NCT00016042

Fluorouracil and Biological Therapy in Treating Patients With Metastatic Kidney or Colorectal Cancer

Interleukin 12-Primed Activated T Cells For Patients With Metastatic Renal Cell Carcinoma Or Colorectal Carcinoma (Phase I)

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• Sponsor: St. Luke's Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining chemotherapy with biological therapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of fluorouracil combined with biological therapy in treating patients who have metastatic kidney or colorectal cancer.

Detailed description

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 regimen. 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.

Conditions

• Colorectal Cancer
• Kidney Cancer

Interventions

Type	Name	Description
BIOLOGICAL	lymphokine-activated killer cells
BIOLOGICAL	recombinant interferon alfa
BIOLOGICAL	sargramostim
DRUG	fluorouracil

Timeline

• Start date: 2001-01-01
• First posted: 2004-04-05
• Last updated: 2013-09-20

Locations

1 site across 1 country: United States