Clinical Trials Using Tetrahydrouridine
Clinical trials are research studies that involve people. The clinical trials on this list are studying Tetrahydrouridine. All trials on the list are supported by NCI.
NCI’s basic information about clinical trials explains the types and phases of trials and how they are carried out. Clinical trials look at new ways to prevent, detect, or treat disease. You may want to think about taking part in a clinical trial. Talk to your doctor for help in deciding if one is right for you.
Oral Decitabine and Tetrahydrouridine as Epigenetic Priming for, Pembrolizumab-Mediated Immune Checkpoint Blockade in Patients With Inoperable, or Unresectable Locally Advanced or Metastatic Non-Small Cell Lung Cancers and Esophageal Carcinomas
Background: Non-small cell lung cancer (NSCLC) is the most common type of lung cancer. Lung cancer is the leading cause of cancer-related death in the United States. Most people with lung cancer are already in the advanced stages of the disease by the time they see a doctor. Researchers want to see if combining an approved drug with two new drugs can help. Objective: To study if tetrahydrouridine-decitabine (THU-DAC) with pembrolizumab is safe and effective in people with non-small cell lung cancer that cannot be removed by surgery. Eligibility: People 18 years and older who have NSCLC that cannot be removed by surgery Design: Participants will be screened with - Medical history - Physical exam - Blood and urine tests - Tests of heart and lung function They may have a small tumor sample taken (biopsy). They may have tumor scans. Before starting treatment, participants will repeat the screening tests. They will also give a stool sample. The study will be done in 3-week cycles for up to 6 cycles. - Participants will take the 2 study drugs by mouth 3-5 days a week. - Participants will get pembrolizumab in a vein for 30 minutes 1 day each cycle. Participants will keep a study medication diary. During cycle 1, participants will have blood taken multiple times on days 1 and 2. Every 3 cycles, participants will repeat screening tests. Participants will have a mandatory tumor biopsy. When they finish treatment, participants will have a physical exam and blood tests.
Location: National Institutes of Health Clinical Center, Bethesda, Maryland