Vaccine Therapy in Treating Women With Previously Treated Metastatic Breast Cancer
RATIONALE: Vaccines may help the body build an effective immune response to kill tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating women with previously treated metastatic breast cancer.
|Study Design:||Allocation: Non-Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Single Arm Open-Label Phase I Study of An Injectable Replication-Incompetent Adenoviral Vector Vaccine Used to Produce An Immune Response to MUC-1 Positive Epithelial Cancer Cells in Metastatic Breast Cancer|
- Characterize the safety profile of the Ad-sig-hMUC-1/ecdCD40L vector vaccine [ Designated as safety issue: Yes ]
- Identification of a tolerable, immunologically active dose level [ Designated as safety issue: Yes ]
- Assess efficacy based on serum MUC-1 level [ Designated as safety issue: No ]
|Study Start Date:||July 2008|
|Primary Completion Date:||April 2009 (Final data collection date for primary outcome measure)|
- Characterize the safety profile of Ad-sig-hMUC-1/ecdCD40L vaccine in women with metastatic breast cancer.
- Identify a tolerable, immunologically active dose level of this vaccine in these patients.
- Evaluate the immune function in these patients before and after treatment with this vaccine.
OUTLINE: Patients receive MUC-1 vector vaccine subcutaneously on day 0.
After completion of study treatment, patients are followed monthly for 9 months.
|United States, California|
|Jonsson Comprehensive Cancer Center at UCLA|
|Los Angeles, California, United States, 90095-1781|
|Principal Investigator:||Sara Hurvitz, MD||Jonsson Comprehensive Cancer Center|