PEG-Interferon Alfa-2b and Sorafenib in Treating Patients With Unresectable or Metastatic Kidney Cancer
Condition: Kidney Cancer
MeSH terms: Kidney Neoplasms; Carcinoma, Renal Cell
Intervention: PEG-interferon alfa-2b; Sorafenib; gene expression analysis; polymerase chain reaction; reverse transcriptase-polymerase chain reaction; flow cytometry; immunoenzyme technique; laboratory biomarker analysis
Intervention description: 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.
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2b; Sorafenib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: clear cell renal cell carcinoma; stage III renal cell cancer; stage IV renal cell cancer

Summary:

      RATIONALE: PEG-interferon alfa-2b may interfere with the growth of tumor cells. Sorafenib may
      stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It may
      also stop the growth of kidney cancer by blocking blood flow to the tumor. Giving
      PEG-interferon alfa-2b together with sorafenib may kill more tumor cells.

      PURPOSE: This phase I trial is studying the side effects and best dose of PEG-interferon
      alfa-2b and sorafenib in treating patients with unresectable or metastatic kidney 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)