HER-2 Protein Vaccine in Treating Women With Breast Cancer
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.
PURPOSE: Phase I trial to study the effectiveness of HER-2 protein vaccine in treating women who have breast cancer.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Trial Evaluating The Safety Of Intramuscular Injections Of HER-2 Protein AUTOVAC (PX104.1.6) In Patients With Breast Cancer|
|Study Start Date:||July 2003|
|Primary Completion Date:||October 2005 (Final data collection date for primary outcome measure)|
- Determine the safety of HER-2 protein AutoVac™ in women with breast cancer.
- Determine the ability of this drug to bypass the tolerance to the HER-2 self-protein by raising HER-2 antibodies in these patients.
- Determine the kinetics of the immune response to HER-2/neu in patients treated with this drug.
OUTLINE: This is an open-label, multicenter study.
Patients receive HER-2 protein AutoVac™ intramuscularly at weeks 0, 2, 6, and 10 in the absence of unacceptable toxicity.
Patients are followed for up to 6 weeks.
PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study within 3 months.
|United States, Ohio|
|Ireland Cancer Center|
|Cleveland, Ohio, United States, 44106-5055|
|Study Chair:||Beth A. Overmoyer, MD, FACP||Case Comprehensive Cancer Center|