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2. Association of Autologous Tumor Lysate-Loaded Dendritic Cell Vaccination With Extension of Survival Among Patients With Newly Diagnosed and Recurrent Glioblastoma

Author

Liau, Linda M, Ashkan, Keyoumars, Brem, Steven, Campian, Jian L, Trusheim, John E, Iwamoto, Fabio M, Tran, David D, Ansstas, George, Cobbs, Charles S, Heth, Jason A, Salacz, Michael E, D’Andre, Stacy, Aiken, Robert D, Moshel, Yaron A, Nam, Joo Y, Pillainayagam, Clement P, Wagner, Stephanie A, Walter, Kevin A, Chaudhary, Rekha, Goldlust, Samuel A, Lee, Ian Y, Bota, Daniela A, Elinzano, Heinrich, Grewal, Jai, Lillehei, Kevin, Mikkelsen, Tom, Walbert, Tobias, Abram, Steven, Brenner, Andrew J, Ewend, Matthew G, Khagi, Simon, Lovick, Darren S, Portnow, Jana, Kim, Lyndon, Loudon, William G, Martinez, Nina L, Thompson, Reid C, Avigan, David E, Fink, Karen L, Geoffroy, Francois J, Giglio, Pierre, Gligich, Oleg, Krex, Dietmar, Lindhorst, Scott M, Lutzky, Jose, Meisel, Hans-Jörg, Nadji-Ohl, Minou, Sanchin, Lhagva, Sloan, Andrew, Taylor, Lynne P, Wu, Julian K, Dunbar, Erin M, Etame, Arnold B, Kesari, Santosh, Mathieu, David, Piccioni, David E, Baskin, David S, Lacroix, Michel, May, Sven-Axel, New, Pamela Z, Pluard, Timothy J, Toms, Steven A, Tse, Victor, Peak, Scott, Villano, John L, Battiste, James D, Mulholland, Paul J, Pearlman, Michael L, Petrecca, Kevin, Schulder, Michael, Prins, Robert M, Boynton, Alton L, and Bosch, Marnix L

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Prevention, Brain Disorders, Brain Cancer, Cancer, Clinical Trials and Supportive Activities, Clinical Research, Rare Diseases, Neurosciences, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Humans, Glioblastoma, Temozolomide, Prospective Studies, Brain Neoplasms, Recurrence, Dendritic Cells, Vaccination, Public Health and Health Services, Oncology and carcinogenesis
Abstract

ImportanceGlioblastoma is the most lethal primary brain cancer. Clinical outcomes for glioblastoma remain poor, and new treatments are needed.ObjectiveTo investigate whether adding autologous tumor lysate-loaded dendritic cell vaccine (DCVax-L) to standard of care (SOC) extends survival among patients with glioblastoma.Design, setting, and participantsThis phase 3, prospective, externally controlled nonrandomized trial compared overall survival (OS) in patients with newly diagnosed glioblastoma (nGBM) and recurrent glioblastoma (rGBM) treated with DCVax-L plus SOC vs contemporaneous matched external control patients treated with SOC. This international, multicenter trial was conducted at 94 sites in 4 countries from August 2007 to November 2015. Data analysis was conducted from October 2020 to September 2021.InterventionsThe active treatment was DCVax-L plus SOC temozolomide. The nGBM external control patients received SOC temozolomide and placebo; the rGBM external controls received approved rGBM therapies.Main outcomes and measuresThe primary and secondary end points compared overall survival (OS) in nGBM and rGBM, respectively, with contemporaneous matched external control populations from the control groups of other formal randomized clinical trials.ResultsA total of 331 patients were enrolled in the trial, with 232 randomized to the DCVax-L group and 99 to the placebo group. Median OS (mOS) for the 232 patients with nGBM receiving DCVax-L was 19.3 (95% CI, 17.5-21.3) months from randomization (22.4 months from surgery) vs 16.5 (95% CI, 16.0-17.5) months from randomization in control patients (HR = 0.80; 98% CI, 0.00-0.94; P = .002). Survival at 48 months from randomization was 15.7% vs 9.9%, and at 60 months, it was 13.0% vs 5.7%. For 64 patients with rGBM receiving DCVax-L, mOS was 13.2 (95% CI, 9.7-16.8) months from relapse vs 7.8 (95% CI, 7.2-8.2) months among control patients (HR, 0.58; 98% CI, 0.00-0.76; P

Published
2023

3. Detection of diagnostic and prognostic methylation-based signatures in liquid biopsy specimens from patients with meningiomas

