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 - 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.