of this therapy. Systemic retinoids, such as isotretinoin and acitretin, have been used for chemoprophylaxis in individuals at high risk of developing many non-melanoma skin cancers, such as immunosuppressed solid organ transplant recipients. These agents may reduce and delay the growth of skin cancers by exerting their effects during the promotion and progression stages of carcinogenesis.
A Randomised, Double Blind, Placebo-Controlled Pilot Study of Oral Artesunate Therapy for Colorectal Cancer. [2018]Artesunate is an antimalarial agent with broad anti-cancer activity in in vitro and animal experiments and case reports. Artesunate has not been studied in rigorous clinical trials for anticancer effects.
Results of a prospective phase II trial with oral low-dose bexarotene plus photochemotherapy (PUVA) in refractory and/or relapsed patients with mycosis fungoides. [2018]Bexarotene is a synthetic retinoid effective in early and advanced stages of mycosis fungoides (MF)/Sezary Syndrome (SS) both in monotherapy and combination schemes. We aimed to assess disease response to low-dose bexarotene and PUVA in maintenance in refractory and/or resistant patients with early and advanced stage MF/SS.
Progress on the study of the anticancer effects of artesunate. [2021]Artesunate (ART) is a derivative of artemisinin that is extracted from the wormwood plant Artemisia annua. ART is an antimalarial drug that has been shown to be safe and effective for clinical use. In addition to its antimalarial properties, ART has been attracting attention over recent years due to its reported inhibitory effects on cancer cell proliferation, invasion and migration. Therefore, ART has a wider range of potential clinical applications than first hypothesized. The aim of the present review was to summarize the latest research progress on the possible anticancer effects of ART, in order to lay a theoretical foundation for the further development of ART as a therapeutic option for cancer.
Randomized Mechlorethamine/Chlormethine Induced Dermatitis Assessment Study (MIDAS) Establishes Benefit of Topical Triamcinolone 0.1% Ointment Cotreatment in Mycosis Fungoides. [2022]Treatment of early-stage mycosis fungoides (MF) requires safe, skin-directed therapies. Medication side effects can lead to underutilization of effective therapies. The objective of this study was to assess the use of topical triamcinolone 0.1% ointment as a means of reducing contact dermatitis associated with topical mechlorethamine/chlormethine gel for the treatment of MF.
Cutaneous lichenoid drug eruptions: A narrative review evaluating demographics, clinical features and culprit medications. [2023]Cutaneous lichenoid drug eruptions (LDE) are adverse drug reactions (ADR) characterized by symmetric, erythematous, violaceous papules reminiscent but rarely fully characteristic of lichen planus (LP). We aimed to analyse the literature describing cases of LDE within the last 20 years to provide additional insight into culprit drugs, typical latency to onset of the eruption, the spectrum of clinical presentations, severity and management. A literature search was conducted in MEDLINE between January 2000 and 27 January 2021. The keywords 'lichenoid drug rash' and 'lichenoid drug eruption' were used. Cases were included if LDE diagnosis was made, and culprit drugs were identified. A total of 323 cases with LDE were identified from 163 published case reports and studies. The mean patient age was 58.5 years (1 month to 92 years), and 135 patients (41.8%) were female. Checkpoint inhibitors (CKI) were the most frequently reported culprit drugs (136 cases; 42.1%), followed by tyrosine kinase inhibitors (TKI) (39 cases; 12.0%) and anti-TNF-ฮฑ-monoclonal antibodies (13 cases; 4.0%). The latency between initiation of the drug and manifestation was 15.7 weeks (range: 0.1-208 weeks). After discontinuing the culprit drug, the median time to resolution was 14.2 weeks (range: 0.71-416 weeks). One hundred thirty-six patients (42.1%) were treated with topical, and 54 patients (16.7%) with systemic glucocorticoids. Overall, we conclude that, albeit rare, LDE is challenging to diagnose ADR induced by mostly CKI, TKI, and biologics. Treatment modalities resemble that of lichen planus, and the culprit drugs had to be discontinued in only 26%, which is low compared with other types of adverse drug reactions. This is probably due to the low risk of aggravation (e.g. toxic epidermal necrolysis) if the drug is continued and the benefit/risk ratio favouring the drug, as is often the case in cancer therapy.
Treatment for taxane-resistant cutaneous angiosarcoma: A multicenter study of 50 Japanese cases. [2023]Cutaneous angiosarcoma (CAS) is a rare and highly aggressive type of vascular tumor. Although chemoradiotherapy with taxanes is recognized as a first-line therapy for CAS, second-line therapy for CAS remains controversial. From the above findings, the efficacy and safety profiles of taxane-switch (change paclitaxel to docetaxel or vise), eribulin methylate, and pazopanib regimens in second-line chemotherapy were evaluated retrospectively in 50 Japanese taxane-resistant CAS patients. Although there was no significant difference in progression-free survival (P = 0.3528) among the regimens, the incidence of all adverse events (AEs) (P = 0.0386), as well as severe G3 or more AEs (P = 0.0477) was significantly higher in the eribulin methylate group and pazopanib group than in the taxane-switch group. The present data suggest that switching to another taxane should be considered for the treatment of taxane-resistant CAS in second-line therapy based on the safety profiles.
Safety and efficacy of topical artesunate for the treatment of vulvar intraepithelial neoplasia 2/3. [2023]To evaluate the safety, tolerability, and efficacy of topical artesunate ointment for treatment of biopsy-confirmed Human papillomavirus (HPV)-associated Vulvar intraepithelial neoplasia (VIN) 2/3.