Clinical trial NCT00091611 (phase 1, status: terminated)
Conditions: kidney neoplasms
ICD codes: D17.71, D30.00, D30.01, D30.02, D41.00, D41.01, D41.02
Drugs: il-2 (interleukin-2), okt3, cyclophosphamide, fludarabine, mesna
SMILES: COC1=CC2=C(C=C1)N=C(N2)S(=O)CC1=NC=C(C)C(OC)=C1C, ClCCN(CCCl)P1(=O)NCCCO1, ClCCN(CCCl)P1(=O)NCCCO1, OS(=O)(=O)CCS
Reason stopped: 
    this study was terminated due to low accrual.
  
Eligibility criteria:

        -  INCLUSION CRITERIA: CELL HARVEST:

          -  Patients must have metastatic renal cell cancer.

          -  age greater than or equal to 18 years.

          -  Clinical performance status of Eastern Cooperative Oncology Group (ECOG) 0, 1 at entry
             to the trial.

          -  Life expectancy of greater than three months.

          -  Seronegative for human immunodeficiency virus (HIV) antibody. (The experimental
             treatment being evaluated in this protocol depends on an intact immune system.
             Patients who are human immunodeficiency virus (HIV) seropositive can have decreased
             immune competence and can thus be less responsive to the experimental treatment and
             more susceptible to it's toxicities.)

          -  Seronegative for hepatitis B antigen.

          -  Seropositive for Epstein-Barr Virus (EBV).

          -  Patients with electrocardiogram (EKG) abnormalities, symptoms of cardiac ischemia or
             arrythmias or age greater than 50 years must have a normal stress cardiac test (stress
             thallium, stress multi-gated acquisition scan (MUGA), dobutamine echocardiogram or
             other stress test).

          -  Patients who have a recent prolonged history of cigarette smoking or symptoms of
             respiratory dysfunction must have pulmonary function testing with an forced expiratory
             volume in 1 second (FEV(1)) greater than 60% predicted.

        EXCLUSION CRITERIA: CELL HARVEST:

        -Active systemic infections, coagulation disorders, contra-indications to receiving
        interleukin-2 (IL-2) or major medical illnesses of the cardiovascular, respiratory or
        immune system.

        INCLUSION CRITERIA: CELL INFUSION:

          -  Patients must have measurable metastatic renal cell cancer and have tumor progression
             after therapy with interleukin-2 (IL-2).

          -  Clinical performance status of Eastern Cooperative Oncology Group (ECOG) 0, 1 at entry
             to the treatment phase of this trial.

          -  Platelet count greater than 100,000/mm^3.

          -  Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) less than three
             times the upper limit of normal.

          -  Serum creatinine less than or equal to 1.6 mg/dl.

          -  Total bilirubin less than or equal to 1.6 mg/dl or direct bilirubin less than or equal
             to 0.5 mg/dl.

          -  Life expectancy of greater than three months.

          -  At the time of T-cell transfer, the patient must have a T-cell population which has
             met the attached Certificate of Analysis for tumor recognition and safety testing.

          -  Any patient receiving interleukin-2 (IL-2) must sign a durable power of attorney.

          -  Male and Female patients must be willing to practice contraception during the
             treatment phase of this study..

          -  Patients with asymptomatic brain metastases may be considered eligible.

        EXCLUSION CRITERIA: CELL INFUSION:

          -  Potentially effective therapy for renal cell cancer (RCC) within four weeks of the
             time the patient receives T-cell transfer (with the exception of local irradiation to
             non-evaluated sites).

          -  Requirement for steroid therapy.

          -  Active systemic infections, coagulation disorders, contra-indications to receiving
             interleukin-2 (IL-2) or major medical illnesses or the cardiovascular, respiratory or
             immune system.

          -  Pregnant patients and nursing mothers will be excluded because of the unknown effects
             of this therapy on the fetus or nursing infant.