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

This study has been terminated.
(protocol underwent significant revisions, decision made to terminate study and open as new study listed NCT00849459)
Information provided by (Responsible Party):
Max Sung, Icahn School of Medicine at Mount Sinai Identifier:
First received: March 8, 2006
Last updated: January 31, 2017
Last verified: January 2017

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.

Condition Intervention Phase
Breast Cancer
Metastatic Cancer
Biological: adenovirus-mediated human interleukin-12
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Max Sung, Icahn School of Medicine at Mount Sinai:

Primary Outcome Measures:
  • Toxicity [ Time Frame: up to 15 days ]
    Serial monitoring of tumor necrosis factor alpha (TNFα) levels

Secondary Outcome Measures:
  • Tumor Response [ Time Frame: up to 2 months ]
    Sequential assessment of tumor on CT or MRI

  • IL12 level Immune response [ Time Frame: up to 2 months ]
    Serum IL12 level

  • IFNγ levels Immune response [ Time Frame: up to 2 months ]
    IFNγ levels

  • Immune response [ Time Frame: up to 2 months ]
    Serum antibodies (titer) to adenovirus.

Enrollment: 2
Study Start Date: October 2005
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Biological: adenovirus-mediated human interleukin-12

The purified ADV-hIL12 is suspended in formulation buffer (10mM Tris, pH 7.5/

1mM MgCl2/ 150mM NaCl/ 10% glycerol) and aliquoted into 1ml cryovials. The filled vials are stored at or below -60 degC.

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).


  • 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.

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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


  • 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)
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Please refer to this study by its identifier: NCT00301106

United States, New York
Mount Sinai Medical Center
New York, New York, United States, 10029
Sponsors and Collaborators
Max Sung
Study Chair: Max W. Sung, MD Icahn School of Medicine at Mount Sinai
  More Information

Responsible Party: Max Sung, Associate Professor, Icahn School of Medicine at Mount Sinai Identifier: NCT00301106     History of Changes
Other Study ID Numbers: GCO 97-779
Study First Received: March 8, 2006
Last Updated: January 31, 2017

Keywords provided by Max Sung, Icahn School of Medicine at Mount Sinai:
stage IV breast cancer
liver metastases

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasm Metastasis
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents processed this record on May 25, 2017