Protocol Number: 04-C-0277

Title:

Treatment of Patients with Metastatic Renal Cell Cancer Using Cultured Tumor-Reactive Lymphocytes and Interleukin-2

Number:

04-C-0277

Summary:

Patients with metastatic renal cell cancer who have failed conventional therapy with interleukin-2, from whom tumor-reactive lymphocytes can be obtained and expanded in vitro will be treated with these cells along with interleukin-2 to support in vivo survival and expansion. Cells may be obtained from either peripheral blood, lymph nodes or tumor-infiltrating lymphocytes. Two sequential cohorts will be treated with either intra-arterial cell administration or antecedent lymphodepleting chemotherapy depending on their patterns of disease. This study will evaluate the potential therapeutic benefits of these treatment approaches.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Active Accrual Of New Subjects

Gender: Male & Female

Referral Letter Required: Yes

Population Exclusion(s): Children

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 ECOG 0, 1 at entry to the trial.

-Life expectancy of greater than three months.

-Seronegative for HIV antibody.

-Seronegative for hepatitis B antigen.

-Seropositive for Epstein-Barr Virus (EBV).

-Patients with EKG abnormalitites, symptoms of cardiac ischemia or arrythmias or age greater than 50 years must have a normal stress cardiac test (stress thallium, stress 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 FEV(1) greater than 60% predicted.

EXCLUSION CRITERIA: CELL HARVEST:

-Active systemic infections, coagulation disorders, contra-indications to receiving 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 IL-2.

-Clinical performance status of ECOG 0, 1 at entry to the treatment phase of this trial.

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

-Serum ALT/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 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.

-Note: After 12 patients have been accrued to Cohort A (retreatment with intravenous cells preceded by chemotherapy preparative regimen), all patients enrolled must meet eligibility criteria for Cohort B (intra-arterial cell infusion after initial intravenous cell infusion).

-Patients with asymptomatic brain metastases may be considered eligible.

EXCLUSION CRITERIA: CELL INFUSION:

-Potentially effective therapy for 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 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.

Special Instructions: Currently Not Provided

Keywords:

Clinical Response

Intravenous

Intra-Arterial

Lymphodepletion

Traffic of Cells

T-Cell Transfer

Recruitment Keywords:

None

Conditions:

Kidney Neoplasms

Investigational Drug(s):

IL-2

OKT3

Investigational Device(s):

None

Contacts:

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations:

Coulie P, Weynants P, Muller C, Lehmann F, Herman J, Baurain JF, Boon T. Genes coding for antigens recognized on human tumors by autologous cytolytic T lymphocytes. Ann N Y Acad Sci. 1993 Aug 12;690:113-9. No abstract available. PMID: 8368730

Rosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL, Restifo NP, Dudley ME, Schwarz SL, Spiess PJ, Wunderlich JR, Parkhurst MR, Kawakami Y, Seipp CA, Einhorn JH, White DE. Immunologic and therapeutic evaluation of a synthetic peptide vaccine for the treatment of patients with metastatic melanoma. Nat Med. 1998 Mar;4(3):321-7.

PMID: 9500606

Rosenberg SA, Zhai Y, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL, Restifo NP, Seipp CA, Einhorn JH, Roberts B, White DE. Immunizing patients with metastatic melanoma using recombinant adenoviruses encoding MART-1 or gp100 melanoma antigens. J Natl Cancer Inst. 1998 Dec 16;90(24):1894-900. PMID: 9862627

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