Intrapleural Measles Virus Therapy in Patients With Malignant Pleural Mesothelioma
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|ClinicalTrials.gov Identifier: NCT01503177|
Recruitment Status : Suspended (study re-design)
First Posted : January 2, 2012
Last Update Posted : June 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Malignant Mesothelioma Stage IA Malignant Mesothelioma Stage IB Malignant Mesothelioma Stage II Malignant Mesothelioma Stage III Malignant Mesothelioma Stage IV Malignant Mesothelioma||Biological: oncolytic measles virus encoding thyroidal sodium iodide symporter Other: laboratory biomarker analysis Procedure: single photon emission computed tomography Procedure: computed tomography||Phase 1|
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.
Safety and toxicity of the repeated (up to 6 cycles) intrapleural administration of MV-NIS in patients with malignant pleural mesothelioma.
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Trial of Oncolytic Measles Virotherapy in Mesothelioma|
|Actual Study Start Date :||November 2011|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||January 2019|
Experimental: Treatment (viral therapy)
Patients receive MV-NIS intrapleurally on day 1. Treatment repeats every 28 days for up to 6 courses in absence of disease progression or unacceptable toxicity.
Biological: oncolytic measles virus encoding thyroidal sodium iodide symporter
Other Name: MV-NIS
Other: laboratory biomarker analysis
Procedure: single photon emission computed tomography
Procedure: computed tomography
Other Name: tomography, computed
- Adverse event (AE) profile [ Time Frame: 90 Days ]The number and severity of toxicity incidents will indicate the level of tolerance for MV-NIS in the therapy of MPM. Non-hematologic toxicities will be evaluated via the CTCAE v4.0 standard toxicity grading. Hematologic toxicity measures such as anemia, neutropenia and thrombocytopenia will be assessed using continuous variables as the outcome measures (nadir and percent change from baseline values) as well as categorization via CTCAE v4.0 standard toxicity grading. Frequency distributions and other descriptive measures will form the basis of the analysis of these variables.
- Describe the safety of the intrapleural administration of MV-NIS in patients with malignant pleural mesothelioma for all cycles out to 90 days. [ Time Frame: 90 Days ]The number and severity of adverse events (AE) over the course of up to 6 cycles of MV-NIS therapy will indicate the level of tolerance for MV-NIS in the therapy of MPM. AE will be evaluated similar to the primary outcome via the CTCAE v4.0 standard toxicity grading and frequency distributions and other descriptive measures will form the basis of the analysis of these variables.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01503177
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Tobias Peikert||Mayo Clinic|