Phase Ib Trial of Folate Binding Protein Vaccine in Ovarian Cancer - Full Text View - ClinicalTrials.gov
Phase Ib Trial of Folate Binding Protein Vaccine in Ovarian Cancer
This study is currently recruiting participants.
Verified April 2012 by San Antonio Military Medical Center
First Received on April 16, 2012.
Last Updated on April 17, 2012
History of Changes
| Sponsor: | COL George Peoples, MD, FACS |
|---|---|
| Information provided by (Responsible Party): | COL George Peoples, MD, FACS, San Antonio Military Medical Center |
| ClinicalTrials.gov Identifier: | NCT01580696 |
Purpose
Folate binding protein (FBP) is highly over-expressed in breast, ovarian and endometrial cancers
and is the source of immunogenic peptides (E39) that can stimulate
cytotoxic T lymphocytes (CTL) to recognize and destroy FBP-expressing cancer
cells in the laboratory. The purpose of this study is to test whether a
peptide-based vaccine consisting of the E39 peptide mixed with the
FDA-approved immunoadjuvant granulocyte macrophage colony-stimulating
factor (GM-CSF) is safe and effective at inducing an in vivo
peptide-specific immune response. Furthermore, the investigators intend
to determine the best dose of the vaccine to utilize to produce this
immunity most efficiently. The investigators will determine whether
immunity to FBP will prevent clinical recurrence. Additionally, the
investigators will compare these results with results from a trial
utilizing the E75 peptide (from the HER2/neu protein) in ovarian and endometrial cancer patients in preparation for studying a combination vaccine.
