A Trial to Compare the Incidence of Squamous Cell Carcinoma (SCC) and Other Skin Neoplasia on Skin...
Actinic KeratosisSquamous Cell CarcinomaOne of the main reasons for treating actinic keratoses (AK) is the wish to lower the risk of progression of AK to squamous cell carcinoma (SCC). This risk is in the order of 1 per 1000 AKs per year, which is in itself a small risk, but since patients can have dozens of AKs and the disease is chronic the cumulative risk for a patient can be substantial. In this extension protocol of trials LP0084-1193, -1194, -1195 and -1196, LEO will study the incidence of SCCs and other skin neoplasia in vehicle and ingenol disoxate treated patients over a period of 2 years, so that the total follow-up time for each patient will be 3 years and 2 months.
Surveillance of Regional Nodal Basins and Gene Expression Profiling in Patients With Primary High...
Cutaneous Squamous Cell Carcinoma of the Head and NeckIn this prospective cohort study, investigators will conduct ultrasound surveillance of the nodal basins of patients with head and neck cutaneous squamous cell carcinoma (cSCC) whose tumors are considered high risk and staged by the Brigham and Women's Hospital (BWH) tumor staging system. The study will enroll patients with tumors staged T2a and who are also immunosuppressed (from solid organ transplant, hematologic malignancy or autoimmune disease), T2b (sentinel lymph node negative), and T3 (sentinel lymph node negative). After two years of surveillance, outcomes regarding local recurrence, nodal metastasis, disease specific death, and overall survival will be compared with historical controls with the overall hypothesis that ultrasound surveillance will detect subclinical disease earlier and help improve outcomes.
Patient Perspectives in Squamous Cell Carcinoma Clinical Trials
Squamous Cell CarcinomaClinical research participation has historically been heavily biased toward specific demographics. This study will invite several participants to gather a wide range of information on clinical trial experiences for squamous cell carcinoma patients. The aim of the study is to identify the factors that limit the ability of a person to enroll in, as well as complete a clinical trial for treatment of squamous cell carcinoma. People with squamous cell carcinoma who are invited to take part in clinical research will benefit from the analysis of the data.
T-cell Based Immunotherapy for Head and Neck Cancer
Squamous Cell CarcinomaHead and Neck CancerThe aim of this study is to investigate the toxicity and immune response of therapy with tumor infiltrating lymphocytes as adjuvant treatment for head and neck cancer after primary operation and radiotherapy. Patient will receive a single treatment consisting of conditioning chemotherapy for seven days (cyclophosphamide for two days and fludarabine for five days), intravenous infusion of high number of in vitro expanded tumor infiltrating lymphocytes followed by two weeks with daily low-dose interleukine-2. Patients will be evaluated for toxicity and immune response.
LIFE-Lung Bronchoscopy in Patients at Risk for Developing Lung Cancer
Non-Small-Cell Lung CarcinomaHead and Neck Squamous Cell Cancer2 moreThe purpose of the study is to evaluate the usefulness and accuracy of the "LIFE-Lung Bronchoscopy" to identify early changes in lung tissues that show precancerous, cancer in situ (just beginning and not spread) and microscopic invasive cancer lesions versus the ability of the standard "White Light Bronchoscopy" to identify the same. This will be done as a part of routine monitoring bronchoscopy. Patients who have had a surgical resection of non-small cell lung cancer (NSCLC) and with no current evidence of disease (NED) will be eligible. Also eligible are patients who have had head or neck squamous cell carcinoma with radical head and/or neck dissection and who are currently NED. Patients with severe chronic, obstructive, pulmonary disease shown by pulmonary function testing abnormalities will also be eligible. In addition to the specialized bronchoscopy, doctors will be investigating the use of imaging spectroscopy. This is using an optical (visualizing) procedure to measure the light reflected back from tissue. Different lesions and normal tissues reflect light differently and in specific color wavelengths. By using measurements over time (different examinations/bronchoscopies) very small changes can be seen. This may allow eventually for very early diagnosing of precancerous or cancer in situ lesions, allowing for earlier treatment.
Prepare to Care, A Supported Self-Management Intervention for Head and Neck Cancer CaregiversHead...
CaregiverMalignant Head and Neck Neoplasm36 moreThis pilot clinical trial studies how well Prepare to Care kit works in improving caregiver support in patients with stage I-IV head and neck cancer that is new or has come back. Prepare to Care kit may increase knowledge about head and neck cancer and enhance stress-management skills.
Changes in Body Composition After EPA Supplementation in Head and Neck Patients
Squamous Cell Carcinoma of Head and NeckEvaluates the effect of EPA supplementation in terms of muscle mass in patients with squamous cell carcinoma of the head and neck locally advanced
Low Level Laser Therapy for Radiation Induced Dermatitis in H & N Squamous Cell Carcinoma
Radiation DermatitisThis study will assess the efficacy of LLLT to mitigate and ameliorate the acneiform-rash, radiation dermatitis, and pain, while assessing its impact on patient reported quality of life.
Ficlatuzumab and Cetuximab in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)...
CarcinomaSquamous Cell of Head and Neck3 moreThe epidermal growth factor receptor (EGFR) is both oncogene and prognostic biomarker in head and neck squamous cell carcinoma (HNSCC). EGFR's functional importance in HNSCC resulted in development of the first molecularly targeted strategy, the anti-EGFR monoclonal antibody cetuximab. Given the lack of therapeutic options for patients with recurrent/metastatic HNSCC after failure of cetuximab, there is strong scientific interest in understanding resistance in order to identify new therapies for this population. A possible resistance mechanism to anti-EGFR therapy in HNSCC is primary or compensatory activation of alternate growth factor receptors including c-Met. The MET oncogene encodes c-Met, an RTK bound exclusively by the ligand, hepatocyte growth factor (HGF). The HGF/c-Met signaling pathway converges with the EGFR network at both the PI3K/Akt and MAPK nodes. Laboratory data suggest the ability for reciprocal compensation between EGFR and c-Met. We hypothesize that HGF/c-Met pathway inhibition may overcome resistance to cetuximab in patients with HNSCC, such as those with clinical cetuximab resistance. Ficlatuzumab (AV-299) is a humanized HGF-inhibitory immunoglobulin G1 (IgG1) monoclonal antibody. The primary objective of this phase 1b study is to find the recommended phase II dose (RP2D) of the combination of ficlatuzumab and cetuximab in patients with recurrent/metastaticHNSCC. The dose-finding study design will follow a Narayana k-in-a-row design with k set to 2 to target a 33% rate of dose-limiting toxicity (DLT). In the dose-finding phase, a total of 8 patients will be treated if no DLTs are observed or 14 patients if at least one DLT occurs. An expansion cohort will then proceed at RP2D until 12 patients have been treated at that dose level with the combination of ficlatuzumab and cetuximab. We will evaluate biomarkers of HGF/cMet pathway activation in baseline tissue, plasma and immune cells for a preliminary relationship with clinical activity.
Pilot Study of Chemotherapy for HPV-Associated Oropharyngeal Cancer
Oropharyngeal Squamous Cell CarcinomaDoctors leading this study will give blood tests to head and neck cancer participants during the beginning of chemotherapy treatment (also known as induction therapy) to see if these blood tests can help predict tumor shrinkage after therapy and reduce the amount of additional radiotherapy or chemotherapy treatment the participant may need. This study will also examine ways to reduce overall side effects of treatment using robotic surgery, chemotherapy and radiotherapy, or radiotherapy alone.