Phase I Trial of Adenoviral Vector Delivery of the Human Interleukin-12 cDNA by Intratumoral Injection in Patents With Metastatic Breast Cancer
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Max Sung
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- Maximum tolerated dose
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Detailed Description
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.
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
Maximum tolerated dose
Time Frame: up to 1 month
Serum antibodies (titer) to adenovirus
Toxicity and safety
Time Frame: up to 2 months
adverse events as assessed by NCI CTCAE v3.0
Secondary Outcomes
- Tumor response progression)(up to 2 months)
- Immune response(up to 2 months)