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