Randomized, Double-Blind, Placebo-Controlled Phase II Study of Yeast-Brachyury Vaccine (GI-6301) in Combination with Standard-of-Care Radiotherapy in Locally Advanced, Unresectable Chordoma.
Peter Joseph DeMariaMarijo BilusicDeric M ParkChristopher R HeeryRenee N DonahueRavi A MadanMohammad Hadi BagheriJulius StraussVictoria ShenJennifer L MartéSeth M SteinbergJeffrey SchlomMark R GilbertJames L GulleyPublished in: The oncologist (2021)
Chordoma is a rare neoplasm lacking effective systemic therapies for advanced, unresectable disease. Lack of clinically actionable somatic mutations in chordoma makes development of targeted therapy quite challenging. While the combination of yeast-brachyury vaccine (GI-6301) and standard radiation therapy did not demonstrate synergistic antitumor effects, brachyury still remains a good target for developmental therapeutics in chordoma. Patients and their oncologists should consider early referral to centers with expertise in chordoma (or sarcoma) and encourage participation in clinical trials.
Keyphrases
- locally advanced
- phase ii study
- placebo controlled
- double blind
- radiation therapy
- clinical trial
- rectal cancer
- neoadjuvant chemotherapy
- squamous cell carcinoma
- phase iii
- phase ii
- open label
- end stage renal disease
- ejection fraction
- healthcare
- chronic kidney disease
- study protocol
- palliative care
- newly diagnosed
- prognostic factors
- patient reported outcomes
- primary care
- physical activity
- small molecule
- cell wall
- peritoneal dialysis
- saccharomyces cerevisiae
- lymph node
- pain management
- chronic pain
- gene expression
- randomized controlled trial