The National Cancer Institute has expanded an ongoing Phase I clinical trial of a therapeutic vaccine targeting the brachyury protein to include up to 10 patients with chordoma, a cancer that is defined by expression of brachyury.
About the trial
Researchers at the National Cancer Institute (NCI) are conducting a Phase 1 clinical trial of a therapeutic vaccine, GI-6301, in patients with cancers known to express a protein called brachyury. Brachyury is sometimes over-expressed in a variety of important tumor types including breast, colon, lung, prostate cancers, and others, but is not generally found in normal tissues. Additionally and importantly, brachyury is also present in nearly 100% of chordomas and it has become a defining marker for the disease. The GI-6301 vaccine is intended to stimulate the immune system to fight cancer cells that express the brachyury protein.
The NCI Phase 1 trial of GI-6301, led by Dr. James Gulley, has completed the dose-escalation portion of the trial and has reached the maximum planned dose without any serious adverse reactions. Now the NCI is beginning to enroll a group of 10 patients at the highest dose. Originally, the trial was designed to enroll only patients with metastatic or unresectable locally recurrent cancers, not including chordoma. However, because chordomas nearly always express brachyury, the clinical protocol was recently modified to allow any patient with recurrent chordoma to be enrolled in the trial. This phase of the trial aims to (i) continue to assess the safety of the vaccine, (ii) test whether it causes an immune response to the brachyury protein, and (iii) to assess signs of clinical benefit.
The trial is taking place at the National Institutes of Health clinical center in Bethesda, MD. It involves injections of the vaccine every other week over the course of 7 visits, and then monthly until disease progression. The NCI will pay for transportation costs (including airfare) and a portion of lodging costs for patients enrolled in this study. If you are interested in learning more about possibly enrolling in this study, please contact Christopher Heery, MD at firstname.lastname@example.org.
About the treatment
GI-6301 is a therapeutic vaccine being developed through a Collaborative Research and Development Agreement between the National Cancer Institute and the biopharmaceutical company, GlobeImmune. Designed to stimulate the human immune system to fight cancer, GI-6301 is composed of heat-inactivated S. cerevisiae yeast that expresses human brachyury protein. This product candidate is the fifth of a novel class of yeast-based immunotherapeutics designed to stimulate immune responses to eliminate diseased cells. Spanning cancer and infectious diseases, these products have been evaluated in ten different Phase 1 and Phase 2 clinical trials. They have shown a good tolerability profile in clinical programs to date. Over 400 subjects have been treated thus far, including some who have received monthly dosing for over four years. Expected adverse events from these products are limited to redness, swelling and tenderness at the injection site, and mild, brief flu-like symptoms.
For eligibility criteria and more information about this trial visit clinicaltrials.gov/ct2/show/NCT01519817