Intrapleural Measles Virus Therapy in Patients with Malignant Pleural Mesothelioma

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion 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

Exclusion 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 exclusion criteria
      • 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
      • Men or women of childbearing potential who are unwilling to employ adequate contraception
    • Any ancillary therapy considered investigational (utilized for a non-Food and Drug Administration [FDA] approved indication and in the context of a research investigation) or any other treatment specifically for treating the current malignancy
    • Immunocompromised patients, including patients known to be HIV positive
    • Other active malignancy ≤ 2 years prior to pre-registration; EXCEPTIONS: non-melanotic skin cancer or carcinoma-in-situ of the cervix
    • History of organ transplantation
    • Known hepatitis B or C
    • Treatment with oral/systemic corticosteroids; NOTE: with the exception of topical or inhaled steroids
    • Exposure to household contacts ≤15 months old or household contact with a person with known immunodeficiency
    • Allergy to measles vaccine or history of severe reaction to prior measles vaccination
    • Allergy to iodine; NOTE: this does not include reactions to intravenous contrast materials
    • History of tuberculosis or purified protein derivative (PPD) skin test positivity
    • Inability or unwillingness to have pleural catheter placed
    • Requiring ongoing blood product support at time of pre-registration 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Tobias Peikert, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publications

Publications are currently not available
.

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