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Protocol: Phase I/IIa Trial of Folate Binding Protein (FBP) Peptides (E39 and J65) Vaccine in Ovarian and Endometrial Cancer Patients

The purposes of the study are as follows: 1) to test the development of a potential anticancer study called E39 peptide vaccine and J65 peptide vaccine; 2) to determine if the study vaccine is safe; 3) to determine the best dose of the study vaccine 4) to learn more about the side effects of the study vaccine and how it affects the immune system; and 5) to determine if folate binding protein expression in tumor is associated with the effectiveness of the vaccine.

The study involves injection of a study vaccine, which is referred to as E39 or J65. Folate binding protein (FBP) is a protein that is found on almost all ovarian and certain types of endometrial cancer cells in large amounts and may be recognized by the immune system. FBP is also found in a limited number of normal cells as well as certain other types of cancer cells. The FBP peptide ( a chemical compound which is named “E39”) is a piece of FBP that has been shown to stimulate immune cells and cause them to kill ovarian and endometrial cancer cells in the laboratory. The J65 peptide is a weaker version of the E39 peptide and may be helpful in sustaining the killing ability of the immune cells. The E39 or J65 peptide will be mixed with a natural substance (GM-CSF) that stimulates the immune system. The mixture will be given as a shot under the patient’s skin. Giving the shot in this manner is not approved by the U.S. Food and Drug Administration (FDA) but it has been permitted for this study. E39 and J65 are an investigational (experimental) vaccine and is not FDA-approved. GM-CSF is a FDA-approved drug that stimulates the immune system in general and may help E39 or J65 work better.

Patients taking part in the study will have blood drawn to determine if they carry the leukocyte antigen HLA type. HLA is a set of unique proteins expressed on all of the cells in the body that is required to make the study vaccine work. If the patient is considered HLA+, they will begin treatment. The study vaccine will be administered into the skin in two injections each time it is given and administered every 21-28 days for a total of 6 vaccinations (12 injections). After completion of the 6-shot series, the patient will receive a total of two booster inoculations. The first will be administered 6 months from their last vaccine and the second 12 months from the last vaccine.

Five different sites will participate in this study with up to 60 participants taking part in the study.

 

For more detailed criteria, eligibility, and trial specifics at ClinicalTrials.gov, please click here.

ClinicalTrials.gov Identifier NCT01580696