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HER-2 Protein Vaccine in Treating Women With Breast Cancer

A Phase I Trial Evaluating The Safety Of Intramuscular Injections Of HER-2 Protein AUTOVAC (PX104.1.6) In Patients With Breast Cancer

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00068614
Enrollment
Unknown
Registered
2003-09-11
Start date
2003-07-31
Completion date
Unknown
Last updated
2014-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

stage IV breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer

Brief summary

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.

Detailed description

OBJECTIVES: Primary * Determine the safety of HER-2 protein AutoVac™ in women with breast cancer. Secondary * 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.

Interventions

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Case Comprehensive Cancer Center
Lead SponsorOTHER

Study design

Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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 * Have been receiving a stable endocrine therapy regimen (e.g., aromatase inhibitor, tamoxifen, fulvestrant, or gonadotropin-releasing hormone agonist) for at least 30 days OR status post oophorectomy * 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: * Stage IIB with involvement of at least 4 nodes * Stage IIIA (T3 disease with involvement of at least 4 nodes) * Any stage IIIB or IIIC disease * Stage IV with no evidence of disease (e.g., prior resection of local chest wall recurrence with no evidence of disease elsewhere) * 1+, 2+, or 3+ HER2/neu expression by immunohistochemistry * Treatment with trastuzumab (Herceptin®) not clinically indicated * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age * 18 and over Sex * Female Menopausal status * Not specified Performance status * ECOG 0-1 Life expectancy * At least 6 months Hematopoietic * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 10 g/dL * Absolute neutrophil count at least 1,500/mm\^3 Hepatic * ALT or AST no greater than 2.5 times upper limit of normal (ULN) (5 times ULN for patients with liver metastases) * Bilirubin no greater than 2 mg/dL (unless due to Gilbert's disease) Renal * Creatinine no greater than 2 mg/dL Cardiovascular * No history of significant cardiovascular disease * No myocardial infarction within the past 6 months * No poorly controlled cardiac arrhythmia * No New York Heart Association class III or IV heart disease * LVEF at least 50% by MUGA Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other malignancy except basal cell skin cancer or adequately treated carcinoma in situ of the cervix * No concurrent severe autoimmune disease * No other clinically significant or serious medical disease that would preclude study participation or compromise patient safety or the results of this study PRIOR CONCURRENT THERAPY: Biologic therapy * More than 4 months since prior trastuzumab * No prior anticancer vaccine therapy * No concurrent trastuzumab * No concurrent immunomodulators (e.g., thalidomide or interferons/interleukins) Chemotherapy * More than 4 weeks since prior chemotherapy * No concurrent low-dose methotrexate or cyclophosphamide * No concurrent cytotoxic chemotherapy Endocrine therapy * See Disease Characteristics * No concurrent corticosteroids * Topical or inhaled steroids are allowed * No changes to current endocrine therapy regimen (e.g., discontinuation or addition of an agent) Radiotherapy * More than 3 months since prior radiotherapy involving more than 25% of the bone marrow * No concurrent radiotherapy Surgery * See Disease Characteristics * No prior bilateral breast procedures Other * More than 4 weeks since prior immunosuppressive therapy * More than 30 days since prior investigational agents or clinical trial participation * No other concurrent experimental or investigational agents * No concurrent cyclosporine * No concurrent immunosuppressive agents

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026