PEG-Interferon Alfa-2b and Sorafenib in Treating Patients With Unresectable or Metastatic Kidney Cancer
Kidney Cancer
About this trial
This is an interventional treatment trial for Kidney Cancer focused on measuring clear cell renal cell carcinoma, stage III renal cell cancer, stage IV renal cell cancer
Eligibility Criteria
Inclusion Criteria: Must have histologically or cytologically confirmed clear cell renal cell carcinoma (RCC) Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension and is ≥ 1.0 cm by spiral CT scan No prior treatment except PATIENT CHARACTERISTICS: ECOG performance status 0-1 Life expectancy > 6 months Good/intermediate Motzer prognostic status ANC ≥ 1,000/mm³ Platelet count ≥ 100,000/mm³ Hemoglobin ≥ 10.0 g/dL Total bilirubin ≤ 2.0 mg/dL AST and ALT < 2.5 times normal Creatinine ≤ 1.8 mg/dL OR creatinine clearance > 50 mL/min Calcium < 12 mg/dL (when corrected for serum albumin) INR < 1.5 times upper limit of normal Adequate cardiac function, defined as left ventricular ejection fraction ≥ 40% by 2D echo Pulse oximetry ≥ 90% at rest on room air Not pregnant Negative pregnancy test Fertile patients must use effective contraception No evidence of bleeding diathesis No uncontrolled coagulation disorders No active infections requiring IV antibiotics No known HIV, hepatitis C, or hepatitis B No autoimmune disease requiring ongoing therapy No requirement for adrenal replacement No angina (controlled or uncontrolled) No uncontrolled hypertension No history of other major medical illnesses including, but not limited to, any of the following: Cardiac ischemia Myocardial infarction Major cardiac arrhythmias Inflammatory bowel disorders No other prior malignancy except for previously treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for 3 years No significant psychiatric disease that, in the opinion of the principal investigator, would preclude giving adequate informed consent or render immunotherapy unsafe PRIOR CONCURRENT THERAPY: No prior treatment for RCC except sunitinib malate Patients may have progressed or have been intolerant to sunitinib malate No prior systemic treatment for metastatic disease (other than sunitinib malate) No prior organ allografts At least 2 weeks since prior laparoscopic/robotic surgery At least 4 weeks since prior open nephrectomy More than 4 weeks since prior and no concurrent radiotherapy or other surgery More than 4 weeks since prior systemic steroids More than 2 weeks since prior topical, injected, or inhaled steroids No concurrent steroid therapy No concurrent Hypericum perforatum (St. John's wort)
Sites / Locations
- Ohio State University Comprehensive Cancer Center
Arms of the Study
Arm 1
Experimental
Peginterferon alfa-2b
Peginterferon alfa-2b will be administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.