Clinical Trials

Below is a listing of liver and pancreas-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 Institutes of Health website.

If you have any questions regarding clinical trials at Emory, please contact Emory HealthConnection℠ at 404-778-7777.

Liver Clinical Trials

Treatment Study for Hepatocellular Carcinoma After Surgical Resection

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 in Organ Transplant Recipients

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

Solid Tumors and Lymphomas in Patients with Hepatic Dysfunction

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.

Study for Locally Advanced or Metastatic Solid Tumors

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.

Study of 1-Methyl-D-tryptophan in Combination with Docetaxel in Metastatic Solid Tumors

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.

Pancreas Clinical Trials

A 2-Arm Randomized Phase II Study of Carboplatin

NCI 8601: A 2-arm Randomized Phase II Study of Carboplatin, Paclitaxel plus Reovirus Serotype-3 Dearing Strain (Reolysin®) vs. Carboplatin and Paclitaxel in the First Line Treatment of Patients with Recurrent or Metastatic Pancreatic Cancer

Detailed Eligibility Disease Characteristics:

-    Histologically confirmed adenocarcinoma of the pancreas that is recurrent or metastatic

o    Cytological confirmation not allowed

o    Diagnosis of pancreatic cancer with histologic confirmation of adenocarcinoma would suffice - Paraffin-embedded tissue from tumor blocks required

-    Patients must have measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension per RECIST 1.1 (longest diameter to be recorded) as ≥ 10 mm by spiral CT scan (CT scan slice thickness no > 5 mm)

o    Malignant lymph nodes will be considered measurable if they are ≥ 15 mm in short axis o For patients previously irradiated, the measurable lesion must be outside the radiated field - No untreated brain metastases

o    Resected oligometastasis eligible if post-resection MRI demonstrates resolution

o    Gamma-knife treated patients are also eligible if there are no more than two treated metastases confined to the same area of the brain and a post-treatment MRI shows a decrease in the metastases

Phase I Trial of Gemcitabine with TheraSphere®

WCI 1907-10: Phase I Trial of Gemcitabine with TheraSphere® (Yttrium-90) in Patients with Hepatic Tumors of Pancreatobiliary Origin

Description: The rationale for combining gemcitabine with Y90 in hepatic tumors of pancreatobiliary origin is based on the following: 1) the liver is the predominate site of disease for both stage IV pancreatic cancer and cholangiocarcinoma 2) gemcitabine is the standard chemotherapy in both tumor types, 3) gemcitabine is a potent radio sensitizer, and 4) preliminary reports suggest activity for Y90 against liver tumors of pancreatobiliary histology. Prior to evaluating the efficacy of adding gemcitabine to Y90, a phase I trial evaluating the safety of the combination is needed.

Gemcitabane/Cisplatin for Resected Pancreas Cancer

WCI 1738-09: Gemcitabine/Cisplatin for Resected Pancreas Cancer: Establishing the Role of ERCC1 in Treatment Decision

Description: After undergoing surgery to remove the pancreatic cancer, patients will receive chemotherapy consisting of 2 different agents: gemcitabine and cisplatin. It is standard of care and highly recommended to get chemotherapy after having pancreatic tumors removed. Although gemcitabine chemotherapy alone is the traditional approach, the ¿standard of care¿ regimen is definitely in flux. Both of the agents that will be given have been used for many patients with pancreatic cancer. The removed tumor will be saved in the pathology lab to test it for a specific marker. Also one vial of blood will be saved and tested for a specific marker. This study will not alter the quality of treatment for pancreatic cancer. The study will not change the operation that is done. The study will not change the way patients are followed and treated after the surgery.

Liver Conditions