Author

Herrgott, Grayson A., Snyder, James M., She, Ruicong, Malta, Tathiane M., Sabedot, Thais S., Lee, Ian Y., Pawloski, Jacob, Podolsky-Gondim, Guilherme G., Asmaro, Karam P., Zhang, Jiaqi, Cannella, Cara E., Nelson, Kevin, Thomas, Bartow, deCarvalho, Ana C., Hasselbach, Laura A., Tundo, Kelly M., Newaz, Rehnuma, Transou, Andrea, Morosini, Natalia, Francisco, Victor, Poisson, Laila M., Chitale, Dhananjay, Mukherjee, Abir, Mosella, Maritza S., Robin, Adam M., Walbert, Tobias, Rosenblum, Mark, Mikkelsen, Tom, Kalkanis, Steven, Tirapelli, Daniela P. C., Weisenberger, Daniel J., Carlotti, Jr, Carlos G., Rock, Jack, Castro, Ana Valeria, and Noushmehr, Houtan

Published
2023
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6. Durable complete responses in some recurrent high-grade glioma patients treated with Toca 511 + Toca FC

Author

Cloughesy, Timothy F, Landolfi, Joseph, Vogelbaum, Michael A, Ostertag, Derek, Elder, James B, Bloomfield, Stephen, Carter, Bob, Chen, Clark C, Kalkanis, Steven N, Kesari, Santosh, Lai, Albert, Lee, Ian Y, Liau, Linda M, Mikkelsen, Tom, Nghiemphu, Phioanh, Piccioni, David, Accomando, William, Diago, Oscar R, Hogan, Daniel J, Gammon, Dawn, Kasahara, Noriyuki, Kheoh, Thian, Jolly, Douglas J, Gruber, Harry E, Das, Asha, and Walbert, Tobias

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Rare Diseases, Clinical Trials and Supportive Activities, Brain Cancer, Clinical Research, Cancer, Brain Disorders, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Antimetabolites, Brain Neoplasms, Combined Modality Therapy, Cytosine Deaminase, Drug Synergism, Flucytosine, Fluorouracil, Follow-Up Studies, Genetic Vectors, Glioma, Humans, Prognosis, Retroviridae, Survival Rate, durable response rate, gene therapy, immuno-oncology, immunotherapy, recurrent high grade glioma, Neurosciences, Oncology & Carcinogenesis, Oncology and carcinogenesis
Abstract

BackgroundVocimagene amiretrorepvec (Toca 511) is an investigational gamma-retroviral replicating vector encoding cytosine deaminase that, when used in combination with extended-release 5-fluorocytosine (Toca FC), results preclinically in local production of 5-fluorouracil, depletion of immune-suppressive myeloid cells, and subsequent induction of antitumor immunity. Recurrent high-grade glioma (rHGG) patients have a high unmet need for effective therapies that produce durable responses lasting more than 6 months. In this setting, relapse is nearly universal and most responses are transient.MethodsIn this Toca 511 ascending-dose phase I trial (NCT01470794), HGG patients who recurred after standard of care underwent surgical resection and received Toca 511 injected into the resection cavity wall, followed by orally administered cycles of Toca FC.ResultsAmong 56 patients, durable complete responses were observed. A subgroup was identified based on Toca 511 dose and entry requirements for the follow-up phase III study. In this subgroup, which included both isocitrate dehydrogenase 1 (IDH1) mutant and wild-type tumors, the durable response rate is 21.7%. Median duration of follow-up for responders is 35.7+ months. As of August 25, 2017, all responders remain in response and are alive 33.9+ to 52.2+ months after Toca 511 administration, suggesting a positive association of durable response with overall survival.ConclusionsMultiyear durable responses have been observed in rHGG patients treated with Toca 511 + Toca FC in a phase I trial, and the treatment will be further evaluated in a randomized phase III trial. Among IDH1 mutant patients treated at first recurrence, there may be an enrichment of complete responders.

Published
2018

8. Autologous Cell Immunotherapy (IGV-001) with IGF-1R Antisense Oligonucleotide in Newly Diagnosed Glioblastoma Patients

