Vaccine Therapy Plus Sargramostim and Chemotherapy in Treating Women With Stage II or Stage III Breast Cancer

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the breast

  • Stage II or III
  • At least 4 positive lymph nodes
  • No inflammatory ductal carcinoma
• No positive lymph nodes by immunohistochemistry only

• Carcinoembryonic antigen (CEA) expression, as indicated by 1 of the following:

  • At least 30% of tumor stains for CEA on immunohistochemistry
  • Elevated serum CEA (greater than 5 ng/mL) anytime during disease course
• Must be HLA-A2 positive

• Must have received prior vaccinia for smallpox immunization with 1 of the following as evidence:

  • If age 25 and under, physician certification of prior vaccination
  • If over age 25, patient recollection and vaccination-site scar
  • Any age, detectable anti-vaccinia antibodies
• No metastases by CT scan of chest, abdomen, and pelvis and a bone scan

• Hormone receptor status:

  • Estrogen receptor status and progesterone receptor status known

PATIENT CHARACTERISTICS:

Age

• 18 and over

Sex

• Female

Menopausal status:

• Not specified

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• WBC at least 3,000/mm^3
• Absolute neutrophil count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3

Hepatic

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• SGOT and SGPT no greater than 1.5 times ULN
• Hepatitis B and C negative

Renal

• Creatinine no greater than 1.5 mg/dL OR
• Creatinine clearance greater than 60 mL/min
• No proteinuria OR
• Protein less than 1,000 mg per 24-hour urine collection
• No hematuria
• No abnormal sediment

Cardiovascular

• LVEF at least 45% by echocardiogram or MUGA if either of the following are true:

  • History of cardiac disease
  • Received prior cardiotoxic chemotherapy

Immunologic

• No evidence of immunocompromised status

• No autoimmune disease such as any of the following:

  • Autoimmune neutropenia, thrombocytopenia, or hemolytic anemia
  • Systemic lupus erythematosus
  • Sjogren's syndrome
  • Scleroderma
  • Myasthenia gravis
  • Goodpasture syndrome
  • Addison's disease
  • Hashimoto's thyroiditis
  • Active Graves' disease
• No active or prior eczema or other eczematoid skin disorders
• No other acute, chronic, or exfoliative skin conditions (e.g., atopic dermatitis, burns, impetigo, varicella zoster, severe acne, or other open rashes or wounds)
• HIV negative
• No active infection within the past 3 days
• No allergy to eggs
• No history of allergy or untoward reaction to prior vaccination with vaccinia virus

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No other serious illness
• No other malignancy within the past 3 years except squamous cell or basal cell skin cancer
• No history of seizures, encephalitis, or multiple sclerosis
• No active inflammatory bowel disease

• Must be able to avoid close household contact with the following during and for 2 weeks after vaccinations:

  • Persons with active or prior eczema or other eczematoid skin disorders
  • Persons with any other acute, chronic, or exfoliative skin conditions (e.g., atopic dermatitis, burns, impetigo, varicella zoster, severe acne, or other open rashes or wounds)
  • Pregnant or nursing women
  • Children under 5 years old
  • Immunodeficient or immunosuppressed persons (by disease or therapy), including those with HIV infection

PRIOR CONCURRENT THERAPY:

Biologic therapy

• See Disease Characteristics

Chemotherapy

• No prior doxorubicin, cyclophosphamide, or paclitaxel

Endocrine therapy

• No concurrent steroids except the following:

  • Topical steroids
  • Inhaled steroids for moderate asthma
  • Dexamethasone prior to taxanes

Radiotherapy

• No prior radiotherapy to more than 50% of the lymph nodes

Surgery

• At least 2 weeks since prior surgery and recovered
• No prior splenectomy

Other

• No other concurrent anti-tumor therapies