Phase I Dose-Escalation /Phase II Monocentric Open Trial for Evaluation of Safety and Efficacy of Intracavitary Cisplatin-Fibrin Localized Chemotherapy After Pleurectomy/Decortication or Extrapleural Pneumonectomy for the Treatment of Patients With Malignant Pleural Mesothelioma
The aim is to introduce a new therapeutic method of intracavitary chemotherapy (cisplatin) combined with a fibrin carrier (Vivostat®) after pleurectomy/decortication or extrapleural pneumonectomy in a phase I and II study for Malignant Pleural Mesothelioma patients by evaluation of the safety in a dose-escalating model (phase I), and confirmation of safety and efficacy in phase II with the maximum tolerated dose in phase I.
NCT01644994 — Malignant Pleural Mesothelioma
Status: Completed
http://inclinicaltrials.com/malignant-pleural-mesothelioma/NCT01644994/
A Single-center, Open Label Study for Evaluation of the Safety and Efficacy of Oshadi D and Oshadi R for Malignant Mesothelioma Treatment - A Phase IIa Study
Malignant 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.
NCT01627795 — Mesothelioma
Status: Suspended
http://inclinicaltrials.com/mesothelioma/NCT01627795/
PIT: A Phase III Randomised Trial of Prophylactic Irradiation of Tracts in Patients With Malignant Pleural Mesothelioma Following Invasive Chest Wall Intervention
The PIT (Prophylactic Irradiation of Tracts) trial will determine whether or not PIT radiotherapy is effective in preventing or delaying the onset of chest nodules in patients with Mesothelioma.
NCT01604005 — Mesothelioma
Status: Terminated
http://inclinicaltrials.com/mesothelioma/NCT01604005/
Phase II Study of Erlotinib for Patients With Malignant Peritoneal Mesothelioma (MPeM) Exhibiting EGFR Mutations
The purpose of this study is to test the drug erlotinib (erlotinib hydrochloride) in people with malignant peritoneal mesothelioma who have a specific genetic mutation in their cancer. Erlotinib has been approved by the United States Food and Drug Administration (FDA) for other cancers, but erlotinib has not been approved for malignant peritoneal mesothelioma. This research is being done because there is no current standard treatment for malignant peritoneal mesothelioma and the study doctors want to see how erlotinib affects malignant peritoneal mesothelioma.
NCT01592383 — Malignant Peritoneal Mesothelioma
Status: Completed
http://inclinicaltrials.com/malignant-peritoneal-mesothelioma/NCT01592383/
Consortium for the Sharing of Germ Line DNA and Tissue From Subjects With Mesothelioma
The purpose of this research study is to investigate the possibility that a person's genes put a person at a higher risk of developing mesothelioma. The investigators will examine genes from DNA (genetic material) isolated from blood. This study will also examine the impact of environmental and work exposures and family history of common cancers on the development of mesothelioma. The genetic markers in this study will basically identify how a person's body processes frequently encountered environmental pollutants and will not tell about chromosomes, specific diseases, or other potential health problems.
NCT01590472 — Mesothelioma
Status: Completed
http://inclinicaltrials.com/mesothelioma/NCT01590472/
A Phase I/II Study of First Line Ganetespib With Platinum, in Patients With Malignant Pleural Mesothelioma
Malignant pleural mesothelioma (MPM) is a rapidly lethal cancer arising from the parietal pleural mesothelium, and is associated with exposure to asbestos. Once a rare disease, it is increasing in incidence in the UK and is presently more common than cervical cancer. MPM is characterized by local invasion of adjacent structures including the chest wall, mediastinum, diaphragm and pericardium resulting in progressive shortness of breath. Median survival with best supportive care alone is approximately 6-9 months and most cases of mesothelioma present in the advanced setting. Therefore this trial will be looking at whether a new drug, Ganetespib has any improvement on survival for these types of patients.
NCT01590160 — Lung Cancer - Malignant Pleural Mesothelioma
Status: Completed
http://inclinicaltrials.com/lung-cancer-malignant-pleural-mesothelioma/NCT01590160/
A Phase II Trial to Assess the Safety, Immunological Activity of TroVax® Plus Pemetrexed/Cisplatin in Patients With Malignant Pleural Mesothelioma
This study is for patients with malignant mesothelioma of the lung lining (called pleura) who are planning to have pemetrexed-cisplatin chemotherapy. We are investigating whether giving a vaccine called TroVax® with pemetrexed-cisplatin chemotherapy is both safe and potentially beneficial in patients with mesothelioma. This vaccine has been used in combination with chemotherapy in other types of cancer and has been shown to be safe. Cancer vaccines work by stimulating the person's immune system to fight the disease, in a similar way to the immune system fighting infection. In laboratory experiments, the vaccine has been shown to stimulate an immune response to a particular protein widely found on mesothelioma cells called 5T4. In patients with mesothelioma it is hoped that the vaccine will stimulate the immune system to attack mesothelioma cells carrying the 5T4 protein. Pemetrexed-cisplatin chemotherapy is currently seen as the best treatment for patients with mesothelioma, and this is why we plan to combine it with the vaccine. It is hoped that the combination of the TroVax® vaccine and chemotherapy is more beneficial than chemotherapy alone. Pemetrexed-cisplatin will be given into a vein in the arm (intravenously) every 3 weeks. The TroVax® vaccine will be given as an injection into the shoulder muscle (intramuscularly) 3 weeks before chemotherapy starts, one week before chemotherapy starts, then every 3 weeks. Each participant will receive 4 chemotherapy and 9 vaccine treatments if they complete the planned trial schedule. We aim to recruit 26 patients into the trial over a two year period. If this study shows that pemetrexed-cisplatin chemotherapy plus the TroVax® vaccine is safe and beneficial in terms of stimulating the immune system, the combination will be tested further in larger clinical trials.
