Clinical trial NCT00589550 (phase 1, status: terminated)
Conditions: kidney cancer
ICD codes: D17.71, D30.00, D30.01, D30.02, D41.00, D41.01, D41.02
Drugs: sorafenib
SMILES: CNC(=O)C1=NC=CC(OC2=CC=C(NC(=O)NC3=CC(=C(Cl)C=C3)C(F)(F)F)C=C2)=C1
Reason stopped: 
    low accrual
  
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)