Status:
TERMINATED
Cultured White Cells Plus Interleukin-2 to Treat Advanced Kidney Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Kidney Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Background: * Some patients with advanced kidney cancer have immune cells that can recognize and kill their cancer, but the cells are not active enough or numerous enough to accomplish this on their ...
Detailed Description
Background: One area of therapeutic advancement in immunotherapy has been to identify autologous tumor-reactive T-cells and expand them in vitro, and administer them in adoptive transfer back to pati...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00091611
Start Date
September 1 2004
End Date
March 1 2008
Last Update
October 26 2012
Active Locations (1)
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1
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892