Author

Lee, Ian Y., Hanft, Simon, Schulder, Michael, Judy, Kevin D., Wong, Eric T., Elder, J. Bradley, Evans, Linton T., Zuccarello, Mario, Wu, Julian, Aulakh, Sonikpreet, Agarwal, Vijay, Ramakrishna, Rohan, Gill, Brian J., Quiñones-Hinojosa, Alfredo, Brennan, Cameron, Zacharia, Brad E., Silva Correia, Carlos Eduardo, Diwanji, Madhavi, Pennock, Gregory K., Scott, Charles, Perez-Olle, Raul, Andrews, David W., Boockvar, John A., Lee, Ian Y., Hanft, Simon, Schulder, Michael, Judy, Kevin D., Wong, Eric T., Elder, J. Bradley, Evans, Linton T., Zuccarello, Mario, Wu, Julian, Aulakh, Sonikpreet, Agarwal, Vijay, Ramakrishna, Rohan, Gill, Brian J., Quiñones-Hinojosa, Alfredo, Brennan, Cameron, Zacharia, Brad E., Silva Correia, Carlos Eduardo, Diwanji, Madhavi, Pennock, Gregory K., Scott, Charles, Perez-Olle, Raul, Andrews, David W., and Boockvar, John A.

Abstract

Standard-of-care first-line therapy for patients with newly diagnosed glioblastoma (ndGBM) is maximal safe surgical resection, then concurrent radiotherapy and temozolomide, followed by maintenance temozolomide. IGV-001, the first product of the Goldspire™ platform, is a first-in-class autologous immunotherapeutic product that combines personalized whole tumor-derived cells with an antisense oligonucleotide (IMV-001) in implantable biodiffusion chambers, with the intent to induce a tumor-specific immune response in patients with ndGBM. Here, we describe the design and rationale of a randomized, double-blind, phase IIb trial evaluating IGV-001 compared with placebo, both followed by standard-of-care treatment in patients with ndGBM. The primary end point is progression-free survival, and key secondary end points include overall survival and safety.

Published
2024

9. Temporalis Muscle Thickness as a Prognostic Factor for 30-day, 90-day, and Overall Mortality in Newly-Diagnosed Glioblastoma

Author

Abouelleil, Mohamed, primary, Nabulsi, Omar, additional, Chandra, Ankush, additional, Massie, Lara, additional, Mansour, Tarek, additional, Mustaquim, Momina, additional, Macki, Mohamed, additional, Walbert, Tobias, additional, Robin, Adam, additional, Griffith, Brent, additional, Chang, Victor, additional, Kalkanis, Steven N., additional, Lee, Ian Y., additional, and Zakaria, Hesham Mostafa, additional

Published
2024
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10. Preoperative validation of edema-corrected tractography in neurosurgical practice: translating surgeon insights into novel software implementation

Author

Koga, Sebastian F., primary, Hodges, Wesley B., additional, Adamyan, Hayk, additional, Hayes, Tim, additional, Fecci, Peter E., additional, Tsvankin, Vadim, additional, Pradilla, Gustavo, additional, Hoang, Kimberly B., additional, Lee, Ian Y., additional, Sankey, Eric W., additional, Codd, Patrick J., additional, Huie, David, additional, Zacharia, Brad E., additional, Verma, Ragini, additional, and Baboyan, Vatche G., additional

Published
2024
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11. Phase 1 trial of vocimagene amiretrorepvec and 5-fluorocytosine for recurrent high-grade glioma

Author

Cloughesy, Timothy F, Landolfi, Joseph, Hogan, Daniel J, Bloomfield, Stephen, Carter, Bob, Chen, Clark C, Elder, J Bradley, Kalkanis, Steven N, Kesari, Santosh, Lai, Albert, Lee, Ian Y, Liau, Linda M, Mikkelsen, Tom, Nghiemphu, Phioanh Leia, Piccioni, David, Walbert, Tobias, Chu, Alice, Das, Asha, Diago, Oscar R, Gammon, Dawn, Gruber, Harry E, Hanna, Michelle, Jolly, Douglas J, Kasahara, Noriyuki, McCarthy, David, Mitchell, Leah, Ostertag, Derek, Robbins, Joan M, Rodriguez-Aguirre, Maria, and Vogelbaum, Michael A

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Brain Disorders, Rare Diseases, Brain Cancer, Genetics, Cancer, Clinical Research, Clinical Trials and Supportive Activities, Confidence Intervals, Cytosine Deaminase, Flucytosine, Fluorouracil, Genetic Vectors, Glioma, Prodrugs, RNA, Messenger, Retroviridae, Biological Sciences, Medical and Health Sciences, Medical biotechnology, Biomedical engineering
Abstract

