Clinical Trials

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

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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.

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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

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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).

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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).

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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.

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Intrapleural Administration of HSV1716 to Treat Patients With Malignant Pleural Mesothelioma.

Purpose: HSV1716, an oncolytic virus, is a mutant herpes simplex virus (HSV) type I, deleted in the RL1 gene which encodes the protein ICP34.5.

Malignant mesothelioma is an aggressive, asbestos-related tumour of the pleural and peritoneal cavities. It is a rare cancer which occurs in individuals who have been exposed to asbestos, although it typically occurs decades after exposure (10-40 years later). Malignant pleural mesothelioma forms plaques that are distributed on the surface of the pleural space in the lung. Approximately 30% of patients require an indwelling pleural catheter for drainage of pleural effusions. In this patient group, the indwelling catheter may be used to facilitate loco-regional delivery of HSV1716 to the pleural space.

This study seeks to evaluate the safety and biological effects of single and multiple administrations of HSV1716 in the treatment of malignant pleural mesothelioma.

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CRS-207 Cancer Vaccine in Combination With Chemotherapy as Front-line Treatment for Malignant Pleural Mesothelioma

Purpose: This clinical trial will evaluate the safety and immune response of the sequential administration cancer vaccine CRS-207 followed by standard of care chemotherapy (pemetrexed and cisplatin). CRS-207 is a weakened (attenuated) form of Listeria monocytogenes that has been genetically-modified to reduce its capacity to cause disease, while maintaining its ability to stimulate potent immune responses. CRS-207 has been engineered to elicit an immune response against the tumor-associated antigen mesothelin, which has been shown to be present at higher levels on certain tumor cells (such asmesothelioma) than on normal cells. Pemetrexed and cisplatin are the standard chemotherapy regimen to treat malignant pleural mesothelioma. This trial will evaluate whether giving CRS-207 cancer vaccine with chemotherapy will induce anti-tumor immune responses and/or objective tumor response.

Experimental Arm: Vaccine plus chemotherapy
Weeks 1 and 3: CRS-207 (1 × 10^9 CFU)
Weeks 5, 8, 11, 14, 17 and 20 (up to 6 cycles every 21 days): Pemetrexed (500 mg/m2) and cisplatin (75 mg/m2)
Weeks 23 and 26: CRS-207
Maintenance Vaccinations: CRS-207 every 16 weeks (starting at Week 30) until disease progression
Assigned Interventions: Biological: Vaccine plus chemotherapy

  • CRS-207
  • Listeria
  • Pemetrexed
  • Cisplatin
  • ALIMTA
  • Platinol

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