A Phase I Study Of Active Immunotherapy With Autologous Dendritic Cells Infected With CEA-6D Expressing Fowlpox -Tricom In Patients With Advanced Or Metastatic Malignancies Expressing CEA
- Determine the safety and feasibility of active immunotherapy comprising autologous
dendritic cells infected with recombinant fowlpox-CEA-TRICOM vaccine in patients with
advanced or metastatic malignancies expressing CEA.
- Assess the CEA-specific immune response of patients treated with this regimen.
- Assess, in a preliminary manner, the clinical response rate of patients treated with
OUTLINE: This is a dose-escalation study.
Autologous dendritic cells (ADCs) are harvested and infected with fowlpox-CEA-TRICOM
vaccine. Patients receive the infected ADCs intradermally and subcutaneously (SC) followed
by ADCs mixed with CMV pp65 peptide and ADCs mixed with tetanus toxoid SC and intradermally
on day 1. Treatment repeats every 3 weeks for a total of 4, 8, or 12 immunizations in the
absence of unacceptable toxicity.
Cohorts of 6 patients receive an escalating number of immunizations until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2
of 6 patients experience dose-limiting toxicity.
Patients are followed every 3 months for 1 year.
PROJECTED ACCRUAL: A total of 6-18 patients will be accrued for this study.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary objective of this protocol is to determine the safety and feasibility of rF-CEA(6D)-TRICOM loaded DC in, subjects with metastatic, CEA expressing malignancies.
Herbert K. Lyerly, MD
Duke Cancer Institute
United States: Federal Government
|Duke Comprehensive Cancer Center||Durham, North Carolina 27710|