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Investigator(s):
James C. Yang, M.D. Principal Investigator Phone: 301-496-1574 Fax: 301-496-0011 james_yang@nih.gov
Referral Contact(s):
June A. Kryk, R.N. Research Nurse Phone: 1-866-820-4505 (Toll Free) Fax: 301-451-1927 ncisbirc@mail.nih.gov	Linda Williams, R.N. Research Nurse Phone: 1-866-820-4505 (Toll Free) Fax: 301-451-1927 ncisbirc@mail.nih.gov

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Primary Eligibility:

• Histologically confirmed clear cell renal cell carcinoma
• Metastatic disease
• Measurable disease
• Must have received ≥ 2 prior systemic standard therapy regimens that included cytokine immunotherapy and a tyrosine kinase inhibitor AND have progressed or was found to have been intolerant of therapy
• No history of > 2 CNS metastases
• Symptomatic CNS lesions > 1 cm in diameter or showing significant surrounding edema on MRI scan allowed provided they have been treated and have demonstrated no clinical or radiologic CNS progression for ≥ 2 months
• Recovered from prior therapy
• Prior anti-CTLA4 antibody allowed provided patient has a normal colonoscopy with normal colinic biopsies
• No concurrent systemic steroid therapy
• ECOG performance status 0–1
• ANC ≥ 1,000/mm³ (without filgrastim support)
• WBC ≥ 3,000/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 8 g/dL
• Serum ALT and AST ≤ 2.5 x upper limit of normal
• Total bilirubin ≤ 1.5 mg/dL (< 3 mg/dL in patients with Gilbert's syndrome)
• Serum creatinine ≤ 1.6 mg/dL
• Not pregnant or nursing; fertile patients must use effective contraception during and for 4 months after completion of the preparative regimen
• Documented LVEF > 45% in patients ≥ 60 years of age OR in those with a history of ischemic heart disease, chest pain, or clinically significant atrial and/or ventricular arrhythmias
• Documented FEV₁ > 60% predicted in patients with a prolonged history of cigarette smoking OR in those with symptoms of respiratory dysfunction
• HIV antibody negative
• Hepatitis B surface antigen and hepatitis C antibody negative (unless antigen negative)
• No history of myocardial infarction, cardiac arrhythmias, or obstructive or restrictive pulmonary disease
• No history of coronary revascularization or ischemic symptoms
• No medical condition that would preclude study participation
• No history of severe immediate hypersensitivity reaction to any of the agents used in this study

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Study Outline:

This is a phase I dose-escalation study of T cells retrovirally transduced with the 2G-1 T-cell receptor (TCR) followed by a phase II study.

Nonmyeloablative preparative chemotherapy regimen:

• Patients receive cyclophosphamide IV over 1 hour on Days -7 and -6 and fludarabine IV over 30 minutes on Days -5 to -1

T-cell infusion and aldesleukin administration

• Patients receive 2G-1 TCR-transduced peripheral blood lymphocytes or tumor-infiltrating lymphocytes IV over 20–30 minutes on Day 0
• Patients also receive aldesleukin IV over 15 minutes every 8 hours on Days 0–4 (maximum of 15 doses)

• Patients who achieve a partial or complete response to treatment and who subsequently progress may receive a second course of treatment (as above) beginning approximately 10 weeks after the last dose of aldesleukin
• Blood samples are collected periodically
• After completion of study therapy, patients are evaluated at 4–6 weeks and then periodically for up to 15 years

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 
Updated: 6/22/09