NCT01569919 — Mesothelioma
Status: Recruiting
http://inclinicaltrials.com/mesothelioma/NCT01569919/
A Phase 1 Trial of Oncolytic Measles Virotherapy in Mesothelioma
This phase I clinical trial investigates the side effects and the best dose of local (intrapleural measles virus therapy in treating patients with malignant pleural mesothelioma (MPM). The investigators anticipate that the intrapleural of the vaccine strain measles virus will enable the virus to specifically infect and kill cancer cells and spare, without damaging normal cells. Furthermore, the investigators expect the measles virus to trigger an anti-tumor immune response which will result in additional destruction of the tumor by immune cells
NCT01503177 — Recurrent Malignant Mesothelioma
Status: Completed
http://inclinicaltrials.com/recurrent-malignant-mesothelioma/NCT01503177/
A Phase II Study of PF-03446962 in Patients With Advanced Malignant Pleural Mesothelioma
This is a non-randomized open label multicentre Phase II trial to evaluate the response rate of PF03446962 in patients with advanced malignant pleural mesothelioma who have been previously treated with cytotoxic chemotherapy.
NCT01486368 — Malignant Pleural Mesothelioma
Status: Completed
http://inclinicaltrials.com/malignant-pleural-mesothelioma/NCT01486368/
A Phase 1, Single Center, Dose-Escalation Study of SS1(dsFv)PE38 Administered Concurrently With Pemetrexed and Cisplatin in Subjects With Unresectable Malignant Epithelial Pleural Mesothelioma
Background: Standard therapy for mesothelioma is a combination of the drugs pemetrexed and cisplatin. However, the benefits of this treatment are limited, and in most treated patients the disease continues to worsen. SS1(dsFV)PE38 is a genetically engineered drug. It contains an antibody that binds to a certain protein on mesothelioma cells and a toxin (type of poison) made from a product of a bacterium called Pseudomonas aeruginosa. It is hoped that the antibody will attach to the cancer cells, allowing the toxin to enter and kill the cells. Objectives: To find out if SS1(dsFV)PE38, together with pemetrexed and cisplatin is safe and tolerable in patients with mesothelioma. To determine the maximum tolerated dose of SS1(dsFV)PE38 (the highest dose that does not cause unacceptable side effects). To see if SS1(dsFV)PE38 given with pemetrexed and cisplatin has any effect on patients tumors. To learn how the body breaks down SS1(dsFV)PE38. Eligibility: Patients 18 years of age and older with epithelial pleural mesothelioma whose disease cannot be cured with surgery, and have not had prior treatment with chemotherapy. Design: Treatment with pemetrexed, cisplatin and SS1(dsFV)PE38 in two 21-day cycles as follows: - Day 1 - Intravenous (through a vein) infusions of pemetrexed and cisplatin. - Days 1 and 2 - Intravenous solution to prevent dehydration that might occur with SS1(dsFV)PE38. - Days 1, 3 and 5 Intravenous infusion of SS1(dsFV)PE38. Small groups (3 to 6) of patients are given SS1(dsFV)PE38 at a certain dose level. If the first group experiences no significant side effects, the next group a higher dose. This continues in succeeding groups until the maximum tolerated study dose (highest dose that patients can be given safely) is determined. Continuing standard treatment with additional cycles of pemetrexed and cisplatin. Evaluations during the treatment period: - Physical examination, including vital signs and body weight checks, and pregnancy test for women who can become pregnant. - Questions about medications and side effects. - Blood and urine tests. - Disease evaluation with CT, chest X-ray, and possibly PET scans, lung function tests, pulse oximetry, performance of daily activities and quality-of-life questionnaires. Post-treatment evaluations: - Clinic visits at months 1, 3, 6, 12, 15, 18 and 21 for physical examination and disease assessment. - End-of-study visit for blood tests, vital signs and weight measurements, disease assessment, electrocardiogram, pregnancy test for women who can become pregnant
NCT01445392 — Mesothelioma
Status: Terminated
http://inclinicaltrials.com/mesothelioma/NCT01445392/