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.
OBJECTIVES: * 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
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.
Icahn Medical Center at Mount Sinai
New York, New York, United States
Maximum tolerated dose
Serum antibodies (titer) to adenovirus
Time frame: up to 1 month
Toxicity and safety
adverse events as assessed by NCI CTCAE v3.0
Time frame: up to 2 months
Tumor response progression)
Sequential assessment of tumor on CT or MRI (complete response, partial response, stable disease, or disease)
Time frame: up to 2 months
Immune response
Serum IL12, and IFNγ levels. Serum antibodies (titer) to adenovirus.
Time frame: up to 2 months
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