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Phase I Study of Zotiraciclib in Combination with Temozolomide for Patients with Recurrent High-grade Astrocytomas

Wu, Jing; Yuan, Ying; Long Priel, Debra A; Fink, Danielle; Peer, Cody J; Sissung, Tristan M; Su, Yu-Ting; Pang, Ying; Yu, Guangyang; Butler, Madison K; Mendoza, Tito R; Vera, Elizabeth; Ahmad, Salman; Bryla, Christine; Lindsley, Matthew; Grajkowska, Ewa; Mentges, Kelly; Boris, Lisa; Antony, Ramya; Garren, Nancy; Siegel, Christine; Lollo, Nicole; Cordova, Christine; Aboud, Orwa; Theeler, Brett J; Burton, Eric M; Penas-Prado, Marta; Leeper, Heather; Gonzales, Javier; Armstrong, Terri S; Calvo, Katherine R; Figg, William D; Kuhns, Douglas B; Gallin, John I; Gilbert, Mark R
PURPOSE/OBJECTIVE:To investigate the toxicity profile and establish an optimal dosing schedule of zotiraciclib with temozolomide (TMZ) in patients with recurrent high-grade astrocytoma. EXPERIMENTAL DESIGN/METHODS:This two-stage phase 1 trial determined the maximum tolerated dose (MTD) of zotiraciclib combined with either dose-dense (Arm1) or metronomic (Arm2) TMZ using a Bayesian Optimal Interval design; then a randomized cohort-expansion compared the progression-free survival rate at 4 month (PFS4) of the two arms for an efficient determination of a TMZ schedule to combine with zotiraciclib at MTD. Pharmacokinetics (PK) and pharmacogenomic (PG) profiling were included. Patient-reported outcome was evaluated by longitudinal symptom burden. RESULTS:Fifty-three patients were enrolled. Dose-limiting toxicities were neutropenia, diarrhea, elevated liver enzymes, and fatigue. MTD of zotiraciclib was 250mg in both arms and thus selected for the cohort expansion. Dose-dense TMZ plus zotiraciclib (PSF4 40%) compared favorably with metronomic TMZ (PFS4 25%). Symptom burden worsened at Cycle 2 but stabilized by Cycle 4 in both arms. A significant decrease in absolute neutrophil count and neutrophil reactive oxygen species production occurred 12-24 hours after an oral dose of zotiraciclib but both recovered by 72 hours. PK/PG analyses revealed that the CYP1A2_5347T>C (rs2470890) polymorphism was associated with higher AUCinf value. CONCLUSIONS:Zotiraciclib combined with TMZ is safe in patients with recurrent high-grade astrocytomas. Zotiraciclib-induced neutropenia can be profound but mostly transient, warranting close monitoring rather than treatment discontinuation. Once validated, polymorphisms predicting drug metabolism may allow personalized dosing of zotiraciclib.
PMID: 33785481
ISSN: 1557-3265
CID: 4830742

Functional connectivity of the default mode, dorsal attention and fronto-parietal executive control networks in glial tumor patients

Tordjman, Mickael; Madelin, Guillaume; Gupta, Pradeep Kumar; Cordova, Christine; Kurz, Sylvia C; Orringer, Daniel; Golfinos, John; Kondziolka, Douglas; Ge, Yulin; Wang, Ruoyu Luie; Lazar, Mariana; Jain, Rajan
PURPOSE/OBJECTIVE:Resting state functional magnetic resonance imaging (rsfMRI) is an emerging tool to explore the functional connectivity of different brain regions. We aimed to assess the disruption of functional connectivity of the Default Mode Network (DMN), Dorsal Attention Network(DAN) and Fronto-Parietal Network (FPN) in patients with glial tumors. METHODS:rsfMRI data acquired on 3T-MR of treatment-naive glioma patients prospectively recruited (2015-2019) and matched controls from the 1000 functional-connectomes-project were analyzed using the CONN functional toolbox. Seed-Based Connectivity Analysis (SBCA) and Independent Component Analysis (ICA, with 10 to 100 components) were performed to study reliably the three networks of interest. RESULTS:). For the FPN, increased connectivity was noted in the precuneus, posterior cingulate gyrus, and frontal cortex. No difference in the connectivity of the networks of interest was demonstrated between low- and high-grade gliomas, as well as when stratified by their IDH1-R132H (isocitrate dehydrogenase) mutation status. CONCLUSION/CONCLUSIONS:Altered functional connectivity is reliably found with SBCA and ICA in the DMN, DAN, and FPN in glioma patients, possibly explained by decreased connectivity between the cerebral hemispheres across the corpus callosum due to disruption of the connections.
PMID: 33528739
ISSN: 1573-7373
CID: 4789692

Advances in Molecular Classification and Therapeutic Opportunities in Meningiomas

