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2. Oncolytic DNX-2401 virotherapy plus pembrolizumab in recurrent glioblastoma: a phase 1/2 trial

Author

Nassiri, Farshad, Patil, Vikas, Yefet, Leeor S., Singh, Olivia, Liu, Jeff, Dang, Rachel M. A., Yamaguchi, Takafumi N., Daras, Mariza, Cloughesy, Timothy F., Colman, Howard, Kumthekar, Priya U., Chen, Clark C., Aiken, Robert, Groves, Morris D., Ong, Shirley S., Ramakrishna, Rohan, Vogelbaum, Michael A., Khagi, Simon, Kaley, Thomas, Melear, Jason M., Peereboom, David M., Rodriguez, Analiz, Yankelevich, Maxim, Nair, Suresh G., Puduvalli, Vinay K., Aldape, Kenneth, Gao, Andrew, López-Janeiro, Álvaro, de Andrea, Carlos E., Alonso, Marta M., Boutros, Paul, Robbins, Joan, Mason, Warren P., Sonabend, Adam M., Stupp, Roger, Fueyo, Juan, Gomez-Manzano, Candelaria, Lang, Frederick F., and Zadeh, Gelareh

Published
2023
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3. Designing Clinical Trials for Combination Immunotherapy: A Framework for GlioblastomaCombining Immunotherapy for Glioblastoma

Author

Singh, Kirit, Batich, Kristen A, Wen, Patrick Y, Tan, Aaron C, Bagley, Stephen J, Lim, Michael, Platten, Michael, Colman, Howard, Ashley, David M, Chang, Susan M, Rahman, Rifaquat, Galanis, Evanthia, Mansouri, Alireza, Puduvalli, Vinay K, Reardon, David A, Sahebjam, Solmaz, Sampson, John H, Simes, John, Berry, Donald A, Zadeh, Gelareh, Cloughesy, Tim F, Mehta, Minesh P, Piantadosi, Steven, Weller, Michael, Heimberger, Amy B, and Khasraw, Mustafa

Subjects
Cancer, Immunization, Clinical Research, Rare Diseases, Brain Disorders, Vaccine Related, Clinical Trials and Supportive Activities, Brain Cancer, 5.1 Pharmaceuticals, Health and social care services research, 8.4 Research design and methodologies (health services), Development of treatments and therapeutic interventions, Brain Neoplasms, Glioblastoma, Humans, Immune Tolerance, Immunosuppression Therapy, Immunotherapy, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

Immunotherapy has revolutionized treatment for many hard-to-treat cancers but has yet to produce significant improvement in outcomes for patients with glioblastoma. This reflects the multiple and unique mechanisms of immune evasion and escape in this highly heterogeneous tumor. Glioblastoma engenders profound local and systemic immunosuppression and is remarkably effective at inducing T-cell dysfunction, posing a challenge to any immunotherapy-based approach. To overcome these mechanisms, multiple disparate modes of immune-oriented therapy will be required. However, designing trials that can evaluate these combinatorial approaches requires careful consideration. In this review, we explore the immunotherapy resistance mechanisms that have been encountered to date and how combinatorial approaches may address these. We also describe the unique aspects of trial design in both preclinical and clinical settings and consider endpoints and markers of response best suited for an intervention involving multiple agents.

Published
2022

4. Systematic review of combinations of targeted or immunotherapy in advanced solid tumors

Author

Tan, Aaron C, Bagley, Stephen J, Wen, Patrick Y, Lim, Michael, Platten, Michael, Colman, Howard, Ashley, David M, Wick, Wolfgang, Chang, Susan M, Galanis, Evanthia, Mansouri, Alireza, Khagi, Simon, Mehta, Minesh P, Heimberger, Amy B, Puduvalli, Vinay K, Reardon, David A, Sahebjam, Solmaz, Simes, John, Antonia, Scott J, Berry, Don, and Khasraw, Mustafa

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Immunology, Clinical Research, Cancer, Clinical Trials and Supportive Activities, Good Health and Well Being, Combined Modality Therapy, Humans, Immunotherapy, Neoplasms, immunotherapy, drug therapy, combination, clinical trials as topic, Oncology and carcinogenesis
Abstract

