Vaccine Therapy in Treating Women With Previously Treated Metastatic Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00706615|
Recruitment Status : Withdrawn (no accrual)
First Posted : June 27, 2008
Last Update Posted : October 30, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Biological: Ad-sig-hMUC-1/ecdCD40L vaccine||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||July 2008|
|Actual Primary Completion Date :||April 2009|
- Characterize the safety profile of the Ad-sig-hMUC-1/ecdCD40L vector vaccine
- Identification of a tolerable, immunologically active dose level
- Assess efficacy based on serum MUC-1 level
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00706615
|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|