A Phase I Trial Combining Papaverine and Stereotactic Body Radiation Therapy for Non-Small Cell Lung Cancer or Lung Metastases
This phase I trial studies the side effects and how well papaverine hydrochloride and stereotactic radiation therapy body (SBRT) work in treating patients with non-small cell lung cancer. Papaverine hydrochloride may help radiation therapy work better by making tumor cells more sensitive to the radiation therapy. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving papaverine hydrochloride with SBRT may work in treating patients with non-small cell lung cancer.
• Histologically or cytologically proven NSCLC for whom SBRT to a single lesion has been chosen as the primary treatment modality (planned dose 50 Gy in 4-5 daily fractions). Patients with lung metastases from solid tumors are eligible.
• Patients must have a tumor =\< 5 cm as defined by computed tomography (CT) largest axial dimension. Presence of adjacent nodules considered neoplastic in the same lobe or other ipsilateral lobe are allowed as long as the nodule(s) can be encompassed in an SBRT gross tumor volume (GTV) of =\< 5 cm, within 1 isocenter. Multiple isocenters are not allowed
• No prior radiation resulting in overlapping fields
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Must be able to undergo correlative research MRIs
• 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)