Nintedanib as Maintenance Treatment of Pleural Malignant Mesothelioma (NEMO): a Randomized Double Blinded Phase II Study of the EORTC Lung Cancer Group
This is a multicenter, randomized, 1:1, double blinded phase II trial. Patients with unresectable malignant pleural mesothelioma (MPM) will be randomized between arm A: nintedanib and arm B:placebo
NCT02863055 — Malignant Pleural Mesothelioma
Status: Active, not recruiting
http://inclinicaltrials.com/malignant-pleural-mesothelioma/NCT02863055/
A Multicenter Study of the EZH2 Inhibitor Tazemetostat in Adult Subjects With Relapsed or Refractory Malignant Mesothelioma With BAP1 Loss of Function
This is a Phase 2, multicenter, open-label, 2-part, single-arm, 2-stage study of tazemetostat 800 mg two times a day (BID) administered orally. Screening of subjects to determine eligibility for the study will be performed within 21 days of the first planned dose of tazemetostat. In Part 1: planned to enroll 12 subjects with relapsed or refractory malignant mesothelioma regardless of BAP1 status will be treated and undergo pharmacokinetics (PK) blood sample collection after a single tazemetostat 800 mg. Part 2 plans to include 55 subjects with BAP1-deficient relapsed or refractory malignant mesothelioma. Treatment with tazemetostat will continue until disease progression, unacceptable toxicity or withdrawal of consent, or termination of the study. Response assessment will be evaluated after 6 weeks of treatment and then every 12 weeks thereafter while on study.
NCT02860286 — Mesothelioma
Status: Completed
http://inclinicaltrials.com/mesothelioma/NCT02860286/
Genomic Analysis of Peritoneal Mesothelioma by CGH Arrays
Peritoneal mesothelioma is a rare disease representing one third of all mesothelioma and nothing is known about molecular characteristics of this disease. As main cancers, genetic heterogeneity is probable. This genomic profiling associates Comparative Genomic Hybridization (CGH) array, BAP1 sequencing and gene expression in order to discover a biomarker that could be used in the treatment of this rare disease. Corresponding histopathological and immunohistochemical report as all clinical data are available. All data with be merged to underline a few genes of interest on which we will focus our next investigations. Depending of our preliminary results, BAP1 mutations are expected, as it was also described in pleural mesothelioma. Mutations in oncogenic drivers that could be targeted by specific therapy will be on particular interest in management of this rare disease with bad prognosis.
NCT02834234 — Peritoneal Mesothelioma
Status: Completed
http://inclinicaltrials.com/peritoneal-mesothelioma/NCT02834234/
A Phase I Study of the Mesothelin-Targeted Immunotoxin LMB-100 With or Without Nab-Paclitaxel (Abraxane) in Patients With Malignant Mesothelioma
Background: LMB-100 is a man-made protein. It is attracted to the mesothelin protein. This is found in many tumors, including mesothelioma. But it is found in only a very small number of normal tissues. After binding to mesothelin on tumors, LMB-100 attacks and kills cancer cells. Researchers want to test LMB-100 in people with advanced mesothelioma. Objective: To find a safe dose and anti-tumor activity of LMB-100 for people with advanced mesothelioma. Eligibility: Adults ages 18 and older with: Advanced pleural or peritoneal mesothelioma that has not responded to platinum-based therapy Adequate organ function Design: Participants will be screened with: Samples of tumor tissue or tumor fluid. These can be new or from a previous procedure. Medical history Physical exam Blood, urine, and heart tests Chest x-rays Computed tomography (CT) or magnetic resonance imaging (MRI) scans Fluorodeoxyglucose (FDG)-positron emission tomography (PET) scans Participants will get LMB-100 on days 1, 3, and 5 of each 21-day cycle. It will be given through an intravenous (IV) catheter, a tube inserted in an arm vein. They will get standard medicines before each infusion to help prevent side effects. Each infusion lasts about 30 minutes. They will be monitored for up to 2 hours after. During each cycle, participants will repeat the screening tests. Participants will get the study drug for up to 4 cycles or until their disease worsens or they have intolerable side effects. About 4-6 weeks after their last infusion, participants will have a follow-up visit. They will repeat the study tests. Participants will have follow-up scans every 6 weeks until their disease gets worse. Participants will be called about once a year to see how they are doing.
NCT02798536 — Mesothelioma
Status: Completed
http://inclinicaltrials.com/mesothelioma/NCT02798536/
A Phase II/III Randomized Study of Pembrolizumab in Patients With Advanced Malignant Pleural Mesothelioma
Pembrolizumab is a new type of drug for mesothelioma (immunotherapy). Laboratory tests show that this drug works by helping improve the body's immune response to help fight cancer. Pembrolizumab may help the immune system to recognize cancer cells and slow down the growth and/or spreading of cancer.
NCT02784171 — Mesothelioma
Status: Active, not recruiting
http://inclinicaltrials.com/mesothelioma/NCT02784171/
Efficacy and Safety of PIPAC/PITAC With Cisplatin and Doxorubicin in Gastric, Ovarian and Colorectal Cancer With Peritoneal Carcinomatosis and Oxaliplatin in Patients With Mesothelioma/Pleural Cancer With Pleural Carcinomatosis.
