4 Clinical Trials for Various Conditions
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.
Cervical Adenocarcinoma, Cervical Adenocarcinoma in Situ, Cervical Intraepithelial Neoplasia, Cervical Squamous Cell Carcinoma, Not Otherwise Specified, Cervical Squamous Intraepithelial Neoplasia, Early Invasive Cervical Adenocarcinoma, Early Invasive Cervical Squamous Cell Carcinoma, High Grade Cervical Squamous Intraepithelial Neoplasia, High Grade Vaginal Intraepithelial Neoplasia, Low Grade Vaginal Intraepithelial Neoplasia, Stage I Cervical Cancer AJCC V8, Stage I Vaginal Cancer AJCC V8, Stage I Vulvar Cancer AJCC V8, Stage IA Cervical Cancer AJCC V8, Stage IA Vaginal Cancer AJCC V8, Stage IA Vulvar Cancer AJCC V8, Stage IA1 Cervical Cancer AJCC V8, Stage IA2 Cervical Cancer AJCC V8, Stage IB Cervical Cancer AJCC V8, Stage IB Vaginal Cancer AJCC V8, Stage IB Vulvar Cancer AJCC V8, Stage IB1 Cervical Cancer AJCC V8, Stage IB2 Cervical Cancer AJCC V8, Stage II Cervical Cancer AJCC V8, Stage II Vaginal Cancer AJCC V8, Stage II Vulvar Cancer AJCC V8, Stage IIA Cervical Cancer AJCC V8, Stage IIA Vaginal Cancer AJCC V8, Stage IIA1 Cervical Cancer AJCC V8, Stage IIA2 Cervical Cancer AJCC V8, Stage IIB Cervical Cancer AJCC V8, Stage IIB Vaginal Cancer AJCC V8, Stage III Cervical Cancer AJCC V8, Stage III Vaginal Cancer AJCC V8, Stage III Vulvar Cancer AJCC V8, Stage IIIA Cervical Cancer AJCC V8, Stage IIIA Vulvar Cancer AJCC V8, Stage IIIB Cervical Cancer AJCC V8, Stage IIIB Vulvar Cancer AJCC V8, Stage IIIC Vulvar Cancer AJCC V8, Stage IV Cervical Cancer AJCC V8, Stage IV Vaginal Cancer AJCC V8, Stage IV Vulvar Cancer AJCC V8, Stage IVA Cervical Cancer AJCC V8, Stage IVA Vaginal Cancer AJCC V8, Stage IVA Vulvar Cancer AJCC V8, Stage IVB Cervical Cancer AJCC V8, Stage IVB Vaginal Cancer AJCC V8, Stage IVB Vulvar Cancer AJCC V8, Vaginal Adenocarcinoma, Vulvar Adenocarcinoma, Vulvar High Grade Squamous Intraepithelial Lesion, Vulvar Intraepithelial Neoplasia, Vulvar Squamous Cell Carcinoma, Vulvar Squamous Intraepithelial Lesion
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.
Cervical Squamous Cell Carcinoma In Situ, Vulvar High Grade Squamous Intraepithelial Lesion
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.
Cancer Risk, Cancer Predisposition Syndrome, Hereditary Cancer Prediction, Childhood Cancer Survivors, Adult Cancer Survivors, IARC Carcinogens, Smoking History, Lung Cancer, Ductal/Lobular Carcinoma, Barrett Esophagus, Pancreatic Precursor Lesions, Colonic Dysplasia/Adenomata, Non-Alcoholic Fatty Liver Disease, Non Alcoholic Steatohepatitis, Cirrhosis, High Grade Prostatic Epithelial Neoplasia, High-grade Bladder Urothelial Dysplasia/Carcinoma in Situ, Adenomatous Hyperplasia, High-risk Oral Precancerous Diseases, Melanocytic Lesion, Adult, Hematologic Malignancy, Lung; Node, Serous Tubal Intraepithelial Carcinoma, Endometrial Intraepithelial Neoplasia, Cervical and Endocervical Carcinoma in Situ, Vulvar Intraepithelial Neoplasia, Nephrogenic Rests, Benign Bone Lesions With Risk of Malignant Degeneration, Giant Cell Tumor, Osteochondroma, Spitz Nevus
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.
Papillomavirus Infections, Cervical Intraepithelial Neoplasia, Carcinoma In Situ, Vulvar Neoplasms, Vulvar Diseases