Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Randomized, Double-Blind, Phase 2 Trial of GI-6301 (Yeast-Brachyury Vaccine) Versus Placebo in Combination With Standard of Care Definitive Radiotherapy in Locally Advanced, Unresectable,
Brief Summary:
TRIAL SUMMARY
Researchers at the National Cancer Institute (NCI) are now enrolling patients in a phase 2 clinical trial to determine whether the yeast-brachyury vaccine GI-6301 improves the effectiveness of radiation for patients with localized chordoma. Chordoma patients with inoperable or residual tumor who do not have metastases and are planning to be treated with definitive (>70Gy) radiation are eligible to participate. Patients will initially be randomized to receive radiation plus the vaccine or radiation plus a blinded placebo. Those randomized to receive radiation plus placebo will have the option to receive vaccine if their tumor grows while on the study. The study will compare the outcomes of patients treated with radiation with and without the vaccine to determine whether the vaccine can increase the chances of shrinking the tumor and/or preventing further tumor growth.
WHY THIS TRIAL IS BEING DONE
The primary treatment options for chordoma currently consist of surgery and high dose radiation. Radiation has been shown to improve patient outcomes following surgery. Radiation is also sometimes used instead of surgery when surgery would carry unacceptable risks.
The chance of tumor growth after radiation is significantly higher for patients who have residual tumor than for those whose tumor is completely removed. Unfortunately for patients with a tumor that cannot be completely removed, there tends to be a short time until the tumor grows back and eventually causes death. For this reason, our team at the NCI seeks to identify a therapy that can reduce the risk of recurrence and improve survival after radiation for patients who have residual tumor.
One approach we a