644 Clinical Trials for Various Conditions
To prospectively collect blood and tumor tissue from esophageal cancer patients to identify specific esophageal cancer mutations that can be measured in the blood (cell free DNA) during the course of treatment as a marker of response and recurrence.
Esophageal adenocarcinoma (EAC) is one of the few cancers with a rising incidence in the United States, with an estimated 17,000 new cases diagnosed in 2012. Most patients with esophageal cancer present with tumors which are not amenable to surgery and are treated with chemotherapy and radiation. The most common and bothersome symptoms from esophageal cancer is dysphagia (difficulty swallowing). Chemotherapy and radiation are effective in shrinking tumors and allowing patients with EAC to swallow more easily; however it usually takes 1-2 months for swallowing to improve with this treatment. Another method of shrinking esophageal tumors and allowing for better swallowing is endoscopic spray cryotherapy (freezing the tumor from inside the esophagus with the aid of an endoscope); cryotherapy is a well established method for treating cancerous and pre-cancerous esophageal disease. This is a particularly attractive treatment option, as patients with esophageal cancer usually undergo endoscopy on several occasions before starting treatment in order to biopsy and evaluate the tumor. The goal of this study is to evaluate the effectiveness of cryotherapy in treating EAC related dysphagia in patients who are getting ready to start chemotherapy and radiation. In order to do this the investigators are planning to invite patients who are already undergoing endoscopy for pre-chemotherapy evaluation of known EAC. Patients would undergo cryotherapy after the diagnostic portion of the endoscopy has been completed. After the cryotherapy patients will be contacted by phone in order to evaluate change in symptoms, 2 and 4 weeks after cryotherapy.
This phase I trial studies the side effects and best dose of ganetespib when given together with paclitaxel, carboplatin, and radiation therapy in treating patients with stage II-III esophageal cancer. Ganetespib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving ganetespib in combination with paclitaxel, carboplatin, and radiation therapy may be a better treatment for patients with esophageal cancer.
The purpose of this study is to see whether giving azacitidine before each cycle of chemotherapy prior to surgery is safe.
Background: - Recent research has shown that causing an immune response to tumor cells may help slow or stop the growth of tumors. One treatment that has come from this research involves collecting and modifying a cancer patient's tumor cells in the laboratory, then returning the cells to the patient as a vaccine to encourage the immune system to respond to them. Researchers are interested in testing tumor cell vaccines with an experimental drug called ISCOMATRIX , which can be added to a vaccine in order to elicit a stronger immune response in the body. ISCOMATRIX has not been approved for sale and use in any country and its use is still experimental, though it has been tested and used safely in other clinical studies. Researchers are also interested in determining whether the anti-inflammatory drug celecoxib will improve the body's immune reaction if given with the vaccine. Objectives: - To assess the safety and effectiveness of tumor cell vaccines given with ISCOMATRIX and celecoxib in the treatment of lung and esophagus cancers. Eligibility: * Individuals at least 18 years of age who have primary small cell or non-small cell lung cancer, esophageal cancer, or pleural mesothelioma that can be removed by surgery. * Only individuals whose tumor cells are able to produce a tumor cell line for vaccine development will be eligible for treatment. Design: * Participants will be screened with a physical examination and medical history, and will have tumor tissue collected during their surgery to determine whether the tumor cells can be used to produce a vaccine. * Participants will take celecoxib twice daily for 7 days before having the first tumor cell vaccination. Participants will also have leukapheresis to collect blood cells for testing before the first vaccination. * Participants will receive one vaccine (which may be given in two shots) monthly for 6 months, and will continue to take celecoxib twice daily. One month after the 6th vaccine shot, participants will have another leukapheresis and skin test. If these tests show that a participant is responding to the vaccine, additional vaccines will be given every 3 months for up to 2 years. * Participants will have a physical exam and lab tests before each vaccination, blood samples and imaging studies every 3 months, and a skin test every 6 months. * Participants will have regular followup visits with imaging studies and blood samples for up to 5 years after the first vaccination, or until a new tumor develops.
Background: - Certain types of lung, esophageal, or thymic cancers and mesotheliomas have specific antigens (protein molecules) on their surfaces. Research studies have shown that giving a vaccine that contains antigens similar to these may cause an immune response, which may keep tumors from growing. Researchers are also interested in determining whether the chemotherapy drug cyclophosphamide and the anti-inflammatory drug celecoxib may help the vaccine work better, particularly in patients with lung cancer. Objectives: - To evaluate the safety and effectiveness of tumor cell vaccines in combination with cyclophosphamide and celecoxib in patients with cancers involving the chest. Eligibility: - Individuals at least 18 years of age who have had surgery for small cell or non-small cell lung cancer, esophageal cancer, thymoma or thymic carcinoma, and malignant pleural mesothelioma. Design: * Following recovery from surgery, chemotherapy, or radiation, participants will have leukapheresis to collect lymphocytes (white blood cells) for testing. * Participants will receive celecoxib and cyclophosphamide to take twice a day at home, 7 days before the vaccine. * Participants will have the vaccine in the clinical center (one or two shots per month for 6 months), and will stay in the clinic for about 4 hours after the vaccine. Participants will keep a diary at home of any side effects from the vaccine, and will continue to take cyclophosphamide and celecoxib. * One month after the sixth vaccine, participants will provide another blood sample for testing, and if the tests are satisfactory will return to the clinic every 3 months for 2 additional vaccines. * Participants will return to clinic for follow-up physical examinations, lab tests, and scans every 3 months for 2 years and then every 6 months for up to 3 years.
