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Mesothelioma clinical trials

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NCT ID: NCT03560973 Recruiting - Mesothelioma Clinical Trials

A Double Blind, Placebo Controlled, Randomized Phase II Study Evaluating Gemcitabine With or Without Ramucirumab , for II Line Treatment MPM

RAMES
Start date: December 22, 2016
Phase: Phase 2
Study type: Interventional

Study RAMES is a multicentre, double-blind, randomized Phase II study exploring the efficacy and evaluating the safety of the addition of ramucirumab to gemcitabine as the second-line treatment of patients with diffuse pleural mesothelioma. Patients will be randomly assigned (1:1) to receive intravenous gemcitabine 1000 mg/m2 on days 1 and 8 every 21 days with placebo or combined with intravenous ramucirumab 10 mg/Kg (ramucirumab group) on day 1 of a 21 day cycle until PD. Randomisation will be done via a centralized system and will stratified by performance status (0-1 vs 2), age (≤70 vs >70), histology (epithelioid vs others), time to progression (TTP) after a previous treatment (first line therapy, adjuvant or neoadjuvant therapy) (< 6 months vs ≥6 months).

NCT ID: NCT03558932 Not yet recruiting - Clinical trials for Malignant Mesothelioma

IP3R Modulation by Cancer Genes in Mesothelioma

Start date: January 2019
Phase:
Study type: Observational

Obtaining pleural biopsies in cases of malignant mesothelioma to detect molecular mechnisms and signal transduction

NCT ID: NCT03546426 Not yet recruiting - Advanced Cancer Clinical Trials

Pembrolizumab Plus Autologous Dendritic Cell Vaccine in Patients With PD-L1 Negative Advanced Mesothelioma Who Have Failed Prior Therapies

MESOVAX
Start date: August 2018
Phase: Phase 1
Study type: Interventional

Pembrolizumab plus autologous dendritic cell vaccine in patients with PD-L1 negative advanced mesothelioma who have failed prior therapies.This is an exploratory, single-arm, open-label, phase 1b clinical trial. Patients will receive pembrolizumab 200 mg and autologous dendritic cell vaccine every 3 weeks for the first 6 cycles, followed by pembrolizumab 200 mg every 3 weeks until confirmed progression or for a maximum of 2 years (see Figure 1 Study Schema). After each vaccine administration patients will receive IL-2 3 MU s.c. for 5 days, from day +2 to day +6.

NCT ID: NCT03538028 Not yet recruiting - Ovarian Cancer Clinical Trials

A Safety and Tolerability Study of INCAGN02385 in Select Advanced Malignancies

Start date: July 2018
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the safety, tolerability, and preliminary efficacy of INCAGN02385 in participants with advanced malignancies.

NCT ID: NCT03537833 Recruiting - Clinical trials for Patients With Non-small Cell Lung Cancer (NSCLC) and Pleural Mesothelioma and Treated With a Pemetrexed-based Chemotherapy

Association Between Proton Pump Inhibitors and Hematologic Toxicity of Pemetrexed

IPPEM
Start date: September 1, 2017
Phase:
Study type: Observational

Pemetrexed is a multi-folate inhibitor approved in the treatment of non-small cell lung cancer (NSCLC) and pleural mesothelioma. Its toxicity profile is mainly hematologic (anemia, neutropenia and thrombopenia) and can be limiting when > grade 2 according to NCI-CTCAE criteria. First clinical trials highlighted hematologic toxicity, especially anemia, which was reduced by decreasing pemetrexed dosage from 600 to 500 mg/m² Q3W and by adding systematic vitamin supplementation (B9/B12). Despite this, incidence of hematological toxicity remains frequent with anemia occurring in more than 20% of patients treated by pemetrexed in combination. Methotrexate, a well-known antineoplastic drugs used in several cancer and non-cancer disease conditions can also induced severe hematologic toxicity in case of methotrexate-reduced elimination and, as a consequence, its accumulation. For example, the elimination of methotrexate is mediated by tubular secretion through type 1 and type 3 organic anion transport (hOAT1 and hOAT3). Association with drugs that inhibits hOATs can induced a hematological toxicity caused by methotrexate accumulation. Among these, proton pump inhibitors (PPIs) are known to inhibit hOATs. The drug interaction that results from their combination with methotrexate is clinically relevant and lead to an increased hematological toxicity. However, hypothetical drug interaction between PPIs and pemetrexed is unknown while pemetrexed seems to be mostly eliminated by hOAT3 (11-fold higher than methotrexate). One study revealed lansoprazole to inhibits in vitro hOAT3. This same study investigates in a retrospective chart patients treated by pemetrexed and the study found a significant association between combination with PPI and hematological toxicity by pemetrexed. Unfortunately this study lacks of relevant methodology and suffered from its retrospective chart. This potential drug interaction must be a real concern for oncologists and clinical pharmacists. The investigators aim to investigate the potential association between PPIs and pemetrexed combination and the incidence of hematological toxicity in a multicenter and prospective study.

