Axitinib and L-Selenomethionine in Treating Patients with Previously Treated Advanced Metastatic Clear Cell Renal Cell Carcinoma

Inclusion Criteria

• Histologically and radiologically confirmed advanced metastatic CCRCC in patients who have had at least one prior systemic therapy, which can include axitinib for the dose escalation part; in the expansion and pilot phases, patients with prior axitinib are allowed, as long as the last dose of axitinib was longer than 6 months ago
• Written and voluntary informed consent
• At least one Response Evaluation Criteria in Solid Tumors (RECIST)-defined target lesion * Patient must have documented disease progression
• Creatinine level within normal institutional limit, or creatinine clearance > 15 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal, calculated using the Cockcroft-Gault formula) (within 28 days prior to the start of treatment)
• Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 X institutional upper limit of normal OR =< 5 x institutional upper limit of normal in cases of liver metastases (within 28 days prior to the start of treatment)
• Total bilirubin =< 1.5 times upper limit of normal (ULN) (within 28 days prior to the start of treatment)
• Absolute neutrophil count (ANC) >= 1.0 x 10^9/L (within 28 days prior to the start of treatment)
• Platelets >= 100 x 10^9/L (within 28 days prior to the start of treatment)
• Hemoglobin >= 7.0 g/dL (within 28 days prior to the start of treatment)
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 (fully active, able to carry on all pre-disease performance without restriction), 1 (restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, such as light housework or office work) or 2 (ambulatory and capable of all self-care but unable to carry out any work activities; up and about more than 50% of waking hours)
• Age of at least 18 years
• Life expectancy of 12 weeks and more
• 2 weeks or more since end of previous systemic or radiation treatment (4 weeks or more for bevacizumab plus interferon-alfa); 3 days wash out for palliative radiation
• Must have a safely accessible biopsy per treating physician and the provider performing that biopsy. Patient must agree to have this biopsy done as outlined in the calendar. If patient does not have safely accessible biopsy, the patient may still be enrolled per investigator discretion

Exclusion Criteria

• Patients with prior malignancies of the same or different tumor type in the last 5 years and patients with concurrent malignancies of the same or different tumor type UNLESS the natural history of the disease or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational drug
• Symptomatic untreated metastases in the central nervous system
• Subject that is pregnancy or lactating
• Pre-existing uncontrolled hypertension defined as > 150/90 mm Hg with medication
• Present use or anticipated need for cytochrome P450 (CYP) family 3, subfamily A, polypeptide 4 (3A4)-inhibiting, CYP3A4-inducing drugs (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, and voriconazole, rifampin, phenytoin, carbamazepine, rifabutin, rifapentine, phenobarbital, and St. John's wort, bosentan, efavirenz, etravirine, modafinil, and nafcillin)
• Myocardial infarction, uncontrolled angina, congestive heart failure, or cerebrovascular accident within previous 6 months; subjects with a history of deep vein thrombosis or pulmonary embolism, at provider discretion
• Major surgery within 4 weeks of starting study treatment
• Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome-related disease