Cordova, Christine; Kurz, Sylvia C
PURPOSE OF REVIEW/OBJECTIVE:Our understanding of the genetic and epigenetic alterations in meningioma and the underlying tumor biology of meningioma has significantly changed over the past decade and resulted in revision of prognostically relevant meningioma subclasses within and beyond the WHO classification of CNS tumors. RECENT FINDINGS/RESULTS:The 2016 WHO classification of CNS tumors recognizes WHO grade I, II, and III based on histopathological features. Recent work has identified genetic alterations with prognostic implications, including mutations of the TERT promoter, loss of function of the DMD gene, and inactivation of the tumor suppressor BAP-1. Studies of DNA methylation patterns in meningiomas have resulted in a novel and prognostically relevant meningioma subclassification schema. There have been major advances in our understanding of prognostically relevant genetic and epigenetic changes in meningioma which will hopefully allow for improvement in clinical trial design and the development of more effective therapies for meningioma.
PMID: 32617743
ISSN: 1534-6269
CID: 4525042

SINGLE ARM, OPEN-LABEL, MULTICENTER PHASE II STUDY OF THE RADIONUCLIDE (LU)-L-177-DOTATATE (LUTATHERA) IN ADULTS WITH ADVANCED INTRACRANIAL MENINGIOMA [Meeting Abstract]

Kurz, Sylvia; Zan, Elcin; Gurewitz, Jasone; Cordova, Christine; Troxel, Andrea B.; Sawaged, Zacharia; Sevillano-Torres, Hector; Silverman, Joshua S.; Snuderl, Matija; Zagzag, David; Golfinos, John; Kondziolka, Douglas; Sulman, Erik
ISI:000590061300220
ISSN: 1522-8517
CID: 4688132

Plasma cell-free circulating tumor DNA (ctDNA) detection in longitudinally followed glioblastoma patients using TERT promoter mutation-specific droplet digital PCR assays

Cordova, Christine; Syeda, Mahrukh M; Corless, Broderick; Wiggins, Jennifer M; Patel, Amie; Kurz, Sylvia Christine; Delara, Malcolm; Sawaged, Zacharia; Utate, Minerva; Placantonakis, Dimitris; Golfinos, John; Schafrick, Jessica; Silverman, Joshua Seth; Jain, Rajan; Snuderl, Matija; Zagzag, David; Shao, Yongzhao; Karlin-Neumann, George Alan; Polsky, David; Chi, Andrew S
ORIGINAL:0014231
ISSN: 1527-7755
CID: 4032352

State of the Art Treatment and Surveillance Imaging of Glioblastomas

Margiewicz, Stefan; Cordova, Christine; Chi, Andrew S; Jain, Rajan
PMID: 29405952
ISSN: 1558-4658
CID: 2947532

DETECTION OF TERT MUTATIONS IN CELL-FREE CIRCULATING TUMOR DNA (cTDNA) OF GLIOBLASTOMA PATIENTS USING DROPLET DIGITAL PCR [Meeting Abstract]

Cordova, Christine; Corless, Broderick; Syeda, Mahrukh; Patel, Amie; Delara, Malcolm; Eisele, Sylvia; Schafrick, Jessica; Placantonakis, Dimitris; Pacione, Donato; Silverman, Joshua; Fatterpekar, Girish; Shepherd, Timothy; Jain, Rajan; Snuderl, Matija; Zagzag, David; Golfinos, John; Jafar, Jafar J; Shao, Yongzhao; Karlin-Neumann, George; Polsky, David; Chi, Andrew S
ISI:000415152503095
ISSN: 1523-5866
CID: 2802392

A PHASE II, OPEN-LABEL, SINGLE ARM, MULTICENTER STUDY OF AVELUMAB WITH HYPOFRACTIONATED RE-IRRADIATION IN ADULT SUBJECTS WITH TRANSFORMED IDH MUTANT GLIOBLASTOMA [Meeting Abstract]

Chi, Andrew S; Eisele, Sylvia; Arrillaga-Romany, Isabel; Batchelor, Tracy; Cahill, Daniel; Taylor, Jennie; Cloughesy, Timothy F; Patel, Amie; Delara, Malcolm; Latchman, Sunita; Placantonakis, Dimitris; Pacione, Donato; Fatterpekar, Girish; Shepherd, Timothy; Jain, Rajan; Cordova, Christine; Schafrick, Jessica; Snuderl, Matija; Zagzag, David; Kondziolka, Douglas; Golfinos, John; Silverman, Joshua
ISI:000415152500099
ISSN: 1523-5866
CID: 2802502

Osimertinib Dose Escalation Induces Regression of Progressive EGFR T790M-Mutant Leptomeningeal Lung Adenocarcinoma [Letter]

Cordova, Christine; Chi, Andrew S; Chachoua, Abraham; Kondziolka, Douglas; Silverman, Joshua S; Shepherd, Timothy M; Jain, Rajan; Snuderl, Matija
PMID: 29074213
ISSN: 1556-1380
CID: 2756442

ACTR-69. PHASE I TRIAL OF TG02 PLUS DOSE-DENSE OR METRONOMIC TEMOZOLOMIDE FOR ADULTS WITH RECURRENT ANAPLASTIC ASTROCYTOMA AND GLIOBLASTOMA

Wu, Jing; Bryla, Christine; McCoy, Ann; Lisa, Boris; Garren, Nancy; Siegel, Christine; Grajkowska, Ewa; Theeler, Brett; Park, Deric M; Parrott, Tracy; Armstrong, Terri S; Yuan, Ying; Gilbert, Mark R
ORIGINAL:0014232
ISSN: 1523-5866
CID: 4033752