Intrapleural Measles Virus Therapy in Patients With Malignant Pleural Mesothelioma

Completed · Phase 1

Conditions studied: Recurrent Malignant Mesothelioma, Stage IA Malignant Mesothelioma, Stage IB Malignant Mesothelioma, Stage II Malignant Mesothelioma, Stage III Malignant Mesothelioma, Stage IV Malignant Mesothelioma

In brief

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

Key facts

Study ID

NCT01503177

Run by

Mayo Clinic

People needed

15

Starts

2011-11-01

Expected to finish

2019-04-11

Last updated by the study team

2021-01-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• 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

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
• 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

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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