Our Research & Clinical Trials
A clinical trial utilizes a group of patient volunteers to measure the effectiveness of a new screening method, a new diagnostic procedure, a new drug or a new treatment plan. The physicians and researchers at the James Graham Brown Cancer Center have coordinated more than 75 clinical trials involving more than 14,000 patients. Today’s most common drugs, diagnostic techniques and procedures were at one time revolutionary ideas that were tested, proven and improved by the clinical trial system. In addition to coordinating our own studies (those written by University of Louisville/Brown Cancer Center physician investigators), the Brown Cancer Center also participates in clinical trials coordinated by major pharmaceutical companies specializing in oncology research and in clinical trials run by the National Cancer Institute.
As an academic medical center, we are committed to clinical trials, which result in translational research for our patients. Therefore, our patients benefit from the very latest in revolutionary treatment options, often long before they become available in non-teaching settings.
Clinical trials are conducted in four phases, as defined by the National Institutes of Health:
Phase I
Researchers test a new drug or treatment in a small group of volunteers (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects. When results from Phase I are promising (meaning the benefits appear to outweigh the risks), then Phase II trials may begin.
Phase II
The study drug or treatment is given to a larger group of volunteers (100 - 300) to see if it is effective and to further evaluate its safety.
Phase III
The study drug or treatment is given to large groups of volunteers (1,000 - 3,000) 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 IV
Post-marketing studies outline additional information including the drug’s risks, benefits and optimal use. Researchers at the Brown Cancer Center have coordinated and/or participated in many clinical trials including:
- The ONTAK Trial – is a study evaluating the effectiveness of denileukin diftitox, immune therapy, for melanoma. Investigators (physicians) at the Brown Cancer Center conceived, authored and are directing this Phase II clinical trial.
- The Beta-Glucan Trial – is a study evaluating the effects of adding an immune enhancing oral supplement to the standard therapy of a monoclonal antibody for Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL). This study is written and directed by physicians at the Brown Cancer Center and may lay the groundwork for future research in the benefits of enhancing immunity in CLL and SLL.
- The Biochemo Digoxin Trial – is a study evaluating the effects of adding the drug, digoxin, to standard biochemotherapy for melanoma. It is a Phase II study conceived, written and directed by physicians at the Brown Cancer Center.
- The AS1411 Phase I Trial – was a study to test the safety of Agro100, a compound developed by the UofL researchers, but the drug also had dramatic effect on some patients’ tumors. The compound is now in Phase II clinical trials.
- The Sunbelt Melanoma Trial – was the world’s largest study of melanoma. This multi-center study involved 79 centers with more than 3,600 patients from around the United States and Canada. The study was conceived, written, and directed by physicians from the University of Louisville Department of Surgery. Brown Cancer Center physicians also participated as co-investigators.
- The University of Louisville Breast Cancer Sentinel Lymph Node Study – a 4,000 patient study that has allowed this minimally invasive procedure for breast cancer to be adopted as a standard treatment of care alternative to complete axillary lymph node dissection.
- The National Registry of Image-Guided Breast Biopsy – a 3,000 patient study of minimally invasive alternatives to open surgical breast biopsy.
- The NAFTA Trial – a 2,000 patient study of hormonal therapy for breast cancer. The real heroes of this process are the patients who are helping to advance science, and are also the earliest beneficiaries of emerging treatments.
To see if there are clinical trials available for your type of cancer, please use the search tool below.
Our Research & Clinical Trials
A clinical trial utilizes a group of patient volunteers to measure the effectiveness of a new screening method, a new diagnostic procedure, a new drug or a new treatment plan. The physicians and researchers at the James Graham Brown Cancer Center have coordinated more than 75 clinical trials involving more than 14,000 patients. Today’s most common drugs, diagnostic techniques and procedures were at one time revolutionary ideas that were tested, proven and improved by the clinical trial system. In addition to coordinating our own studies (those written by University of Louisville/Brown Cancer Center physician investigators), the Brown Cancer Center also participates in clinical trials coordinated by major pharmaceutical companies specializing in oncology research and in clinical trials run by the National Cancer Institute.
As an academic medical center, we are committed to clinical trials, which result in translational research for our patients. Therefore, our patients benefit from the very latest in revolutionary treatment options, often long before they become available in non-teaching settings.
Clinical trials are conducted in four phases, as defined by the National Institutes of Health:
Phase I
Researchers test a new drug or treatment in a small group of volunteers (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects. When results from Phase I are promising (meaning the benefits appear to outweigh the risks), then Phase II trials may begin.
Phase II
The study drug or treatment is given to a larger group of volunteers (100 - 300) to see if it is effective and to further evaluate its safety.
Phase III
The study drug or treatment is given to large groups of volunteers (1,000 - 3,000) 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 IV
Post-marketing studies outline additional information including the drug’s risks, benefits and optimal use. Researchers at the Brown Cancer Center have coordinated and/or participated in many clinical trials including:
- The ONTAK Trial – is a study evaluating the effectiveness of denileukin diftitox, immune therapy, for melanoma. Investigators (physicians) at the Brown Cancer Center conceived, authored and are directing this Phase II clinical trial.
- The Beta-Glucan Trial – is a study evaluating the effects of adding an immune enhancing oral supplement to the standard therapy of a monoclonal antibody for Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL). This study is written and directed by physicians at the Brown Cancer Center and may lay the groundwork for future research in the benefits of enhancing immunity in CLL and SLL.
- The Biochemo Digoxin Trial – is a study evaluating the effects of adding the drug, digoxin, to standard biochemotherapy for melanoma. It is a Phase II study conceived, written and directed by physicians at the Brown Cancer Center.
- The AS1411 Phase I Trial – was a study to test the safety of Agro100, a compound developed by the UofL researchers, but the drug also had dramatic effect on some patients’ tumors. The compound is now in Phase II clinical trials.
- The Sunbelt Melanoma Trial – was the world’s largest study of melanoma. This multi-center study involved 79 centers with more than 3,600 patients from around the United States and Canada. The study was conceived, written, and directed by physicians from the University of Louisville Department of Surgery. Brown Cancer Center physicians also participated as co-investigators.
- The University of Louisville Breast Cancer Sentinel Lymph Node Study – a 4,000 patient study that has allowed this minimally invasive procedure for breast cancer to be adopted as a standard treatment of care alternative to complete axillary lymph node dissection.
- The National Registry of Image-Guided Breast Biopsy – a 3,000 patient study of minimally invasive alternatives to open surgical breast biopsy.
- The NAFTA Trial – a 2,000 patient study of hormonal therapy for breast cancer. The real heroes of this process are the patients who are helping to advance science, and are also the earliest beneficiaries of emerging treatments.
To see if there are clinical trials available for your type of cancer, please use the search tool below.