GI-6301 + radiation
Clinical trial of GI-6301 (yeast-brachyury vaccine) versus placebo in combination with radiotherapy in locally advanced, unresectable chordoma
Researchers at the National Cancer Institute in Bethesda, Maryland, are now enrolling patients in a Phase 2 Research studies involving human subjects that are done to test whether a treatment is safe, and how well it will work to treat a specific disease. evaluating whether a therapeutic vaccine called GI-6301 given in combination with radiation is more effective than radiation alone in causing tumor regression or preventing tumor progression.
The trial is designed specifically for chordoma patients 18 years and older with inoperable tumor, residual tumor following surgery, or locally recurrent tumor who are planning to have radiation.
Why this trial is being done
Radiotherapy is a standard treatment option for chordoma patients with residual or inoperable tumor. However, the majority of chordomas that are not fully resected will eventually progress after radiation. Research in other cancers suggests that the combination of radiation plus therapies that stimulate the immune system can have powerful antitumor effects. Therefore, in this trial, researchers are seeking to determine whether stimulating the immune system to target chordoma in combination with radiation can cause tumor shrinkage and/or prevent further tumor growth to a greater degree than radiation alone.
Specifically, this trial will test the therapeutic vaccine GI-6301, which is designed to stimulate the immune system to attack chordoma. Therapeutic vaccines are meant to help the immune system fight disease more effectively, as opposed to prophylactic vaccines (like the flu shot) which help to prevent disease. GI-6301 works by generating immunity against a protein called A gene that makes a protein, also called brachyury, that is present at high levels in nearly all chordoma tumors., which is found on most chordoma tumors but is absent from nearly all normal tissues. In other words, GI-6301 trains the immune system to attack chordoma but not healthy parts of the body.
A recently completed Phase 1 trial of GI-6301 demonstrated that the vaccine could be delivered safely. It also showed that the vaccine was capable of inducing immune responses against brachyury in chordoma patients. Of the eight chordoma patients whose tumors were growing when they entered the Phase 1 trial, five stopped growing and one shrunk by more than 30 percent while in the study.
Who can participate
The trial is designed specifically for chordoma patients who are at high risk of tumor regrowth following radiation, including:
- Patients who have residual tumor remaining after surgery
- Newly diagnosed patients who are unable to have surgery
- Patients who have a Tumor that has grown back in the same location after treatment. following previous surgery
Patients must meet the following basic criteria to be eligible:
- Confirmed diagnosis of chordoma
- Localized (no evidence of When tumors have spread to other parts of the body from the original tumor site.) and inoperable tumor
- Age 18 years or older
- At least 1cm of tumor measurable on imaging
- Able to receive at least 50 The abbreviation for gray equivalents, which refers to the unit of measurement for an absorbed dose of radiation. of radiation to the tumor
- No major laboratory abnormalities
- No history of autoimmune disease
- No allergy to yeast
- Willing and able to travel to the National Cancer Institute (NCI) in Bethesda, MD for treatment and follow-up visits
How the trial will work
The trial is taking place at the National Institutes of Health Clinical Center in Bethesda, MD. The NCI will pay for transportation costs (including airfare) within the US and a portion of lodging costs for patients enrolled in this trial.
Participants in the trial will initially be randomized to receive radiation plus the vaccine, or radiation plus a blinded placebo. Those who receive radiation plus placebo will have the option to “cross-over” and begin receiving the vaccine if their tumor grows while on the study. This means that everyone who enters the study will be given the opportunity to receive the vaccine if radiation alone is not stopping the growth of the tumor.
The process of participating in the trial is as follows:
- Patients travel to NIH to receive injections of the vaccine (or placebo) every 2 weeks for 3 doses prior to starting radiation (approximately 4 weeks).
- Patients then complete radiation treatment with their home radiation oncologist (typically over a 1-2 month timespan).
- Following completion of radiation, patients travel back to NIH to resume injections every 2 weeks for 3 more doses (approximately 6 weeks).
- Doses then spread out to every 4 weeks for 4 doses, and then 1 dose every 3 months. This schedule is continued until disease progression.
Between all doses of vaccine, patients may return home and travel back for the next visit. There is no requirement to stay locally in Bethesda at any point in the study outside of clinic visits and dosing days.
Repeat imaging studies will be performed about 3 months after completion of radiation and then every 3 months for the first year, every 6 months for the second year, and yearly thereafter. Scans can be done earlier if new symptoms develop between scheduled scans.
How to enroll
If you have more questions about this trial or other clinical trials that may be options for chordoma patients, please contact a Chordoma Foundation Patient Navigator.
Learn more about immunotherapy
From the National Cancer Institute
From the Chordoma Foundation
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