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Phase I Trial of Adenoviral Vector Delivery of the Human Interleukin-12 cDNA by Intratumoral Injection in Patients With Metastatic Breast Cancer to the Liver

Phase 1
18 Years
85 Years
Open (Enrolling)
Breast Cancer, Metastatic Cancer

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Trial Information

Phase I Trial of Adenoviral Vector Delivery of the Human Interleukin-12 cDNA by Intratumoral Injection in Patients With Metastatic Breast Cancer to the Liver


- 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.

OUTLINE: This is a dose-escalation study.

Patients receive adenovirus-mediated human interleukin-12 via percutaneous intratumoral
needle puncture under ultrasound guidance on day 1.

Cohorts of 3-6 patients receive escalating doses of adenovirus-mediated human interleukin-12
until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose
preceding that at which 2 of 6 patients experience dose-limiting toxicity.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.

Inclusion Criteria


- Histologically or cytologically confirmed* breast adenocarcinoma metastatic to the

- 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


- 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


- 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)

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Max W. Sung, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mount Sinai School of Medicine


United States: Food and Drug Administration

Study ID:




Start Date:

October 2005

Completion Date:

Related Keywords:

  • Breast Cancer
  • Metastatic Cancer
  • stage IV breast cancer
  • liver metastases
  • Breast Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary



Mount Sinai Medical Center New York, New York  10029