Erlotinib, Docetaxel, and Radiation Therapy in Treating Patients With Locally Advanced Head and...
Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell CarcinomaStage III Squamous Cell Carcinoma of the Hypopharynx25 moreDrugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining erlotinib with docetaxel may make the tumor cells more sensitive to radiation therapy and may kill more tumor cells. Phase I trial to study the maximum tolerated dose (MTD) of combining erlotinib with docetaxel and radiation therapy in treating patients who have locally advanced head and neck cancer
T Cell Receptor Immunotherapy Targeting HPV-16 E6 for HPV-Associated Cancers
Vaginal CancerCervical Cancer3 moreBackground: The National Cancer Institute (NCI) Surgery Branch has developed an experimental therapy for treating patients with cancer that involves taking white blood cells from the patient, growing them in the laboratory in large numbers, genetically modifying these specific cells with a type of virus (retrovirus) to attack only the tumor cells, and then giving the cells back to the patient. This type of therapy is called gene transfer. Researchers want to test this on human papilloma virus (HPV)-associated cancers. Objective: - The purpose of this study is to determine a safe number of these cells to infuse and to see if these particular tumor-fighting cells (Anti-HPV E6) can shrink tumors associated with HPV and test the toxicity of this treatment. Eligibility: - Adults age 18-66 with an HPV-16-associated cancer. Design: Work up stage: Patients will be seen as an outpatient at the National Institutes of Health (NIH) clinical Center and undergo a history and physical examination, scans, x-rays, lab tests, and other tests as needed Leukapheresis: If the patients meet all of the requirements for the study they will undergo leukapheresis to obtain white blood cells to make the anti HPV E6 cells. {Leukapheresis is a common procedure, which removes only the white blood cells from the patient.} Treatment: Once their cells have grown, the patients will be admitted to the hospital for the conditioning chemotherapy, the anti HPV E6 cells and aldesleukin. They will stay in the hospital for about 4 weeks for the treatment. Follow up: Patients will return to the clinic for a physical exam, review of side effects, lab tests, and scans about every 1-3 months for the first year, and then every 6 months to 1 year as long as their tumors are shrinking. Follow up visits take up to 2 days.
Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Human Papillomavirus-Associated...
Cervical CancerOropharyngeal Cancer3 moreBackground: The human papillomavirus (HPV) can cause a number of cancers, including cervical and throat cancers. The National Cancer Institute (NCI) Surgery Branch has developed an experimental therapy that involves taking white blood cells from patients' tumors, growing them in the laboratory in large numbers, and then giving the cells back to the patient. These cells are called Tumor Infiltrating Lymphocytes, or TIL and we have given this type of treatment to over 200 patients with melanoma. Researchers want to know if TIL shrink s tumors in people with human papilloma virus (HPV)-related cancer. In this study, we are selecting a specific subset of white blood cells from the tumor that we think are the most effective in fighting tumors and will use only these cells in making the tumor fighting cells. Objective: The purpose of this study is to see if these specifically selected tumor fighting cells can cause HPV-related cancers to shrink and to see if this treatment is safe. Eligibility: - Adults age 18-66 with HPV-related cancer who have a tumor that can be safely removed. Design: Work up stage: Patients will be seen as an outpatient at the National Institutes of Health (NIH) clinical Center and undergo a history and physical examination, scans, x-rays, lab tests, and other tests as needed. Surgery: If the patients meet all of the requirements for the study they will undergo surgery to remove a tumor that can be used to grow the TIL product. Leukapheresis: Patients may undergo leukapheresis to obtain additional white blood cells. {Leukapheresis is a common procedure, which removes only the white blood cells from the patient.} Treatment: Once their cells have grown, the patients will be admitted to the hospital for the conditioning chemotherapy, the TIL cells and aldesleukin. They will stay in the hospital for about 4 weeks for the treatment. Follow up: Patients will return to the clinic for a physical exam, review of side effects, lab tests, and scans about every 1-3 months for the first year, and then every 6 months to 1 year as long as their tumors are shrinking. Follow up visits will take up to 2 days.
18F-FDG-PET Guided Dose-Painting With Intensity Modulated Radiotherapy in Oropharyngeal Tumours...