With rapid advances in our understanding of cancer, there is an expanding number of potential novel combination therapies, including novel-novel combinations. Identifying which combinations are appropriate and in which subpopulations are among the most difficult questions in medical research. We conducted a Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)-guided systematic review of trials of novel-novel combination therapies involving immunotherapies or molecular targeted therapies in advanced solid tumors. A MEDLINE search was conducted using a modified Cochrane Highly Sensitive Search Strategy for published clinical trials between July 1, 2017, and June 30, 2020, in the top-ranked medical and oncology journals. Trials were evaluated according to a criterion adapted from previously published Food and Drug Administration guidance and other key considerations in designing trials of combinations. This included the presence of a strong biological rationale, the use of a new established or emerging predictive biomarker prospectively incorporated into the clinical trial design, appropriate comparator arms of monotherapy or supportive external data sources and a primary endpoint demonstrating a clinically meaningful benefit. Of 32 identified trials, there were 11 (34%) trials of the novel-novel combination of anti-programmed death 1 (PD-1)/programmed death ligand 1 (PD-L1) and anti-cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) therapy, and 10 (31%) trials of anti-PD-1/PD-L1 and anti-vascular endothelial growth factor (VEGF) combination therapy. 20 (62.5%) trials were phase II trials, while 12 (37.5%) were phase III trials. Most (72%) trials lacked significant preclinical evidence supporting the development of the combination in the given indication. A majority of trials (69%) were conducted in biomarker unselected populations or used pre-existing biomarkers within the given indication for patient selection. Most studies (66%) were considered to have appropriate comparator arms or had supportive external data sources such as prior studies of monotherapy. All studies were evaluated as selecting a clinically meaningful primary endpoint. In conclusion, designing trials to evaluate novel-novel combination therapies presents numerous challenges to demonstrate efficacy in a comprehensive manner. A greater understanding of biological rationale for combinations and incorporating predictive biomarkers may improve effective evaluation of combination therapies. Innovative statistical methods and increasing use of external data to support combination approaches are potential strategies that may improve the efficiency of trial design. Designing trials to evaluate novel-novel combination therapies presents numerous challenges to demonstrate efficacy in a comprehensive manner. A greater understanding of biological rationale for combinations and incorporating predictive biomarkers may improve effective evaluation of combination therapies. Innovative statistical methods and increasing use of external data to support combination approaches are potential strategies that may improve the efficiency of trial design.

Published
2021

6. Final Report of the Phase II NEXT/CNS-GCT-4 Trial: GemPOx followed by Marrow-ablative Chemotherapy for Recurrent Intracranial Germ Cell Tumors

Author

Shatara, Margaret, primary, Blue, Megan, additional, Stanek, Joseph, additional, Liu, Yin A, additional, Prevedello, Daniel M, additional, Giglio, Pierre, additional, Puduvalli, Vinay K, additional, Gardner, Sharon L, additional, Allen, Jeffrey C, additional, Wong, Kenneth K, additional, Nelson, Marvin D, additional, Gilles, Floyd H, additional, Adams, Roberta H, additional, Pauly, Jasmine, additional, O’Halloran, Katrina, additional, Margol, Ashley S, additional, Dhall, Girish, additional, and Finlay, Jonathan L, additional

Published
2023
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7. Phase I Study of Vorinostat in Combination with Temozolomide in Patients with High-Grade Gliomas: North American Brain Tumor Consortium Study 04-03

Author

Lee, Eudocia Q, Puduvalli, Vinay K, Reid, Joel M, Kuhn, John G, Lamborn, Kathleen R, Cloughesy, Timothy F, Chang, Susan M, Drappatz, Jan, Yung, WK Alfred, Gilbert, Mark R, Robins, H Ian, Lieberman, Frank S, Lassman, Andrew B, McGovern, Renee M, Xu, Jihong, Desideri, Serena, Ye, Xiabu, Ames, Matthew M, Espinoza-Delgado, Igor, Prados, Michael D, and Wen, Patrick Y

Subjects
Brain Disorders, Orphan Drug, Rare Diseases, Cancer, Brain Cancer, Neurosciences, Clinical Research, Clinical Trials and Supportive Activities, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols, Brain Neoplasms, Dacarbazine, Female, Glioma, Humans, Hydroxamic Acids, Male, Middle Aged, Neoplasm Grading, Temozolomide, Treatment Outcome, Vorinostat, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

PurposeA phase I, dose-finding study of vorinostat in combination with temozolomide (TMZ) was conducted to determine the maximum tolerated dose (MTD), safety, and pharmacokinetics in patients with high-grade glioma (HGG).Experimental designThis phase I, dose-finding, investigational study was conducted in two parts. Part 1 was a dose-escalation study of vorinostat in combination with TMZ 150 mg/m(2)/day for 5 days every 28 days. Part 2 was a dose-escalation study of vorinostat in combination with TMZ 150 mg/m(2)/day for 5 days of the first cycle and 200 mg/m(2)/day for 5 days of the subsequent 28-day cycles.ResultsIn part 1, the MTD of vorinostat administered on days 1 to 7 and 15 to 21 of every 28-day cycle, in combination with TMZ, was 500 mg daily. Dose-limiting toxicities (DLT) included grade 3 anorexia, grade 3 ALT, and grade 5 hemorrhage in the setting of grade 4 thrombocytopenia. In part 2, the MTD of vorinostat on days 1 to 7 and 15 to 21 of every 28-day cycle, combined with TMZ, was 400 mg daily. No DLTs were encountered, but vorinostat dosing could not be escalated further due to thrombocytopenia. The most common serious adverse events were fatigue, lymphopenia, thrombocytopenia, and thromboembolic events. There were no apparent pharmacokinetic interactions between vorinostat and TMZ. Vorinostat treatment resulted in hyperacetylation of histones H3 and H4 in peripheral mononuclear cells.ConclusionVorinostat in combination with temozolomide is well tolerated in patients with HGG. A phase I/II trial of vorinostat with radiotherapy and concomitant TMZ in newly diagnosed glioblastoma is underway.

