Phase I Trial of Adenoviral Vector Delivery of the Human Interleukin-12 cDNA by Intratumoral Injection in Patents With Metastatic Breast Cancer
- 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.
Primary Purpose: Treatment
Maximum tolerated dose
Max W. Sung, MD
Mount Sinai School of Medicine
|Mount Sinai School of Medicine||New York, New York 10029|