Gene Therapy in Treating Women With Metastatic Breast Cancer

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically or cytologically confirmed metastatic adenocarcinoma of the breast
• •* Malignant disease in the skin, chest wall, or other sites (lymph nodes or primary tumor in the breast) accessible to percutaneous needle placement and injection
• •* Solitary or multiple tumors
• •* Measurable disease in ≥ 2 dimensions by physical examination or CT/MRI scan
• •* Malignant tumors in the skin and chest wall must be ≥ 4 mm in diameter by physical examination
• •* Malignant tumors in other accessible sites must be ≥ 1 cm in diameter on physical examination
• •* Malignant disease in other organs (in addition to skin or chest wall metastases) allowed
• •Hormone receptor status not specified
• •PATIENT CHARACTERISTICS:
• •Menopausal status not specified
• •Karnofsky performance status 70-100%
• •Life expectancy ≥ 16 weeks
• •Granulocyte count ≥ 1,500/mm\^3
• •Platelet count ≥ 100,000/mm\^3
• •Hemoglobin ≥ 9.0 mg/dL
• •PT normal
• •Serum creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 45 mL/min
• •Serum total bilirubin ≤ 2.0 times upper limit of normal (ULN)
• •Serum transaminases ≤ 2.5 times ULN
• •Not pregnant or nursing
• •Negative pregnancy test
• •Weight ≥ 30 kg (for patients treated with the highest dose level of study drug)
• •No active infection or concurrent serious medical illness
• •No HIV positivity
• •No other malignancy within the past 5 years except for the following:
• •* Inactive nonmelanoma skin cancer
• •* In situ carcinoma of the cervix
• •* Grade 1 papillary bladder cancer
• •PRIOR CONCURRENT THERAPY:
• •More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
• •No anticoagulant therapy with heparin or warfarin for ≥ 2 months after completion of study treatment