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.
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). OBJECTIVES: * 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
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.
Mount Sinai Medical Center
New York, New York, United States
Toxicity
Serial monitoring of tumor necrosis factor alpha (TNFα) levels
Time frame: up to 15 days
Tumor Response
Sequential assessment of tumor on CT or MRI
Time frame: up to 2 months
IL12 level Immune response
Serum IL12 level
Time frame: up to 2 months
IFNγ levels Immune response
IFNγ levels
Time frame: up to 2 months
Immune response
Serum antibodies (titer) to adenovirus.
Time frame: up to 2 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.