Treatment Trials

11 Clinical Trials for Various Conditions

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RECRUITING
A Study Evaluating the Effect of Frozen-Section Directed Excision Surgery on Vulvar Dysplasia
Description

The purpose of this study is to compare "Frozen-Section Directed Excision", which has been a proven method of surgery used in dermatology, versus the current, standard method called "Wide Local Excision" to treat high-grade vulvar dysplasia.

COMPLETED
Artesunate Ointment for the Treatment of High Grade Vulvar Intraepithelial Neoplasia (HSIL VIN2/3)
Description

This is a Phase I, proof-of-concept treatment study to evaluate the safety, tolerability and feasibility of topical artesunate ointment to treat high grade vulvar intraepithelial neoplasia (HSIL VIN2/3).

ACTIVE_NOT_RECRUITING
Biospecimen Collection and Testing for the Prevalence of Anal Dysplasia and Anal Cancer in Patients with Cervical, Vaginal and Vulvar Dysplasia and Cancer
Description

This trial studies the prevalence of anal dysplasia and anal cancer in patients with cervical, vaginal, and vulvar dysplasia and cancer. Studying samples collected from patients in the laboratory may help doctors learn more about the human papillomavirus and how often anal cancer occurs in patients with cervix, vagina, or vulvar cancer.

Conditions
Cervical AdenocarcinomaCervical Adenocarcinoma in SituCervical Intraepithelial NeoplasiaCervical Squamous Cell Carcinoma, Not Otherwise SpecifiedCervical Squamous Intraepithelial NeoplasiaEarly Invasive Cervical AdenocarcinomaEarly Invasive Cervical Squamous Cell CarcinomaHigh Grade Cervical Squamous Intraepithelial NeoplasiaHigh Grade Vaginal Intraepithelial NeoplasiaLow Grade Vaginal Intraepithelial NeoplasiaStage I Cervical Cancer AJCC V8Stage I Vaginal Cancer AJCC V8Stage I Vulvar Cancer AJCC V8Stage IA Cervical Cancer AJCC V8Stage IA Vaginal Cancer AJCC V8Stage IA Vulvar Cancer AJCC V8Stage IA1 Cervical Cancer AJCC V8Stage IA2 Cervical Cancer AJCC V8Stage IB Cervical Cancer AJCC V8Stage IB Vaginal Cancer AJCC V8Stage IB Vulvar Cancer AJCC V8Stage IB1 Cervical Cancer AJCC V8Stage IB2 Cervical Cancer AJCC V8Stage II Cervical Cancer AJCC V8Stage II Vaginal Cancer AJCC V8Stage II Vulvar Cancer AJCC V8Stage IIA Cervical Cancer AJCC V8Stage IIA Vaginal Cancer AJCC V8Stage IIA1 Cervical Cancer AJCC V8Stage IIA2 Cervical Cancer AJCC V8Stage IIB Cervical Cancer AJCC V8Stage IIB Vaginal Cancer AJCC V8Stage III Cervical Cancer AJCC V8Stage III Vaginal Cancer AJCC V8Stage III Vulvar Cancer AJCC V8Stage IIIA Cervical Cancer AJCC V8Stage IIIA Vulvar Cancer AJCC V8Stage IIIB Cervical Cancer AJCC V8Stage IIIB Vulvar Cancer AJCC V8Stage IIIC Vulvar Cancer AJCC V8Stage IV Cervical Cancer AJCC V8Stage IV Vaginal Cancer AJCC V8Stage IV Vulvar Cancer AJCC V8Stage IVA Cervical Cancer AJCC V8Stage IVA Vaginal Cancer AJCC V8Stage IVA Vulvar Cancer AJCC V8Stage IVB Cervical Cancer AJCC V8Stage IVB Vaginal Cancer AJCC V8Stage IVB Vulvar Cancer AJCC V8Vaginal AdenocarcinomaVulvar AdenocarcinomaVulvar High Grade Squamous Intraepithelial LesionVulvar Intraepithelial NeoplasiaVulvar Squamous Cell CarcinomaVulvar Squamous Intraepithelial Lesion
TERMINATED
IRX-2 Regimen in Treating Women With Cervical Squamous Intraepithelial Neoplasia 3 or Squamous Vulvar Intraepithelial Neoplasia 3
Description

This randomized phase II trial studies how well an IRX-2 Regimen works in treating women with cervical squamous intraepithelial neoplasia 3 or squamous vulvar intraepithelial neoplasia 3. The IRX-2 Regimen consists of a single dose of cyclophosphamide, followed by 21 days of indomethacin, zinc-containing multivitamins, and omeprazole. IRX-2, a human cell-derived biologic with multiple active cytokine components, may act as an immune booster to stimulate the immune system. Giving cyclophosphamide and IRX-2 may work better at treating cervical squamous intraepithelial neoplasia or squamous vulvar intraepithelial neoplasia.

