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
- 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).
- 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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Disease-free survival at 2 years
Michael A. Morse, MD
Duke Cancer Institute
United States: Food and Drug Administration
|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|