Docetaxel Alone or in Combination With Vaccine to Treat Breast Cancer

Inclusion Criteria

• •Metastatic Breast Cancer (either male or female) with evidence of metastatic disease (must have radiographic evidence of measurable disease) on computed tomography (CT) scan or X-ray, or evidence of evaluable disease on bone scan that is consistent with metastasis and a life expectancy of at least 4 months. Patients may have received unlimited prior hormonal therapy and chemotherapy.
• •Histologically confirmed adenocarcinoma of the breast cancer confirmed in the Pathology Clinical Center at National Cancer Institute (NCI), (or National Naval Medical Center (NNMC)) or MD Anderson Pathology Department prior to starting this study. Note: However, if no pathologic specimen is available, patients may enroll with a clinical course consistent with breast cancer and a pathological documentation of the disease.
• •18 years of age or greater.
• •May have received docetaxel in the adjuvant setting at least 12 months prior to study entry.
• •Able to understand and give informed consent.
• •Able to avoid close household contact (close household contacts are those who share housing or have close physical contact) for at least two weeks after recombinant vaccinia vaccination with persons with active or a history of eczema or other eczematoid skin disorders; those with other acute, chronic or exfoliative skin conditions (e.g., atopic dermatitis, burns, impetigo, varicella zoster, severe acne, or other open rashes or wounds) until condition resolves; pregnant or nursing women; children 3 years of age and under; and immunodeficient or immunosuppressed persons (by disease or therapy), including human immunodeficiency virus (HIV) infection. We have vaccinated over 700 cancer patients and have reported no cases of either self inoculation or person to person transmission of the virus.
• •Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1.
• •Serum creatinine less than 1.5 times upper limits of normal (ULN) OR creatinine clearance on a 24 hour urine collection of greater than or equal to 60 mL/min, standard liver function tests (LFT) limitations for patients receiving docetaxel therapy include bilirubin within ULN and serum glutamic oxaloacetic transaminase (SGOT)/serum glutamic pyruvic transaminase (SGPT) less than 1.5 times the ULN. If transaminases are greater than 1.5 times the ULN up to 2 times the ULN (as currently indicated), then alk phos should be less than 2.5 times the ULN. (Patients with renal abnormalities should be evaluated for creatinine clearance (CrCl) and interstitial abnormalities. A Cr Cl of greater than or equal to 60ml/min measured or calculated and proteinuria less than 1000mg per 24 hours are eligible unless explained by non-renal causes.)
• •Recovered completely from any grade 3 or 4 reversible hematologic and non hematologic toxicity associated with recent therapy. Typically this is 3-4 weeks for patients who most recently received cytotoxic therapy. Patients previously treated with mitomycin c or carboplatin will require a minimum of 6 weeks.
• •Hematological eligibility parameters (within 16 days of starting therapy):
• •1. Granulocyte count greater than or equal to1,500/mm\^3
• •2. Platelet count greater than or equal to 100,000/mm\^3
• •3. Hemoglobin (Hgb) greater than or equal to 8 Gm/dL
• •Must agree to use effective birth control or abstinence during and for a period of 4 months after the last vaccination therapy.
• •Patients whose tumors are estrogen receptor (ER) positive should have failed primary hormone therapy unless clinically indicated, i.e. in patients with visceral disease or symptomatic bone disease where up front chemotherapy is warranted. Patients who progressed or recurred following Trastuzumab (Herceptin) therapy if a patient is fluorescence in situ hybridization (FISH) positive or immunohistochemistry (IHC) 3+ positive for human epidermal growth factor receptor 2 (Her-2 neu). Those patients who have progressed on trastuzumab may continue to receive the drug by their referring physician. However, if trastuzumab has been discontinued at the time of enrolling on study, it cannot be resumed while a patient remains on study.
• •Patients randomized to docetaxel alone (arm B) may at time of progression go on to receive vaccine alone if their ECOG performance status remains 0-1, and they do not have any uncontrolled pain or organ dysfunction that would require another intervention such as radiation or chemotherapy.