Vaccine Therapy in Treating Patients With Advanced or Metastatic Cancer
RATIONALE: Vaccines made from a person's white blood cells that have been treated in the laboratory may make the body build an immune response to kill tumor cells.
PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have advanced or metastatic cancer.
|Breast Cancer Colorectal Cancer Gallbladder Cancer Gastric Cancer Head and Neck Cancer Liver Cancer Ovarian Cancer Pancreatic Cancer Testicular Germ Cell Tumor||Biological: TRICOM-CEA(6D)||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||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|
- Safety [ Time Frame: 12-36 weeks ]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.
- Immune response [ Time Frame: 12-36 weeks ]The immune response to the injections of the TRICOM-CEA(6D) antigen loaded DC will be evaluated
|Study Start Date:||January 2002|
|Study Completion Date:||October 2007|
|Primary Completion Date:||October 2007 (Final data collection date for primary outcome measure)|
Subjects receiving TRICOM-CEA(6D)
dendritic cells loaded with TRICOM-CEA(6D)
Other Name: recombinant fowlpox-CEA(6D)/TRICOM vaccine
- 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 this regimen.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00027534
|United States, North Carolina|
|Duke Comprehensive Cancer Center|
|Durham, North Carolina, United States, 27705|
|Study Chair:||Herbert K. Lyerly, MD||Duke Cancer Institute|