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
- 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
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
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
Response as measured by RECIST guidelines and Kaplan-Meier method at 5 years
John P. Hanson, MD
St. Luke's Medical Center
United States: Federal Government
|Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center||Milwaukee, Wisconsin 53201-2901|