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John Nemunaitis
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Journal Articles

Pilot Study of Recurrent Ewing's Sarcoma Management with Vigil/Temozolomide/Irinotecan and Assessment of Circulating Tumor (ct) DNA

Peter Anderson, Maurizio Ghisoli, Brian D. Crompton, Kelly S. Klega, Leonard H. Wexler, Emily K. Slotkin, Laura Stanbery, Luisa Manning, Gladice Wallraven, Meghan Manley, Staci Horvath, Ernest Bognar, John Nemunaitis
Journal: Clinical Cancer Research
Clin Cancer Res (2023) 29 (9): 1689–1697.
https://doi.org/10.1158/1078-0432.CCR-22-2292
Published: 01 May 2023
View article titled, Pilot Study of Recurrent Ewing's Sarcoma Management with Vigil/Temozolomide/Irinotecan and Assessment of Circulating Tumor (ct) DNA
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Includes: Supplementary data
Journal Articles

Safety and Efficacy of Pembrolizumab in Combination with Acalabrutinib in Advanced Head and Neck Squamous Cell Carcinoma: Phase 2 Proof-of-Concept Study

Matthew H. Taylor, Courtney B. Betts, Lauren Maloney, Eric Nadler, Alain Algazi, Michael J. Guarino, John Nemunaitis, Antonio Jimeno, Priti Patel, Veerendra Munugalavadla, Lin Tao, Douglas Adkins, Jerome H. Goldschmidt, Jr, Ezra E.W. Cohen, Lisa M. Coussens
Journal: Clinical Cancer Research
Clin Cancer Res (2022) 28 (5): 903–914.
https://doi.org/10.1158/1078-0432.CCR-21-2547
Published: 01 March 2022
View article titled, Safety and Efficacy of Pembrolizumab in Combination with Acalabrutinib in Advanced Head and Neck Squamous Cell Carcinoma: Phase 2 Proof-of-Concept Study
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Includes: Supplementary data
Journal Articles

A Randomized Phase II Trial of Epigenetic Priming with Guadecitabine and Carboplatin in Platinum-resistant, Recurrent Ovarian Cancer

Amit M. Oza, Ursula A. Matulonis, Angeles Alvarez Secord, John Nemunaitis, Lynda D. Roman, Sarah P. Blagden, Susana Banerjee, William P. McGuire, Sharad Ghamande, Michael J. Birrer, Gini F. Fleming, Merry Jennifer Markham, Hal W. Hirte, Diane M. Provencher, Bristi Basu, Rebecca Kristeleit, Deborah K. Armstrong, Benjamin Schwartz, Patricia Braly, Geoff D. Hall, Kenneth P. Nephew, Simone Jueliger, Aram Oganesian, Sue Naim, Yong Hao, Harold Keer, Mohammad Azab, Daniela Matei
Journal: Clinical Cancer Research
Clin Cancer Res (2020) 26 (5): 1009–1016.
https://doi.org/10.1158/1078-0432.CCR-19-1638
Published: 02 March 2020
View article titled, A Randomized Phase II Trial of Epigenetic Priming with Guadecitabine and Carboplatin in Platinum-resistant, Recurrent Ovarian Cancer
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Includes: Supplementary data
Journal Articles

Phase 1 Open-Label, Multicenter Study of First-in-Class RORγ Agonist LYC-55716 (Cintirorgon): Safety, Tolerability, and Preliminary Evidence of Antitumor Activity

Devalingam Mahalingam, Judy S. Wang, Erika P. Hamilton, John Sarantopoulos, John Nemunaitis, Garry Weems, Laura Carter, Xiao Hu, Marshall Schreeder, H. Jeffrey Wilkins
Journal: Clinical Cancer Research
Series: Author Choice
Clin Cancer Res (2019) 25 (12): 3508–3516.
https://doi.org/10.1158/1078-0432.CCR-18-3185
Published: 14 June 2019
View article titled, Phase 1 Open-Label, Multicenter Study of First-in-Class RORγ Agonist LYC-55716 (Cintirorgon): Safety, Tolerability, and Preliminary Evidence of Antitumor Activity
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Includes: Supplementary data
Journal Articles

A Phase I Clinical Trial of Guadecitabine and Carboplatin in Platinum-Resistant, Recurrent Ovarian Cancer: Clinical, Pharmacokinetic, and Pharmacodynamic Analyses

Daniela Matei, Sharad Ghamande, Lynda Roman, Angeles Alvarez Secord, John Nemunaitis, Merry Jennifer Markham, Kenneth P. Nephew, Simone Jueliger, Aram Oganesian, Sue Naim, Xiang Yao Su, Harold Keer, Mohammad Azab, Gini F. Fleming
Journal: Clinical Cancer Research
Series: Author Choice
Clin Cancer Res (2018) 24 (10): 2285–2293.
https://doi.org/10.1158/1078-0432.CCR-17-3055
Published: 14 May 2018
View article titled, A Phase I Clinical Trial of Guadecitabine and Carboplatin in Platinum-Resistant, Recurrent Ovarian Cancer: Clinical, Pharmacokinetic, and Pharmacodynamic Analyses
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Includes: Supplementary data
Journal Articles

A First-in-Human, Phase I, Dose-Escalation Study of TAK-117, a Selective PI3Kα Isoform Inhibitor, in Patients with Advanced Solid Malignancies

Dejan Juric, Johann S. de Bono, Patricia M. LoRusso, John Nemunaitis, Elisabeth I. Heath, Eunice L. Kwak, Teresa Macarulla Mercadé, Elena Geuna, Maria Jose de Miguel-Luken, Chirag Patel, Keisuke Kuida, Serap Sankoh, Eric H. Westin, Fabian Zohren, Yaping Shou, Josep Tabernero
Journal: Clinical Cancer Research
Series: Author Choice
Clin Cancer Res (2017) 23 (17): 5015–5023.
https://doi.org/10.1158/1078-0432.CCR-16-2888
Published: 31 August 2017
View article titled, A First-in-Human, Phase I, Dose-Escalation Study of TAK-117, a Selective PI3Kα Isoform Inhibitor, in Patients with Advanced Solid Malignancies
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Includes: Supplementary data
Journal Articles

Phase I Dose-Escalation Study of the Multikinase Inhibitor Lenvatinib in Patients with Advanced Solid Tumors and in an Expanded Cohort of Patients with Melanoma

David S. Hong, Razelle Kurzrock, Jennifer J. Wheler, Aung Naing, Gerald S. Falchook, Siqing Fu, Kevin B. Kim, Michael A. Davies, Ly M. Nguyen, Goldy C. George, Lucy Xu, Robert Shumaker, Min Ren, Jennifer Mink, Cynthia Bedell, Corina Andresen, Pallavi Sachdev, James P. O'Brien, John Nemunaitis
Journal: Clinical Cancer Research
Clin Cancer Res (2015) 21 (21): 4801–4810.
https://doi.org/10.1158/1078-0432.CCR-14-3063
Published: 01 November 2015
View article titled, Phase I Dose-Escalation Study of the Multikinase Inhibitor Lenvatinib in Patients with Advanced Solid Tumors and in an Expanded Cohort of Patients with Melanoma
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Includes: Supplementary data
Journal Articles

Tumor p53 biomarkers personalize selection of adenoviral p53 gene therapy or methotrexate as potentially efficacious treatments in different and complementary groups of recurrent squamous cell carcinoma of the head and neck (SCCHN)

Robert Sobol, John Nemunaitis, Gary Clayman, John Hamm, Laura Licato, Sunil Chada, Kerstin Menander, Jack Roth, Jarrard Goodwin
Journal: Clinical Cancer Research
Clin Cancer Res (2008) 14 (15_Supplement): B36.
Published: 15 August 2014
View article titled, Tumor p53 biomarkers personalize selection of adenoviral p53 gene therapy or methotrexate as potentially efficacious treatments in different and complementary groups of recurrent squamous cell carcinoma of the head and neck (SCCHN)
Journal Articles

Clinical study of personalized therapeutics based on genomic/proteomic profiling

John Nemunaitis, Neil Senzer, Jerry Shen, Phillip Maples, Donald Rao, Alex Tong, Padmasini Kumar, Joe Kuhn, Yu-An Zhang, Jian Liao, Iya Khalil, Colin Hill, Adi Gazdar
Journal: Clinical Cancer Research
Clin Cancer Res (2006) 12 (19_Supplement): A118.
Published: 15 August 2014
View article titled, Clinical study of personalized therapeutics based on genomic/proteomic profiling
Journal Articles

Individual Determinants of Vaccine Therapy

John Nemunaitis
Journal: Clinical Cancer Research
Clin Cancer Res (2006) 12 (19_Supplement): PL-14.
Published: 15 August 2014
View article titled, Individual Determinants of Vaccine Therapy
Journal Articles

A Live-Attenuated Listeria Vaccine (ANZ-100) and a Live-Attenuated Listeria Vaccine Expressing Mesothelin (CRS-207) for Advanced Cancers: Phase I Studies of Safety and Immune Induction

Dung T. Le, Dirk G. Brockstedt, Ran Nir-Paz, Johannes Hampl, Shruti Mathur, John Nemunaitis, Daniel H. Sterman, Raffit Hassan, Eric Lutz, Bentley Moyer, Martin Giedlin, Jana-Lynn Louis, Elizabeth A. Sugar, Alice Pons, Andrea L. Cox, Jordana Levine, Aimee Luck Murphy, Peter Illei, Thomas W. Dubensky, Jr, Joseph E. Eiden, Elizabeth M. Jaffee, Daniel A. Laheru
Journal: Clinical Cancer Research
Clin Cancer Res (2012) 18 (3): 858–868.
https://doi.org/10.1158/1078-0432.CCR-11-2121
Published: 31 January 2012
View article titled, A Live-Attenuated Listeria Vaccine (ANZ-100) and a Live-Attenuated Listeria Vaccine Expressing Mesothelin (CRS-207) for Advanced Cancers: Phase I Studies of Safety and Immune Induction
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Includes: Supplementary data
Journal Articles

Phase I Trial of TGF-β2 Antisense GM-CSF Gene-Modified Autologous Tumor Cell (TAG) Vaccine

Jairo Olivares, Padmasini Kumar, Yang Yu, Phillip B. Maples, Neil Senzer, Cynthia Bedell, Minal Barve, Alex Tong, Beena O. Pappen, Joseph Kuhn, Mitchell Magee, Gladice Wallraven, John Nemunaitis
Journal: Clinical Cancer Research
Clin Cancer Res (2011) 17 (1): 183–192.
https://doi.org/10.1158/1078-0432.CCR-10-2195
Published: 04 January 2011
View article titled, Phase I Trial of TGF-β2 Antisense GM-CSF Gene-Modified Autologous Tumor Cell (TAG) Vaccine
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Journal Articles

Biomarkers Predict p53 Gene Therapy Efficacy in Recurrent Squamous Cell Carcinoma of the Head and Neck

John Nemunaitis, Gary Clayman, Sanjiv S. Agarwala, William Hrushesky, James R. Wells, Charles Moore, John Hamm, George Yoo, Jose Baselga, Barbara A. Murphy, Kerstin A. Menander, Laura L. Licato, Sunil Chada, Robert D. Gibbons, Magali Olivier, Pierre Hainaut, Jack A. Roth, Robert E. Sobol, W. Jarrard Goodwin
Journal: Clinical Cancer Research
Clin Cancer Res (2009) 15 (24): 7719–7725.
https://doi.org/10.1158/1078-0432.CCR-09-1044
Published: 14 December 2009
View article titled, Biomarkers Predict <em>p53</em> Gene Therapy Efficacy in Recurrent Squamous Cell Carcinoma of the Head and Neck
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Journal Articles

Allogeneic Granulocyte Macrophage Colony-Stimulating Factor–Secreting Tumor Immunotherapy Alone or in Sequence with Cyclophosphamide for Metastatic Pancreatic Cancer: A Pilot Study of Safety, Feasibility, and Immune Activation

Dan Laheru, Eric Lutz, James Burke, Barbara Biedrzycki, Sara Solt, Beth Onners, Irena Tartakovsky, John Nemunaitis, Dung Le, Elizabeth Sugar, Kristen Hege, Elizabeth Jaffee
Journal: Clinical Cancer Research
Clin Cancer Res (2008) 14 (5): 1455–1463.
https://doi.org/10.1158/1078-0432.CCR-07-0371
Published: 03 March 2008
View article titled, Allogeneic Granulocyte Macrophage Colony-Stimulating Factor–Secreting Tumor Immunotherapy Alone or in Sequence with Cyclophosphamide for Metastatic Pancreatic Cancer: A Pilot Study of Safety, Feasibility, and Immune Activation
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Includes: Supplementary data
Journal Articles

Granulocyte Macrophage Colony-Stimulating Factor–Secreting Allogeneic Cellular Immunotherapy for Hormone-Refractory Prostate Cancer

Eric J. Small, Natalie Sacks, John Nemunaitis, Walter J. Urba, Eugene Dula, Arthur S. Centeno, William G. Nelson, Dale Ando, Catherine Howard, Flavia Borellini, Minh Nguyen, Kristen Hege, Jonathan W. Simons
Journal: Clinical Cancer Research
Clin Cancer Res (2007) 13 (13): 3883–3891.
https://doi.org/10.1158/1078-0432.CCR-06-2937
Published: 02 July 2007
View article titled, Granulocyte Macrophage Colony-Stimulating Factor–Secreting Allogeneic Cellular Immunotherapy for Hormone-Refractory Prostate Cancer
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Journal Articles

Phase I Clinical and Pharmacodynamic Evaluation of Oral CI-1033 in Patients with Refractory Cancer

Ralph G. Zinner, John Nemunaitis, Irene Eiseman, Hyung Ju C. Shin, Stephen C. Olson, James Christensen, Xin Huang, Peter F. Lenehan, Nicholas J. Donato, Dong M. Shin
Journal: Clinical Cancer Research
Clin Cancer Res (2007) 13 (10): 3006–3014.
https://doi.org/10.1158/1078-0432.CCR-06-1958
Published: 15 May 2007
View article titled, Phase I Clinical and Pharmacodynamic Evaluation of Oral CI-1033 in Patients with Refractory Cancer
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Journal Articles

Phase 1 Clinical and Pharmacokinetics Evaluation of Oral CI-1033 in Patients with Refractory Cancer

John Nemunaitis, Irene Eiseman, Casey Cunningham, Neil Senzer, Adrienne Williams, Peter F. Lenehan, Stephen C. Olson, Paul Bycott, Michael Schlicht, Rebecca Zentgraff, Dong M. Shin, Ralph G. Zinner
Journal: Clinical Cancer Research
Clin Cancer Res (2005) 11 (10): 3846–3853.
https://doi.org/10.1158/1078-0432.CCR-04-1950
Published: 16 May 2005
View article titled, Phase 1 Clinical and Pharmacokinetics Evaluation of Oral CI-1033 in Patients with Refractory Cancer
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Journal Articles

A Phase I Trial of TNFerade Biologic in Patients with Soft Tissue Sarcoma in the Extremities

Arno J. Mundt, Srinivasan Vijayakumar, John Nemunaitis, Alan Sandler, Herbert Schwartz, Nader Hanna, Terrence Peabody, Neil Senzer, Karen Chu, Camilla S. Rasmussen, Paul D. Kessler, Henrik S. Rasmussen, Michael Warso, Donald W. Kufe, Tapas Das Gupta, Ralph R. Weichselbaum
Journal: Clinical Cancer Research
Clin Cancer Res (2004) 10 (17): 5747–5753.
https://doi.org/10.1158/1078-0432.CCR-04-0296
Published: 08 September 2004
View article titled, A Phase I Trial of TNFerade Biologic in Patients with Soft Tissue Sarcoma in the Extremities
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Journal Articles

A Phase I Trial of c-Raf Kinase Antisense Oligonucleotide ISIS 5132 Administered as a Continuous Intravenous Infusion in Patients with Advanced Cancer

C. Casey Cunningham, Jon T. Holmlund, Joan H. Schiller, Richard S. Geary, T. Jesse Kwoh, Andrew Dorr, John Nemunaitis
Journal: Clinical Cancer Research
Clin Cancer Res (2000) 6 (5): 1626–1631.
Published: 01 May 2000
View article titled, A Phase I Trial of c-<em>Raf</em> Kinase Antisense Oligonucleotide ISIS 5132 Administered as a Continuous Intravenous Infusion in Patients with Advanced Cancer
Open the PDF for A Phase I Trial of c-<em>Raf</em> Kinase Antisense Oligonucleotide ISIS 5132 Administered as a Continuous Intravenous Infusion in Patients with Advanced Cancer in another window