Phase I Trial of Adenoviral Vector Delivery of the Human Interleukin-12 cDNA by Intratumoral Injection in Patients With Metastatic Breast Cancer to the Liver
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Max Sung
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- Toxicity
- Status
- Terminated
- Last Updated
- 9 years ago
Overview
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.
Investigators
Max Sung
Associate Professor
Icahn School of Medicine at Mount Sinai
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Toxicity
Time Frame: up to 15 days
Serial monitoring of tumor necrosis factor alpha (TNFα) levels
Secondary Outcomes
- Tumor Response(up to 2 months)
- IFNγ levels Immune response(up to 2 months)
- Immune response(up to 2 months)
- IL12 level Immune response(up to 2 months)