Decitabine/Cedazuridine (INQOVI), an Oral DNA Demethylating Agent, in Subjects With BAP1 Cancer...
MesotheliomaMalignant Mesothelioma (MM)4 moreThis is a Phase II study to determine the rate of stabilization or disease improvement from investigational decitabine/cedazuridine (INQOVI) treatment in subjects with BRCA1-Associated Protein-1 (BAP1) Cancer Predisposition Syndrome (CPDS) and subclinical, early-stage mesothelioma. Progression-free survival (PFS) will also be determined for treated subjects, and the treatment safety (toxicity) evaluated.
A Study of Yervoy and Opdivo Combination Therapy in Participants With Unresectable Advanced/Recurrent...
MesotheliomaMalignantThe purpose of this study is to observe the safety of the combination therapy with Yervoy and Opdivo in Japanese participants for the treatment of unresectable advanced/recurrent malignant pleural mesothelioma (MPM).
Prospective Data Collection on Clinical, Radiological and Patient Reported Outcomes After Pleural...
Pleural DiseasesPleural Mesothelioma10 moreThe PROSPECT study aims to look at the number of problems or side effects which occur after patients have had a procedure completed to remove fluid or air from the space between the lung and the chest wall. Other information will also be collected to see whether anything else affects which patients have problems after the procedure such as bleeding or infection. This study will also investigate whether it is possible to find out which patients are likely to feel a lot better after the procedure. Not all patients feel significantly better but it is not clear why this is. There are a number of different reasons patients may not feel better, for example if the lung is not able to fully re-expand. The study aims to look at whether it is possible to predict these problems before the procedure using ultrasound. If it is possible to find the answers to some of these questions it might be possible to prevent patients undergoing treatments which are not likely to benefit them. The study will use information already collected as part of clinical care, as well as questionnaires from patients receiving care at a variety of centres. The different features of these centres will also be considered in analysis.
Peritoneal Surface Malignancies - Characterization, Models and Treatment Strategies
Pseudomyxoma PeritoneiColorectal Carcinoma2 moreThe aim of this study is to identify biomarkers of disease recurrence and prognosis to optimize patient selection for treatment with cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC), and through animal models to explore different treatment strategies for peritoneal surface malignancies (PSM).
Assessment of Histologic Prognostic Factors in Peritoneal Malignant Mesothelioma
Peritoneal Malignant MesotheliomaMalignant peritoneal mesothelioma is a rare neoplasm. The most common type, the epithelioid type, has been further divided into histological patterns of tubulo-papillary, acinar, adenomatoid, micropapillary, or solid. Its prognosis is improved by the use of a locoregional treatment combining extensive cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC), which increases survival up to 50 months. Histology is one of the most important prognostic variable that, forms the basis for treatment decisions. However, the prognostic of the epithelioid type varies greatly due to its tumor heterogeneity. It is therefore necessary to find prognostic factors of malignant epithelioid peritoneal mesothelioma in order to better define the therapeutic strategy. Among histological factors, solid growth, tumor necrosis, nuclear atypia, and mitotic count were found to be independent prognostic factors in epithelioid malignant pleural mesothelioma. However, in epithelioid malignant peritoneal mesothelioma (EMPM), these factors were studied in small and heterogeneous series in terms of histological growth and definitions used for histological factors. The present large study was conducted to investigate the prognostic impact of several histologic factors in EMPM. Their prognosis impacts were assessed using overall survival (OS) and progression-free survival (PFS) in EMPM.
Clinical Study to Evaluate Safety and Dosing of CA9hu-1 in Patients With Advanced Solid Tumours...
Clear Cell Renal Cell Carcinoma MetastaticTNBC - Triple-Negative Breast Cancer4 moreCarbonic anhydrase IX (CA IX) has been implicated in the progression of most solid tumours and expression has been demonstrated in clinical samples from a variety of solid cancers. High expression is often associated with high grade or metastatic disease and poor prognosis. CA IX is not expressed in normal tissue, potentially providing a cancer-associated target that would not likely result in significant interruption of normal biologic function in organs not affected by cancer. A humanized monoclonal antibody CA9hu-1 has shown robust activity in a variety of tumour models including models of ovarian, prostate, breast, pancreatic, colon and lung where tumour growth and metastasis are inhibited when CA9hu-1 is used as a monotherapy. Enhancement of chemotherapy has also been demonstrated in several models in combination with CA9hu-1. CA IX is also expressed by tumour-associated cells (angiogenic endothelium, tumour-associated macrophages), which also drive cancer progression. Thus, targeting CA IX with CA9hu-1 in cancer patients is expected to affect multiple pathways and multiple tumour compartments that are important to tumour progression. Taken together, there is strong rationale for developing hu-CA91 for the treatment of advanced cancer. The present study was designed to establish safety and toxicity profile and maximum tolerated dose of CA9hu-1, evaluate pharmacokinetics, investigate the presence of anti-drug antibody, to document anti-tumour activity at a clinically relevant dose, and to document the use of [18F]FLT-PET as a biomarker for detection of early tumour response at a clinically relevant dose.
