HIL 2 PLASMID GENE THERAPY PATIENTS WITH SQUAMOUS CELL CARCINOMA

$0M01FY2001RRNIH

Johns Hopkins University, Baltimore MD

Investigators

Linked publications & trials

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Abstract

Cationic lipid formulations complexed with the plasmid carrying hIL-2 have been shown to produce a significant anti-tumor response in animal squamous cell carcinomas of the head and neck. Based on these preclinical investigations, a Phase I clinical trial has been initiated. The primary purpose of this trial is to define the safety and tolerability of formulated hIL-2 plasmid when administered as a single intratumoral injection at three dose levels in patients with unresectable or recurrent/refractory squamous cell carcinoma of the head and neck. A secondary goal is to document expression of the IL-2 gene in squamous cell carcinoma by molecular biologic, histologic and immuno- histochemical methods.

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