Biological Therapy in Treating Women With Breast Cancer That Has Spread to the Liver
Breast Cancer, Metastatic Cancer

About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring stage IV breast cancer, liver metastases
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed* breast adenocarcinoma metastatic to the liver Solitary or multiple hepatic metastases No malignant involvement of > 40% of the estimated liver volume NOTE: *Must be from the hepatic tumor designated for study injection Metastatic liver tumors must be measurable in ≥ 2 dimensions on CT scan or MRI At least 1 metastatic hepatic tumor ≥ 2 cm in diameter must be visualized by ultrasound and accessible for percutaneous injection under ultrasound guidance Extrahepatic metastasis allowed No solitary hepatic metastasis eligible for liver resection No clinical evidence for severe liver disease (e.g., prior or current ascites or portosystemic encephalopathy) Hormone-receptor status not specified PATIENT CHARACTERISTICS: Female Menopausal status not specified Granulocyte count ≥ 1,500/mm^3 Hemoglobin ≥ 9.0 g/dL Platelet count ≥ 100,000/mm^3 PT ≤ 14.5 sec Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 45 mL/min Bilirubin ≤ 2 times upper limit of normal (ULN) Transaminases ≤ 2.5 times ULN Karnofsky performance status ≥ 70% Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for at least 2 months after completion of study treatment No active infection or serious intercurrent medical illness No HIV infection Life expectancy ≥ 16 weeks No other malignancy within the past 5 years except inactive nonmelanoma skin cancer, in situ carcinoma of the cervix, or grade 1 papillary bladder cancer At highest dose level, patient must weigh ≥ 30 kg PRIOR CONCURRENT THERAPY: No systemic immunosuppressive drugs, including corticosteroids, within 2 months prior to study entry Not require immunosuppressive drugs or anticoagulant therapy with heparin or warfarin for at least 2 months after study treatment No chemotherapy within 4 weeks of study entry (6 weeks for nitrosoureas)
Sites / Locations
- Mount Sinai Medical Center
Arms of the Study
Arm 1
Experimental
adenovirus-mediated human interleukin-12
starting dose of ADV-hIL12 - 1 x 10 to the 10th power vp (virus particles) per patient, escalating in half-log increments up to 1 x 10 to the 13th power vp per patient, after which dose escalation will be at lower increments of 2 x 10 to the 13th power vp, to a maximum of 3.0 x 10 to the 13th power vp per patient.