Outcome measurement for patients with gastric, ovarian, colorectal, or pleural cancer/mesothelioma with peritoneal/pleural carcinomatosis undergoing pressurized intraperitoneal/intrathoracal aerosol chemotherapy (PIPAC/PITAC) with cisplatin and doxorubicin or oxaliplatin. Record of (partial/total) tumor response rate via survival rate, time until tumor progression (according to RECIST-criteria), peritoneal carcinomatosis index (PCI) before and after therapy, histological tumor progression/regression, ascites/pleural affusion volume, degree of tumor cell apoptosis.
NCT02720835 — Colorectal Cancer
Status: Recruiting
http://inclinicaltrials.com/colorectal-cancer/NCT02720835/
A Randomized Phase II Study Evaluating Efficacy and Safety of 2nd or 3rd Line Treatment by Nivolumab Monotherapy or Nivolumab Plus Ipilimumab, for Unresectable Malignant Pleural Mesothelioma (MPM) Patients
The sponsor raise the hypothesis that inhibition of immune PD-1+/- CTLA-4 check-point(s) would delay tumor progression in patients with unresectable MPM, experiencing disease progression after one or two lines of chemotherapy including at least first-line with pemetrexed and platinum, without altering significantly the quality of life of patients.
NCT02716272 — Mesothelioma
Status: Completed
http://inclinicaltrials.com/mesothelioma/NCT02716272/
Neoadjuvant Accelerated Hypofractionated Radiation Therapy Immediately Prior to Radical Pleurectomy/Decortication for Malignant Pleural Mesothelioma: A Pilot Study
This pilot phase 0 trial studies accelerated hypofractionated radiation therapy immediately before surgery in treating patients with malignant pleural mesothelioma (cancer in the thin layer of tissue that covers the lungs and lines the interior wall of the chest cavity). Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Hypofractionated radiation therapy is a type of radiation therapy in which the total prescribed dose of radiation is divided into fewer but larger doses as compared to conventional radiation therapy. Giving accelerated hypofractionated radiation therapy immediately before surgery may improve survival, and may also reduce side effects experienced by patients with pleural mesothelioma.
NCT02672033 — Pleural Malignant Mesothelioma
Status: Terminated
http://inclinicaltrials.com/pleural-malignant-mesothelioma/NCT02672033/
Pilot Study of the Feasibility of Intrapleural Photodynamic Therapy in a Multimodal Treatment Combining Extended Pleurectomy/Decortication, Adjuvant Chemotherapy and Prophylactic Radiotherapy in Patients With Malignant Pleural Mesothelioma
Malignant pleural mesothelioma (MPM) is an aggressive tumour with poor prognosis (median survival <13 months), and high resistance to chemotherapy. Extended pleurectomy/decortication (eP/D) is a debulking surgery of MPM but cannot be considered as a curative treatment. Therefore it has been suggested that eP/D may be of interest if combined with intra-operative treatment and adjuvant therapies. Photodynamic Therapy (PDT) is an innovative treatment based on the rationale that tumour cells, if previously treated with photosensitizing drugs (Photofrin), will die when exposed to light at a particular wavelength. Interestingly PDT might also stimulate anti-tumour immune response through the release of tumour antigens and induced inflammation. PDT was tested in phase I-II trials for MPM in combination with EPP or eP/D, and chemotherapy. US studies from J Friedberg et al found very promising survival results in MPM when combining eP/D, but not EPP, intra-operative PDT and chemotherapy (cisplatin-pemetrexed), with a median overall survival of 31.7 months. However, the definitive value of intra-pleural PDT combined to eP/D in the treatment of MPM still need to be validated. The same multimodal treatment has been established in Lille, the French national expert centre for MPM, with the help of our american colleagues. Therefore, this phase II trial proposes to patients to benefit from the combination of eP/D, intra-operative PDT then chemotherapy by cisplatin-pemetrexed and prophylactic radiotherapy. Primary endpoint is the feasibility for the patients to have the full multimodal treatment of MPM including intrapleural PDT without unacceptable or unexpected grade III-IV toxicities. Secondary endpoints are PFS, OS, ORR, and quality of life. If the feasibility of such treatment would be confirmed in France, a multicentric, randomized trial comparing this experimental treatment vs control arm (same multimodal treatment without PDT) is planned.
NCT02662504 — Malignant Pleural Mesothelioma
Status: Completed
http://inclinicaltrials.com/malignant-pleural-mesothelioma/NCT02662504/
First-line Immunotherapy Using Wilms' Tumor Protein 1 (WT1)-Targeted Dendritic Cell Vaccinations for Malignant Pleural Mesothelioma
In this multicenter phase I/II trial, dendritic cells (DCs) loaded with the mesothelioma-associated tumor antigen WT1 will be used in conjunction with conventional chemotherapy for the frontline treatment of malignant pleural mesothelioma (MPM). The general objective is to provide the first-in-human experimental demonstration that the combination of platinum/pemetrexed-based chemotherapy with WT1-targeted DC vaccination is feasible and safe and enables the induction of both systemic and in situ mesothelioma-specific immune responses in patients with MPM.
NCT02649829 — Malignant Pleural Mesothelioma
Status: Active, not recruiting
http://inclinicaltrials.com/malignant-pleural-mesothelioma/NCT02649829/