HER-2 Protein Vaccine in Treating Women With 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: NCT00068614|
Recruitment Status : Completed
First Posted : September 11, 2003
Last Update Posted : February 5, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Biological: HER-2/neu peptide vaccine||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Masking:||None (Open Label)|
|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|
|Actual Primary Completion Date :||October 2005|
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): NCT00068614
|United States, Ohio|
|Ireland Cancer Center|
|Cleveland, Ohio, United States, 44106-5055|
|Study Chair:||Beth A. Overmoyer, MD, FACP||Case Comprehensive Cancer Center|