Papaverine Hydrochloride and Stereotactic Body Radiation Therapy in Treating Patients with Non-small Cell Lung Cancer or Lung Metastases

Inclusion Criteria

• Histologically or cytologically-proven NSCLC (any stage) for whom SBRT to one or more lesions (that can be treated within a single isocenter) has been chosen as the primary treatment modality (planned dose 50 Gy in 4-5 daily fractions). For a patient with NSCLC, if treating multiple tumors, at least one must be histologically or cytologically-proven NSCLC
• Patients with lung metastases from solid tumors are eligible, which include (but are not limited to) colorectal cancer, sarcoma/soft-tissue tumors, breast cancer, pancreatic cancer, urothelial/bladder/kidney cancer, anal cancer, and skin cancer (e.g. melanoma). For lung tumors metastatic from another primary cancer, histologic/cytologic proof that the patient has Stage IV (metastatic) disease must be documented by biopsying another nodule/mass in the lung (which can include the lesion being treated) or another organ (e.g. liver, bones, etc.)
• Patients must have one or more tumors that can be treated within a single isocenter. Multiple isocenters are not allowed
• No prior radiation resulting in overlapping fields
• Age >= 18 years
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• For patients in expansion cohort, they must be willing to undergo correlative research MRIs. (For all patients consenting to optional MRIs or enrolling on the expansion cohort, the ideal patient is as follows: Patients who do not require supplemental oxygen during the day. If the patient uses supplemental oxygen during the day, the ideal patient will be able to discontinue his/her supplemental oxygen 30 min before the MRI scan, and stay off for 2-3 hours while lying flat. For patients in the expansion cohort who undergo mandatory MRIs: if patient is not able to complete either or both research MRIs, the MRIs can be discontinued and the patient can still proceed with PPV and SBRT treatments at the discretion of the principal investigator [PI])
• No active connective tissue disease (scleroderma) or idiopathic pulmonary fibrosis (IPF)
• No history of complete atrioventricular block, hepatic dysfunction (e.g. cirrhosis), or priapism
• Within 30 days of registration: patients must have vital signs, history/physical examination, and laboratory studies (liver function tests, creatinine or creatinine clearance assessment)
• Life expectancy of at least 12 weeks in the opinion of investigator
• Women of child-bearing potential (WOCBP) must have a negative pregnancy test within 14 days of registration. Urine human chorionic gonadotropin (HCG) is an acceptable pregnancy assessment. Nursing women may participate only if nursing is discontinued, due to the possibility of harm to nursing infants from the treatment regimen
• Within 90 days of registration: pulmonary function tests (PFTs) including forced expiratory volume in 1 second (FEV-1) and diffusion capacity of the lung for carbon monoxide (DLCO)
• Albumin >= 2.5 g/dL (within 30 days of study registration)
• Total bilirubin =< 1.5 x upper limit of normal (ULN) (within 30 days of study registration)
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x ULN (within 30 days of study registration)
• Creatinine =< 1.5 x ULN or calculated creatinine >= 50 mL/min, calculated by the Cockcroft-Gault formula or 24-hour urine creatinine clearance >= 50 mL/min (within 30 days of study registration)

Exclusion Criteria

• Any serious and/or unstable pre-existing medical disorder (aside from malignancy exception above), psychiatric disorder, or other conditions that could interfere with subject’s safety, obtaining informed consent or compliance to the study procedures, in the opinion of the investigator
• Pregnancy or breastfeeding: Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, the duration of study participation and for 4 months after the last dose of study treatment. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. No breastfeeding while patient is on study
• Patients with history of pneumonectomy
• Prior cytotoxic chemotherapy, molecularly-targeted agents (e.g. erlotinib, crizotinib), or immunotherapy unless >= 2 weeks from last dose. Patients can start chemotherapy, immunotherapy, or other systemic therapy after completion of SBRT, but this should be planned for >= 2 weeks from last SBRT dose
• History of active connective tissue disease (scleroderma), idiopathic pulmonary fibrosis, pneumonitis
• Hepatic insufficiency resulting in jaundice and/or coagulation defects, or not meeting laboratory values (albumin, total bilirubin, AST/ALT)
• Patients that have taken nitrates within the last 6 months