James L. Gulley

Last updated
James L. Gulley
Education Loma Linda University, Emory University, National Cancer Institute
Medical career
Profession Medical oncologist
Institutions National Cancer Institute
Sub-specialties genitourinary oncology, immunotherapy
Research cancer research
Website

James L. Gulley is an American cancer researcher and the Director of the Medical Oncology Service at National Cancer Institute. [1]

Contents

Early life and education

He graduated from Loma Linda University, California [2] and his M.D./Ph.D. Medical Scientist Training Program, at National Institutes of Health (NIH) and his dissertation on tumor immunology. [3] Later, Gulley did his residency in internal medicine at Emory University in 1998, followed by a medical oncology fellowship at the NCI. [4]

Research and career

Gulley did his research in immunotherapy for prostate cancer. His studies involved the use of cancer vaccine [5] and immune checkpoint inhibitors or other strategies to enhance vaccine-mediated killing. [6] Since 1999, he ran clinical trials at the NCI, [7] serving as Principal Investigator or an Associate Investigator on approximately 40 trials. He is also running studies on cancer patients. [8] [9] [10]

Publications

He published over 250 research papers & book chapters across leading journals. [11] [12] Some of his notable publications are listed below:

FDA approval

At the 2010 ASCO meeting Gulley and his group reported on the use of Ipilimumab with a vector-based vaccine for treating advanced prostate cancer. This phase I trial using PSA-TRICOM with Ipilimumab (Ipi) showed promise for Overall Survival (OS). [21] Ipi is used in melanoma vaccine clinical trials. [22] It was approved by the FDA in March 2011. [23] [24] [25] [26]

Awards

Related Research Articles

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Nicholas J. Vogelzang was a medical oncologist with Comprehensive Cancer Centers of Nevada (CCCN). He serves as medical director of the Research Executive Committee and Associate Chair of the Developmental Therapeutics and Genitourinary Committees for US Oncology Research. His research interests include clinical trials for genitourinary malignancies and mesothelioma.

<span class="mw-page-title-main">Ipilimumab</span> Pharmaceutical drug

Ipilimumab, sold under the brand name Yervoy, is a monoclonal antibody medication that works to activate the immune system by targeting CTLA-4, a protein receptor that downregulates the immune system.

<span class="mw-page-title-main">Enzalutamide</span> Antiandrogen medication used in treatment of prostate cancer

Enzalutamide, sold under the brand name Xtandi, is a nonsteroidal antiandrogen (NSAA) medication which is used in the treatment of prostate cancer. It is indicated for use in conjunction with castration in the treatment of metastatic castration-resistant prostate cancer (mCRPC), nonmetastatic castration-resistant prostate cancer, and metastatic castration-sensitive prostate cancer (mCSPC). It is taken by mouth.

<span class="mw-page-title-main">Veliparib</span> Chemical compound

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William K. Oh, is an American medical oncologist, academic and industry leader and expert in the management of genitourinary malignancies, including prostate, renal, bladder and testicular cancers.

<span class="mw-page-title-main">Cabazitaxel</span> Chemical compound

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Sipuleucel-T, sold under the brand name Provenge, developed by Dendreon Pharmaceuticals, LLC, is a cell-based cancer immunotherapy for prostate cancer (CaP). It is an autologous cellular immunotherapy.

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<span class="mw-page-title-main">Galeterone</span> Chemical compound

Galeterone is a steroidal antiandrogen which was under development by Tokai Pharmaceuticals for the treatment of prostate cancer. It possesses a unique triple mechanism of action, acting as an androgen receptor antagonist, androgen receptor down regulator, and CYP17A1 inhibitor, the latter of which prevents the biosynthesis of androgens. As a CYP17A1 inhibitor, galeterone shows selectivity for 17,20-lyase over 17α-hydroxylase.

PROSTVAC is a cancer immunotherapy candidate in clinical development by Bavarian Nordic for the treatment of all prostate cancer although clinical trials are focusing on more advanced cases of metastatic castration-resistant prostate cancer (mCRPC). PROSTVAC is a vaccine designed to enable the immune system to recognize and attack prostate cancer cells by triggering a specific and targeted T cell immune response to cancer cells that express the tumor-associated antigen prostate-specific antigen (PSA).

Darolutamide, sold under the brand name Nubeqa, is an antiandrogen medication which is used in the treatment of non-metastatic castration-resistant prostate cancer in men. It is specifically approved to treat non-metastatic castration-resistant prostate cancer (nmCRPC) in conjunction with surgical or medical castration. The medication is taken by mouth twice per day with food.

<span class="mw-page-title-main">Apalutamide</span> Chemical compound

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Abituzumab is a humanized IgG2 monoclonal antibody (mAb) targeted at CD51 currently in development by Merck KGaA Darmstadt, Germany in an attempt to prevent bone lesion metastases in castration-resistant prostate cancer.

