NCT01503177

Intrapleural Measles Virus Therapy in Patients With Malignant Pleural Mesothelioma

A Phase 1 Trial of Oncolytic Measles Virotherapy in Mesothelioma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Recurrent Malignant Mesothelioma
• Stage IA Malignant Mesothelioma
• Stage IB Malignant Mesothelioma
• Stage II Malignant Mesothelioma
• Stage III Malignant Mesothelioma
• Stage IV Malignant Mesothelioma

Interventions

Type	Name	Description
BIOLOGICAL	oncolytic measles virus encoding thyroidal sodium iodide symporter	Given intrapleurally
OTHER	laboratory biomarker analysis	Correlative studies
PROCEDURE	single photon emission computed tomography	Correlative studies
PROCEDURE	computed tomography	Correlative studies

Timeline

• Start date: 2011-11-01
• Primary completion: 2019-04-11
• Completion: 2019-04-11
• First posted: 2012-01-02
• Last updated: 2021-01-11

Locations

1 site across 1 country: United States