Intervention: Sorafenib
Trial phase: Phase 1
ATC code: L01EX02 | L01XE05
SMILES: CNC(=O)c1cc(Oc2ccc(NC(=O)Nc3ccc(Cl)c(C(F)(F)F)c3)cc2)ccn1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: 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.

PEG-interferon alfa-2b: 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.

Sorafenib

gene expression analysis

polymerase chain reaction

reverse transcriptase-polymerase chain reaction

flow cytometry

immunoenzyme technique

laboratory biomarker analysis
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)