Oropharyngeal CancerTreatment of cancers of the head and neck, including oropharyngeal tumours, usually consist of a combination of radiotherapy and chemotherapy, although surgery may also play a part. Radiotherapy works by using the high energy x-rays to destroy cancer cells. Head and neck cancers often respond well to radiotherapy in the first instance and a proportion of patients will be cured by this treatment. However, not all of the cancer cells are destroyed by the combination of radiotherapy and chemotherapy and, in some patients, the cancer does come back. Studies have suggested that more efficient killing of cancer cells, and therefore, better cure rates, can be achieved by increasing the radiotherapy dose. However, in the past, this was not possible due to side effects. Intensity Modulated Radiotherapy (IMRT) is a new radiotherapy delivery technique that allows better shaping of the dose to the areas that need irradiating with the potential for fewer side effects. If the investigators use IMRT to deliver an intentionally higher dose of radiation (called a boost) to small selected areas whilst, at the same time giving standard treatment doses to the remaining areas, this approach is called IMRT dose-painting. These selected areas can be identified by a scan called 18F-FDG-PET (18F-fluorodeoxyglucose-positron emission tomography, also known as a 'PET' scan) which is a type of scan that can give information about the activity of a cancer. The purpose of this study is to find out whether the investigators can use IMRT dose-painting to boost the dose to the region inside a tumour which appears most active on 18F-FDG-PET. If this study shows that this approach is well-tolerated, then the investigators may be able to improve cure rates with this treatment. This would need to be tested in a subsequent study.
Prospective, Multicenter da Vinci® SP™ Surgical System TORS Study
Oropharyngeal CancerA prospective, multicenter investigation of the da Vinci® SP™ Surgical System in Transoral Robotic Surgery (TORS) procedures for malignant oropharyngeal tumors.
Neoadjuvant Erbitux Based Chemotherapy for Locally Advanced Oral/Oropharyngeal Cancer
Locally Advanced Malignant NeoplasmOral Cancer2 moreEGFR is a potential target for new anticancer therapy in head and neck squamous cell carcinoma, because blocking the EGFR by a monoclonal antibody results in inhibition of the stimulation of the receptor, therefore, in inhibition of cell proliferation, enhanced apoptosis, and reduced angiogenesis, invasiveness and metastases. The study hypothesis is that neo-adjuvant Erbitux-based chemotherapy followed by surgery and radiotherapy for locally advanced oral/oropharyngeal cancer could benefit the patients on prognosis. The endpoints of this study are the pathological complete response after neo-adjuvant Erbitux-based chemotherapy followed by surgery and radiotherapy, the survival rate, and the safety.
Robotic Assisted Surgery in Upper Aerodigestive Tract Surgery
Head and Neck CancerOropharyngeal Cancer2 moreTo evaluate the use of the daVinci Robotic System for better visibility and access of head and neck lesions and decreased amount of surgery time.
People Living With HIV, Oral and Oropharyngeal Cancer, and Health Equity
HIV InfectionsOral Squamous Cell Carcinoma1 moreThis is an exploratory qualitative study among People Living With HIV (PLWH) of diverse racial/ethnic and sexual and gender minority (SGM) identities to explore individual, interpersonal, and structural oral health equity factors that serve as barriers or facilitators of accessing oral health care, knowledge and perceptions of human papillomavirus (HPV) vaccination and Oral squamous cell carcinoma (OSCC) /Oropharyngeal squamous cell carcinoma (OPSCC), and to collect recommendations on how to increase access to oral health care and engage PLWH in OSCC/OPSCC prevention.
Postoperative Pain, Why Still in Hospital and DAOH Following TORS for SCCUP & OSAS
AnalgesiaSurgery6 moreThis protocol investigates the effect of a high dose dexamethasone regimen in the treatment of postoperative pain following Transoral Robotic Surgery (TORS). The protocol consists of three substudies. Randomized double-blinded clinical trial assigning half of the participants to a high-dose dexamethasone regimen while the other half will receive a low-dose dexamethasone dosage and placebo in the first postoperative period. A investigation of "Why in hospital?" following TORS. From the first postoperative day until discharge reasons for continued hospitalization will be registered in order to identify clinical and organizational factors contributing to hospitalization An assessment of "Days Alive and Out of Hospital" following TORS. From the day of surgery and the first 12 postoperative months all admissions to a hospital ward will be registered along with admission reasons. Any death during the first 12 months will be noted with a cause of death.
TLR8 Agonist VTX-2337 and Cetuximab in Treating Patients With Locally Advanced, Recurrent, or Metastatic...
Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell CarcinomaRecurrent Metastatic Squamous Neck Cancer With Occult Primary39 moreThis phase I trial studies the side effects and best dose of TLR8 Agonist VTX-2337 when given together with cetuximab in treating patients with locally advanced, recurrent, or metastatic squamous cell cancer of the head and neck (SCCHN). Biological therapies, such as TLR8 Agonist VTX-2337 may stimulate the immune system in different ways and stop tumor cells from growing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving TLR8 Agonist VTX-2337 together with cetuximab may kill more tumor cells.