Biological Therapy in Treating Women With Breast Cancer That Has Spread to the Liver
- Conditions
- Breast CancerMetastatic Cancer
- Registration Number
- NCT00301106
- Lead Sponsor
- Max Sung
- Brief Summary
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.
- 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).
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 2
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Toxicity up to 15 days Serial monitoring of tumor necrosis factor alpha (TNFα) levels
- Secondary Outcome Measures
Name Time Method IL12 level Immune response up to 2 months Serum IL12 level
Tumor Response up to 2 months Sequential assessment of tumor on CT or MRI
IFNγ levels Immune response up to 2 months IFNγ levels
Immune response up to 2 months Serum antibodies (titer) to adenovirus.
Trial Locations
- Locations (1)
Mount Sinai Medical Center
🇺🇸New York, New York, United States
Mount Sinai Medical Center🇺🇸New York, New York, United States