Poly-ICLC Vaccine before Surgery for the Treatment of Malignant Pleural Mesothelioma

Inclusion Criteria

• Biopsy proven MPM or clinical and radiologic evaluation highly suspicious for MPM * If biopsied at an outside institution, must have a tissue block sample available * If criterion is clinical and radiologic evaluation highly suspicious for MPM, this must be documented by two physicians in the medical record.
• Deemed to be surgically resectable by a dedicated thoracic surgeon
• Absolute neutrophil count > 1000/mm^3
• Platelets > 50,000/mm^3
• Creatinine =< 2.5 mg/dl
• Total bilirubin =< 1.5 mg/dl, unless patient has known Gilbert's syndrome
• Transaminases =< 2 times above the upper limits of the institutional normal
• International normalized ratio (INR) < 1.6 if off of anticoagulation. Patients on anticoagulation therapy with an INR > 1.6 may be enrolled at the discretion of the investigator if they have not had any episodes of severe hemorrhage and if the site to be injected is fully surrounded by pleura where achieving homeostasis would be complicated
• Patient must be able to provide informed consent
• Subject is willing to adhere to the study visit schedule and other protocol requirements

Exclusion Criteria

• Serious concurrent infection or medical illness, which would jeopardize the ability of the patient to receive poly-ICLC with reasonable safety
• History of any pulmonary process that precludes a biopsy to be done safely
• Known severe pulmonary hypertension; having a history of pulmonary hypertension or an estimated pulmonary (PA) systolic pressure of > 60 mmHg as measured by tricuspid regurgitation on preoperative echocardiogram
• Subject unable to cooperate in terms of maintaining position during the biopsy procedure
• Acquired immunodeficiency syndrome (AIDS) defined as a CD4 count less than 200 in the context of human immunodeficiency virus (HIV) seropositivity or chronically is taking immunosuppressive medication such as steroids or transplant related medications
• Persistent toxicity from recent therapy that has not sufficiently resolved in the judgment of the study physician
• Subject has an active infection requiring therapy
• Subject has had an allogeneic tissue/solid organ transplant
• Subject has active autoimmune disease that has required systemic treatment within the past 2 years (e.g., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
• Subject has known active hepatitis B, hepatitis C or tuberculosis. Active hepatitis B is defined as a known positive hepatitis B surface antigen (HBsAg) result. Active hepatitis C is defined by a known positive hepatitis (Hep) C antibody (Ab) result and known quantitative hepatitis C virus (HCV) ribonucleic acid (RNA) results greater than the lower limits of detection of the assay
• Concomitant comorbidities that are uncontrolled that would preclude the patient from being a surgical candidate including uncontrolled congestive heart failure (CHF), diabetes or heart disease
• Women with a positive serum or urine pregnancy test at baseline, or are pregnant or breastfeeding