A Phase I Study of Active Immunotherapy With CAP-1 (6D) and CMVpp65 Peptide-Pulsed, Autologous Dendritic Cells Produced in the Aastromreplicell Cell Production System in Patients With Stage IV CEA Expressing Malignancies
- Determine the safety and feasibility of administering 1 or 2 courses of vaccination
with carcinoembryonic antigen peptide 1-6D (CAP 1-6D)- and CMV pp65 peptide-pulsed
autologous dendritic cells in patients with refractory stage IV CEA-expressing
- Determine the ability of this regimen to induce CAP 1-6D- and CMV pp65-specific T cells
in these patients.
- Determine the antitumor effect of this regimen, in terms of progression-free survival,
of these patients.
OUTLINE: This is an open-label, dose-escalation study.
Patients undergo leukapheresis and collection of peripheral blood mononuclear cells from
which dendritic cells (DC) are generated and pulsed with carcinoembryonic antigen peptide
1-6D (CAP 1-6D) and CMV pp65 peptide. Patients are assigned to 1 of 2 vaccination cohorts.
- Cohort I: Patients receive vaccination with CAP 1-6D-pulsed DC and CMV pp65
peptide-pulsed DC subcutaneously and intradermally every 3 weeks for a total of 4
- Cohort II: Patients receive vaccinations as in cohort I every 3 weeks for a total of 8
For both cohorts, a safe dose of the vaccine is defined as the dose at which no more than 1
of 6 patients experiences unacceptable toxicity.
Patients are followed every 3 months for 1 year.
PROJECTED ACCRUAL: A total of 12 patients (6 per cohort) will be accrued for this study
within 24 months.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The safety and feasibility of administering one cycle of CAP-1(6D) and CMV pp65 peptide-pulsed, matured, autologous human DC produced by the AastromReplicell™ Cell Production System
Herbert K. Lyerly, MD
Duke Cancer Institute
United States: Federal Government
|Duke Comprehensive Cancer Center||Durham, North Carolina 27710|