Rapid Autopsy and Procurement of Cancer Tissue
Thymus TumorsAdoptive Cellular Therapy3 moreBackground: - Individuals with cancer of the lung, chest cavity, ovary, or bladder, as well as patients who have been treated with adoptive cell therapy unfortunately commonly succumb to their disease. Some agree to donate their bodies to cancer research that may help the medical community better understand these diseases. Studies of cancer tumor tissue obtained soon after death may be used to answer questions about the origins, progression, and treatment of cancer. Researchers want to conduct a study that involves planned collection of cancer tumor tissue shortly after death. To do so, they will arrange to provide inpatient hospice care for people with non-small cell lung cancer, ovarian cancer, bladder cancer, or patients who have been treated with adoptive cell therapy. <TAB> Objectives: - To collect cancer tissue biopsy samples as soon as possible after death. Eligibility: - Individuals who have cancer of the lung, chest cavity, ovary, or bladder, or those who have been treated with adoptive cell therapy and are planning to receive end-of-life hospice care are eligible to participate. Design: Participants will agree to receive inpatient hospice care at the National Institutes of Health Clinical Center. Full details on end-of-life care preference will be acknowledged. An autopsy will be performed at the clinical center within 3 hours of death. Tumor tissue will be collected from the primary site of cancer and from any areas of the body to which the cancer has spread. Participants will not receive further cancer treatments as part of this study. This is a tissue collection study only....
Improving Patient and Caregiver Understanding of Risks and Benefits of Immunotherapy for Advanced...
Stage IV MelanomaAdvanced Lung Cancer20 moreThe purpose of this study is to refine and pilot test educational material developed to educate and support patients receiving immunotherapy for advanced cancer. The intervention is an educational video and question prompt list (QPL) to promote communication between patients, caregivers, and the oncology team about the risks and benefits of immunotherapy.
eRAPID: Online Symptom Reporting in Lung Cancer
Thoracic CancerNon-small Cell Lung Cancer2 moreLung cancer is a leading cause of cancer-related ill-health and death in the United Kingdom (UK), but with advances in systemic anti-cancer therapies the prognosis for people in later stages is improving. There is growing evidence that electronic systems which enable patients to monitor and report symptoms can help improve symptom control and patient care. This study aims to investigate optimal ways of introducing an electronic symptom reporting system (eRAPID) in lung cancer care at Leeds Cancer Centre. eRAPID was developed by the University of Leeds and its integration with the electronic health records at Leeds Cancer Centre enables staff to view patient symptom reports directly. eRAPID provides advice to patients about self-management of milder symptoms, for serious symptoms patients are encouraged to contact the hospital and an alert is sent to the nurse or doctor by email. The aim of the study is to assess the feasibility and usefulness of an electronic symptom reporting system (eRAPID) for lung cancer patients and healthcare professionals during the treatment of lung cancer and during one year follow up. Two groups of patients will be recruited on the basis of their access to the internet at home (rather than randomisation). It is anticipated that approximately 100 patients will enrol into one of two groups: Group 1: Patients with online access at home will be asked to report weekly using their own devices. Group 2: Patients without online access will be asked to report on a tablet computer before their planned clinic appointments. The eRAPID questionnaire is based on existing eRAPID items with the addition of new items specific to lung cancer. These have been developed by the clinical team and patient groups have been consulted over the suitability of the wording used. Analysis of patient reported symptoms, quality of life and clinical information will be descriptive. Disease-related symptoms and health-related quality of life will be compared across groups of patients with a diagnosis of lung cancer. Treatment-related side effects of patients will be compared across the different types of treatment received. To determine the best means of engaging patients in systematic electronic reporting, the recruitment and compliance rate will be compared between the two patient groups. The utility of patient reported information to healthcare staff will be assessed through staff interviews.
Safety and Efficacy of Oshadi D and Oshadi R for Malignant Mesothelioma Treatment
MesotheliomaMalignant mesothelioma is a rare neoplasm that arises most commonly from the mesothelial surfaces of the pleural cavity, occasionally from the peritoneal surface, and rarely from the tunica vaginalis or pericardium. It has an extremely poor prognosis with a median survival of 4 to 13 months for untreated patients 1 and 6 to 18 months for treated patients, regardless of the therapeutic approach. The anticancer activity of Oshadi D and Oshadi R treatment was tested in preclinical studies and in phase I clinical study. Four metastatic mesothelioma patients are treated for 5 to 12 months. The Oshadi D and Oshadi R combination treatment was generally well-tolerated with no dose-limiting toxicities observed.