Colorectal Cancer Clinical Trial
Official title:
A Phase I/II Study Of Interleukin-12-Primed Activated T Cells In Combination With 5FU, GM-CSF And Interferon Alfa-2b In Metastatic Renal Cell Carcinoma Or Colorectal Carcinoma
RATIONALE: Biological therapies use different ways to stimulate the immune system and stop
cancer cells from growing. Drugs used in chemotherapy use different ways to stop tumor cells
from dividing so they stop growing or die. Combining biological therapy with chemotherapy
may kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of biological therapy combined with
chemotherapy in treating patients who have metastatic kidney cancer or colorectal cancer.
OBJECTIVES:
- Determine the safety of a repeat course of interleukin-12-primed activated T cells
(12ATC) in combination with fluorouracil, sargramostim (GM-CSF), and interferon alfa-2b
in patients with metastatic renal cell or colorectal carcinoma.
- Determine the clinical responses of patients treated with this regimen.
- Determine the efficacy of 12ATC in these patients.
- Determine whether there are changes in immunologic parameters related to 12ATC as
measured by lymphocyte phenotype and cytokine secretion in these patients.
- Determine the correlation between clinical responses in patients treated with this
regimen and in vitro immune functions of lymphocytes.
OUTLINE: Patients are stratified according to disease type (renal cell carcinoma vs
colorectal carcinoma).
Patients receive sargramostim (GM-CSF) subcutaneously (SC) daily on days 1-5 and then
undergo collection of autologous peripheral blood mononuclear cells (PBMC) on days 6 and 7
of week 1. The PBMC are treated ex vivo to form interleukin-12-primed activated T cells
(12ATC).
Patients receive fluorouracil IV over 24 hours on day 6 of week 2 and interferon alfa-2b SC
and GM-CSF SC 3 times weekly on weeks 3-5. Patients receive 12ATC IV over 15-30 minutes
twice weekly and interferon alfa-2b SC (at least 24 hours after 12ATC infusion) once weekly
on weeks 6-8. Patients with complete or partial response or stable disease at 3 weeks after
the last 12ATC infusion may receive an additional 8-week course as above.
Patients are followed every 2-3 months for 1 year and then every 6 months for 2 years or at
any time when the physical examination or symptoms are suspicious for tumor progression.
PROJECTED ACCRUAL: A total of 60 patients (30 per stratum) will be accrued for this study
within 2-3 years.
;
Primary Purpose: Treatment
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