Toca 511 (vocimagene amiretrorepvec) is an investigational nonlytic, retroviral replicating vector (RRV) that delivers a yeast cytosine deaminase, which converts subsequently administered courses of the investigational prodrug Toca FC (extended-release 5-fluorocytosine) into the antimetabolite 5-fluorouracil. Forty-five subjects with recurrent or progressive high-grade glioma were treated. The end points of this phase 1, open-label, ascending dose, multicenter trial included safety, efficacy, and molecular profiling; survival was compared to a matching subgroup from an external control. Overall survival for recurrent high-grade glioma was 13.6 months (95% confidence interval, 10.8 to 20.0) and was statistically improved relative to an external control (hazard ratio, 0.45; P = 0.003). Tumor samples from subjects surviving more than 52 weeks after Toca 511 delivery disproportionately displayed a survival-related mRNA expression signature, identifying a potential molecular signature that may correlate with treatment-related survival rather than being prognostic. Toca 511 and Toca FC show excellent tolerability, with RRV persisting in the tumor and RRV control systemically. The favorable assessment of Toca 511 and Toca FC supports confirmation in a randomized phase 2/3 trial (NCT02414165).

Published
2016

12. Autologous cell immunotherapy (IGV-001) with IGF-1R antisense oligonucleotide in newly diagnosed glioblastoma patients

Author

Lee, Ian Y, primary, Hanft, Simon, additional, Schulder, Michael, additional, Judy, Kevin D, additional, Wong, Eric T, additional, Elder, J. Bradley, additional, Evans, Linton T, additional, Zuccarello, Mario, additional, Wu, Julian, additional, Aulakh, Sonikpreet, additional, Agarwal, Vijay, additional, Ramakrishna, Rohan, additional, Gill, Brian J, additional, Quiñones-Hinojosa, Alfredo, additional, Brennan, Cameron, additional, Zacharia, Brad E, additional, Silva Correia, Carlos Eduardo, additional, Diwanji, Madhavi, additional, Pennock, Gregory K, additional, Scott, Charles, additional, Perez-Olle, Raul, additional, Andrews, David W, additional, and Boockvar, John A, additional

Published
2023
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14. Autologous cell immunotherapy (IGV-001) with IGF-1R antisense oligonucleotide in newly diagnosed glioblastoma patients.

Author

Lee, Ian Y, Hanft, Simon, Schulder, Michael, Judy, Kevin D, Wong, Eric T, Elder, J. Bradley, Evans, Linton T, Zuccarello, Mario, Wu, Julian, Aulakh, Sonikpreet, Agarwal, Vijay, Ramakrishna, Rohan, Gill, Brian J, Quiñones-Hinojosa, Alfredo, Brennan, Cameron, Zacharia, Brad E, Silva Correia, Carlos Eduardo, Diwanji, Madhavi, Pennock, Gregory K, and Scott, Charles

Abstract

Standard-of-care first-line therapy for patients with newly diagnosed glioblastoma (ndGBM) is maximal safe surgical resection, then concurrent radiotherapy and temozolomide, followed by maintenance temozolomide. IGV-001, the first product of the Goldspire™ platform, is a first-in-class autologous immunotherapeutic product that combines personalized whole tumor–derived cells with an antisense oligonucleotide (IMV-001) in implantable biodiffusion chambers, with the intent to induce a tumor-specific immune response in patients with ndGBM. Here, we describe the design and rationale of a randomized, double-blind, phase IIb trial evaluating IGV-001 compared with placebo, both followed by standard-of-care treatment in patients with ndGBM. The primary end point is progression-free survival, and key secondary end points include overall survival and safety. Glioblastoma (GBM) is a fast-growing brain tumor that happens in about half of all gliomas. Surgery is the first treatment for patients with newly diagnosed GBM, followed by the usual radiation and chemotherapy pills named temozolomide. Temozolomide pills are then given as a long-term treatment. The outcome for the patient with newly diagnosed GBM remains poor. IGV-001 is specially made for each patient. The tumor cells are removed during surgery and mixed in the laboratory with a small DNA, IMV-001. This mix is the IGV-001 therapy that is designed to give antitumor immunity against GBM. IGV-001 is put into small biodiffusion chambers that are irradiated to stop the growth of any tumor cells in the chambers. In the phase IIb study, patients with newly diagnosed GBM are chosen and assigned to either the IGV-001 or the placebo group. A placebo does not contain any active ingredients. The small biodiffusion chambers containing either IGV-001 or placebo are surgically placed into the belly for 48 to 52 h and then removed. Patients then receive the usual radiation and chemotherapy treatment. Patients must be adults aged between 18 and 70 years. Patients also should be able to care for themselves overall, but may be unable to work or have lower ability to function. Patients with tumors on both sides of the brain are not eligible. The main point of this study is to see if IGV-001 helps patients live longer without making the illness worse compared with placebo. Clinical Trial Registration:NCT04485949 (ClinicalTrials.gov) IGV-001, an autologous cell biologic-device product, is being tested versus placebo, each followed by standard of care, in a randomized phase IIb trial in newly diagnosed glioblastoma. IGV-001, designed to induce antitumor immunity, is delivered via implantable biodiffusion chambers. [ABSTRACT FROM AUTHOR]

