NCT01503177

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Nov 2011

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2011

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 2, 2012

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 11, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 11, 2019

Completed
Last Updated

January 11, 2021

Status Verified

January 1, 2021

Enrollment Period

7.4 years

First QC Date

December 16, 2011

Last Update Submit

January 8, 2021

Conditions

Recurrent Malignant MesotheliomaStage IA Malignant MesotheliomaStage IB Malignant MesotheliomaStage II Malignant MesotheliomaStage III Malignant MesotheliomaStage IV Malignant Mesothelioma

Outcome Measures

Primary Outcomes (1)

  • Adverse event (AE) profile

    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.

    90 Days

Secondary Outcomes (1)

  • Describe the safety of the intrapleural administration of MV-NIS in patients with malignant pleural mesothelioma for all cycles out to 90 days.

    90 Days

Study Arms (1)

Treatment (viral therapy)

EXPERIMENTAL

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 symporterOther: laboratory biomarker analysisProcedure: single photon emission computed tomographyProcedure: computed tomography

Interventions

oncolytic measles virus encoding thyroidal sodium iodide symporterBIOLOGICAL

Given intrapleurally

Also known as: MV-NIS
Treatment (viral therapy)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (viral therapy)
single photon emission computed tomographyPROCEDURE

Correlative studies

Also known as: SPECT imaging, tomography, emission computed, single photon
Treatment (viral therapy)
computed tomographyPROCEDURE

Correlative studies

Also known as: tomography, computed
Treatment (viral therapy)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • PRE-REGISTRATION:
  • Diagnosis of MPM, confined to single pleural cavity, with histologic confirmation of the primary tumor
  • Measurable disease per modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria for mesothelioma
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1, or 2
  • Ability to provide informed consent
  • Willingness to return to Mayo Clinic Rochester or the University of Minnesota Cancer Center for follow up
  • Life expectancy \>= 12 weeks (in the opinion of the enrolling investigator)
  • Willingness to provide the biologic specimens and participate in the SPECT/CT imaging as required by the protocol
  • Presence of a pleural effusion with the ability to safely place an intrapleural catheter or have pre-existing intrapleural catheter
  • Absolute neutrophil count (ANC) \>= 1500/μL
  • Platelet count \>= 100,000/μL
  • Total bilirubin =\< 1.5 x upper limit of institutional normal
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) =\< 2 x upper limit of institutional normal
  • Serum Creatinine =\< 1.5 x upper limit of institutional normal
  • Hemoglobin \>= 9.0 g/dL
  • +8 more criteria

You may not qualify if:

  • PRE-REGISTRATION
  • Uncontrolled intercurrent illness including, but not limited to:
  • Active infection =\< 5 days prior to pre-registration
  • Psychiatric illness/social situations that would limit compliance with study requirements
  • Symptomatic congestive heart failure New York Heart Association classification III or IV
  • Symptomatic coronary artery disease (CAD)
  • Symptoms of CAD on systems review
  • Cardiac arrhythmias
  • Any of the following therapies prior to pre-registration:
  • Chemotherapy =\< 4 weeks
  • Immunotherapy =\< 4 weeks
  • Radiotherapy =\< 4 weeks Failure to fully recover from acute, reversible effects of prior anti-cancer therapy regardless of interval since last treatment; NOTE: patients must have fully recovered from all acute, reversible toxicities (defined as Common Terminology Criteria for Adverse Events \[CTCAE\] 4.0 =\< grade 1) associated with previous treatment
  • Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:
  • Pregnant women
  • Nursing women
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Mesothelioma, Malignant

Interventions

Photons

Condition Hierarchy (Ancestors)

MesotheliomaAdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, MesothelialLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SitePleural NeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Elementary ParticlesPhysical PhenomenaLightElectromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaOptical PhenomenaRadiationRadiation, Nonionizing

Study Officials

  • Tobias Peikert

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2011

First Posted

January 2, 2012

Study Start

November 1, 2011

Primary Completion

April 11, 2019

Study Completion

April 11, 2019

Last Updated

January 11, 2021

Record last verified: 2021-01

Locations

US(1)