Published
2012

8. Apparent diffusion coefficient histogram analysis stratifies progression-free and overall survival in patients with recurrent GBM treated with bevacizumab: a multi-center study.

Author

Pope, Whitney B, Qiao, Xin Joe, Kim, Hyun J, Lai, Albert, Nghiemphu, Phioanh, Xue, Xi, Ellingson, Benjamin M, Schiff, David, Aregawi, Dawit, Cha, Soonmee, Puduvalli, Vinay K, Wu, Jing, Yung, Wai-Kwan A, Young, Geoffrey S, Vredenburgh, James, Barboriak, Dan, Abrey, Lauren E, Mikkelsen, Tom, Jain, Rajan, Paleologos, Nina A, Lada, Patricia, Prados, Michael, Goldin, Jonathan, Wen, Patrick Y, and Cloughesy, Timothy

Subjects
Humans, Glioblastoma, Brain Neoplasms, Neoplasm Recurrence, Local, Angiogenesis Inhibitors, Diffusion Magnetic Resonance Imaging, Prognosis, Survival Rate, Algorithms, Adult, Aged, Middle Aged, Female, Male, Young Adult, Antibodies, Monoclonal, Humanized, Bevacizumab, Apparent diffusion coefficient, Glioblastoma multiforme, Progression-free survival, Brain Disorders, Cancer, Neurosciences, Rare Diseases, Clinical Research, Brain Cancer, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

We have tested the predictive value of apparent diffusion coefficient (ADC) histogram analysis in stratifying progression-free survival (PFS) and overall survival (OS) in bevacizumab-treated patients with recurrent glioblastoma multiforme (GBM) from the multi-center BRAIN study. Available MRI's from patients enrolled in the BRAIN study (n = 97) were examined by generating ADC histograms from areas of enhancing tumor on T1 weighted post-contrast images fitted to a two normal distribution mixture curve. ADC classifiers including the mean ADC from the lower curve (ADC-L) and the mean lower curve proportion (LCP) were tested for their ability to stratify PFS and OS by using Cox proportional hazard ratios and the Kaplan-Meier method with log-rank test. Mean ADC-L was 1,209 × 10(-6)mm(2)/s ± 224 (SD), and mean LCP was 0.71 ± 0.23 (SD). Low ADC-L was associated with worse outcome. The hazard ratios for 6-month PFS, overall PFS, and OS in patients with less versus greater than mean ADC-L were 3.1 (95 % confidence interval: 1.6, 6.1; P = 0.001), 2.3 (95 % CI: 1.3, 4.0; P = 0.002), and 2.4 (95 % CI: 1.4, 4.2; P = 0.002), respectively. In patients with ADC-L 0.71 versus ADC-L >1,209 and LCP

Published
2012

12. A Case Study of Chimeric Antigen Receptor T Cell Function: Donor Therapeutic Differences in Activity and Modulation with Verteporfin

Author

Liang, Jiyong, primary, Fang, Dexing, additional, Gumin, Joy, additional, Najem, Hinda, additional, Sooreshjani, Moloud, additional, Song, Renduo, additional, Sabbagh, Aria, additional, Kong, Ling-Yuan, additional, Duffy, Joseph, additional, Balyasnikova, Irina V., additional, Pollack, Seth M., additional, Puduvalli, Vinay K., additional, and Heimberger, Amy B., additional

Published
2023
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14. Characterization of recurrence patterns and outcomes of medulloblastoma in adults: The University of Texas MD Anderson Cancer Center experience

Author

Gregory, Timothy A, primary, Mastall, Maximilian, additional, Lin, Heather, additional, Hess, Kenneth R, additional, Yuan, Ying, additional, Martin-Bejarano Garcia, Manuela, additional, Fuller, Gregory N, additional, Alfaro, Kristin D, additional, Gule-Monroe, Maria K, additional, Huse, Jason T, additional, Khatua, Soumen, additional, Rao, Ganesh, additional, Sandberg, David I, additional, Wefel, Jeffrey S, additional, Yeboa, Debra N, additional, Paulino, Arnold C, additional, McGovern, Susan L, additional, Zaky, Wafik, additional, Mahajan, Anita, additional, Suki, Dima, additional, Weathers, Shiao-Pei, additional, Harrison, Rebecca A, additional, de Groot, John F, additional, Puduvalli, Vinay K, additional, Penas-Prado, Marta, additional, and Majd, Nazanin K, additional

Published
2023
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15. HDAC1 regulates the chromatin landscape to control transcriptional dependencies in chronic lymphocytic leukemia

Author

Lai, Tzung-Huei, primary, Ozer, Hatice Gulcin, additional, Gasparini, Pierluigi, additional, Nigita, Giovanni, additional, Distefano, Rosario, additional, Yu, Lianbo, additional, Ravikrishnan, Janani, additional, Yilmaz, Selen, additional, Gallegos, Juan Jesus, additional, Shukla, Sachet A, additional, Puduvalli, Vinay K, additional, Woyach, Jennifer A., additional, Lapalombella, Rosa, additional, Blachly, James S., additional, Byrd, John C., additional, and Sampath, Deepa, additional

Published
2022
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17. Designing Clinical Trials for Combination Immunotherapy: A Framework for Glioblastoma.

