RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for their growth or by blocking blood flow to the tumor. Interferon alfa may interfere with the growth of tumor cells and slow the growth of kidney cancer. Sorafenib may help interferon alfa kill more tumor cells by making tumor cells more sensitive to the drug. Giving sorafenib together with interferon alfa may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving sorafenib with interferon alfa works in treating patients with locally advanced or metastatic kidney cancer.

Condition	Treatment or Intervention	Phase
recurrent renal cell cancer stage III renal cell cancer Stage IV Renal Cell Cancer renal clear cell carcinoma renal granular cell carcinoma	Drug: interferon alfa  Drug: sorafenib  Procedure: anti-cytokine therapy  Procedure: antiangiogenesis therapy  Procedure: biological response modifier therapy  Procedure: chemosensitization/potentiation  Procedure: cytokine therapy  Procedure: enzyme inhibitor therapy  Procedure: growth factor antagonist therapy  Procedure: interferon therapy	Phase II

Further Study Details: 

OBJECTIVES: Primary

• Determine the feasibility and tolerability of sorafenib and interferon alfa in patients with locally advanced or metastatic renal cell carcinoma.
• Determine the response rate (complete response and partial response) in patients treated with this regimen.

Secondary

• Determine the progression-free survival, response duration, and overall survival of patients treated with this regimen.
• Correlate changes in laboratory parameters with response in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive oral sorafenib twice daily and interferon alfa subcutaneously three times a week for 8 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.

Patients with stable or responding disease are followed every 3 months for 2 years, every 6 months for 2 years, and then annually for 1 year or until disease progression. After disease progression, patients are followed every 6 months.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 10 months.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed renal cell carcinoma
• Locally advanced or metastatic disease
• All histologic subtypes allowed
• Measurable disease
• At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
• No known brain metastases or leptomeningeal disease

PATIENT CHARACTERISTICS: Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• WBC ≥ 3,000/mm^3
• Absolute neutrophil count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3
• No bleeding diathesis

Hepatic

• Bilirubin normal
• AST and ALT ≤ 2.5 times upper limit of normal

Renal

• Creatinine normal OR
• Creatinine clearance ≥ 60 mL/min

Cardiovascular

• No uncontrolled hypertension
• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No history of sensitivity to E. coli-derived products
• No history of severe depression
• No active infection requiring antibiotics
• No seizure disorder requiring antiepileptic medication
• No medical condition likely to require systemic corticosteroids
• No autoimmune disorder that could result in life-threatening complications
• No other uncontrolled illness
• No psychiatric illness or social situation that would preclude study compliance

PRIOR CONCURRENT THERAPY: Biologic therapy

• No more than 1 prior biologic response modifier regimen
• At least 4 weeks since prior biologic response modifiers
• No prior interferon alfa

Chemotherapy

• No prior chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• At least 4 weeks since prior radiotherapy to non-index lesions
• Prior radiotherapy to index lesion allowed provided irradiated lesion progressed ≥ 20% in diameter

Surgery

• At least 2 weeks since prior major surgery

Other

• No concurrent combination antiretroviral therapy for HIV-positive patients
• No concurrent therapeutic anticoagulation therapy
• Concurrent prophylactic anticoagulation, such as low-dose warfarin, for venous or arterial access device allowed provided PT, PTT, and INR are normal
• No other concurrent investigational agents
• No other concurrent anticancer therapy

North Carolina
      Duke Comprehensive Cancer Center, Durham,  North Carolina,  27710,  United States; Recruiting
      Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill,  North Carolina,  27599-7295,  United States; Recruiting

Study chairs or principal investigators

Jared A. Gollob, MD,  Study Chair,  Duke Comprehensive Cancer Center   

Study ID Numbers:  CDR0000398171; DUMC-6258-04-9R0; NCI-6553; NCT00098618
Record last reviewed:  November 2004
Last Updated:  April 4, 2005
Record first received:  December 7, 2004
ClinicalTrials.gov Identifier:  NCT00098618
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08