COMPLETED
Ultrasonic Aspiration Versus CO2 Laser Ablation for the Treatment of Vulvar Intraepithelial Neoplasia
Description

The primary objective of this study is to evaluate the incidence of vulva dysplasia recurrence within 12 months of treatment with Carbon Dioxide (CO2) laser ablation or ultrasonic aspiration.

COMPLETED
A Randomized Trial of Surgical Treatments for Vulvar and Vaginal Dysplasia
Description

1. To compare the recurrence rate between the use of laser vaporization and ultrasonic surgical aspiration in the treatment of vulvar and vaginal dysplasias 2. To compare healing related complications, post-operative pain, and scarring between the two procedures.

COMPLETED
Cavitronic Ultrasonic Surgical Aspiration (CUSA) Women's Health Study
Description

The study is a single arm, retrospective, single-center, post market registry. The purpose of this Registry is to collect data to demonstrate the safety and performance of CUSA® for the treatment of Vulvar Intraepithelial Neoplasia (VIN) and condyloma acuminata.

RECRUITING
InAdvance: Surveillance, Prevention, and Interception in a Population at Risk for Cancer
Description

This research study is creating a way to collect and store specimens and information from participants who may be at an increased risk of developing cancer, or has been diagnosed with an early phase of a cancer or a family member who has a family member with a precursor condition for cancer. * The objective of this study is to identify exposures as well as clinical, molecular, and pathological changes that can be used to predict early development of cancer, malignant transformation, and risks of progression to symptomatic cancer that can ultimately be fatal. * The ultimate goal is to identify novel markers of early detection and risk stratification to drive potential therapeutic approaches to intercept progression to cancer.

COMPLETED
Evaluation of VGX-3100 and Electroporation Alone or in Combination With Imiquimod for the Treatment of HPV-16 and/or HPV-18 Related Vulvar HSIL (Also Referred as: VIN 2 or VIN 3)
Description

The purpose of this study is to test the safety and efficacy of an investigational immunotherapy VGX-3100, in combination with a study device, to treat women with vulvar high-grade squamous intraepithelial lesion (HSIL) \[vulval intraepithelial neoplasia 2 or 3 (VIN 2 or VIN 3)\] associated with human papilloma virus (HPV) types 16 and/or 18. VGX-3100 is being assessed as an alternative to surgery with the potential to clear the underlying HPV infection. For more information visit our study website at: www.VINresearchstudy.com

RECRUITING
E7 TCR T Cells for Human Papillomavirus-Associated Cancers
Description

Background: Human papillomavirus (HPV) can cause cervical, throat, anal, and genital cancers. Cancers caused by HPV have a HPV protein called E7 inside of their cells. In this new therapy, researchers take a person s blood, remove certain white blood cells, and insert genes that make them to target cancer cells that have the E7 protein. The genetically changed cells, called E7 TCR cells, are then given back to the person to fight the cancer. Researchers want to see if this can help people. Objective: To determine a safe dose and efficacy of E7 TCR cells and whether these cells can help patients. Eligibility: Adults ages 18 and older with an HPV-16-associated cancer, including cervical, vulvar, vaginal, penile, anal, or oropharyngeal. Design: Participants will list all their medicines. Participants will have many screening tests, including imaging procedures, heart and lung tests, and lab tests. They will have a large catheter inserted into a vein. Participants will have leukapheresis. Blood will be removed through a needle in the arm. A machine separates the white blood cells. The rest of the blood is returned through a needle in the other arm. The cells will be changed in the lab. Participants will stay in the hospital. Over several days, they will get: Chemotherapy drugs E7 TCR cells Shots or injections to stimulate the cells Participants will be monitored in the hospital up to 12 days. They will get support medicine and have blood and lab tests. Participants will have a clinic visit about 40 days after cell infusion. They will have a physical exam, blood work, scans, and maybe x-rays. Participants will have many follow-up visits with the same procedures. At some visits, they may undergo leukapheresis. Participants will be followed for 15 years.

RECRUITING
Phase II Study of Artesunate Ointment for the Treatment of Vulvar High Grade Squamous Intraepithelial Lesions (Vulvar HSIL, VIN2/3)
Description

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).