RATIONALE: Placing a stent in the esophagus may lessen swallowing difficulties and improve quality of life in patients with malignant dysphagia caused by esophageal cancer or gastroesophageal junction cancer. PURPOSE: This randomized clinical trial is studying self-expanding plastic stents to see how well they work compared with self-expanding metal stents in treating patients with malignant dysphagia caused by esophageal cancer or gastroesophageal junction cancer.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of decitabine in treating patients who have unresectable lung or esophageal cancer or malignant mesothelioma of the pleura.
This is a prospective, randomized, open-label, two-arm phase 2 trial that will evaluate whether the use of Pulsed Low-Dose-Rate radiation technique, as compared to standard radiation, is associated with reduced rates of clinically significant esophagitis during and following chemoradiation.
This phase II trial tests how well itraconazole works in combination with standard of care endoscopy with ablation for the prevention of esophageal cancer in patients with high-risk Barrett's esophagus (BE). BE is a condition in which the lining of the esophagus changes. The tissue that lines the esophagus becomes more like the tissue that lines the intestine. People with Barrett's esophagus have a higher risk of developing esophageal cancer. Itraconazole is a drug used to prevent or treat fungal infections. It belongs to the family of drugs called antifungal agents. Ablation refers to the removal of abnormal tissue using heat. Endoscopy is a procedure for looking at the esophagus using a long, flexible tube called an endoscope, which has a video camera at the end. Radiofrequency ablation is a type of heat therapy that uses radiofrequency energy (similar to microwave heat) to destroy the abnormal tissue in the esophagus. Giving itraconazole in combination with standard of care endoscopy with ablation may improve the effects of ablation and prevent esophageal cancer in patients with high-risk Barrett's esophagus.
This study plans to learn more about what patients think about screening for esophageal cancer (EAC) and Barrett's esophagus (BE); a pre-cancerous condition associated with esophageal cancer. The plan is to use this information to modify screening practices in the United States with the goal to decrease the number of people who die from esophageal cancer.
This study is being done to learn how 18F-FSPG PET/CT scan results may be related to the response to chemotherapy and radiation in patients with esophageal cancer.
The purpose of this study is to investigate whether exhaled breath can be used to detect and monitor esophageal cancer.
In a previous clinical trial in China and the United States (US), the investigators developed and validated a mobile, high-resolution microendoscope (mHRME) for screening and surveillance of esophageal squamous cell neoplasia (ESCN). The trial revealed higher specificity for qualitative (visual) interpretation by experts but not the novice and in the surveillance arm (100% vs. 19%, p \<0.05). In the screening arm, diagnostic yield (neoplastic biopsies/total biopsies) increased 3.6 times (8 to 29%); 16% of patients were correctly spared any biopsy, and 18% had a change in clinical plan. In a pilot study in Brazil, the investigators tested a software-assisted mHRME with deep-learning software algorithms to aid in the detection of neoplastic images and determine the performance, efficiency, and impact of the AI-mHRME when to Lugol's chromoendoscopy (LCE) alone and when using AI-mHRME with LCE. In this clinical trial, the investigators will build on the Brazil pilot trial data to optimize an artificial intelligence (AI) mHRME and evaluate its clinical impact and implementation potential in ethnically and socioeconomically diverse populations in the US and Brazil.
The purpose of the study is to examine the feasibility and acceptability of exercise "prehabilitation" for patients preparing for esophageal cancer resection (removal).
To learn if 18F-FAraG PET scans can find tumors in participants with esophageal cancer and predict a participant's response to treatment.
Recent advancements in swallowable esophageal cell-collection devices (SECD) offer a safe, minimally invasive, accurate, and low-cost alternative to esophageal screening without the need for an upper endoscopy. The BEST-RPP study aims to evaluate the acceptability and feasibility of using this novel approach to screen for Barrett's Esophagus (BE) and Esophageal Carcinoma (EAC) in rural primary care clinic settings in Oregon.
Prospective multicenter longitudinal (observational) study recruiting from tertiary centers for the surgical management of esophageal cancer; Virginia Mason Medical Center (Seattle, USA) and St Mary's Hospital (Imperial College, London, UK). This is intended to be a pilot study.