Published
2024
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19. Laser Interstitial Thermal Therapy for Deep-seated Perivascular Brain Tumors is Not Associated with Distal Ischemia

Author

Reese, Jared C., primary, Fadel, Hassan A., additional, Pawloski, Jacob A., additional, Samir, Mariam, additional, Haider, Sameah, additional, Komatar, Ricardo J., additional, Luther, Evan, additional, Morell, Alexis A., additional, Ivan, Mike E., additional, Robin, Adam M., additional, Kalkanis, Steven N., additional, and Lee, Ian Y., additional

Published
2023
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20. Dynamic contrast enhanced (DCE) MRI estimation of vascular parameters using knowledge-based adaptive models

Author

Bagher-Ebadian, Hassan, primary, Brown, Stephen L., additional, Ghassemi, Mohammad M., additional, Nagaraja, Tavarekere N., additional, Valadie, Olivia Grahm, additional, Acharya, Prabhu C., additional, Cabral, Glauber, additional, Divine, George, additional, Knight, Robert A., additional, Lee, Ian Y., additional, Xu, Jun H., additional, Movsas, Benjamin, additional, Chetty, Indrin J., additional, and Ewing, James R., additional

Published
2023
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21. Characterization of Calcium-Mediated Intracellular and Intercellular Signaling in the rMC-1 Glial Cell Line

Author

Yu, Diana, Buibas, Marius, Chow, Siu-Kei, Lee, Ian Y., Singer, Zakary, and Silva, Gabriel A.

Subjects
Engineering, Cell Biology, Biomaterials, Biophysics/Biomedical Physics, Continuum Mechanics and Mechanics of Materials, Mechanics, Biomedical Engineering, Glial cells, Müller cells, Calcium signaling, Calcium dynamics, Retina
Abstract

Retinal Müller glial cells, in addition to providing homeostatic support to retinal neurons, have been shown to engage in modulation of neuronal activity and regulate vasomotor responses in the retina, among other functions. Calcium-mediated signaling in Müller cells has been implicated to play a significant role in the intracellular and intercellular interactions necessary to carry out these functions. Although the basic molecular mechanisms of calcium signaling in Müller cells have been described, the dynamics of calcium responses in Müller cells have not been fully explored. Here, we provide a quantitative characterization of calcium signaling in an in vitro model of Müller cell signaling using the rMC-1 cell line, a well-established line developed from rat Müller cells. rMC-1 cells displayed robust intracellular calcium transients and the capacity to support calcium transient-mediated intercellular calcium waves with signaling dynamics similar to that reported for Müller cells in in situ retinal preparations. Furthermore, pharmacological perturbations of intracellular calcium transients with thapsigargin and intercellular calcium waves with purinergic receptor antagonists and gap junction blockers (PPADS and FFA, respectively) suggest that the molecular mechanisms that underlie calcium signaling in rMC-1 cells has been conserved with those of Müller cells. This model provides a robust in vitro system for investigating specific mechanistic hypotheses of intra- and intercellular calcium signaling in Müller cells.

Published
2009

22. Persistent Peri-Ablation Blood-Brain Barrier Opening After Laser Interstitial Thermal Therapy for Brain Tumors

Author

Bartlett, Seamus, primary, Nagaraja, Tavarekere N, additional, Griffith, Brent, additional, Farmer, Katelynn G, additional, Van Harn, Meredith, additional, Haider, Sameah, additional, Hunt, Rachel J, additional, Cabral, Glauber, additional, Knight, Robert A, additional, Valadie, O. Grahm, additional, Brown, Stephen L, additional, Ewing, James R, additional, and Lee, Ian Y, additional

Published
2023
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23. Association of Autologous Tumor Lysate-Loaded Dendritic Cell Vaccination With Extension of Survival Among Patients With Newly Diagnosed and Recurrent Glioblastoma: A Phase 3 Prospective Externally Controlled Cohort Trial.

