Interleukin 12-Primed Activated T Cells For Patients With Metastatic Renal Cell Carcinoma Or Colorectal Carcinoma (Phase I)
OBJECTIVES: I. Determine the safety of fluorouracil and interleukin-12-primed activated T
cells (12ATC) with sargramostim (GM-CSF) and interferon alfa in patients with metastatic
renal cell cancer or colorectal cancer. II. Determine the maximum tolerated dose of 12ATC in
this patient population. III. Determine the clinical response of patients treated with this
OUTLINE: This is a dose-escalation study of interleukin-12-primed activated T cells (12ATC).
Patients receive sargramostim (GM-CSF) subcutaneously (SC) on days 1-5 and undergo
leukopheresis on day 6 to obtain peripheral blood mononuclear cells (PBMC). Patients treated
at dose level 3 also undergo leukopheresis on day 7. The PBMC are treated with monoclonal
antibody anti-CD3, interleukin-12 and interleukin-2 to form 12ATC. Patients receive
chemo/immunotherapy comprising fluorouracil IV continuously over 24 hours on day 13 and
GM-CSF and interferon alfa SC on days 17, 19, 21, 24, 26, and 28. Patients receive 12ATC IV
over 15-30 minutes on days 31, 34, 38, 41, 45, and 48 and interferon alfa SC on days 35, 42,
and 49. Cohorts of 3-6 patients receive escalating doses of 12ATC until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2
of 3 or 6 patients experience dose-limiting toxicity. Patients are followed at 2 weeks,
every 3 months for 1 year, and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 9-18 patients will be accrued for this study.
Primary Purpose: Treatment
John P. Hanson, MD
St. Luke's Medical Center
United States: Federal Government
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