Pentostatin, Cyclophosphamide, and SS1(dsFv)-PE38 Immunotoxin in Treating Patients with Mesothelioma, Lung Cancer, or Pancreatic Cancer

Inclusion Criteria

• MESOTHELIOMA COHORTS (COHORTS 1 AND 2 ONLY): Subjects must have histologically confirmed epithelial or biphasic mesothelioma not amenable to potentially curative surgical resection; however, patients with biphasic tumors that have a >= 50% sarcomatoid component will be excluded; the diagnosis will be confirmed by the Laboratory of Pathology/Center for Cancer Research (CCR)/National Cancer Institute (NCI)
• MESOTHELIOMA COHORTS (COHORTS 1 AND 2 ONLY): Patients must have had at least one prior chemotherapy regimen, with the Food and Drug Administration (FDA)-approved regimen of a platinum-based therapy in combination with pemetrexed being preferred unless there was a specific contraindication for an individual patient; there is no limit to the number of prior chemotherapy regimens received
• MESOTHELIOMA COHORTS (COHORTS 1 AND 2 ONLY): Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)
• LUNG ADENOCARCINOMA COHORT (COHORT 3 ONLY): Subjects must have histologically confirmed advanced (stage IIIB/IV) lung adenocarcinoma; the diagnosis will be confirmed by the Laboratory of Pathology/CCR/NCI
• LUNG ADENOCARCINOMA COHORT (COHORT 3 ONLY): Patients must have had at least one prior therapy for advanced disease (platinum-containing chemotherapy or one of the approved targeted therapies [an approved epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) for EGFR mutant tumors or crizotinib and ceritinib for anaplastic lymphoma receptor tyrosine kinase (ALK) translocated tumors]); there is no limit to the number of prior chemotherapy regimens received
• LUNG ADENOCARCINOMA COHORT (COHORT 3 ONLY): Mesothelin expression in at least 5% of cells as assessed in archival tumor tissue samples, determined by the immunohistochemistry (IHC) assay performed at Laboratory of Pathology/CCR/NCI; archival samples must be available for eligibility
• LUNG ADENOCARCINOMA COHORT (COHORT 3 ONLY): Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)
• PANCREATIC CANCER COHORT (COHORT 4 ONLY): Subjects with recurrent, locally advanced unresectable or metastatic adenocarcinoma of the pancreas; the diagnosis will be confirmed by the Laboratory of Pathology/CCR/NCI
• PANCREATIC CANCER COHORT (COHORT 4 ONLY): Patients must have had at least one prior chemotherapy for advanced disease; there is no limit to the number of prior chemotherapy regimens received
• PANCREATIC CANCER COHORT (COHORT 4 ONLY): Total bilirubin =< 2 x institutional upper limit of normal (ULN)
• Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as > 20 mm with conventional techniques or as > 10 mm with spiral computed tomography (CT) scan
• Patients must not have had major surgery, radiation therapy, chemotherapy, biologic therapy (including any investigational agents), or hormonal therapy (other than replacement), within 4 weeks prior to entering the study and must have evidence of stable or progressive disease to be eligible
• Performance status (Eastern Cooperative Oncology Group [ECOG]) =< 1
• Leukocytes >= 3,000/mm^3
• Absolute neutrophil count >= 1,500/mm^3
• Hemoglobin >= 9 g/dL; patients may be transfused to obtain a hemoglobin of >= 9 g/Dl
• Platelets >= 90,000/mm^3
• Total bilirubin: see guidelines for individual cohorts
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 x institutional ULN (5 x if liver function test [LFT] elevations due to liver metastases)
• Creatinine =< 1.5 x institutional ULN or creatinine clearance >= 45 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal, obtained through calculated or measured creatinine clearance
• Women of child-bearing potential and men must agree to use adequate contraception (barrier method of birth control; abstinence) for the duration of study therapy and for 3 months after the last dose of therapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; we ask that female patients who are participating in the study cease hormonal forms of birth control; patients must be off hormonal forms of birth control for at least 4 weeks prior to initiating the study
• Ability to comply with intravenous administration schedule, and the ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

• Patients with symptomatic brain metastases should be excluded from this clinical trial; however, patients who have had treatment for their brain metastases and whose brain metastatic disease status has remained stable for at least 4-6 weeks without steroids may be enrolled at the discretion of the principal investigator
• Uncontrolled medical illness including, but not limited to, ongoing or uncontrolled, symptomatic congestive heart failure (American Heart Association [AHA] class II or worse), uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Human immunodeficiency virus (HIV) positive patients will be excluded
• Patients with hepatitis B and C will be excluded
• Serum neutralization antibody assay shows >= 75% neutralization of the SS1 (dsFv) PE38 activity at 200 ng/ml
• Patients may not be receiving any other investigational agents
• History of another invasive malignancy in the last two years; adequately treated non-invasive, non-melanoma skin cancers as well as in situ carcinoma of the cervix will be allowed
• Prior treatment with drugs of the immunotoxin class
• Patients with tumor amenable to potentially curative therapy as assessed by the investigator
• Pregnant women are excluded from this study; breastfeeding women should be excluded; women of childbearing potential and men must agree to use adequate contraception (barrier methods) before, during the study and for a period of 3 months after the last dose of the investigational agent
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to SS1(dsFv)PE38