Status:
COMPLETED
Intrapleural Measles Virus Therapy in Patients With Malignant Pleural Mesothelioma
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Recurrent Malignant Mesothelioma
Stage IA Malignant Mesothelioma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 investigato...
Detailed Description
PRIMARY OBJECTIVES: Maximum tolerated dose (MTD) for the intrapleural administration of a modified vaccine strain measles virus (MV) genetically engineered to produce human thyroidal sodium iodine sy...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 11 2019
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01503177
Start Date
November 1 2011
End Date
April 11 2019
Last Update
January 11 2021
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905