Poly-ICLC (Hiltonol®) Vaccine In Malignant Pleural Mesothelioma

Inclusion Criteria:

1. Biopsy proven MPM a. If biopsied at an outside institution, must have a tissue block sample available

2. Deemed to be surgically resectable by a dedicated thoracic surgeon.

3. Acceptable hematologic, renal and liver function as follows:

• Absolute neutrophil count > 1000/mm3

• Platelets > 50,000/mm3,

• Creatinine ≤ 2.5 mg/dl,

• Total bilirubin ≤ 1.5 mg/dl, unless patient has known Gilberts syndrome

• Transaminases ≤ 2 times above the upper limits of the institutional normal.

• INR<1.6 if off of anticoagulation. Patients on anticoagulation therapy with anINR>1.6 may be enrolled at the discretion of the investigator if they have nothad any episodes of severe hemorrhage and if the site to be injected is fullysurrounded by pleura where achieving homeostasis would be complicated.

4. Patient must be able to provide informed consent

5. Subject is willing to adhere to the study visit schedule and other protocolrequirements.

Exclusion Criteria:

1. Serious concurrent infection or medical illness, which would jeopardize the abilityof the patient to receive Poly-ICLC with reasonable safety.

2. History of any pulmonary process that precludes a biopsy to be done safely.

3. Known severe pulmonary hypertension; having a history of pulmonary hypertension oran estimated PA systolic pressure of >60mmHg as measured by tricuspid regurgitationon preoperative echocardiogram.

4. Subject unable to cooperate in terms of maintaining position during the biopsyprocedure.

5. AIDS defined as a CD4 count less than 200 in the context of HIV seropositivity orchronically is taking immunosuppressive medication such as steroids or transplantrelated medications.

6. Persistent toxicity from recent therapy that has not sufficiently resolved in thejudgment of the study physician.

7. Subject has an active infection requiring therapy.

8. Subject has had an allogeneic tissue/solid organ transplant.

9. Subject has active autoimmune disease that has required systemic treatment withinthe past 2 years (eg, with use of disease modifying agents, corticosteroids orimmunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, orphysiologic corticosteroid replacement therapy for adrenal or pituitaryinsufficiency, etc.) is not considered a form of systemic treatment.

10. Subject has known active Hepatitis B, Hepatitis C or tuberculosis. Active HepatitisB is defined as a known positive HBsAg result. Active Hepatitis C is defined by aknown positive Hep C Ab result and known quantitative HCV ribonucleic acid (RNA)results greater than the lower limits of detection of the assay.

11. Concomitant comorbidities that are uncontrolled that would preclude the patient frombeing a surgical candidate including uncontrolled CHF, diabetes or heart disease

12. Women with a positive serum or urine pregnancy test at baseline, or are pregnant orbreastfeeding.