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NCT ID: NCT03411486 Not yet recruiting - Breast Cancer Clinical Trials

Safety and Tolerability of a Modified Vaccinia Ankara (MVA) Priming Followed by Fowlpox Booster Vaccines Modified to Express Brachyury and T-Cell Costimulatory Molecules (MVA-BN-Brachyury/FPV-Brachyury)

Start date: February 6, 2018
Phase: Phase 1
Study type: Interventional

Background: Brachyury controls the expression of other genes in our cells. How this happens is not fully understood. Research shows that in some cancers, brachyury is over-expressed. This may play a role in cancer growth and metastasis. Researchers want to test a vaccine that turns the immune system against brachyury. The vaccine is made up of 2 viruses: Modified Vaccinia Ankara (MVA) and Fowlpox virus (FPV). The goal is to teach the immune system to kill the tumor cells that express the Brachyury protein. Objectives: To test if the booster doses of FPV-Brachyury Fowlpox are safe and can improve the immune response and make it last longer in people with advanced cancer. Eligibility: Adults 18 85 years old with cancer that has not responded to standard therapies. Design: Participants will be screened with medical history, review of their tumor sample, and physical exam. They will have blood and urine tests. They will have scans and X-rays to assess their cancer. They will have a heart test. Participants will get the vaccine in shots under the skin, close to lymph nodes. Shots will be given every 4 12 weeks for 2 years as long as participants can and are willing to continue to participate. At these visits, they will repeat some or all the screening tests, except the tumor sample review. After 2 years, participants will get phone calls every 3 months for 5 years. They will talk about any symptoms they have had.

NCT ID: NCT02179515 Completed - Breast Cancer Clinical Trials

Safety and Tolerability of a Modified Vaccinia Ankara (MVA)-Based Vaccine Modified to Express Brachyury and T-cell Costimulatory Molecules (MVA-Brachyury-TRICOM)

Start date: June 28, 2014
Phase: Phase 1
Study type: Interventional

Background: - This cancer vaccine was developed to help teach the body's immune system to attack and destroy cancer cells. It teaches immune cells to target the Brachyury protein. This protein is present in some tumor cells, and it can help tumor cells spread to other parts of the body. Researchers want to see whether the new Brachyury protein vaccine can help treat people with advanced carcinomas. Objective: - To test the safety and effectiveness of giving the modified vaccinia Ankara (MVA)-brachyury-B7-1, ICAM-1 (Intercellular Adhesion Molecule 1), and LFA-3 (lymphocyte function-associated antigen 3) TRICOM vaccine to people with cancer. Eligibility: - Adults ages 18 and over whose type of cancer has not responded to standard therapies who do not have a history of autoimmune diseases and are capable of taking care of themselves. Design: - Participants will be screened with a medical history and physical exam. They will have blood and urine tests. They may have a computed tomography (CT) scan, a positron emission tomography (PET) scan, and a brain magnetic resonance imaging (MRI) scan. They may have a bone scan. They will have an electrocardiogram (ECG) to test heart rhythm. - Participants will have visits about every 4 weeks. They will have a physical exam and blood and urine tests. They will be injected with the vaccine under the skin into the upper thigh or around the armpits. - CT scans or MRI scans will be done at visit 1, after 3 months on study, and again 3 months later if still on the study. Another ECG will be done at their last vaccine visit. - When participants stop the vaccine, they will return for visits until they recover from any side effects. They will have tests including physical exam, blood tests, scans, and x-rays. - Participants will be asked to enroll in another study for long-term follow-up.