Clinical Trials Logo

Clinical Trial Summary

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


Clinical Trial Description

PRIMARY OBJECTIVES: Maximum tolerated dose (MTD) for the intrapleural administration of a modified vaccine strain measles virus (MV) genetically engineered to produce human thyroidal sodium iodine symporter (NIS) (MV-NIS [oncolytic measles virus encoding thyroidal sodium iodide symporter])in patients with MPM. SECONDARY OBJECTIVES: Safety and toxicity of the repeated (up to 6 cycles) intrapleural administration of MV-NIS in patients with malignant pleural mesothelioma. TERTIARY OBJECTIVES: I. Time course of viral infection, dissemination and elimination by non-invasive measurements of NIS gene expression using radioactive iodine and single-photon emission computed tomography (SPECT)/ computed tomography (CT) imaging with. II. Viremia, viral replication, and viral shedding following intrapleural administration. III. Changes in humoral and cellular anti-MV immunity following the intrapleural administration of MV-NIS. IV. Antitumor efficacy of this approach by serial measurements of radioiodine uptake by SPECT/CT, radiographic response, and time to disease progression. V. Changes in both local and systemic innate and adaptive anti-tumor immunity following the intrapleural administration of MV-NIS. VI. Effect of MV-NIS administration on the eukaryotic initiation factor (eIF) 4F translation complex in mesothelioma cells. OUTLINE: This is a dose-escalation study. Patients receive the oncolytic measles virus encoding thyroidal sodium iodide symporter (MV-NIS) intrapleurally. In the absence of unacceptable side effects or disease progression treatment can be repeated every 28 days for up to 6 courses. After completion of study treatment, patients are followed up every 3 to 6 months for up to 5 years. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01503177
Study type Interventional
Source Mayo Clinic
Contact
Status Completed
Phase Phase 1
Start date November 2011
Completion date April 11, 2019

See also
  Status Clinical Trial Phase
Completed NCT00025207 - Gefitinib in Treating Patients With Malignant Mesothelioma Phase 2
Completed NCT00107432 - Sorafenib Tosylate in Treating Patients With Malignant Mesothelioma. Phase 2
Completed NCT00027703 - Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Malignant Mesothelioma Phase 2
Terminated NCT00028782 - EF5 in Detecting Oxygen Level and Blood Vessels in Tumor Cells of Patients Undergoing Photodynamic Therapy for Intraperitoneal or Pleural Cancer N/A
Recruiting NCT04213794 - Heated Intra-peritoneal Chemotherapy With Doxorubicin and Cisplatin for Abdominal for Pelvic Tumors in Pediatric Patients Early Phase 1
Completed NCT00243074 - S0509 - AZD2171 in Treating Patients With Malignant Pleural Mesothelioma That Cannot Be Removed By Surgery Phase 2
Completed NCT01126346 - Quality of Life and Survivorship Care in Patients Undergoing Hyperthermic Intraperitoneal Chemotherapy (HIPEC) N/A
Completed NCT00039182 - Erlotinib in Treating Patients With Malignant Mesothelioma of the Lung Phase 2
Withdrawn NCT01325753 - Cryotherapy in Treating Patients With Lung Cancer That Has Spread to the Other Lung or Parts of the Body N/A
Completed NCT00459862 - Pazopanib in Treating Patients With Malignant Pleural Mesothelioma Phase 2
Active, not recruiting NCT01064648 - Pemetrexed Disodium and Cisplatin With or Without Cediranib Maleate in Treating Patients With Malignant Pleural Mesothelioma Phase 1/Phase 2
Completed NCT00365053 - PXD101 as Second-Line Therapy in Treating Patients With Malignant Mesothelioma of the Chest That Cannot Be Removed By Surgery Phase 2
Terminated NCT01861301 - Tivantinib in Treating Patients With Previously Treated Malignant Mesothelioma Phase 2
Completed NCT00392444 - Sunitinib in Treating Patients With Advanced Malignant Pleural Mesothelioma Phase 2
Completed NCT00309946 - Cediranib Maleate in Treating Patients With Malignant Mesothelioma That Cannot Be Removed By Surgery Phase 2
Completed NCT00030498 - Erlotinib in Treating Patients With Solid Tumors and Liver or Kidney Dysfunction Phase 1
Recruiting NCT03420963 - Donor Natural Killer Cells, Cyclophosphamide, and Etoposide in Treating Children and Young Adults With Relapsed or Refractory Solid Tumors Phase 1
Withdrawn NCT01105390 - AMG 102, Pemetrexed Disodium, and Cisplatin in Treating Patients With Malignant Pleural Mesothelioma Phase 2