Purpose: Surgery for malignant pleural mesothelioma is complex and prolonged, and may involve significant blood loss with considerable blood and product transfusion. Thromboelastography (TEG) is a global assay of coagulation that uses whole blood to produce a tracing that records kinetic changes in clot formation. This study aims provide a better understanding of the coagulation profile of these patients, and will form the basis of a TEG-based transfusion algorithm for future surgeries for mesothelioma.
Pleural Mesothelioma
Nintedanib (BIBF 1120) in Mesothelioma
Purpose: This is an exploratory study designed to evaluate the safety and efficacy of nintedanib (BIBF 1120) in combination + (pemetrexed / cisplatin) followed by nintedanib (BIBF 1120) versus placebo + pemetrexed / cisplatin followed by placebo for the treatment of patients with unresectable malignant pleural mesothelioma.
Pharmacogenetics Of Vinorelbine In Malignant Pleural Mesothelioma Patients
Purpose: This is a multicenter retrospective analysis .The aim of the present study is to investigate the molecular predictors of vinorelbine response in tumor samples of a series of MPM patients and evaluate the possible impact on clinical outcome.
Tivantinib in Treating Patients With Previously Treated Malignant Mesothelioma
Purpose: This phase II trial studies how well tivantinib works in treating patients with previously treated malignant mesothelioma. Tivantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
- Arms
- Experimental: Treatment (tivantinib)
- Patients receive tivantinib PO BID. Treatment continues in the absence of disease progression or unacceptable toxicity.
- Assigned Interventions
- Drug: tivantinib
- Given PO
- Other Name: ARQ 197
- Other: laboratory biomarker analysis
- Correlative studies
Randomized, Double-blind Study Comparing Tremelimumab to Placebo in Subjects With Unresectable Malignant Mesothelioma
Purpose: This is a Phase 2, randomized, double-blind, parallel-group study. Subjects with unresectable pleural or peritoneal malignant mesothelioma will be randomized in a 2:1 ratio to receive either tremelimumab or placebo. Approximately 180 subjects will be enrolled at study centers in multiple countries. The study consists of a screening period, a treatment period, and a 90-day follow-up period.
Arms and Assigned Interventions:
- Experimental: Tremelimumab
- Drug: Tremelimumab
- Tremelimumab is to be administered as an IV solution, followed by observation.
- Placebo Comparator: Placebo
- Drug: Placebo
- Placebo is to be administered as an IV solution, followed by observation.
Biomarkers to Detect Mesothelioma Early in Patients Exposed to Asbestos or Vermiculite
RATIONALE: Studying samples of body fluid and blood from patients who have been exposed to asbestos or vermiculite in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.
PURPOSE: This laboratory study is looking for biomarkers to detect mesothelioma early in patients exposed to asbestos or vermiculite
Clinical and Histopathologic Characteristics of BAP1 Mutations
Purpose: The goal of this protocol is to determine the prevalence of somatic and germline mutations in BAP1 (BRCA associated protein-1) among patients with malignant pleural mesothelioma (MPM), choroidal nevus, primary uveal melanoma (UM), or metastatic UM seen at our institution.
A Phase II Study of Single-agent DOVitinib in Advanced Malignant Pleural Mesothelioma Which Has Progressed Following Prior Platinum-Antifolate Chemotherapy (DOVE-M)
Purpose: This is a single-arm, open label, two stage, phase II study of dovitinib in patients with advanced Malignant Pleural Mesothelioma (MPM). The primary purpose of this study is to evaluate the potential efficacy of dovitinib in the second- or third-line treatment of MPM using progression free survival (PFS).
Intra-pleural Administration of GL-ONC1, a Genetically Modified Vaccinia Virus, in Patients With Malignant Pleural Effusion: Primary, Metastases and Mesothelioma
Purpose: The purpose of this study is to test the safety of the GL-ONC1 vaccinia virus at different dose levels. The investigators want to find out what effects, good and/or bad, it has on the patient and the malignant pleural effusion. A malignant pleural effusion is a build up of fluid in the chest cavity cause by the cancer.
- Arms: Experimental: GL-ONC1
- This is an open-label, dose-escalating, non-randomized, single-center phase I study to determine the dose recommended for further evaluation of the genetically modified vaccinia virus GL-ONC1 when administered intrapleurally as a single dose to patients with malignant pleural effusion.
- Assigned Interventions:
- Biological: GL-ONC1. Patients will be enrolled in groups of three and individually assessed for safety and dose limiting toxicity (DLT).
Re-directed T Cells for the Treatment (FAP)-Positive Malignant Pleural Mesothelioma
Purpose: MPM patients not eligible for surgical procedures like decortication or pleuro-pneumectomy have a median survival of 12 months with palliative chemotherapy. Therefore, new therapeutic approaches are of crucial need in this clinical situation. This is a phase I trial for patients with malignant pleural mesothelioma with pleural effusion testing the safety of a fixed single dose of 1x10e6 adoptively transferred FAP-specific re-directed T cells given directly in the pleural effusion. Lymphocytes will be taken 21 days before transfer from peripheral blood. CD8 positive T cells will be isolated and re-programmed by retroviral transfer of a chimeric antigen receptor (CAR) recognizing FAP which serves as target structure in MPM.