Author

Liau, Linda M, Liau, Linda M, Ashkan, Keyoumars, Brem, Steven, Campian, Jian L, Trusheim, John E, Iwamoto, Fabio M, Tran, David D, Ansstas, George, Cobbs, Charles S, Heth, Jason A, Salacz, Michael E, D'Andre, Stacy, Aiken, Robert D, Moshel, Yaron A, Nam, Joo Y, Pillainayagam, Clement P, Wagner, Stephanie A, Walter, Kevin A, Chaudhary, Rekha, Goldlust, Samuel A, Lee, Ian Y, Bota, Daniela A, Elinzano, Heinrich, Grewal, Jai, Lillehei, Kevin, Mikkelsen, Tom, Walbert, Tobias, Abram, Steven, Brenner, Andrew J, Ewend, Matthew G, Khagi, Simon, Lovick, Darren S, Portnow, Jana, Kim, Lyndon, Loudon, William G, Martinez, Nina L, Thompson, Reid C, Avigan, David E, Fink, Karen L, Geoffroy, Francois J, Giglio, Pierre, Gligich, Oleg, Krex, Dietmar, Lindhorst, Scott M, Lutzky, Jose, Meisel, Hans-Jörg, Nadji-Ohl, Minou, Sanchin, Lhagva, Sloan, Andrew, Taylor, Lynne P, Wu, Julian K, Dunbar, Erin M, Etame, Arnold B, Kesari, Santosh, Mathieu, David, Piccioni, David E, Baskin, David S, Lacroix, Michel, May, Sven-Axel, New, Pamela Z, Pluard, Timothy J, Toms, Steven A, Tse, Victor, Peak, Scott, Villano, John L, Battiste, James D, Mulholland, Paul J, Pearlman, Michael L, Petrecca, Kevin, Schulder, Michael, Prins, Robert M, Boynton, Alton L, Bosch, Marnix L, Liau, Linda M, Liau, Linda M, Ashkan, Keyoumars, Brem, Steven, Campian, Jian L, Trusheim, John E, Iwamoto, Fabio M, Tran, David D, Ansstas, George, Cobbs, Charles S, Heth, Jason A, Salacz, Michael E, D'Andre, Stacy, Aiken, Robert D, Moshel, Yaron A, Nam, Joo Y, Pillainayagam, Clement P, Wagner, Stephanie A, Walter, Kevin A, Chaudhary, Rekha, Goldlust, Samuel A, Lee, Ian Y, Bota, Daniela A, Elinzano, Heinrich, Grewal, Jai, Lillehei, Kevin, Mikkelsen, Tom, Walbert, Tobias, Abram, Steven, Brenner, Andrew J, Ewend, Matthew G, Khagi, Simon, Lovick, Darren S, Portnow, Jana, Kim, Lyndon, Loudon, William G, Martinez, Nina L, Thompson, Reid C, Avigan, David E, Fink, Karen L, Geoffroy, Francois J, Giglio, Pierre, Gligich, Oleg, Krex, Dietmar, Lindhorst, Scott M, Lutzky, Jose, Meisel, Hans-Jörg, Nadji-Ohl, Minou, Sanchin, Lhagva, Sloan, Andrew, Taylor, Lynne P, Wu, Julian K, Dunbar, Erin M, Etame, Arnold B, Kesari, Santosh, Mathieu, David, Piccioni, David E, Baskin, David S, Lacroix, Michel, May, Sven-Axel, New, Pamela Z, Pluard, Timothy J, Toms, Steven A, Tse, Victor, Peak, Scott, Villano, John L, Battiste, James D, Mulholland, Paul J, Pearlman, Michael L, Petrecca, Kevin, Schulder, Michael, Prins, Robert M, Boynton, Alton L, and Bosch, Marnix L

Abstract

ImportanceGlioblastoma is the most lethal primary brain cancer. Clinical outcomes for glioblastoma remain poor, and new treatments are needed.ObjectiveTo investigate whether adding autologous tumor lysate-loaded dendritic cell vaccine (DCVax-L) to standard of care (SOC) extends survival among patients with glioblastoma.Design, setting, and participantsThis phase 3, prospective, externally controlled nonrandomized trial compared overall survival (OS) in patients with newly diagnosed glioblastoma (nGBM) and recurrent glioblastoma (rGBM) treated with DCVax-L plus SOC vs contemporaneous matched external control patients treated with SOC. This international, multicenter trial was conducted at 94 sites in 4 countries from August 2007 to November 2015. Data analysis was conducted from October 2020 to September 2021.InterventionsThe active treatment was DCVax-L plus SOC temozolomide. The nGBM external control patients received SOC temozolomide and placebo; the rGBM external controls received approved rGBM therapies.Main outcomes and measuresThe primary and secondary end points compared overall survival (OS) in nGBM and rGBM, respectively, with contemporaneous matched external control populations from the control groups of other formal randomized clinical trials.ResultsA total of 331 patients were enrolled in the trial, with 232 randomized to the DCVax-L group and 99 to the placebo group. Median OS (mOS) for the 232 patients with nGBM receiving DCVax-L was 19.3 (95% CI, 17.5-21.3) months from randomization (22.4 months from surgery) vs 16.5 (95% CI, 16.0-17.5) months from randomization in control patients (HR = 0.80; 98% CI, 0.00-0.94; P = .002). Survival at 48 months from randomization was 15.7% vs 9.9%, and at 60 months, it was 13.0% vs 5.7%. For 64 patients with rGBM receiving DCVax-L, mOS was 13.2 (95% CI, 9.7-16.8) months from relapse vs 7.8 (95% CI, 7.2-8.2) months among control patients (HR, 0.58; 98% CI, 0.00-0.76; P < .001). Survival at 24 and 30 months after rec

Published
2023

25. Characterization of the Response of 9L and U-251N Orthotopic Brain Tumors to 3D Conformal Radiation Therapy

Author

Valadie, O. Grahm, primary, Brown, Stephen L., additional, Farmer, Katelynn, additional, Nagaraja, Tavarekere N., additional, Cabral, Glauber, additional, Shadaia, Sheldon, additional, Divine, George W., additional, Knight, Robert A., additional, Lee, Ian Y., additional, Dolan, Jennifer, additional, Rusu, Sam, additional, Joiner, Michael C., additional, and Ewing, James R., additional

Published
2023
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28. Detection of tumor-specific DNA methylation markers in the blood of patients with pituitary neuroendocrine tumors

Author

Herrgott, Grayson A, primary, Asmaro, Karam P, additional, Wells, Michael, additional, Sabedot, Thais S, additional, Malta, Tathiane M, additional, Mosella, Maritza S, additional, Nelson, Kevin, additional, Scarpace, Lisa, additional, Barnholtz-Sloan, Jill S, additional, Sloan, Andrew E, additional, Selman, Warren R, additional, deCarvalho, Ana C, additional, Poisson, Laila M, additional, Mukherjee, Abir, additional, Robin, Adam M, additional, Lee, Ian Y, additional, Snyder, James, additional, Walbert, Tobias, additional, Rosenblum, Mark, additional, Mikkelsen, Tom, additional, Bhan, Arti, additional, Craig, John, additional, Kalkanis, Steven, additional, Rock, Jack, additional, Noushmehr, Houtan, additional, and Castro, Ana Valeria, additional

Published
2022
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30. Reducing Superfluous Opioid Prescribing Practices After Brain Surgery: It Is Time to Talk About Drugs

Author

Asmaro, Karam, primary, Fadel, Hassan A, additional, Haider, Sameah A, additional, Pawloski, Jacob, additional, Telemi, Edvin, additional, Mansour, Tarek R, additional, Chandra, Ankush, additional, Bazydlo, Michael, additional, Robin, Adam M, additional, Lee, Ian Y, additional, Air, Ellen L, additional, Rock, Jack P, additional, Kalkanis, Steven N, additional, and Schwalb, Jason M, additional

Published
2021
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31. Sarcopenia as a Prognostic Factor for 90-Day and Overall Mortality in Patients Undergoing Spine Surgery for Metastatic Tumors: A Multicenter Retrospective Cohort Study

Author

Zakaria, Hesham Mostafa, primary, Wilkinson, Brandon Michael, additional, Pennington, Zach, additional, Saadeh, Yamaan S, additional, Lau, Darryl, additional, Chandra, Ankush, additional, Ahmed, A Karim, additional, Macki, Mohamed, additional, Anand, Sharath Kumar, additional, Abouelleil, Mohamed A, additional, Fateh, Jibran A, additional, Rick, Jonathan W, additional, Morshed, Ramin A, additional, Deng, Hansen, additional, Chen, Kai-Yuan, additional, Robin, Adam, additional, Lee, Ian Y, additional, Kalkanis, Steven, additional, Chou, Dean, additional, Park, Paul, additional, Sciubba, Daniel M, additional, and Chang, Victor, additional

Published
2021
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33. Imaging acute effects of bevacizumab on tumor vascular kinetics in a preclinical orthotopic model of U251 glioma

Author

Nagaraja, Tavarekere N., primary, Elmghirbi, Rasha, additional, Brown, Stephen L., additional, Rey, Julian A., additional, Schultz, Lonni, additional, Mukherjee, Abir, additional, Cabral, Glauber, additional, Panda, Swayamprava, additional, Lee, Ian Y., additional, Sarntinoranont, Malisa, additional, Keenan, Kelly A., additional, Knight, Robert A., additional, and Ewing, James R., additional