Author

Singh, Kirit, Singh, Kirit, Batich, Kristen A, Wen, Patrick Y, Tan, Aaron C, Bagley, Stephen J, Lim, Michael, Platten, Michael, Colman, Howard, Ashley, David M, Chang, Susan M, Rahman, Rifaquat, Galanis, Evanthia, Mansouri, Alireza, Puduvalli, Vinay K, Reardon, David A, Sahebjam, Solmaz, Sampson, John H, Simes, John, Berry, Donald A, Zadeh, Gelareh, Cloughesy, Tim F, Mehta, Minesh P, Piantadosi, Steven, Weller, Michael, Heimberger, Amy B, Khasraw, Mustafa, Singh, Kirit, Singh, Kirit, Batich, Kristen A, Wen, Patrick Y, Tan, Aaron C, Bagley, Stephen J, Lim, Michael, Platten, Michael, Colman, Howard, Ashley, David M, Chang, Susan M, Rahman, Rifaquat, Galanis, Evanthia, Mansouri, Alireza, Puduvalli, Vinay K, Reardon, David A, Sahebjam, Solmaz, Sampson, John H, Simes, John, Berry, Donald A, Zadeh, Gelareh, Cloughesy, Tim F, Mehta, Minesh P, Piantadosi, Steven, Weller, Michael, Heimberger, Amy B, and Khasraw, Mustafa

Abstract

Immunotherapy has revolutionized treatment for many hard-to-treat cancers but has yet to produce significant improvement in outcomes for patients with glioblastoma. This reflects the multiple and unique mechanisms of immune evasion and escape in this highly heterogeneous tumor. Glioblastoma engenders profound local and systemic immunosuppression and is remarkably effective at inducing T-cell dysfunction, posing a challenge to any immunotherapy-based approach. To overcome these mechanisms, multiple disparate modes of immune-oriented therapy will be required. However, designing trials that can evaluate these combinatorial approaches requires careful consideration. In this review, we explore the immunotherapy resistance mechanisms that have been encountered to date and how combinatorial approaches may address these. We also describe the unique aspects of trial design in both preclinical and clinical settings and consider endpoints and markers of response best suited for an intervention involving multiple agents.

Published
2022

18. Infigratinib in Patients with Recurrent Gliomas and FGFR Alterations: A Multicenter Phase II Study

Author

MS Medische Oncologie, Cancer, Lassman, Andrew B, Sepúlveda-Sánchez, Juan Manuel, Cloughesy, Timothy, Gil-Gil, Miguel J, Puduvalli, Vinay K, Raizer, Jeffrey, De Vos, Filip Y F, Wen, Patrick Y, Butowski, Nicholas, Clement, Paul M J, Groves, Morris D, Belda-Iniesta, Cristobal, Giglio, Pierre, Soifer, Harris S, Rowsey, Steven, Xu, Cindy, Avogadri, Francesca, Wei, Ge, Moran, Susan, Roth, Patrick, MS Medische Oncologie, Cancer, Lassman, Andrew B, Sepúlveda-Sánchez, Juan Manuel, Cloughesy, Timothy, Gil-Gil, Miguel J, Puduvalli, Vinay K, Raizer, Jeffrey, De Vos, Filip Y F, Wen, Patrick Y, Butowski, Nicholas, Clement, Paul M J, Groves, Morris D, Belda-Iniesta, Cristobal, Giglio, Pierre, Soifer, Harris S, Rowsey, Steven, Xu, Cindy, Avogadri, Francesca, Wei, Ge, Moran, Susan, and Roth, Patrick

Published
2022

19. Infigratinib in Patients with Recurrent Gliomas and FGFR Alterations: A Multicenter Phase II Study

Author

Lassman, Andrew B; https://orcid.org/0000-0001-7386-9928, Sepúlveda-Sánchez, Juan Manuel, Cloughesy, Timothy F, Gil-Gil, Miguel J; https://orcid.org/0000-0003-1380-2718, Puduvalli, Vinay K, Raizer, Jeffrey J, De Vos, Filip Y F; https://orcid.org/0000-0002-9082-5991, Wen, Patrick Y, Butowski, Nicholas A; https://orcid.org/0000-0001-5162-2406, Clement, Paul M J; https://orcid.org/0000-0001-7600-0806, Groves, Morris D, Belda-Iniesta, Cristóbal, Giglio, Pierre, Soifer, Harris S, Rowsey, Steven, Xu, Cindy, Avogadri, Francesca, Wei, Ge, Moran, Susan, Roth, Patrick, Lassman, Andrew B; https://orcid.org/0000-0001-7386-9928, Sepúlveda-Sánchez, Juan Manuel, Cloughesy, Timothy F, Gil-Gil, Miguel J; https://orcid.org/0000-0003-1380-2718, Puduvalli, Vinay K, Raizer, Jeffrey J, De Vos, Filip Y F; https://orcid.org/0000-0002-9082-5991, Wen, Patrick Y, Butowski, Nicholas A; https://orcid.org/0000-0001-5162-2406, Clement, Paul M J; https://orcid.org/0000-0001-7600-0806, Groves, Morris D, Belda-Iniesta, Cristóbal, Giglio, Pierre, Soifer, Harris S, Rowsey, Steven, Xu, Cindy, Avogadri, Francesca, Wei, Ge, Moran, Susan, and Roth, Patrick