NCT ID: NCT03531840 Not yet recruiting - Mesothelioma Clinical Trials

Olaparib in People With Malignant Mesothelioma

Start date: June 22, 2018
Phase: Phase 2
Study type: Interventional

Background: The drug olaparib may stop cancer cells from fixing damage to their DNA. It has been approved to treat certain cancers in people that were born with a mutation in the BRCA gene. It has not been approved for treating mesothelioma. But some people with mesothelioma have mutations in a gene, BAP1 related to BRCA. Researchers want to see if olaparib can work in patients with mutations in this gene. They also want to see if works on mutations in other genes or patients without any mutations. They want to see if olaparib causes mesothelioma tumors to shrink. Objective: To study the effect of olaparib on mesothelioma. Eligibility: People ages 18 and older with malignant mesothelioma that has already been treated Design: Participants will be screened with Sample of tumor tissue or fluid Medical history Physical exam Blood, heart, and urine tests Scans and x-rays Participants will give blood and tissue samples. These will be genetically tested. The study will be done in 21-day cycles. Participants will take tables of the study drug 2 times each day. They will get information on what food and drugs to avoid during the study. They will get information about birth control. They will keep a diary of doses and symptoms. Participants will have blood and urine tests and scans every few weeks. Participants will be told any important genetic testing results. Participants will stay in the study until their disease gets worse or the participant or their doctor chooses to stop it. About 30 days after stopping the study drug, participants will have a follow-up visit. They will have a medical history, physical exam, blood tests, and scans. Some participants will continue to have scans every 6 weeks.

NCT ID: NCT03507452 Not yet recruiting - Clinical trials for Mesothelioma, Ovarian Neoplasms

First-in-human Study of BAY2287411 Injection, a Thorium-227 Labeled Antibody-chelator Conjugate, in Patients With Tumors Known to Express Mesothelin

Start date: June 29, 2018
Phase: Phase 1
Study type: Interventional

The primary objective of this study is, to determine the safety, tolerability, maximum tolerated dose (MTD) or maximum feasible dose of BAY2287411 Injection in patients with epithelioid malignant mesothelioma and serous ovarian cancer

NCT ID: NCT03502746 Not yet recruiting - Clinical trials for Mesothelioma, Malignant

Phase II Nivolumab and Ramucirumab for Patients With Previously-Treated Mesothelioma

Start date: May 2018
Phase: Phase 2
Study type: Interventional

This study will evaluate the combination of Nivolumab and Ramucirumab in patients with previously-treated mesothelioma.

NCT ID: NCT03436732 Recruiting - Mesothelioma Clinical Trials

Mesothelin-Targeted Immunotoxin LMB-100 in Combination With SEL-110 in Subjects With Malignant Pleural or Peritoneal Mesothelioma

Start date: February 28, 2018
Phase: Phase 1
Study type: Interventional

Background: Mesothelioma is cancer of the tissue that lines some organs. A new drug, LMB-100, may bind to a protein on mesothelioma tumors and kill cancer cells. But sometimes the body makes antibodies that reduce how well LMB-100 works. Researchers want to see if adding the drug SEL-110 to LMB-100 will prevent these antibodies from forming. Objective: To learn how safe and tolerable LMB-100 plus SEL-110 is in people with advanced mesothelioma. Eligibility: Adults ages 18 and older who have pleural or peritoneal mesothelioma that has not responded to prior platinum-based therapy Design: Participants will be screened with - Medical history - Physical exam - Blood and urine tests - Sample of tumor tissue. This can be from a previous procedure. - Scan of the chest, abdomen, and pelvis. Participants will lie on a table in a scanner that takes pictures. A special dye may be injected in a vein. - Positron emission tomography (FDG-PET) scan. A sugar attached to a chemical that gives off a signal will be injected before the scan. - Heart function tests The study will be done in 21-day cycles. Participants will get the study drugs for up to 4 cycles. They will get them through an IV catheter (a tube inserted in a vein, usually in the arm): - LMB-100 for about 30 minutes on day 1, day 3, and day 5 of each cycle - SEL-110 for about 1 hour on day 1 of each cycle Participants will get standard medicines to help prevent side effects. Participants will repeat some screening tests during each cycle and about 5 weeks after the last dose of study drug.

NCT ID: NCT03412357 Recruiting - Clinical trials for Malignant Pleural Mesothelioma

MesoTRAP: A Study Comparing Video-assisted Thoracoscopic Partial Pleurectomy/Decortication With Indwelling Pleural Catheter in Patients With Trapped Lung Due to Malignant Pleural Mesothelioma.

MesoTRAP
Start date: August 10, 2017
Phase: N/A
Study type: Interventional

Malignant pleural mesothelioma is a cancer, caused by asbestos, which currently affects 2500 people in the UK each year. The main symptom is breathlessness caused by fluid building up in the space between the lung and the chest wall (pleural effusion). Treatment involves draining the fluid to allow the lung to re-expand (pleurodesis). However, sometimes tumour growth over the surface of the lung can prevent it from re-expanding. This 'trapped' lung results in fluid re-accumulation and repeated drainage which can lead to discomfort and multiple hospital visits. One approach to dealing with 'trapped' lung in mesothelioma is to insert a thin tube (Indwelling Pleural Catheter - IPC) into the space around the lung. The tube can stay in place for a long time allowing patients to drain off fluid at home. Another approach is a keyhole surgical operation (video-assisted thoracoscopic partial pleurectomy/decortication - VAT-PD) to remove as much tumour as possible from the lining of the lung to allow it to re-expand. While both approaches are currently offered in clinical practice, it is not known which of the two is most effective at relieving breathlessness. The only way to find out is to conduct a research trial comparing the two. The Investigators plan to do this, but first of all need to carry out a small pilot study to collect information necessary to help plan the full study.