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
- 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.
OUTLINE: This is a dose-escalation study.
Patients receive adenovirus-mediated human interleukin-12 via percutaneous intratumoral
needle puncture under ultrasound guidance on day 1.
Cohorts of 3-6 patients receive escalating doses of adenovirus-mediated human interleukin-12
until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose
preceding that at which 2 of 6 patients experience dose-limiting toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
Primary Purpose: Treatment
Max W. Sung, MD
Mount Sinai School of Medicine
United States: Food and Drug Administration
|Mount Sinai Medical Center||New York, New York 10029|