A Phase I Trial of the Safety and Immunogenicity of a DNA Plasmid Based Vaccine Encoding the Amino Acids 1-163 of Insulin-Like Growth Factor Binding Protein-2 (IGFBP-2) in Patients With Advanced Ovarian Cancer
I. To determine the safety of an insulin like growth factor binding protein 2 (IGFBP-2) Th
polyepitope plasmid based vaccine in patients with advanced stage or recurrent ovarian
I. To determine the immunogenicity of IGFBP-2 Th polyepitope plasmid based vaccine in
patients with advanced stage or recurrent ovarian cancer.
II. To determine whether intermolecular epitope spreading occurs with the generation of an
IGFBP-2 specific Th1 immune response.
III. To determine whether IGFBP-2 vaccination modulates T regulatory cells.
Patients receive pUMVC3-hIGFBP-2 multi-epitope plasmid DNA vaccine intradermally (ID)
monthly for 3 months.
After completion of study treatment, patients are followed up at 1, 3, 6, and 12 months, and
then every 6 months for 5 years.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety as assessed per Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Demographic and background characteristics obtained at enrollment will be listed and summarized. The type and grade of toxicities noted during the immunization regimen will be summarized. All adverse events noted by the investigator will be tabulated according to the affected body system. Descriptive statistics will be used to summarize changes from baseline in clinical laboratory parameters.
Up to 12 months
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Food and Drug Administration
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Seattle, Washington 98109|