Cancer Vaccine Targeting Brachyury Protein in Tumors

Completed · Phase 1

Conditions studied: Neoplasms, Malignant Solid Tumors, Colon Neoplasms, Adenocarcinoma

In brief

Background: \- Cancer vaccines are being developed to help teach the body's immune system to attack and destroy cancer cells. A new vaccine being tested targets 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. Objectives: \- To test the safety and effectiveness of a cancer vaccine that targets Brachyury protein in tumor cells. Eligibility: * Individuals at least 18 years of age who have advanced cancers that have not responded or are no longer responding to standard treatments. * Because the vaccine is made with yeast, people with yeast allergies will not be eligible. Design: * Participants will be screened with a medical history and physical exam. Imaging studies will be used to examine the cancer. Heart and thyroid function tests will be conducted. Blood and urine samples will also be collected. * Participants will receive vaccine injections every 2 weeks, for a total of seven visits. After seven visits, if the cancer has shrunk or stopped growing, participants will continue to have the vaccine about once a month. * Treatment will be monitored with frequent blood tests and imaging studies. Other tests will be given as directed by the study doctors. Some participants will have apheresis to collect additional blood cells for study. * Participants will continue to receive the vaccine as long the tumor does not start growing again and there are no serious side effects....

Key facts

Study ID

NCT01519817

Run by

National Cancer Institute (NCI)

People needed

34

Starts

2012-01-05

Expected to finish

2016-09-01

Last updated by the study team

2018-01-29

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Patients with any of the following will not be eligible for participation in this study:
• Patients should have no evidence of immune dysfunction as listed below.
• Human immunodeficiency virus (HIV) positivity due to the potential for decreased immune response to the vaccine.
• Active autoimmune diseases requiring treatment or a history of autoimmune disease that might be stimulated by vaccine treatment. This requirement is due to the potential risks of exacerbating autoimmunity. However, patients with vitiligo, diabetes mellitus, and hashimoto s thyroiditis on appropriate replacement therapy may be
• enrolled.
• -Concurrent use of systemic steroids, except for physiologic doses of systemic steroid replacement or local (topical, nasal, or inhaled) steroid use. Limited doses of systemic steroids (e.g., in patients with exacerbations of reactive airway disease or to prevent intravenous (IV) contrast allergic reaction or anaphylaxis in patients who have known contrast allergies) are allowed.
• History of allergy or untoward reaction to yeast-based products (any hypersensitivity to yeast-based products will be excluded).
• Pregnant or breast-feeding women, due to the unknown effects of the Yeast Brachyury vaccine on the fetus or infant.
• Serious intercurrent medical illness which would interfere with the ability of the patient to carry out the treatment program, including, but not limited to, inflammatory bowel disease, Crohn's disease, ulcerative colitis, or active diverticulitis.
• Untreated brain metastases (or local treatment of brain metastases within the last 6 months) and or spinal cord metastasis.
• Patients with pericardial masses >1 cm will be excluded.
• Concurrent chemotherapy. (However, the following anti-tumor therapies will be allowed: Trastuzumab for human epidermal growth factor receptor 2 (HER2+) breast cancer and hormonal therapy for breast (e.g., selective estrogen receptor modulators, aromatase inhibitors) and prostate cancer (e.g., GnRH antagonists/agonists or antagonists and androgen receptor antagonists).
• Chronic hepatitis infection, including B and C, because potential immune impairment caused by these disorders may diminish the effectiveness of this immunologic therapy.
• Patients requiring continuous tricyclic antidepressant therapy should be excluded due to the interference with the yeast skin test in creating false negative test results.
• Participation in another interventional clinical trial within 28 days before start of study treatment.
• Any significant disease that, in the opinion of the investigator, may impair the patient s tolerance of study treatment.
• Significant dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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