Cancer Vaccine Targeting Brachyury Protein in Tumors
- 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.
- To test the safety and effectiveness of a cancer vaccine that targets Brachyury protein in tumor cells.
- 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.
- 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....
|Neoplasms Malignant Solid Tumors Colon Neoplasms Adenocarcinoma||Biological: GI-6301 (Yeast Brachyury Vaccine)||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open Label Phase I Study to Evaluate the Safety and Tolerability of GI-6301 Vaccine Consisting of Whole, Heat-Killed Recombinant Saccharomyces Cerevisiae (Yeast) Genetically Modified to Express Brachyury Protein in Adults With Solid Tumors|
- Change in T cell precursors [ Time Frame: 1 year ]
- Adverse events of escalating doses of GI- 6301 vaccine [ Time Frame: At end of treatment (36 months) ]
- Clinical benefit [ Time Frame: At the end of treatment (36 months) ]
- General immune activation [ Time Frame: At the end of treatment (36 months) ]
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||January 2018|
|Estimated Primary Completion Date:||January 2017 (Final data collection date for primary outcome measure)|
Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.
Biological: GI-6301 (Yeast Brachyury Vaccine)
GI-6301 is a heat-killed, recombinant yeast-based vaccine engineered to express the transcription factor, Brachyury. The Brachyury gene is used to transfect the parental yeast strain (S. cerevisiae W303 - a haploid strain with known mutations from wildtype yeast) to produce the final recombinant vaccine product.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01519817
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||James L Gulley, M.D.||National Cancer Institute (NCI)|