James L. Gulley, M.D., Ph.D.

James L. Gulley, M.D., Ph.D.
Senior Investigator
Head, Immunotherapy Section
Director, Medical Oncology Service, CCR Office of the Clinical Director

In addition to his role as Branch Chief, Dr. James L. Gulley is also Director of the Medical Oncology Service, Office of the Clinical Director.

Dr. Gulley is an internationally recognized expert in cancer immunotherapy with a strong interest in prostate cancer. Since 1998 he has authored and run a variety of clinical trials at the NCI. These innovative investigator initiated studies involve the use of cancer vaccines and other immunostimulatory agents, and the combination of immunotherapy with other treatment strategies.  In particular, he has played a central role in the clinical development of a prostate cancer vaccine, created in the NCI, and serves as the principal investigator on an international Phase III randomized clinical trial of this vaccine. He is also the coordinating principal investigator of an international trial of an anti-PDL1 antibody.

Areas of Expertise
1) immunotherapy, 2) therapeutic cancer vaccines, 3) immune checkpoint inhibitors, 4) prostate cancer, 5) clinical trials, 6) combining immunotherapy with other therapies

Contact Info

James L. Gulley, M.D., Ph.D.
Center for Cancer Research
National Cancer Institute
Building 10, Room 13N240
Bethesda, MD 20892-1750
Ph: 301-480-7164
Fax: 301-480-8867

Dr. Gulley is especially interested in immunotherapy for prostate cancer. He works collaboratively with the Laboratory of Tumor Immunology and Biology, CCR, and takes promising laboratory findings and uses these to design and conduct clinical trials. These innovative, investigator-initiated studies involve the use of cancer vaccines and other immunostimulatory agents to modulate the immune response in cancer patients, and the addition of other strategies to enhance vaccine-mediated killing. In particular, he played a pivotal role in the clinical development of a prostate cancer vaccine, created at the NCI, and he now serves as the Principal Investigator on a global Phase III randomized clinical trial (Prospect) of this vaccine.

Scientific Focus Areas:
Clinical Research, Immunology
  1. Arlen PM, Skarupa L, Pazdur M, Seetharam M, Tsang KY, Grosenbach DW, Feldman J, Poole DJ, Litzinger M, Steinberg SM, Jones E, Chen C, Marte J, Parnes H, Wright J, Dahut W, Schlom J, Gulley JL.
    J. Urol. 178: 1515-20, 2007. [ Journal Article ]
  2. Kantoff PW, Schuetz TJ, Blumenstein BA, Glode LM, Bilhartz DL, Wyand M, Manson K, Panicali DL, Laus R, Schlom J, Dahut WL, Arlen PM, Gulley JL, Godfrey WR.
    J. Clin. Oncol. 28: 1099-105, 2010. [ Journal Article ]
  3. Gulley JL, Arlen PM, Madan RA, Tsang KY, Pazdur MP, Skarupa L, Jones JL, Poole DJ, Higgins JP, Hodge JW, Cereda V, Vergati M, Steinberg SM, Halabi S, Jones E, Chen C, Parnes H, Wright JJ, Dahut WL, Schlom J.
    Cancer Immunol. Immunother. 59: 663-74, 2010. [ Journal Article ]
  4. Madan RA, Mohebtash M, Arlen PM, Vergati M, Rauckhorst M, Steinberg SM, Tsang KY, Poole DJ, Parnes HL, Wright JJ, Dahut WL, Schlom J, Gulley JL.
    Lancet Oncol. 13: 501-8, 2012. [ Journal Article ]
  5. Gulley JL, Heery CR, Madan RA, Walter BA, Merino MJ, Dahut WL, Tsang KY, Schlom J, Pinto PA.
    Cancer Immunol. Immunother. 62: 1521-31, 2013. [ Journal Article ]

Dr. James Gulley is an internationally recognized expert in immunotherapy for cancer. He graduated from Loma Linda University 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 he completed a dissertation on tumor immunology. Dr. Gulley completed his residency in internal medicine at Emory University in 1998, followed by a medical oncology fellowship at the NCI. Since 1999 he has authored and run a variety of clinical trials at the NCI, serving as Principal Investigator or Associate Investigator on more than 60 trials. Dr. Gulley has received numerous awards, including the 2010 Presidential Early Career Award for Scientists and Engineers (PECASE), the highest award bestowed by the U.S. government on outstanding scientists early in their careers. He serves on many national and NIH boards and committees. Dr. Gulley has authored more than 180 scientific papers and book chapters, edited 4 books and has made numerous invited presentations at national and international meetings.

Name Position
Houssein Abdul Sater M.D. Assistant Research Physician
Marijo Bilusic, M.D., Ph.D. Associate Research Physician
Isaac Brownell M.D., Ph.D. Adjunct Investigator
William Figg Predoctoral Fellow (Graduate Student)
Amy Hankin PA-C, MMSc Physician Assistant
Christopher Heery M.D. Special Volunteer
Fatima Karzai, M.D. Assistant Research Physician
Sunnie Kim M.D. Special Volunteer
Michell Manu R.N. Research Nurse (Contr.)
Ariel Marciscano M.D. Clinical Fellow
Jennifer Marte M.D. Clinical Research Coordinator
Lee Pai-Scherf M.D. Clinical Collaborator
Lilian Spear Special Volunteer
Marc Theoret M.D. Clinical Collaborator
Armine Tumasyan M.D., M.P.H., CCRP Clinical Research Associate II (Contr.)
Beatriz Walter Rodriguez Ph.D. Scientist (Contr.)
Monique Williams N.P. Nurse Practitioner (Contr.)