Abstract

Purpose: FGFR genomic alterations (amplification, mutations, and/or fusions) occur in ∼8% of gliomas, particularly FGFR1 and FGFR3. We conducted a multicenter open-label, single-arm, phase II study of a selective FGFR1-3 inhibitor, infigratinib (BGJ398), in patients with FGFR-altered recurrent gliomas. Patients and methods: Adults with recurrent/progressive gliomas harboring FGFR alterations received oral infigratinib 125 mg on days 1 to 21 of 28-day cycles. The primary endpoint was investigator-assessed 6-month progression-free survival (PFS) rate by Response Assessment in Neuro-Oncology criteria. Comprehensive genomic profiling was performed on available pretreatment archival tissue to explore additional molecular correlations with efficacy. Results: Among 26 patients, the 6-month PFS rate was 16.0% [95% confidence interval (CI), 5.0-32.5], median PFS was 1.7 months (95% CI, 1.1-2.8), and objective response rate was 3.8%. However, 4 patients had durable disease control lasting longer than 1 year. Among these, 3 had tumors harboring activating point mutations at analogous positions of FGFR1 (K656E; n = 2) or FGFR3 (K650E; n = 1) in pretreatment tissue; an FGFR3-TACC3 fusion was detected in the other. Hyperphosphatemia was the most frequently reported treatment-related adverse event (all-grade, 76.9%; grade 3, 3.8%) and is a known on-target toxicity of FGFR inhibitors. Conclusions: FGFR inhibitor monotherapy with infigratinib had limited efficacy in a population of patients with recurrent gliomas and different FGFR genetic alterations, but durable disease control lasting more than 1 year was observed in patients with tumors harboring FGFR1 or FGFR3 point mutations or FGFR3-TACC3 fusions. A follow-up study with refined biomarker inclusion criteria and centralized FGFR testing is warranted.

Published
2022

21. Infigratinib in Patients with Recurrent Gliomas and FGFR Alterations: A Multicenter Phase II Study

Author

Lassman, Andrew B., primary, Sepúlveda-Sánchez, Juan Manuel, additional, Cloughesy, Timothy F., additional, Gil-Gil, Miguel J., additional, Puduvalli, Vinay K., additional, Raizer, Jeffrey J., additional, De Vos, Filip Y.F., additional, Wen, Patrick Y., additional, Butowski, Nicholas A., additional, Clement, Paul M.J., additional, Groves, Morris D., additional, Belda-Iniesta, Cristóbal, additional, Giglio, Pierre, additional, Soifer, Harris S., additional, Rowsey, Steven, additional, Xu, Cindy, additional, Avogadri, Francesca, additional, Wei, Ge, additional, Moran, Susan, additional, and Roth, Patrick, additional

Published
2022
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22. Disruption of DNA Repair and Survival Pathways through Heat Shock Protein Inhibition by Onalespib to Sensitize Malignant Gliomas to Chemoradiation Therapy

Author

Xu, Jihong, primary, Wu, Pei-Jung, additional, Lai, Tzung-Huei, additional, Sharma, Pratibha, additional, Canella, Alessandro, additional, Welker, Alessandra M., additional, Beattie, Christine E., additional, Elder, J. Brad, additional, Easley, Michelle, additional, Lonser, Russell, additional, Jacob, Naduparambil K., additional, Pietrzak, Maciej, additional, Timmers, Cynthia M., additional, Lang, Frederick, additional, Sampath, Deepa, additional, and Puduvalli, Vinay K., additional

Published
2022
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23. Patterns of failure after radiation therapy in primary spinal high-grade gliomas: A single institutional analysis

Author

Upadhyay, Rituraj, primary, Khose, Swapnil, additional, Pokhylevych, Halyna, additional, Paulino, Arnold C, additional, McAleer, Mary Frances, additional, Ghia, Amol, additional, Li, Jing, additional, Yeboa, Debra Nana, additional, Loghin, Monica, additional, Harrison, Rebecca, additional, O’Brien, Barbara, additional, Kamiya-Matsuoka, Carlos, additional, De Groot, John, additional, Puduvalli, Vinay K, additional, Tatsui, Claudio, additional, Alvarez-Breckenridge, Christopher, additional, Prabhu, Sujit, additional, Rhines, Larry, additional, Zaky, Wafik, additional, Lin, Frank, additional, Weinberg, Jeffery S, additional, Fuller, Gregory, additional, Sandberg, David I, additional, Johnson, Jason Michael, additional, and McGovern, Susan L, additional

Published
2022
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25. Designing Clinical Trials for Combination Immunotherapy: A Framework for Glioblastoma

Author

Singh, Kirit, primary, Batich, Kristen A., additional, Wen, Patrick Y., additional, Tan, Aaron C., additional, Bagley, Stephen J., additional, Lim, Michael, additional, Platten, Michael, additional, Colman, Howard, additional, Ashley, David M., additional, Chang, Susan M., additional, Rahman, Rifaquat, additional, Galanis, Evanthia, additional, Mansouri, Alireza, additional, Puduvalli, Vinay K., additional, Reardon, David A., additional, Sahebjam, Solmaz, additional, Sampson, John H., additional, Simes, John, additional, Berry, Donald A., additional, Zadeh, Gelareh, additional, Cloughesy, Tim F., additional, Mehta, Minesh P., additional, Piantadosi, Steven, additional, Weller, Michael, additional, Heimberger, Amy B., additional, and Khasraw, Mustafa, additional

Published
2021
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27. Inhibition of nicotinamide phosphoribosyltransferase (NAMPT), the rate-limiting enzyme of the nicotinamide adenine dinucleotide (NAD) salvage pathway, to target glioma heterogeneity through mitochondrial oxidative stress

Author

Sharma, Pratibha, primary, Xu, Jihong, additional, Williams, Katie, additional, Easley, Michelle, additional, Elder, J Brad, additional, Lonser, Russell, additional, Lang, Frederick F, additional, Lapalombella, Rosa, additional, Sampath, Deepa, additional, and Puduvalli, Vinay K, additional

Published
2021
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28. Tumor Treating Fields for Glioblastoma Therapy During the COVID-19 Pandemic

Author

Gatson, Na Tosha N., Barnholtz-Sloan, Jill, Drappatz, Jan, Henriksson, Roger, Hottinger, Andreas F., Hinoul, Piet, Kruchko, Carol, Puduvalli, Vinay K., Tran, David D., Wong, Eric T., and Glas, Martin

Subjects
Cancer och onkologi, Oncology, Medizinische Fakultät » Universitätsklinikum Essen » Klinik für Neurologie, Cancer and Oncology, Perspective, Medizin, glioblastoma, COVID-19, ddc:610, elderly, recurrent glioblastoma, tumor treating fields
Abstract

Background: The COVID-19 pandemic has placed excessive strain on health care systems and is especially evident in treatment decision-making for cancer patients. Glioblastoma (GBM) patients are among the most vulnerable due to increased incidence in the elderly and the short survival time. A virtual meeting was convened on May 9, 2020 with a panel of neuro-oncology experts with experience using Tumor Treating Fields (TTFields). The objective was to assess the risk-to-benefit ratio and provide guidance for using TTFields in GBM during the COVID-19 pandemic. Panel Discussion: Topics discussed included support and delivery of TTFields during the COVID-19 pandemic, concomitant use of TTFields with chemotherapy, and any potential impact of TTFields on the immune system in an intrinsically immunosuppressed GBM population. Special consideration was given to TTFields' use in elderly patients and in combination with radiotherapy regimens. Finally, the panel discussed the need to better capture data on COVID-19–positive brain tumor patients to analyze longitudinal outcomes and changes in treatment decision-making during the pandemic. Expert Opinion: TTFields is a portable home-use device which can be managed via telemedicine and safely used in GBM patients during the COVID-19 pandemic. TTFields has no known immunosuppressive effects which is important during a crisis where other treatment methods might be limited, especially for elderly patients with multiple co-morbidities. It is too early to estimate the full impact of COVID-19 on the global healthcare system and on patient outcomes and the panel strongly recommended collaboration with existing cancer COVID-19 registries to follow CNS tumor patients. OA Förderung 2021

Published
2021

29. Tumor Treating Fields for Glioblastoma Therapy During the COVID-19 Pandemic

Author

Gatson, Na Tosha N., primary, Barnholtz-Sloan, Jill, additional, Drappatz, Jan, additional, Henriksson, Roger, additional, Hottinger, Andreas F., additional, Hinoul, Piet, additional, Kruchko, Carol, additional, Puduvalli, Vinay K., additional, Tran, David D., additional, Wong, Eric T., additional, and Glas, Martin, additional

Published
2021
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30. Clinical characterization of adult medulloblastoma and the effect of first-line therapies on outcome; The MD Anderson Cancer Center experience

Author

Majd, Nazanin K, primary, Mastall, Maximilan, additional, Lin, Heather, additional, Dibaj, Seyede Shiva, additional, Hess, Kenneth R, additional, Yuan, Ying, additional, Garcia, Manuela Martin-Bejarano, additional, Fuller, Gregory N, additional, Alfaro, Kristin D, additional, Gule-Monroe, Maria K, additional, Huse, Jason T, additional, Khatua, Soumen, additional, Rao, Ganesh, additional, Sandberg, David I, additional, Wefel, Jeffrey S, additional, Yeboa, Debra N, additional, Paulino, Arnold C, additional, McGovern, Susan L, additional, Zaky, Wafik, additional, Mahajan, Anita, additional, Suki, Dima, additional, Weathers, Shiao-Pei, additional, Harriso, Rebecca A, additional, De Groo, John F, additional, Puduvalli, Vinay K, additional, and Penas-Prado, Marta, additional

Published
2021
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33. LTBK-04. PHASE 2 MULTICENTER STUDY OF THE ONCOLYTIC ADENOVIRUS DNX-2401 (TASADENOTUREV) IN COMBINATION WITH PEMBROLIZUMAB FOR RECURRENT GLIOBLASTOMA; CAPTIVE STUDY (KEYNOTE-192)

Author

Zadeh, Gelareh, primary, Daras, Mariza, additional, Cloughesy, Timothy F, additional, Colman, Howard, additional, Kumthekar, Priya U, additional, Chen, Clark C, additional, Aiken, Robert, additional, Groves, Morris D, additional, Ong, Shirley, additional, Ramakrishna, Rohan, additional, Vogelbaum, Michael A, additional, Khagi, Simon, additional, Kaley, Thomas, additional, Melear, Jason M, additional, Peereboom, David M, additional, Rodriguez, Analiz, additional, Yankelevich, Maxim, additional, Nair, Suresh G, additional, Puduvalli, Vinay K, additional, Nassiri, Farshad, additional, Sonabend, Adam M, additional, Agensky, Laura, additional, Ewald, Brett, additional, Levisetti, Matteo, additional, and Lang, Frederick F, additional

Published
2020
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34. A Bayesian adaptive randomized phase II multicenter trial of bevacizumab with or without vorinostat in adults with recurrent glioblastoma

Author

Puduvalli, Vinay K, primary, Wu, Jing, additional, Yuan, Ying, additional, Armstrong, Terri S, additional, Vera, Elizabeth, additional, Wu, Jimin, additional, Xu, Jihong, additional, Giglio, Pierre, additional, Colman, Howard, additional, Walbert, Tobias, additional, Raizer, Jeffrey, additional, Groves, Morris D, additional, Tran, David, additional, Iwamoto, Fabio, additional, Avgeropoulos, Nicholas, additional, Paleologos, Nina, additional, Fink, Karen, additional, Peereboom, David, additional, Chamberlain, Marc, additional, Merrell, Ryan, additional, Penas Prado, Marta, additional, Yung, W K Alfred, additional, and Gilbert, Mark R, additional

Published
2020
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36. Assessment of Leptomeningeal Carcinomatosis Diagnosis, Management and Outcomes in Patients with Solid Tumors Over a Decade of Experience.

Author

Rinehardt, Hannah, Kassem, Mahmoud, Morgan, Evan, Palettas, Marilly, Stephens, Julie A., Suresh, Anupama, Ganju, Akansha, Lustberg, Maryam, Wesolowski, Robert, Sardesai, Sagar, Stover, Daniel, Vandeusen, Jeffrey, Cherian, Mathew, Guillermo Prieto Eibl, Maria del Pilar, Miah, Abdul, Alnahhas, Iyad, Giglio, Pierre, Puduvalli, Vinay K., Ramaswamy, Bhuvaneswari, and Williams, Nicole

Subjects
MENINGEAL cancer, CEREBROSPINAL fluid, LUMBAR puncture, CANCER radiotherapy, MEDICAL decision making
Abstract

Objective: Leptomeningeal carcinomatosis (LMC), a common complication of advanced malignancies, is associated with high morbidity and mortality, yet diagnosis and treatment decisions remain challenging. This study describes the diagnostic and treatment modalities for LMC and identifies factors associated with overall survival (OS). Materials and Methods: We performed a single-institution retrospective study (registration #: OSU2016C0053) of 153 patients diagnosed with LMC treated at The Ohio State University, Comprehensive Cancer Center, (OSUCCC)-James between January 1, 2010 and December 31, 2015. Results: Median age at diagnosis was 55.7 years, and 61% had Eastern Cooperative Oncology Group baseline performance status =1. Most common primary tumors were breast (43%), lung (26%), and cutaneous melanoma (10%). At presentation, most patients were stage III-IV (71%) with higher grade tumors (grade III: 46%). Metastases to bone (36%), brain (33%), and lung (12%) were the most common sites with a median of 0.5 years (range, 0-14.9 years) between the diagnosis of first metastasis and of LMC. 153 (100%) patients had MRI evidence of LMC. Of the 67 (44%) who underwent lumbar puncture (LP), 33 (22%) had positive cerebrospinal fluid (CSF) cytology. Most patients received radiotherapy for LMC (60%) and chemotherapy (93%) for either the primary disease or LMC. 28 patients received intrathecal chemotherapy, 22 of whom had a primary diagnosis of breast cancer. 98% died with median OS of all patients was 1.9 months (95% CI: 1.3-2.5 months). Conclusion: Despite improved treatments and targeted therapies, outcomes of LMC remain extremely poor. Positive CSF cytology was associated with lower OS in patients who had cytology assessed and specifically in patients with breast cancer. CSF cytology serves as an important indicator for prognosis and helps aid in developing individualized therapeutic strategies for patients with LMC. [ABSTRACT FROM AUTHOR]

Published
2021
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39. Selective targeting of NAMPT by KPT-9274 in acute myeloid leukemia

Author

Mitchell, Shaneice R., primary, Larkin, Karilyn, additional, Grieselhuber, Nicole R., additional, Lai, Tzung-Huei, additional, Cannon, Matthew, additional, Orwick, Shelley, additional, Sharma, Pratibha, additional, Asemelash, Yerdanose, additional, Zhang, Pu, additional, Goettl, Virginia M., additional, Beaver, Larry, additional, Mims, Alice, additional, Puduvalli, Vinay K., additional, Blachly, James S., additional, Lehman, Amy, additional, Harrington, Bonnie, additional, Henderson, Sally, additional, Breitbach, Justin T., additional, Williams, Katie E., additional, Dong, Shuai, additional, Baloglu, Erkan, additional, Senapedis, William, additional, Kirschner, Karl, additional, Sampath, Deepa, additional, Lapalombella, Rosa, additional, and Byrd, John C., additional

Published
2019
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40. Beyond Alkylating Agents for Gliomas: Quo Vadimus?

Author

Puduvalli, Vinay K., Chaudhary, Rekha, McClugage, Samuel G., and Markert, James

Subjects
Alkylating Agents, Drug Therapy, Radiotherapy, Blood-Brain Barrier, General Surgery, Humans, Glioma, Immunotherapy, Combined Modality Therapy, Article
Abstract

Recent advances in therapies have yielded notable success in terms of improved survival in several cancers. However, such treatments have failed to improve outcome in patients with gliomas for whom surgery followed by radiation therapy and chemotherapy with alkylating agents remain the standard of care. Genetic and epigenetic studies have helped identify several alterations specific to gliomas. Attempts to target these altered pathways have been unsuccessful due to various factors, including tumor heterogeneity, adaptive resistance of tumor cells, and limitations of access across the blood-brain barrier. Novel therapies that circumvent such limitations have been the focus of intense study and include approaches such as immunotherapy, targeting of signaling hubs and metabolic pathways, and use of biologic agents. Immunotherapeutic approaches including tumor-targeted vaccines, immune checkpoint blockade, antibody-drug conjugates, and chimeric antigen receptor-expressing cell therapies are in various stages of clinical trials. Similarly, identification of key metabolic pathways or converging hubs of signaling pathways that are tumor specific have yielded novel targets for therapy of gliomas. In addition, the failure of conventional therapies against gliomas has led to a growing interest among patients in the use of alternative therapies, which in turn has necessitated developing evidence-based approaches to the application of such therapies in clinical studies. The development of these novel approaches bears potential for providing breakthroughs in treatment of more meaningful and improved outcomes for patients with gliomas.

Published
2017

41. Using HSP90 Inhibitors to Target DNA Repair Proteins in AML

Author

Ravikrishnan, Janani, primary, Lai, Tzung-Huei, additional, Mitchell, Shaneice Renee, additional, Wu, Pei-Jung, additional, Orwick, Shelley, additional, Liu, Chaomei, additional, Woyach, Jennifer A., additional, Mims, Alice S., additional, Plunkett, William, additional, Puduvalli, Vinay K, additional, Byrd, John C., additional, Lapalombella, Rosa, additional, and Sampath, Deepa, additional

Published
2018
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42. NAMPT Inhibitor KPT-9274 Selectively Targets Self-Renewal Capacity in Acute Myeloid Leukemia

Author

Mitchell, Shaneice Renee, primary, Grieselhuber, Nicole, additional, Asemelash, Yerdanos, additional, Cannon, Matthew, additional, Orwick, Shelley, additional, Sharma, Pratibha, additional, Goettl, Virginia, additional, Puduvalli, Vinay K, additional, Sampath, Deepa, additional, Mims, Alice S., additional, Blachly, James S., additional, Lehman, Amy M., additional, Harrington, Bonnie K., additional, Breitbach, Justin, additional, Baloglu, Erkan, additional, Senapedis, William, additional, Lapalombella, Rosa, additional, and Byrd, John C., additional

Published
2018
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44. EXTH-83. TARGETING DNA REPAIR AND SURVIVAL PATHWAYS THROUGH HEAT SHOCK PROTEIN INHIBITION USING AT13387 TO SENSITIZE GLIOMA TO CHEMORADIATION THERAPY

Author

Wu, Jasmine P J, primary, Canella, Alessandro, additional, Xu, Jihong, additional, Lai, Tzung-Huei, additional, Welker, Alessandra M, additional, Beattie, Christine E, additional, Nadella, Vijay, additional, Timmers, Cynthia, additional, Kaur, Balveen, additional, Jacob, Naduparambil, additional, Sampath, Deepa, additional, and Puduvalli, Vinay K, additional

Published
2017
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45. Efficacy of Onalespib, a Long-Acting Second-Generation HSP90 Inhibitor, as a Single Agent and in Combination with Temozolomide against Malignant Gliomas

Author

Canella, Alessandro, primary, Welker, Alessandra M., additional, Yoo, Ji Young, additional, Xu, Jihong, additional, Abas, Fazly S., additional, Kesanakurti, Divya, additional, Nagarajan, Prabakaran, additional, Beattie, Christine E., additional, Sulman, Erik P., additional, Liu, Joseph, additional, Gumin, Joy, additional, Lang, Frederick F., additional, Gurcan, Metin N., additional, Kaur, Balveen, additional, Sampath, Deepa, additional, and Puduvalli, Vinay K., additional

Published
2017
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