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CompletedPhase 1NCT01503177
Official study title

Intrapleural Measles Virus Therapy in Patients With Malignant Pleural Mesothelioma

Study 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

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedoncolytic measles virus encoding thyroidal sodium iodide symporter and laboratory biomarker analysis

Plus 2 other study approaches.

Who it may be forMesothelioma · Early-stage or resectable · Locally advanced

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jan 11, 2021 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Mayo Clinic

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Mayo Clinic
Interventions being studied
Biological: oncolytic measles virus encoding thyroidal sodium iodide symporter; Other: laboratory biomarker analysis; Procedure: single photon emission computed tomography; Procedure: computed tomography
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Mesothelioma→
Disease setting
Early-stage or resectable→Locally advanced→Metastatic or stage IV→Recurrent or relapsed→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • 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
  • Must be willing to implement contraception throughout study and for the 4 weeks following last viral administration REGISTRATION:
  • Anti-measles immunity as demonstrated by serum IgG anti-measles antibody levels of ≥ 1.1 EU/ml as determined by BioPlex Measles IgG multiplex flow immunoassay.
  • Hepatitis B and C negative
  • Human immunodeficiency virus (HIV) negative
  • CD4 count \>= 200/μL
  • CT imaging review submission to confirm unilateral pleural involvement; this review for CT imaging is mandatory prior to registration to confirm eligibility; it should be initiated as soon as possible after pre-registration
  • Negative pregnancy test done =\< 7 days prior to registration, for women of childbearing potential only
Reasons someone may not be able to joinExclusion criteria
  • 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
  • Biologic therapy =\< 4 weeks; Note exception: prior viral and/or gene therapy are

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Mayo ClinicRochester, Minnesota

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 11, 2021. Always confirm current availability with the study team.

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