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Gene Therapy in Treating Women With Metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT00849459
Recruitment Status : Completed
First Posted : February 23, 2009
Last Update Posted : January 11, 2017
Information provided by (Responsible Party):
Max Sung, Icahn School of Medicine at Mount Sinai

Brief Summary:

RATIONALE: Placing the gene for interleukin-12 into breast cancer cells may help the body build an immune response to kill tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of gene therapy in treating women with metastatic breast cancer.

Condition or disease Intervention/treatment Phase
Breast Cancer Biological: adenovirus-mediated human interleukin-12 Phase 1

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Trial of Adenoviral Vector Delivery of the Human Interleukin-12 cDNA by Intratumoral Injection in Patents With Metastatic Breast Cancer
Study Start Date : August 2008
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Maximum tolerated dose [ Time Frame: up to 1 month ]
    Serum antibodies (titer) to adenovirus

  2. Toxicity and safety [ Time Frame: up to 2 months ]
    adverse events as assessed by NCI CTCAE v3.0

Secondary Outcome Measures :
  1. Tumor response progression) [ Time Frame: up to 2 months ]
    Sequential assessment of tumor on CT or MRI (complete response, partial response, stable disease, or disease)

  2. Immune response [ Time Frame: up to 2 months ]
    Serum IL12, and IFNγ levels. Serum antibodies (titer) to adenovirus.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00849459

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United States, New York
Icahn Medical Center at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Max Sung
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Principal Investigator: Max W. Sung, MD Icahn Medical Center at Mount Sinai
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Responsible Party: Max Sung, Associate Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT00849459    
Other Study ID Numbers: GCO 02-0797
First Posted: February 23, 2009    Key Record Dates
Last Update Posted: January 11, 2017
Last Verified: January 2017
Keywords provided by Max Sung, Icahn School of Medicine at Mount Sinai:
recurrent breast cancer
stage IV breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents