James L. Gulley

James L. Gulley
Education Loma Linda University, Emory University, National Cancer Institute

Medical career

Profession Medical oncologist
Institutions National Cancer Institute
Specialism genitourinary oncology, immunotherapy
Research cancer research

James L. Gulley is the Director, Clinical Trials Group within the Laboratory of Tumor Immunology and Biology,[1] Center for Cancer Research, National Cancer Institute (NCI), National Institutes of Health (NIH).

Life and career

Gulley 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, designed and funded by the NIH to produce translational researchers, he completed a dissertation on tumor immunology. He completed his residency in internal medicine at Emory University in 1998, followed by a medical oncology fellowship[2] at the NCI. Since 1999 he has authored and run a variety of clinical trials at the NCI, serving as Principal Investigator or an Associate Investigator on approximately 40 trials. Gulley is running several currently enrolling studies for cancer patients[3]

Gulley is especially interested in immunotherapy for prostate cancer. 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 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 within the Medical Oncology Branch at the National Cancer Institute. He serves on many boards and committees including the NCI Prostate Cancer Task Force. He has authored over 125 scientific papers or book chapters,[4] edited 3 books including the Bethesda Handbook of Clinical Oncology[5] and has made numerous presentations at national and international meetings.

Gulley serves as the Principal Investigator of PROSPECT[6] - a global phase III clinical trial of a cancer vaccine, PSA-TRICOM, also known as Prostvac that was initiated in November 2011.[7] This vaccine was developed by the National Cancer Institute and licensed to Bavarian Nordic who is sponsoring this phase III study. Gulley has been involved in many of the earlier clinical trials of PROSTVAC.[8][9][10][11][12][13][14]

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 treatments including 37 co-authored with Schlom.[15] The paper quoting Dr Schlom re:"Rethinking Cancer Vaccine Trials: Would New Measures of Success Make a Difference?" at Sipuleucel-T (reference #14) was co-authored by Gulley, JL.[16]

Ipilimumab

At the 2010 ASCO meeting Gulley's group reported on the use of Ipilimumab with a vector-based vaccine for advanced prostate cancer. This phase I trial using PSA-TRICOM with Ipilimumab (Ipi) showed promise for Overall Survival (OS).[17] Ipi is used in melanoma vaccine clinical trials.[18] It was approved by the FDA in March 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 arena.[19][20]

