Gene Therapy in Treating Women With Metastatic Breast Cancer

OBJECTIVES:

• Determine the toxicity and maximum tolerated dose of intratumoral injection of adenovirus-mediated human interleukin-12 gene in women with metastatic breast cancer.
• Determine the tumor response in patients treated with this regimen.
• Determine the immune response in patients treated with this regimen.

OUTLINE: Patients receive a single dose of adenovirus-mediated human interleukin-12 intratumorally via percutaneous needle placement under ultrasound guidance.

Blood and tumor tissue samples are collected periodically for immunological laboratory studies. Samples are analyzed for serum cytokine levels by ELISA; qualitative analysis of immune biomarkers by IHC staining; and immune cell biomarker analysis by FACS.

After completion of study therapy, patients are followed periodically.

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