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Protocol: Phase Ib Trial of Two Folate Binding Protein (FBP) Peptide Vaccines (E39 and J65) in Breast and Ovarian Cancer Patients 2013-0139

The goal of this clinical research study is to learn the most effective way to give patients a vaccine in order for the immune system to react against folate binding protein (FBP) and FBP-containing cancers. The E39 and J65 peptide (a piece of a protein) vaccines are designed to cause the immune system to attack certain cancer cells (those with FBP), which may help lower the risk that the cancer will come back.

Researchers will be studying the E39 peptide vaccine and the J65 peptide vaccine to learn if it is better to give the vaccines in a certain order. The safety of these vaccines will also be studied.

The study vaccines are also mixed with GM-CSF (sargramostim). Sargramostim is designed to increase the immune reaction.

This is the first study using the E39 and J65 peptide vaccines in humans.

If a patient is found to be eligible to take part in this study, the patient will be randomly assigned (as in the roll of dice) to 1 of 3 study plans for Part 1 of the study. The patient will have an equal chance of being assigned to any of the 3 plans. In Part 1, the patient will receive 6 monthly doses of a study vaccine. If the patient is in Group 1, they will receive 6 doses of the E39 peptide vaccine. If the patient is in Group 2, they will receive 3 doses of the E39 peptide vaccine followed by 3 doses of the J65 peptide vaccine. If the patient is in Group 3, they will receive 3 doses of the J65 peptide vaccine followed by 3 doses of the E39 peptide vaccine.

For Part 2, the patient will be randomly assigned (as in the flip of a coin) to receive 1 dose of the E39 peptide vaccine or 1 dose of the J65 peptide vaccine. The group the patient is assigned to will also be based on how their immune system responds.

The patient may receive up to 7 doses of the study vaccines. They will no longer be able to receive the study vaccine if the disease gets worse, if intolerable side effects occur, or if they are unable to follow study directions.

The patient’s active participation on the study will be over after the visit in Month 6 of Part 2. After the patient’s last study visit, they will continue to see their personal doctor for standard follow-up care for cancer. This usually occurs every 3-6 months for the first 24 months after completing therapy and then every 6 months for an additional 36 months. The study staff will collect information on the disease status from follow-up visits.

 

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

ClinicalTrials.gov Identifier NCT02019524