James L. Gulley
Encyclopedia
Dr. James L. Gulley is the Director, Clinical Trials Group within the Laboratory of Tumor Immunology and Biology, Center for Cancer Research, National Cancer Institute
National Cancer Institute
The National Cancer Institute is part of the National Institutes of Health , which is one of 11 agencies that are part of the U.S. Department of Health and Human Services. The NCI coordinates the U.S...

 (NCI), National Institutes of Health
National Institutes of Health
The National Institutes of Health are an agency of the United States Department of Health and Human Services and are the primary agency of the United States government responsible for biomedical and health-related research. Its science and engineering counterpart is the National Science Foundation...

 (NIH).

Life and career

Gulley graduated from Loma Linda University
Loma Linda University
Loma Linda University is a Seventh-day Adventist coeducational health sciences university located in Loma Linda, California, United States. The University comprises eight schools and the Faculty of Graduate Studies...

 in California with a Ph.D. in microbiology in 1994 and an M.D. in 1995. As part of this eight-year M.D./Ph.D. Medical Scientist Training Program
Medical Scientist Training Program
Medical Scientist Training Programs are combined M.D. and Ph.D. graduate degree programs offered by a small number of United States medical schools with financial support from the National Institute of General Medical Sciences , in recognition of the increasing need for scientists to bridge the...

, designed and funded by the NIH to produce translational researchers, he completed a dissertation on tumor immunology. He completed his residency in internal medicine
Internal medicine
Internal medicine is the medical specialty dealing with the prevention, diagnosis, and treatment of adult diseases. Physicians specializing in internal medicine are called internists. They are especially skilled in the management of patients who have undifferentiated or multi-system disease processes...

 at Emory University
Emory University
Emory University is a private research university in metropolitan Atlanta, located in the Druid Hills section of unincorporated DeKalb County, Georgia, United States. The university was founded as Emory College in 1836 in Oxford, Georgia by a small group of Methodists and was named in honor of...

 in 1998, followed by a medical oncology fellowship at the NCI
NCI
NCI can stand for:*National Cancer Institute*National Captioning Institute*Nordic Centre in India*National College of Ireland*Native Communications Inc - Aboriginal Public Broadcaster in Manitoba, Canada....

. Since 1999 he has authored and run a variety of clinical trials at the NCI
NCI
NCI can stand for:*National Cancer Institute*National Captioning Institute*Nordic Centre in India*National College of Ireland*Native Communications Inc - Aboriginal Public Broadcaster in Manitoba, Canada....

, serving as Principal Investigator
Principal investigator
A principal investigator is the lead scientist or engineer for a particular well-defined science project, such as a laboratory study or clinical trial....

 or an Associate Investigator on approximately 40 trials. Gulley is running several currently enrolling studies for cancer patients

Gulley is especially interested in immunotherapy
Immunotherapy
Immunotherapy is a medical term defined as the "treatment of disease by inducing, enhancing, or suppressing an immune response". Immunotherapies designed to elicit or amplify an immune response are classified as activation immunotherapies. While immunotherapies that reduce or suppress are...

 for prostate cancer
Prostate cancer
Prostate cancer is a form of cancer that develops in the prostate, a gland in the male reproductive system. Most prostate cancers are slow growing; however, there are cases of aggressive prostate cancers. The cancer cells may metastasize from the prostate to other parts of the body, particularly...

. As Director of the Clinical Trials Group of the Laboratory of Tumor Immunology and Biology, he takes promising laboratory findings and uses them to design and conduct clinical trials. These studies involve the use of cancer vaccine
Cancer vaccine
The term cancer vaccine refers to a vaccine that either prevents infections with cancer-causing viruses, treats existing cancer or prevents the development of cancer in certain high risk individuals...

 and other immunostimulatory molecules to modulate the immune response in cancer patients, and the addition of other strategies to enhance vaccine-mediated killing. He is also a Principal Investigator
Principal investigator
A principal investigator is the lead scientist or engineer for a particular well-defined science project, such as a laboratory study or clinical trial....

 within the Medical Oncology Branch at the National Cancer Institute
National Cancer Institute
The National Cancer Institute is part of the National Institutes of Health , which is one of 11 agencies that are part of the U.S. Department of Health and Human Services. The NCI coordinates the U.S...

