A Phase II Study of Active Immunotherapy With PANVAC or Autologous, Cultured Dendritic Cells Infected With PANVAC After Complete Resection of Hepatic or Pulmonary Metastases of Colorectal Carcinoma
OBJECTIVES:
Primary
- Compare 2-year disease-free survival of patients with completely resected hepatic or
pulmonary metastases secondary to colorectal cancer treated with adjuvant vaccine
therapy comprising vaccinia-CEA-MUC-1-TRICOM vaccine (PANVAC-V) and
fowlpox-CEA-MUC-1-TRICOM vaccine (PANVAC-F) administered with autologous dendritic
cells or with sargramostim (GM-CSF).
Secondary
- Compare the rate and magnitude of immune response, as determined by ELISpot, in
patients treated with these regimens.
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo leukapheresis to obtain leukocytes for generation of autologous
dendritic cells (DC). Patients then receive autologous DC loaded with
vaccinia-CEA-MUC-1-TRICOM (PANVAC-V) vaccine subcutaneously (SC) and intradermally (ID)
on day 1 and autologous DC loaded with fowlpox-CEA-MUC-1-TRICOM (PANVAC-F) vaccine SC
and ID on days 28, 56, and 84.
- Arm II: Patients receive PANVAC-V SC on day 1 and PANVAC-F SC on days 28, 56, and 84.
Patients also receive sargramostim (GM-CSF) SC into the same injection site once daily
on days 0-3, 28-31, 56-59, and 84-87.
After completion of study treatment, patients are followed for 2 years.
PROJECTED ACCRUAL: A total of 72 patients (36 per treatment arm) will be accrued for this
study within 2 years.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Disease-free survival at 2 years
No
Michael A. Morse, MD
Study Chair
Duke Cancer Institute
United States: Food and Drug Administration
Pro00007616
NCT00103142
February 2005
Name | Location |
---|---|
Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
Hollings Cancer Center at Medical University of South Carolina | Charleston, South Carolina 29425 |
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center | Washington, District of Columbia 20007 |
Providence Cancer Center at Providence Portland Medical Center | Portland, Oregon 97213-2967 |
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | Tampa, Florida 33612 |
Wake Forest University Baptist Medical Center | Winston-Salem, North Carolina 27157 |