Clinical Drug Experience Knowledgebase

Criteria

DISEASE CHARACTERISTICS:

Histologically proven metastatic breast cancer

Stage IV disease patients who have either been treated to maximal response or who have had high dose chemotherapy or a marrow ablative regimen (if they meet immunologic criteria and have not received more than 2 chemotherapy regimens for treatment of metastatic disease)

Patients with advanced stage disease who:

Received at least 1 standard chemotherapy regimen, but no more than 2, for treatment of metastatic disease
Refused chemotherapy
Refused or progressed despite hormonal therapy
Measurable or evaluable disease
Positive or negative for HLA-A2
Must have superficial inguinal or axillary lymph nodes that are free of tumor involvement and are surgically accessible
No symptomatic or acutely life threatening tumor that is judged likely to require intervention with alternative modalities within 3 months
No brain metastases

Hormone receptor status:

Not specified

PATIENT CHARACTERISTICS:

Age:

18 and over

Sex:

Female

Menopausal status:

Not specified

Performance status:

ECOG 0 or 1

Life expectancy:

Not specified

Hematopoietic:

WBC greater than 3,000/mm^3

Hepatic:

Not specified

Renal:

BUN less than 25 mg/dL
Creatinine less than 1.8 mg/dL

Cardiovascular:

No ischemic or congestive cardiac disease requiring chronic medication
No New York Heart Association class III or IV heart disease
No evidence of ischemic change or ventricular ectopy (greater than 4/min) on electrocardiogram (EKG)
No evidence of type II arterial-ventricular block
No evidence of current cardiac disease by stress test and EKG

Other:

HIV negative
No active infection requiring treatment
No psychiatric illness
No history of seizure disorder
No other prior malignancy within the past 10 years except squamous cell or basal cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

At least 4 weeks since prior specific or nonspecific immunotherapy, unless there is obvious progression of metastatic disease, and recovered

Chemotherapy:

See Disease Characteristics
At least 4 weeks since prior chemotherapy, unless there is obvious progression of metastatic disease, and recovered

Endocrine therapy:

At least 4 weeks since prior steroids, unless there is obvious progression of metastatic disease, and recovered

Radiotherapy:

Concurrent radiotherapy allowed for local control of disease

Surgery:

Not specified