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Gene Therapy in Treating Women With Metastatic Breast Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: February 20, 2009
Last updated: June 9, 2009
Last verified: June 2009

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 Intervention Phase
Breast Cancer
Biological: adenovirus-mediated human interleukin-12
Other: enzyme-linked immunosorbent assay
Other: fluorescence activated cell sorting
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Maximum tolerated dose [ Designated as safety issue: Yes ]
  • Toxicity and safety as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Tumor response (complete response, partial response, stable disease, or disease progression) [ Designated as safety issue: No ]
  • Immune response [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: August 2008
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00849459

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

Responsible Party: Max W. Sung, Mount Sinai Medical Center Identifier: NCT00849459     History of Changes
Other Study ID Numbers: CDR0000629819  MTS-GCO-02-0797  NIH-0707-869 
Study First Received: February 20, 2009
Last Updated: June 9, 2009
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
recurrent breast cancer
stage IV breast cancer

Additional relevant MeSH terms:
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 processed this record on December 05, 2016