References

  1. ↑ "Center for Cancer Research - Organization Pages". Ccr.cancer.gov. 2010-04-28. Retrieved 2010-07-14.
  2. ↑ "Medical Oncology Web - FELLOWSHIP". Medicaloncology.cancer.gov. Retrieved 2010-07-14.
  3. ↑ "Clinical Trials at NIH: Health Care Professionals: Investigator Profiles: James L. Gulley, M.D". Bethesdatrials.cancer.gov. Retrieved 2010-07-14.
  4. ↑ "Center for Cancer Research - Staff Pages". Ccr.cancer.gov. Retrieved 2010-07-14.
  5. ↑ Abraham, Jame; Allegra, Carmen J.; Gulley, James L. (2005). Bethesda handbook of clinical oncology. Hagerstwon, MD: Lippincott Williams & Wilkins. ISBN 978-0-7817-5116-2.
  6. ↑ "PROSPECT Phase 3 Trial". Clinicaltrials.gov. Retrieved 2013-04-12.
  7. ↑ "Prostvac". Bavarian Nordic. Retrieved 2013-04-12.
  8. ↑ Kantoff, P. W.; Schuetz, T. J.; Blumenstein, B. A.; Glode, L. M.; Bilhartz, D. L.; Wyand, M.; Manson, K.; Panicali, D. L.; et al. (2010). "Overall Survival Analysis of a Phase II Randomized Controlled Trial of a Poxviral-Based PSA-Targeted Immunotherapy in Metastatic Castration-Resistant Prostate Cancer". Journal of Clinical Oncology 28 (7): 1099–105. doi:10.1200/JCO.2009.25.0597. PMC 2834462. PMID 20100959.
  9. ↑ Gulley, James L.; Arlen, Philip M.; Madan, Ravi A.; Tsang, Kwong-Yok; Pazdur, Mary P.; Skarupa, Lisa; Jones, Jacquin L.; Poole, Diane J.; et al. (2009). "Immunologic and prognostic factors associated with overall survival employing a poxviral-based PSA vaccine in metastatic castrate-resistant prostate cancer". Cancer Immunology, Immunotherapy 59 (5): 663. doi:10.1007/s00262-009-0782-8.
  10. ↑ Lechleider, R. J.; Arlen, P. M.; Tsang, K.-Y.; Steinberg, S. M.; Yokokawa, J.; Cereda, V.; Camphausen, K.; Schlom, J.; et al. (2008). "Safety and Immunologic Response of a Viral Vaccine to Prostate-Specific Antigen in Combination with Radiation Therapy when Metronomic-Dose Interleukin 2 is Used as an Adjuvant". Clinical Cancer Research 14 (16): 5284–91. doi:10.1158/1078-0432.CCR-07-5162. PMC 2639763. PMID 18698048.
  11. ↑ Arlen, P. M.; Gulley, JL; Parker, C; Skarupa, L; Pazdur, M; Panicali, D; Beetham, P; Tsang, KY; et al. (2006). "A Randomized Phase II Study of Concurrent Docetaxel Plus Vaccine Versus Vaccine Alone in Metastatic Androgen-Independent Prostate Cancer". Clinical Cancer Research 12 (4): 1260–9. doi:10.1158/1078-0432.CCR-05-2059. PMC 1526707. PMID 16489082.
  12. ↑ Arlen, Philip M.; Gulley, James L.; Todd, Nushin; Lieberman, Ronald; Steinberg, Seth M.; Morin, Steve; Bastian, Anne; Marte, Jennifer; et al. (2005). "Antiandrogen, Vaccine and Combination Therapy in Patients with Nonmetastatic Hormone Refractory Prostate Cancer". The Journal of Urology 174 (2): 539–46. doi:10.1097/01.ju.0000165159.33772.5b. PMID 16006888.
  13. ↑ Gulley, J. L.; Arlen, PM; Bastian, A; Morin, S; Marte, J; Beetham, P; Tsang, KY; Yokokawa, J; et al. (2005). "Combining a Recombinant Cancer Vaccine with Standard Definitive Radiotherapy in Patients with Localized Prostate Cancer". Clinical Cancer Research 11 (9): 3353–62. doi:10.1158/1078-0432.CCR-04-2062. PMID 15867235.
  14. ↑ Gulley, James; Chen, Alice P.; Dahut, William; Arlen, Philip M.; Bastian, Anne; Steinberg, Seth M.; Tsang, Kwong; Panicali, Dennis; et al. (2002). "Phase I study of a vaccine using recombinant vaccinia virus expressing PSA (rV-PSA) in patients with metastatic androgen-independent prostate cancer". The Prostate 53 (2): 109–17. doi:10.1002/pros.10130. PMID 12242725.
  15. ↑ Search Results for author Gulley JL on PubMed.
  16. ↑ Stein, W. D.; Gulley, J. L.; Schlom, J.; Madan, R. A.; Dahut, W.; Figg, W. D.; Ning, Y.-m.; Arlen, P. M.; et al. (2010). "Tumor Regression and Growth Rates Determined in Five Intramural NCI Prostate Cancer Trials: The Growth Rate Constant as an Indicator of Therapeutic Efficacy". Clinical Cancer Research 17 (4): 907–17. doi:10.1158/1078-0432.CCR-10-1762. PMID 21106727.
  17. ↑ http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=74&abstractID=51902
  18. ↑ Sarnaik, A. A.; Yu, B.; Yu, D.; Morelli, D.; Hall, M.; Bogle, D.; Yan, L.; Targan, S.; et al. (2010). "Extended Dose Ipilimumab with a Peptide Vaccine: Immune Correlates Associated with Clinical Benefit in Patients with Resected High-Risk Stage IIIc/IV Melanoma". Clinical Cancer Research 17 (4): 896–906. doi:10.1158/1078-0432.CCR-10-2463. PMC 3041838. PMID 21106722.
  19. ↑ Hoos, Axel; Ibrahim, Ramy; Korman, Alan; Abdallah, Kald; Berman, David; Shahabi, Vafa; Chin, Kevin; Canetta, Renzo; Humphrey, Rachel (2010). "Development of Ipilimumab: Contribution to a New Paradigm for Cancer Immunotherapy". Seminars in Oncology 37 (5): 533–46. doi:10.1053/j.seminoncol.2010.09.015. PMID 21074069.
  20. ↑ http://www.cancer.gov/clinicaltrials/results/ipilimumab0610

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