A Multi-Center, Open-Label, Multiple Administration, Rising Dose Study of the Safety, Tolerability, and Efficacy of IL-12 Gene Medicine in Patients With Unresectable or Recurrent/Refractory Squamous Cell Carcinoma of the Head and Neck (SCCHN)
OBJECTIVES: I. Determine the safety and tolerability of interleukin-12 gene in patients with
unresectable, recurrent, or refractory squamous cell carcinoma of the head and neck. II.
Evaluate the efficacy of this regimen in these patients.
OUTLINE: This is a multicenter study. Patients receive interleukin-12 gene by intratumoral
injection twice during week 1 and once weekly during weeks 2-7 in the absence of disease
progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 28-34 patients will be accrued for this study.
Primary Purpose: Treatment
A. Dimitrios Colevas, MD
NCI - Investigational Drug Branch
United States: Federal Government
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|