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Sponsors and Collaborators: |
Ireland Cancer Center National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00068614 |
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 | Intervention | Phase |
Breast Cancer |
Drug: HER-2/neu peptide vaccine |
Phase I |
Genetics Home Reference related topics: | breast cancer |
MedlinePlus related topics: | Breast Cancer Cancer |
Study Type: | Interventional |
Study Design: | Treatment, 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 |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the breast, meeting criteria for 1 of the following:
Metastatic disease currently in complete or partial response or stable disease
Completed a course of local and adjuvant systemic therapy for high-risk stage II or III disease (i.e., anticipated 5-year relative survival is no greater than 50%) meeting any of the following staging criteria:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
No concurrent corticosteroids
Radiotherapy
Surgery
Other
United States, Ohio | |||||
Ireland Cancer Center | |||||
Cleveland, Ohio, United States, 44106-5055 |
Ireland Cancer Center |
National Cancer Institute (NCI) |
Study Chair: | Beth A. Overmoyer, MD, FACP | Case Comprehensive Cancer Center |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000327784, CWRU-030339, PHARMEXA-PMXA-1103, PHARMEXA-PX104.1.6-101 |
First Received: | September 10, 2003 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00068614 |
Health Authority: | United States: Federal Government |
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