Liver Neoplasms — Vaccine Therapy and Radiation to Liver Metastasis in Patients With CEA-Positive Solid Tumors
Citation(s)
Ahlers CM, Camphausen K, Citrin D, Arlen PM, Gulley JL A pilot trial of a carcinoembryonic antigen/ TRICOM-based vaccine and radiation to liver metastases in patients with carcinoembryonic antigen-positive solid tumors. Clin Colorectal Cancer. 2006 May;6(1):72-5.
Ferrara TA, Hodge JW, Gulley JL Combining radiation and immunotherapy for synergistic antitumor therapy. Curr Opin Mol Ther. 2009 Feb;11(1):37-42. Review.
Hodge JW, Guha C, Neefjes J, Gulley JL Synergizing radiation therapy and immunotherapy for curing incurable cancers. Opportunities and challenges. Oncology (Williston Park). 2008 Aug;22(9):1064-70; discussion 1075, 1080-1, 1084. Review.
A Pilot Trial of a CEA-TRICOM Based Vaccine and Radiation to Liver Metastasis in Adults With CEA Positive Solid Tumors
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
