Phase I Trial Of Adenoviral Vector Delivery Of The Human Interleukin-12 cDNA By Intratumoral Injection In Patients With Metastatic Colorectal Cancer To The Liver
- Determine the toxicity and maximum tolerated dose of intratumoral adenoviral
vector-delivered interleukin-12 gene in patients with liver metastases secondary to
colorectal cancer .
- Determine the tumor response in patients treated with this regimen.
- Determine the immune response in patients treated with this regimen.
OUTLINE: This is a dose-escalation study.
Patients receive ultrasound-guided intratumoral injections of adenoviral vector-delivered
interleukin-12 gene (ADV-hIL12) on day 1.
Cohorts of 3-6 patients receive escalating doses of ADV-hIL12 until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
of 6 patients experience dose-limiting toxicity.
Patients are followed at days 11, 15, 29, 43, and 57 and are then followed for survival
PROJECTED ACCRUAL: A total of 30-36 patients will be accrued for this study.
Primary Purpose: Treatment
Max W. Sung, MD
Mount Sinai School of Medicine
|Mount Sinai Medical Center||New York, New York 10029|