Biological Therapy in Treating Patients With Advanced Cancer
RATIONALE: A person's white blood cells mixed with tumor proteins may make the body build an immune response to kill tumor cells.
PURPOSE: Phase I trial to study the effectiveness of biological therapy in treating patients who have advanced cancer that shows no signs of disease following treatment.
|Breast Cancer Gastric Cancer Ovarian Cancer||Biological: HER-2/neu intracellular domain protein Biological: therapeutic autologous dendritic cells|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Study of Active Immunotherapy With HER2/Neu Intracellular Domain (ICD) Protein-Pulsed, Autologous, Cultured Dendritic Cells in Patients With No Evidence of Disease After Standard Treatment for HER2/Neu Expressing Malignancies|
- Safety [ Time Frame: 12 months ]safety
|Study Start Date:||February 2000|
|Study Completion Date:||July 2002|
|Primary Completion Date:||August 2001 (Final data collection date for primary outcome measure)|
Biological: HER-2/neu intracellular domain protein
- Evaluate the immune response of patients with HER2/neu expressing advanced malignancies showing no evidence of disease after standard treatment when injected with HER2/neu intracellular domain protein pulsed autologous dendritic cells.
- Assess time to recurrence in these patients.
OUTLINE: Autologous dendritic cells (DC) are pulsed with HER2/neu intracellular domain protein (ICD). The pulsed DC are administered subcutaneously (SQ) and intradermally, followed by autologous DC mixed with tetanus toxoid (TT) and autologous DC mixed with keyhole limpet hemocyanin (KLH) SQ and intradermally on day 1. HLA-A2 positive patients also receive autologous DC mixed with CMV pp65 peptide SQ and intradermally on day 1. Treatment continues every 3 weeks for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year or until disease progression.
PROJECTED ACCRUAL: A total of 6 patients will be accrued for this study over 6 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005956
|United States, North Carolina|
|Duke Comprehensive Cancer Center|
|Durham, North Carolina, United States, 27710|
|Study Chair:||Michael A. Morse, MD||Duke Cancer Institute|