Published
2021
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34. Fluorescence-Guided High-Grade Glioma Surgery More Than Four Hours After 5-Aminolevulinic Acid Administration

Author

Maragkos, Georgios A., primary, Schüpper, Alexander J., additional, Lakomkin, Nikita, additional, Sideras, Panagiotis, additional, Price, Gabrielle, additional, Baron, Rebecca, additional, Hamilton, Travis, additional, Haider, Sameah, additional, Lee, Ian Y., additional, Hadjipanayis, Constantinos G., additional, and Robin, Adam M., additional

Published
2021
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37. Understanding Risk Factors for Increased Opioid Utilization Following Cranial Surgery

Author

Pawloski, Jacob A, primary, Asmaro, Karam P, additional, Fadel, Hassan A, additional, Haider, Sameah A, additional, Telemi, Edvin, additional, Mansour, Tarek R, additional, Chandra, Ankush, additional, Bazydlo, Michael, additional, Robin, Adam M, additional, Lee, Ian Y, additional, Air, Ellen L, additional, Rock, Jack P, additional, Kalkanis, Steven N, additional, and Schwalb, Jason M, additional

Published
2020
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38. Sarcopenia as a Prognostic Factor for 90-Day and Overall Mortality in Patients Undergoing Spine Surgery for Metastatic Tumors: A Multicenter Retrospective Cohort Study

Author

Zakaria, Hesham Mostafa, primary, Wilkinson, Brandon Michael, additional, Pennington, Zach, additional, Saadeh, Yamaan S, additional, Lau, Darryl, additional, Chandra, Ankush, additional, Ahmed, Karim A, additional, Macki, Mohamed, additional, Anand, Sharath Kumar, additional, Abouelleil, Mohamed A, additional, Fateh, Jibran A, additional, Rick, Jonathan W, additional, Morshed, Ramin A, additional, Deng, Hansen, additional, Chen, Kai-Yuan, additional, Robin, Adam, additional, Lee, Ian Y, additional, Kalkanis, Steven, additional, Chou, Dean, additional, Park, Paul, additional, Sciubba, Daniel M, additional, and Chang, Victor, additional

Published
2020
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40. Detection of Circulating Tumor-specific DNA Methylation Markers in the Blood of Patients with Pituitary Tumors

Author

Wells, Michael, primary, Asmaro, Karam P., additional, Sabedot, Thais S., additional, Malta, Tathiane M., additional, Mosella, Maritza S., additional, Nelson, Kevin, additional, Snyder, James, additional, deCarvalho, Ana, additional, Mukherjee, Abir, additional, Chitale, Dhananjay, additional, Robin, Adam, additional, Rosenblum, Mark, additional, Mikkelsen, Thomas, additional, Poisson, Laila M., additional, Lee, Ian Y., additional, Walbert, Tobias, additional, Bhan, Arti, additional, Kalkanis, Steven, additional, Rock, Jack, additional, Noushmehr, Houtan, additional, and Castro, Ana Valeria, additional

Published
2020
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41. Candidate Regulatory Elements in Coding and Noncoding Regions are Associated With Invasive Behavior in Pituitary Tumors

Author

Asmaro, Karam P, primary, Mosella, Maritza S, additional, Wells, Michael, additional, Sabedot, Thais, additional, Malta, Tathiane, additional, Nelson, Kevin, additional, Snyder, James, additional, DeCarvalho, Ana, additional, Mukherjee, Abir, additional, Chitale, Dhananjay, additional, Aho, Todd, additional, Robin, Adam M, additional, Rosenblum, Mark L, additional, Mikkelsen, Tom, additional, Poisson, Laila, additional, Lee, Ian Y, additional, Walbert, Tobias, additional, Bhan, Arti, additional, Kalkanis, Steven N, additional, Rock, Jack P, additional, Noushmehr, Houtan, additional, and Castro, Anavaleria, additional

Published
2019
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42. Prescriber Aimed Intervention to Optimize Opioid Prescribing Patterns After Intracranial Surgery: Addressing the Nation's Opioid Epidemic and Decreasing the Neurosurgeon's Narcotic Footprint

Author

Asmaro, Karam P, primary, Haider, Sameah A, additional, Chandra, Ankush, additional, Telemi, Edvin, additional, Mansour, Tarek R, additional, Zakaria, Hesham M, additional, Robin, Adam M, additional, Lee, Ian Y, additional, Air, Ellen L, additional, Rock, S Jack P, additional, Kalkanis, Steven N, additional, and Schwalb, Jason M, additional

Published
2019
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