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.
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.
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.
A Phase 2 Study of Durvalumab in Combination With Tremelimumab in Malignant Pleural Mesothelioma...
MesotheliomaThis research study is studying a pair of immunotherapies as a possible treatment for malignant pleural mesothelioma. The drugs involved in this study are: Durvalumab Tremelimumab
Long Term Follow-up of Mesothelioma Patients and Their Family Members With Germline Mutations in...
MesotheliomaFamiliesBackground: -A gene provides instructions to the body. Mutated genes can sometimes cause cancer. Germline mutations are those people are born with. These mutations in the BAP1 gene can cause mesothelioma and other cancers. Researchers want to study people with germline mutations of BAP1 and other genes known to cause cancer. Objective: -To learn how cancer might develop in people with certain gene mutations. Eligibility: -People ages 2 and older with a germline mutation in BAP1 or another gene that might cause cancer Design: Participants will be screened with: Medical and family history Saliva test Participants with mesothelioma will be in the NIH Group. Participants without mesothelioma can choose to be in either the NIH Group or the Remote Group. Remote Group participants will have a medical and family history by phone. If they have tumor tissue from a previous surgery, it will be tested. They will be contacted once a year by phone. NIH Group participants will have a baseline visit. This can take up to 4 days. They may have to stay in the area overnight. The visit will include: Physical exam Evaluation of tumor tissue if available Optional tumor biopsy Blood tests Scans: A machine will take pictures of the body. Photographs of skin lesions or other issues Skin exam Eye exam NIH Group participants will have visits once or twice a year. These will include a physical exam, lab tests, scans, and other tests as needed. Participants who have a confirmed mutation will be asked to contact any relatives who may be at risk and ask them about joining the study.
Glypican-1 Expression in Epithelioid Mesothelioma, Adenocarcinoma and SCC of the Lung
Lung Cancer AdenocarcinomaLung Cancer Squamous Cell1 moreLung carcinoma is the second most common cancer and a leading cause of cancer-related mortality worldwide. In Egypt, lung carcinoma ranks the 5th among all cancer cases. Malignant mesothelioma is an aggressive neoplasm that arises from mesothelial cells which form the lining of the pleural. There is a strong resemblance between epithelioid mesothelioma and lung adenocarcinoma, some of peripheral lung adenocarcinoma or SCC present with pleurotropic growth like mesothelioma. Glypican-1 (GPC1) is one the six glypican family members. It is one of cell surface heparan sulfate proteoglycans that acts as a growth factor signaling. The aim of this study is to evaluate the immunohistochemical expression of Glypican-1 in pleural epitheloid mesothelioma, lung adenocarcinoma and lung SCC
Prospective Evaluation of High Resolution Dual Energy Computed Tomographic Imaging, Noninvasive...
Familial CancerBRCA1-Associated Protein-1 (BAP1) Mutations2 moreBackground: A germline mutation is a change to a person s genes that is carried through their DNA. These mutations can be passed on from parents to their offspring. Germline mutations in a gene called BAP1 are linked to the development of mesothelioma and other cancers. Researchers want to follow people with these mutations to learn more. Objective: To see if researchers can improve how people who have or are suspected to have a BAP1 mutation are monitored over time. Eligibility: People age 30 and older who are suspected to have a BAP1 germline mutation. Design: Participants will be screened with a personal and family medical history. Their medical records may be reviewed. They will give a blood or saliva sample to test for a BAP1 mutation. They will get genetic counseling. To take part in this study, participants will enroll on 2 to 3 other protocols. Participants will have a physical exam. They may have a tumor biopsy. They will give blood and urine samples. They will have skin and eye exams. Some participants will have video-assisted thoracoscopy to examine the chest and lungs and diagnose suspicious areas. For this, a small camera is inserted into the chest through a small incision. Some participants will have laparoscopy to examine the organs inside the abdomen. For this, a small camera is inserted into the abdomen through a small incision. Participants will have imaging scans of the chest, abdomen, and pelvis. They may have brain scans. Participants will visit the NIH once a year for follow-up exams. Participation lasts indefinitely.
Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma
MesotheliomaThymoma3 moreBackground: Malignant mesothelioma is a malignancy arising from the mesothelial cells of the pleura, peritoneum, pericardium, or tunica vaginalis. Mesothelioma accounts for 0.10% of deaths annually in the United States. Malignant pleural mesothelioma is the most common of these, comprising of 80% of the cases with an annual incidence of about 2,500 in the United States. The median survival from diagnosis of pleural mesothelioma is approximately 12 months. The majority of patients present with stage III or IV disease with 85-90% of patients considered unresectable at diagnosis. Peritoneal mesothelioma has a better prognosis than pleural mesothelioma; nevertheless, patients undergoing therapy for peritoneal mesothelioma have few well-studied treatment options due in large part to the rarity of the disease. Objectives: -To allow sample acquisition for use in the study of mesothelioma. Eligibility: All patients age greater than or equal to 2 years with malignant mesothelioma Must be able and willing to provide informed consent if 18 or over; parent or guardian must be able and willing to provide consent for patients under the age of 18 Design: Up to 1000 subjects will be enrolled. Patients will be followed to determine the course of disease and to record any treatment received for mesothelioma. Patients will undergo sampling of blood, urine, tumor and abnormal body fluids for tissue banking. Studies which may be performed on banked material include genetic and genomic studies, establishment of cell cultures and immunologic studies.
Chemotherapy Followed by Surgery and Neoadjuvant Hemothoracic Intensity Modified Radiation Therapy...
MesotheliomaSolitary Fibrous Tumor of the PleuraThe purpose of this study is to determine the response rate and overall survival in patients that have been diagnosed with mesothelioma and will undergo chemotherapy, surgery and intensity modified radiation therapy (IMRT) as part of their standard of care.