Patient case: 56-year-old female with breast cancer; genetic feature: ERBB2

Clinical trial: Biological Therapy in Treating Women With Breast Cancer That Has Spread to the Liver

Summary: RATIONALE: Biological therapy using a gene-modified virus that can make interleukin-12 may help the body build an effective immune response to kill tumor cells.
  PURPOSE: This phase I trial is studying the side effects and best dose of a gene-modified virus that can make interleukin-12 in treating women with breast cancer that has spread to the liver.

Detailed description: Direct intratumoral injection of metastatic hepatic tumors using an adenoviral vector expressing the human recombinant interleukin-12 gene (Adv.RSV-hIL12, also termed ADV-hIL-12).
  OBJECTIVES:
  -  Study the toxicity of escalating doses of adenoviral vector expressing the human recombinant interleukin-12 gene, administered by percutaneous intratumoral injection, in women with liver metastasis secondary to breast cancer.
  -  Determine tumor responses produced by this regimen.
  -  Determine immune responses induced by this regimen.

Eligibility: 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)

Relevance to patient case: not relevant