Clinical Trials
Below is a listing of liver related clinical trials currently under investigation at Emory. As an academic health center, the Woodruff Health Sciences Center offers numerous clinical trials to patients at Emory Healthcare. Many of these trials are developed by investigators and many are multi-institutional trials developed by pharmaceutical companies, the National Institutes of Health, the Centers for Disease Control and Prevention, and other federal agencies. All clinical trials must go through a rigorous review process conducted by the Emory University Institutional Review Board.
Emory trials are available on the National Institute of Health web site.
If you have any questions regarding clinical trials at Emory, please contact HealthConnection℠ at 404-778-7777.
Study of Sorafenib as Adjuvant Treatment for Hepatocellular Carcinoma After Surgical Resection or Local Ablation
Description: Sorafenib is a new drug, which is approved under the brand name Nexavar for the treatment of liver cancer. It is also currently being tested in various other cancers. To date, over 39,000 cancer patients have taken sorafenib either as a single treatment, or together with other chemotherapy drugs for several different types of cancer. Sorafenib works by stopping the development of new cancer cells and new blood vessels. By stopping the growth of new blood vessels around a tumor, it is believed that sorafenib can prevent the growth of tumors. This is a "randomized," "placebo-controlled," "double-blind study." "Placebo controlled" means that this study uses a "dummy pill" which looks like the real sorafenib tablet but does not contain any active study drug. "Randomized" means that the patient will be assigned a treatment group by chance, so as to reduce bias. The patient will have a 1 in 2 chance of receiving sorafenib and a 1 in 2 chance of receiving placebo. This will be randomly determined by a computer program. Neither the patient, Bayer Healthcare nor the patient's doctor will be able to choose which drug is given. This allows the study drug to be assessed in a fair way. "Double-blind" means that Bayer Healthcare has packaged the study drug so that neither the patient nor your study doctor nor any representative from Bayer Healthcare will know whether the patient is receiving sorafenib or placebo tablets. This allows everyone involved in this research study to evaluate the safety and effectiveness of the investigational study drug in a fair way. In an emergency situation where the doctor has determined that it is important to know if the patient is taking sorafenib or placebo, the doctor will be able to find out. Sorafenib and placebo tablets will be taken orally (by mouth). Two tablets are taken twice a day. The treatment in this study will continue for a maximum of 4 years or until the cancer returns to the liver or spreads to other parts of your body or if the patient has intolerable side effects.
Immune Monitoring and Assay Development in Organ Transplant Recipients
Description: Patients that are awaiting liver transplantation or have undergone liver transplantation will be asked to donate blood samples at time points pre- and post-transplant, and tissue samples at time of any clinically indicated liver biopsy. These banked samples will then be used to investigate diseases leading to liver transplantation as well as to evaluate post-transplant events that may have immunologic significance, such as rejections or infections. This study is open to enrollment.
For more information contact:
Emory Transplant Center
Clinical Research Program
404-712-1114
NCI 8846: Phase I, Pharmacokinetic Study of Belinostat for Solid Tumors and Lymphomas in Patients with Varying Degrees of Hepatic Dysfunction
Description: Belinostat is an experimental cancer treatment drug that works by helping to turn on genes that limit cell growth and survival of the tumor that are switched off in cancer cells. Belinostat has been given to patients with different types of cancer to measure its safety and effectiveness, but it has not been given in a formal trial to cancer patients who have abnormal liver function. Because belinostat is processed by the liver, its safety and effectiveness needs to be established in individuals who have abnormal liver function. Researchers are interested in comparing the effects of belinostat as a cancer treatment drug in individuals with normal and abnormal liver function.
CA-ALT-836-02-10: A Phase I Study of ALT-836 in Combination with Gemcitabine for Locally Advanced or Metastatic Solid Tumors
Description: This is a Phase I, open-label, multi-center, competitive enrollment and dose-escalation study of ALT-836 in combination with standard of care gemcitabine in participants who have locally advanced or metastatic solid tumors. The purpose of this study is to determine the maximum tolerated dose (MTD), and to assess the safety and pharmacokinetic profile of ALT-836 given with gemcitabine. The clinical benefit, progression-free survival and overall survival of study participants will also be assessed.
NCI 8784: A Phase I Study of 1-Methyl-D-tryptophan (NSC-721782; IND# 78060) in Combination with Docetaxel in Metastatic Solid Tumors
Description: The purpose of this study is twofold. The first objective is to find the highest dose of 1-Methyl-D-tryptophan (shortened to 1-MT), an experimental drug combined with Docetaxel in metastatic tumors. The secondary objective of this study is to determine pharmacokinetic data (several collected from using the patient's blood sample results) for the combination of oral 1-MT and Docetaxel. Also the study has an objective to determine the overall response rate (complete response or partial response) on the combination. This study initially studies how increasing amounts of the experimental drug 1-MT combined with Docetaxel affects the patient's body. The starting dose of 1-MT is 300 mg twice a day and will be increased in a step-wise fashion (600mg twice daily, 1000mg twice daily) and will be combined with 60 mg/m2 of Docetaxel. If the drug is safe and well tolerated in the starting dose group, then it will be increased for the next group of patients who are enrolled on the trial. Patients will then receive increase dose of Docetaxel (75 mg/m2) which will be combined with 600 mg twice a day of 1-MT or 1000 mg twice a day of 1-MT. This is done in order to find out what is the most effective dose without any major side effects. Administration of 1-MT is given orally every morning 1 hour prior to breakfast and 1 hour prior to dinner in continuous 21 day cycles. Patients will be asked to maintain a pill diary (provided by the study staff) to record their doses of 1-MT.
