Gene Therapy in Treating Women With Metastatic Breast Cancer
Recruitment status was Recruiting
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.
Biological: adenovirus-mediated human interleukin-12
Other: enzyme-linked immunosorbent assay
Other: fluorescence activated cell sorting
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase I Trial of Adenoviral Vector Delivery of the Human Interleukin-12 cDNA by Intratumoral Injection in Patents With Metastatic Breast Cancer|
- Maximum tolerated dose [ Designated as safety issue: Yes ]
- Toxicity and safety as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
- Tumor response (complete response, partial response, stable disease, or disease progression) [ Designated as safety issue: No ]
- Immune response [ Designated as safety issue: No ]
|Study Start Date:||August 2008|
|Estimated Primary Completion Date:||August 2010 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00849459
|United States, New York|
|Mount Sinai School of Medicine||Recruiting|
|New York, New York, United States, 10029|
|Contact: Clinical Trials Office - Mount Sinai School of Medicine 212-659-8050|
|Principal Investigator:||Max W. Sung, MD||Mount Sinai School of Medicine|