. He serves on many boards and committees including the NCI Prostate Cancer Task Force. He has authored over 125 scientific papers or book chapters, edited 3 books including the Bethesda Handbook of Clinical Oncology and has made numerous presentations at national and international meetings.

Gulley will serve as the Principal Investigator
Principal investigator
A principal investigator is the lead scientist or engineer for a particular well-defined science project, such as a laboratory study or clinical trial....

 of a global phase III clinical trial of a cancer vaccine
Cancer vaccine
The term cancer vaccine refers to a vaccine that either prevents infections with cancer-causing viruses, treats existing cancer or prevents the development of cancer in certain high risk individuals...

, PSA-TRICOM, also known as PROSTVAC that is scheduled to start late 2010 or early 2011. This vaccine was developed by the National Cancer Institute
National Cancer Institute
The National Cancer Institute is part of the National Institutes of Health , which is one of 11 agencies that are part of the U.S. Department of Health and Human Services. The NCI coordinates the U.S...

 and licenced to Bavarian Nordic who is sponsoring this phase III study. Gulley has been involved in many of the earlier clinical trials of PROSTVAC.

National Library of Medicine, Publications

Starting in 2003, Gulley, JL has authored or co-authored 82 pubmed.gov recorded papers (as of 2011), on various aspects of prostate cancer
Prostate cancer
Prostate cancer is a form of cancer that develops in the prostate, a gland in the male reproductive system. Most prostate cancers are slow growing; however, there are cases of aggressive prostate cancers. The cancer cells may metastasize from the prostate to other parts of the body, particularly...

 treatments.
These are peer reviewed papers from a variety of medical literature sources.
Drs Schlum and Gulley, JL have co-authored 37 papers recorded at pubmed. The paper quoting Dr Schlum re:"Rethinking Cancer Vaccine Trials: Would New Measures of Success Make a Difference?"
at Sipuleucel-T
Sipuleucel-T
Sipuleucel-T , manufactured by Dendreon Corporation, is a therapeutic cancer vaccine for prostate cancer . It must be prepared specifically for each patient. In metastatic prostate cancer, it has extended survival by about four months...

 (reference #14) was co-authored by Gulley, JL.

Ipilimumab

At the 2010 ASCO
Ascó
Ascó is a large village in the comarca of Ribera d'Ebre, Catalonia, Spain, on the right bank of the Ebre river. The village of Ascó is known for its nuclear power station, and for excellent fishing in the river....

 meeting Gulley's group reported on the use of Ipilimumab
Ipilimumab
Ipilimumab , marketed as Yervoy, is a drug used for the treatment of melanoma, a type of skin cancer. It is a U.S...

 with a vector-based vaccine for advanced prostate cancer. This phase I trial using PSA-TRICOM with Ipilimumab (Ipi) showed promise for Overall Survival
Survival rate
In biostatistics, survival rate is a part of survival analysis, indicating the percentage of people in a study or treatment group who are alive for a given period of time after diagnosis...

 (OS). Ipi is used in melanoma
Melanoma
Melanoma is a malignant tumor of melanocytes. Melanocytes are cells that produce the dark pigment, melanin, which is responsible for the color of skin. They predominantly occur in skin, but are also found in other parts of the body, including the bowel and the eye...

 vaccine clinical trials. It has not been approved by the FDA as of 2011. The understanding of cytotoxic T-lymphocyte antigen-4 (CTLA-4) which lead to the development of Ipi shows again that Gulley and his team have a considerable grasp of what can work in the human cancer vaccine
Cancer vaccine
The term cancer vaccine refers to a vaccine that either prevents infections with cancer-causing viruses, treats existing cancer or prevents the development of cancer in certain high risk individuals...

arena.

External links

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