This phase II/III trial compares the addition of nivolumab to the usual treatment of paclitaxel and ramucirumab to paclitaxel and ramucirumab alone in treating patients with gastric or esophageal adenocarcinoma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Adding nivolumab to ramucirumab and paclitaxel may work better to treat patients with advanced stomach or esophageal cancer.
To learn how radiation treatment may affect your responses to vaccines against pneumonia.
This phase II trial studies how well amiodarone works in the prevention of atrial fibrillation (AF) after a minimally invasive esophagectomy (MIE) in patients with esophageal cancer. Atrial fibrillation (AF) is an irregular heart rhythm, usually associated with a rapid rate, that is caused by abnormal electrical activity within the atria. AF is the most common complication after MIE for esophageal cancer. There has never been a study of AF after MIE that has used unbiased assignment of patients to receive preventative amiodarone or not. Further, there is no standard recommendation or guideline for preventative medications, such as amiodarone, to decrease the risk of AF in patients having MIE performed for cancer. In fact, most medical centers in the United States and around the world do not give preventative amiodarone after esophagectomy. Giving amiodarone after MIE surgery may be able to reduce the risk of AF for patients with esophageal cancer.
The goal of this research study is to investigate the feasibility of implementing a prehabilitation program that aims to improve a patient's physical, nutritional, and sleep health before surgery in an older, at-risk group with esophageal cancer.
This is a Phase I/II study to determine the safety and immune response of the H1299 cell lysate vaccine mixed with Montanide(R) ISA-51 VG adjuvant, to be administered on the study in combination with Entinostat and Nivolumab in eligible participants with locally advanced esophageal cancers (EsC) following either neoadjuvant chemoradiation therapy (nCRT) or nCRT and surgery. Phase I of the protocol aims to determine the safe dose of the H1299 lung cancer cell lysate vaccine mixed with Montanide(R) ISA-51 VG adjuvant when it is administered in combination with Entinostat and Nivolumab. Phase II of the protocol will focus on assessing the level of immune response in participants receiving the study intervention when the H1299 cell lysate vaccine with Montanide(R) ISA-51 VG adjuvant is administered at the dose level determined in Phase I.
This clinical trial examines positron emission tomography (PET)/computed tomography (CT) in evaluating cardiac radiation damage in patients with lung or esophageal cancer. As part of the treatment for lung or esophageal cancer, patients will undergo radiation therapy. Sometimes, during this treatment, the heart is also subjected to some radiation which could affect its function, either increasing or decreasing the function. It is not known the consequences of this change nor is it known if doctors can detect the changes associated with the radiation. Sarcoidosis FDG positron emission tomography (PET)-computed tomography (CT) scans are a common way to image cardiac inflammation and myocardial viability. This study may help doctors image the heart before, during and after radiotherapy to monitor any changes.
Residual tumor at the proximal or distal margin after esophagectomy is a known prognostic factor for poor survival outcomes in patients with esophageal cancer; however, the significance of the circumferential resection margin (CRM) remains controversial. In this study, the investigators sought to evaluate the prognostic significance of the CRM in patients with esophageal cancer undergoing resection.
The purpose of this study is to determine whether the EnteroTracker can obtain biomarkers that have been studied to be significant in screening BE and EAC. The current standard of care is endoscopic biopsy where the pathologist will visualize the tissue under a microscope to interpret diagnosis. Another goal of this study is to understand tolerance of the procedure so it might be used in an at-home setting.
Esophageal cancer, which has a low 5-year overall survival rate (\<20%) is increasing in incidence. Previous studies have shown that Hedgehog, AKT, and angiogenic signaling pathways are activated in a significant number of esophageal cancers. Itraconazole, a widely used anti-fungal medication, effectively inhibits these pathways. In this multi-site phase II trial, the investigators will evaluate the effect of itraconazole as a neoadjuvant therapy added to standard of care chemoradiation and surgery in the the treatment of locoregional esophageal and gastroesophageal junction cancers.
This research study is being done for 2 reasons: 1) The investigators want to learn about the eating, smoking and drinking habits of adults, 18 years of age and older, in various Chicago communities, and 2) the investigators want to offer screening for participants whose smoking and drinking habits put them at risk for cancer.
This is a Phase 1/2, multicenter, randomized, open-label umbrella platform study to evaluate the safety and efficacy of investigational agents with or without pembrolizumab and/or chemotherapy, for the treatment of participants with second line (2L) esophageal squamous cell carcinoma (ESCC) who have previously been exposed to PD-1/PD-L1 based treatment.
This is Phase 1 dose finding trial with potential dose expansion to evaluate the safety, toxicity, recommended phase 2 dose (RP2D), and maximum tolerated dose (MTD) of Neratinib plus TDxD using a standard 3+3 dose escalation design in patients with metastatic or unresectable gastro-esophageal cancer that are HER2-overexpressing (IHC 3+ or IHC2+/ISH+) and any other gastrointestinal cancer with HER2 expression with IHC3+. Patients must have progressed or been intolerant of at least one prior line of chemotherapy + HER2 directed therapy.