A Phase I/II Clinical Study of Immunotherapy for Advanced Colorectal Cancers Using CEA-Pulsed Dendritic Cells Mixed With Tetanus Toxoid and Subsequent IL-2 Treatment
In this trial, we will immunize metastatic colorectal cancer patients with recombinant
CEA-pulsed DCs mixed with tetanus toxoid by subcutaneous injection. Low dose IL-2 will be
given subcutaneously following DC vaccination to boost the growth of T cells. We will adapt
“Simon’s optimal two-stage design” for this study. In the first stage, we will treat 12
patients to evaluate the safety of this new protocol. If there are no severe
toxicities/side effects and there is at least one patient that had stable disease or better
clinical response, then we will proceed to the second stage and treat additional 25
patients. We will follow the clinical outcome of these 37 patients. The immune responses
against CEA before and after vaccination will be examined.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
evaluate the clinical responses of vaccinated patients 6 weeks after the first injection
Jacqueline Whang-Peng, M.D.
National Health Research Institutes, Taiwan
Taiwan: Department of Health