Intrapleural AdV-tk Therapy in Patients With Malignant Pleural Effusion

Inclusion Criteria:

Patients must have MPE (defined as positive pleural fluid cytology). Eligible patients include NSCLC, small cell lung cancer, malignant mesothelioma (MM), breast cancer and ovarian cancer. Diagnosis must be made prior to AdV-tk injection. For patients with MM, histologic proof is needed, but positive pleural fluid cytology is not required.
Patients must have an indication for placement of pleural catheter
Patients must be 18 years of age or older
Performance status must be ECOG 0-1
Acute toxic effects from any prior radiotherapy, chemotherapy, or prior surgical procedures must have resolved to NCI CTCAE v 4.0 grade ≤ 1
Baseline pulmonary function tests must be FEV1 ≥1 liter or 40% of predicted value (may be post-drainage and/or bronchodilator)
Bilirubin ≤ 1.5 x upper limit of normal (ULN) and ALT, AST and alkaline phosphatase ≤ 2 x ULN
Serum creatinine < 2 mg/dl and calculated creatinine clearance > 30 ml/min
Hemoglobin ≥ 9 g/dL, ANC > 1000/mm3 and platelets > 100,000/mm3
Serum albumin level ≥ 2.5 g/dL
Patients must give study specific informed consent prior to enrollment

Exclusion Criteria:

Patients may not be on systemic corticosteroids (>10 mg prednisone per day) or other systemic immunosuppressive drugs
Patient is not known to be HIV+
Patient is not pregnant or breast-feeding. Female patients of childbearing age must have negative serum or urine pregnancy test within 1 week of beginning therapy.
Patient may not have clinically significant pericardial effusion
Patient may not have other serious co-morbid illness or compromised organ function
Patient may not have liver disease including known cirrhosis, active hepatitis or chronic active hepatitis B
No prior allergic reaction or hypersensitivity to sulfonamides, celecoxib, aspirin or other NSAIDs
No concurrent use of other NSAID or aspirin exceeding 100mg/day during celecoxib administration. No wash-out period required.