A Phase I Study of a DNA Plasmid Based Vaccine Encoding the HER-2/Neu Intracellular Domain in Subjects With HER-2/Neu (HER2) Overexpressing Tumors
PRIMARY OBJECTIVES: I. To determine the safety of intradermal administration of 3 doses of a
plasmid-based DNA vaccine encoding the ICD of HER2 administered with a fixed dose of GM-CSF.
II. To determine whether a plasmid DNA vaccine encoding the ICD of HER2 can elicit HER2
specific immune responses. SECONDARY OBJECTIVES: I. To determine if the dose of the
plasmid-based DNA vaccine effects immunologic responses. II. To determine the persistence of
DNA at the site of vaccination. OUTLINE: This is a dose-escalation study of a plasmid-based
DNA (pNGVL3-hICD) vaccine. Patients receive pNGVL3-hICD vaccine admixed with GM-CSF
intradermally once a month for 3 months in the absence of disease progression or
unacceptable toxicity. After completion of study treatment, patients are followed up
periodically for up to 15 years with primary physicians.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety as measured by NCI CTCAE v 3.0
From baseline
Yes
Mary L. Disis
Principal Investigator
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Food and Drug Administration
6532
NCT00436254
October 2001
Name | Location |
---|---|
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle, Washington 98109 |