This is a two phase study, The first phase (phase 1) will identify potential biomarkers among asbestos exposed individuals with pleural mesothelioma. The second phase (phase 2), is a double blinded case-matched controlled study to determine the predictive capability, sensitivity, and specificity of these biomarkers in detecting early stage pleural mesothelioma. Biomarkers in the form of volatile organic compounds (VOC) in exhaled breath samples from subjects with either pleural mesothelioma or pleural plaques, will be evaluated. A biomarker present in serum will also be concurrently evaluated in the same cohort. The soluble serum biomarker mesothelin related peptides (SMRP), which has been posited as a biomarker for mesothelioma, will be analyzed for its relationship to the breath VOC profile.
Clinical Trials: 'Clinical Trials' Category
A Feasibility Study Evaluating Surgery for Mesothelioma After Radiation Therapy Using Extensive Pleural Resection (SMARTER)
Primary Outcome Measures Maximum Tolerated Dose for Background Radiation [ Time Frame: Up to five years ]AEs will be graded by CTCAE. Maximum tolerated dose is the dose level that do not result in fatal lung injury (grade 5 lung toxicity) or life-threatening or fatal treatment related toxicity (grade 4+). Secondary Outcome Measures Patient morbidity [ Time Frame: Up to five years ]NCI more
A Clinical Study of Anetumab Ravtansine in Adults With Solid Tumors Who Have Been Treated in Previous Bayer-sponsored Anetumab Ravtansine Studies
The purpose of this study is to enable patients with solid tumors, who received anetumab ravtansine in a Bayer-sponsored clinical trial, to continue treatment after their respective study has been closed. The patients will be observed to collect information on how safe and efficient the drug is.
Primary Outcome Measures Maximum tolerated dose [ Time Frame: up to 24 months ]A dose will be considered tolerable if there are no more than 2 out of 10 participants with dose limiting toxicities. Inclusion Criteria Age >/= 18 years Karnofsky performance status >/= 70% Pathologic diagnosis of malignant pleural mesothelioma at MSK Positive immunohistochemical staining for WT-1 Patients mesothelioma/" title="Continue reading.">more
Primary Outcome Measures Subjective anxiety score by using the state-trait anxiety inventory form A (STAI-Y form A) questionnaire [ Time Frame: 90 days ]State anxiety reflects the current emotional state, which allows the patient’s nervousness and worry to be assessed during the session. The range is from 20 (lower anxiety) to 80 (higher anxiety). The patient must answer 20 more
Twelve patients with relapsed malignant pleural mesothelioma will be treated with intratumoral injections of MTG201, a replication incompetent adenovirus, modified by the insertion of the reduced expression in immortalized cells (REIC)/Dikkopf (Dkk)-3 gene, on Days 1, 8, 22, and 50. Patients will also receive every 4 weekly intravenous infusions of nivolumab, 480 mg, starting on Day 2. Safety and anti-tumor activity will be monitored at regular intervals throughout the study.
Naptumomab Estafenatox in Combination With Durvalumab in Subjects With Selected Advanced or Metastatic Solid Tumors
This is a dose escalation (Phase 1b) and cohort expansions (Phase 2) study to assess the safety and tolerability of a combination of Nap with durvalumab in subjects with selected advanced or metastatic solid tumors.
Study ASTX295-01 is a first in human Phase 1/2 open-label study of the safety, pharmacokinetics, and preliminary activity of ASTX295 in subjects with wild-type TP53 advanced solid tumors. Phase 1 is a dose escalation and dose expansion study design followed by a Phase 2 study.
Last update: May 07, 2019. 08:38:48 pm.