<span class="mw-page-title-main">BMS-641988</span> Chemical compound

BMS-641988 is a nonsteroidal antiandrogen which was developed by Bristol-Myers Squibb for the treatment of prostate cancer but was never marketed. It acts as a potent competitive antagonist of the androgen receptor (AR) (Ki = 10 nM; IC50Tooltip half-maximal inhibitory concentration = 56 nM). The drug was found to have 20-fold higher affinity for the AR than bicalutamide in MDA-MB-453 cells, and showed 3- to 7-fold the antiandrogenic activity of bicalutamide in vitro. It may have some weak partial agonist activity at the androgen receptor. BMS-641988 is transformed by CYP3A4 into BMS-570511, and this metabolite is then reduced to BMS-501949 by cytosolic reductases. All three compounds show similar antiandrogenic activity. In addition to its antiandrogenic activity, BMS-641988 shows activity as a negative allosteric modulator of the GABAA receptor, and can produce seizures in animals at sufficiently high doses. It also shows some drug-induced QT prolongation. BMS-641988 reached phase I clinical trials prior to the discontinuation of its development. The clinical development of BMS-641988 was terminated due to the occurrence of a seizure in a patient during a phase I study.

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Masofaniten, also known by its developmental code name EPI-7386, is an N-terminal domain antiandrogen, or antagonist of the N-terminal domain (NTD) of the androgen receptor (AR), which is under development for the treatment of prostate cancer. The compound was developed as a successor of previous drugs in the EPI series such as EPI-001, ralaniten (EPI-002), and ralaniten acetate (EPI-506). EPI-7386 shows 20-fold higher antiandrogenic potency than ralaniten in vitro (IC50Tooltip Half-maximal inhibitory concentration = 535 nM vs. 9,580 nM, respectively), as well as greater stability in human hepatocytes. It was planned to enter phase I clinical trials in 2020. Preliminary results of a phase I/II clinical trial were published in 2023.

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<span class="mw-page-title-main">Sabizabulin</span> Chemical compound

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References

  1. ↑ "Medical Oncology Service". Center for Cancer Research. 2016-02-09. Retrieved 2019-08-22.
  2. ↑ "James L. Gulley, M.D., Ph.D." Center for Cancer Research. 2014-08-12. Retrieved 2019-11-16.
  3. ↑ "Principal Investigators". NIH Intramural Research Program. Retrieved 2019-08-06.
  4. ↑ "Medical Oncology Web - FELLOWSHIP". Medicaloncology.cancer.gov. Retrieved 2010-07-14.
  5. ↑ Gulley, James L.; Arlen, Philip M.; Schlom, Jeffrey (2007-07-01). "Cancer Vaccines: Moving Beyond Current Paradigms". Clinical Cancer Research. 13 (13): 3776–3782. doi:10.1158/1078-0432.CCR-07-0588. ISSN   1078-0432. PMC   2536755 . PMID   17606707.
  6. ↑ "James L. Gulley, MD, PhD, on Prostate Cancer: Expanding Immunotherapy Options - The ASCO Post". ascopost.com. Retrieved 2019-08-22.
  7. ↑ Gulley, James (2015-02-23). "James Gulley". NIH Intramural Research Program. Retrieved 2019-11-16.
  8. ↑ "Clinical Trials at NIH: Health Care Professionals: Investigator Profiles: James L. Gulley, M.D". Bethesdatrials.cancer.gov. Archived from the original on 2010-05-27. Retrieved 2010-07-14.
  9. ↑ "Clinical Trials at NIH: Health Care Professionals: Investigator Profiles: James L. Gulley, M.D." 2010-05-27. Archived from the original on 2010-05-27. Retrieved 2019-08-22.
  10. ↑ "Genitourinary Malignancies Branch Clinical Trials". Center for Cancer Research. Retrieved 2019-08-22.
  11. ↑ "My Bibliography James Gulley's Bibliography".
  12. ↑ "Center for Cancer Research - Staff Pages". Ccr.cancer.gov. Archived from the original on 2010-05-27. Retrieved 2010-07-14.
  13. ↑ Kantoff, Philip W.; Schuetz, Thomas J.; Blumenstein, Brent A.; Glode, L. Michael; Bilhartz, David L.; Wyand, Michael; Manson, Kelledy; Panicali, Dennis L.; Laus, Reiner (2010-03-01). "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): 1099–1105. doi:10.1200/JCO.2009.25.0597. ISSN   1527-7755. PMC   2834462 . PMID   20100959.
  14. ↑ Dahut, William L.; Gulley, James L.; Sharifi, Nima (2005-07-13). "Androgen Deprivation Therapy for Prostate Cancer". JAMA. 294 (2): 238–244. doi: 10.1001/jama.294.2.238 . ISSN   0098-7484. PMID   16014598.
  15. ↑ Dahut, William L.; Gulley, James L.; Arlen, Philip M.; Liu, Yinong; Fedenko, Katherine M.; Steinberg, Seth M.; Wright, John J.; Parnes, Howard; Chen, Clara C. (2004-07-01). "Randomized phase II trial of docetaxel plus thalidomide in androgen-independent prostate cancer". Journal of Clinical Oncology. 22 (13): 2532–2539. doi: 10.1200/JCO.2004.05.074 . ISSN   0732-183X. PMID   15226321.
  16. ↑ Gulley, James L.; Arlen, Philip M.; Bastian, Anne; Morin, Steven; Marte, Jennifer; Beetham, Patricia; Tsang, Kwong-Yok; Yokokawa, Junko; Hodge, James W. (2005-05-01). "Combining a recombinant cancer vaccine with standard definitive radiotherapy in patients with localized prostate cancer". Clinical Cancer Research. 11 (9): 3353–3362. doi: 10.1158/1078-0432.CCR-04-2062 . ISSN   1078-0432. PMID   15867235.
  17. ↑ Marshall, John L.; Gulley, James L.; Arlen, Philip M.; Beetham, Patricia K.; Tsang, Kwong-Yok; Slack, Rebecca; Hodge, James W.; Doren, Sandra; Grosenbach, Douglas W. (2005-02-01). "Phase I study of sequential vaccinations with fowlpox-CEA(6D)-TRICOM alone and sequentially with vaccinia-CEA(6D)-TRICOM, with and without granulocyte-macrophage colony-stimulating factor, in patients with carcinoembryonic antigen-expressing carcinomas". Journal of Clinical Oncology. 23 (4): 720–731. doi:10.1200/JCO.2005.10.206. ISSN   0732-183X. PMID   15613691.
  18. ↑ Arlen, Philip M.; Gulley, James L.; Parker, Catherine; Skarupa, Lisa; Pazdur, Mary; Panicali, Dennis; Beetham, Patricia; Tsang, Kwong Y.; Grosenbach, Douglas W. (2006-02-15). "A randomized phase II study of concurrent docetaxel plus vaccine versus vaccine alone in metastatic androgen-independent prostate cancer". Clinical Cancer Research. 12 (4): 1260–1269. doi:10.1158/1078-0432.CCR-05-2059. ISSN   1078-0432. PMC   1526707 . PMID   16489082.
  19. ↑ Gulley, James L.; Arlen, Philip M.; Madan, Ravi A.; Tsang, Kwong-Yok; Pazdur, Mary P.; Skarupa, Lisa; Jones, Jacquin L.; Poole, Diane J.; Higgins, Jack P. (2010). "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): 663–674. doi:10.1007/s00262-009-0782-8. ISSN   1432-0851. PMC   2832083 . PMID   19890632.
  20. ↑ Madan, Ravi A.; Mohebtash, Mahsa; Arlen, Philip M.; Vergati, Matteo; Rauckhorst, Myrna; Steinberg, Seth M.; Tsang, Kwong Y.; Poole, Diane J.; Parnes, Howard L. (2012). "Ipilimumab and a poxviral vaccine targeting prostate-specific antigen in metastatic castration-resistant prostate cancer: a phase 1 dose-escalation trial". The Lancet. Oncology. 13 (5): 501–508. doi:10.1016/S1470-2045(12)70006-2. ISSN   1474-5488. PMC   6359905 . PMID   22326924.
  21. ↑ Madan, Ravi A.; Mohebtash, Mahsa; Arlen, Philip M.; Vergati, Matteo; Rauckhorst, Myrna; Steinberg, Seth M.; Tsang, Kwong Y.; Poole, Diane J.; Parnes, Howard L. (2012). "Ipilimumab and a poxviral vaccine targeting prostate-specific antigen in metastatic castration-resistant prostate cancer: a phase 1 dose-escalation trial". The Lancet. Oncology. 13 (5): 501–508. doi:10.1016/S1470-2045(12)70006-2. ISSN   1474-5488. PMC   6359905 . PMID   22326924.
  22. ↑ 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.
  23. ↑ 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.
  24. ↑ "Experimental Drug Improves Survival in Advanced Melanoma - National Cancer Institute". www.cancer.gov. Archived from the original on 2010-08-11.
  25. ↑ Madan, Ravi A.; Mohebtash, Mahsa; Arlen, Philip M.; Vergati, Matteo; Rauckhorst, Myrna; Steinberg, Seth M.; Tsang, Kwong Y.; Poole, Diane J.; Parnes, Howard L. (2012). "Ipilimumab and a poxviral vaccine targeting prostate-specific antigen in metastatic castration-resistant prostate cancer: a phase 1 dose-escalation trial". The Lancet. Oncology. 13 (5): 501–508. doi:10.1016/S1470-2045(12)70006-2. ISSN   1474-5488. PMC   6359905 . PMID   22326924.
  26. ↑ Schlom, Jeffrey; Gulley, James L. (2018-12-04). "Vaccines as an Integral Component of Cancer Immunotherapy". JAMA. 320 (21): 2195–2196. doi:10.1001/jama.2018.9511. ISSN   1538-3598. PMC   6538063 . PMID   30419097.
  27. ↑ "President Obama Honors Outstanding Early-Career Scientists". whitehouse.gov. 2011-09-26. Retrieved 2019-08-22.
  28. ↑ "CCR Connections (News) - An Early Career Off to a Stellar Start". home.ccr.cancer.gov. Retrieved 2019-08-22.
  29. ↑ "Recent CCR Awards". Center for Cancer Research. 2016-06-21. Retrieved 2019-08-22.
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