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2. NUTMEG: A randomized phase II study of nivolumab and temozolomide versus temozolomide alone in newly diagnosed older patients with glioblastoma

Author

Sim, Hao-Wen, Wachsmuth, Luke, Barnes, Elizabeth H, Yip, Sonia, Koh, Eng-Siew, Hall, Merryn, Jennens, Ross, Ashley, David M, Verhaak, Roel G, Heimberger, Amy B, Rosenthal, Mark A, Hovey, Elizabeth J, Ellingson, Benjamin M, Tognela, Annette, Gan, Hui K, Wheeler, Helen, Back, Michael, McDonald, Kerrie L, Long, Anne, Cuff, Katharine, Begbie, Stephen, Gedye, Craig, Mislang, Anna, Le, Hien, Johnson, Margaret O, Kong, Benjamin Y, Simes, John R, Lwin, Zarnie, and Khasraw, Mustafa

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Aging, Rare Diseases, Cancer, Immunization, Clinical Research, Brain Cancer, Clinical Trials and Supportive Activities, Brain Disorders, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, clinical trials, glioblastoma, immunotherapy, older cancer patients, systemic therapy
Abstract

BackgroundThere is an immunologic rationale to evaluate immunotherapy in the older glioblastoma population, who have been underrepresented in prior trials. The NUTMEG study evaluated the combination of nivolumab and temozolomide in patients with glioblastoma aged 65 years and older.MethodsNUTMEG was a multicenter 2:1 randomized phase II trial for patients with newly diagnosed glioblastoma aged 65 years and older. The experimental arm consisted of hypofractionated chemoradiation with temozolomide, then adjuvant nivolumab and temozolomide. The standard arm consisted of hypofractionated chemoradiation with temozolomide, then adjuvant temozolomide. The primary objective was to improve overall survival (OS) in the experimental arm.ResultsA total of 103 participants were randomized, with 69 in the experimental arm and 34 in the standard arm. The median (range) age was 73 (65-88) years. After 37 months of follow-up, the median OS was 11.6 months (95% CI, 9.7-13.4) in the experimental arm and 11.8 months (95% CI, 8.3-14.8) in the standard arm. For the experimental arm relative to the standard arm, the OS hazard ratio was 0.85 (95% CI, 0.54-1.33). In the experimental arm, there were three grade 3 immune-related adverse events which resolved, with no unexpected serious adverse events.ConclusionsDue to insufficient evidence of benefit with nivolumab, the decision was made not to transition to a phase III trial. No new safety signals were identified with nivolumab. This complements the existing series of immunotherapy trials. Research is needed to identify biomarkers and new strategies including combinations.

Published
2023

7. CTIM-10. A SURGICAL WINDOW-OF-OPPORTUNITY CLINICAL TRIAL EVALUATING THE PCSK9 INHIBITOR EVOLOCUMAB IN PATIENTS WITH GLIOMA

Author

Singh, Kirit, primary, Hotchkiss, Kelly, additional, Foster, Matthew, additional, Railton, Chelsea, additional, Blandford, Emily, additional, Thomas, Elizabeth, additional, Miller, Elizabeth S, additional, Ashley, David, additional, Desjardins, Annick, additional, Friedman, Henry, additional, Johnson, Margaret O, additional, Friedman, Allan, additional, Keir, Steve, additional, Herndon, James, additional, Sampson, John, additional, Li, Chuan-Yuan, additional, Fecci, Peter, additional, Patel, Anoop, additional, and Khasraw, Mustafa, additional

Published
2023
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10. CTIM-09. PHASE 1/1B TRIAL OF FC-ENGINEERED ANTI-CD40 AGONIST MONOCLONAL ANTIBODY (2141-V11) INFUSED WITH D2C7-IT IN ENHANCING DISEASE BY CONVECTION-ENHANCED DELIVERY (CED) FOR RECURRENT MALIGNANT GLIOMA (RMG)

Author

Desjardins, Annick, primary, Chandramohan, Vidya, additional, Landi, Daniel, additional, Peters, Katherine, additional, Johnson, Margaret O, additional, Low, Justin, additional, Khasraw, Mustafa, additional, Threatt, Stevie, additional, Bullock, Chevelle, additional, Herndon, James, additional, Lipp, Eric, additional, Friedman, Allan, additional, Friedman, Henry, additional, Ashley, David, additional, Osorio, Juan, additional, Ravetch, Jeffrey, additional, and Bigner, Darell, additional

Published
2023
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13. RTID-07. A RANDOMIZED WINDOW OF OPPORTUNITY TRIAL WITH DOSE ESCALATION TO EVALUATE FLUOXETINE AND TEMOZOLOMIDE IN GLIOMA

Author

Singh, Kirit, primary, Railton, Chelsea, additional, Hotchkiss, Kelly, additional, Herndon, James, additional, Peters, Katherine, additional, Friedman, Henry, additional, Desjardins, Annick, additional, Ashley, David, additional, Johnson, Margaret O, additional, Patel, Anoop, additional, Friedman, Allan, additional, Lim, Michael, additional, Fecci, Peter, additional, Piccioni, David, additional, McGranahan, Tresa, additional, Nagpal, Seema, additional, Sulman, Erik, additional, Mischel, Paul, additional, and Khasraw, Mustafa, additional

Published
2023
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14. MGMT ProFWise: Unlocking a New Application for Combined Feature Selection and the Rank-Based Weighting Method to Link MGMT Methylation Status to Serum Protein Expression in Patients with Glioblastoma.

Author

Tasci, Erdal, Shah, Yajas, Jagasia, Sarisha, Zhuge, Ying, Shephard, Jason, Johnson, Margaret O., Elemento, Olivier, Joyce, Thomas, Chappidi, Shreya, Cooley Zgela, Theresa, Sproull, Mary, Mackey, Megan, Camphausen, Kevin, and Krauze, Andra Valentina

Subjects
BLOOD proteins, FEATURE selection, O6-Methylguanine-DNA Methyltransferase, PROTEIN expression, GLIOBLASTOMA multiforme
Abstract

Glioblastoma (GBM) is a fatal brain tumor with limited treatment options. O6-methylguanine-DNA-methyltransferase (MGMT) promoter methylation status is the central molecular biomarker linked to both the response to temozolomide, the standard chemotherapy drug employed for GBM, and to patient survival. However, MGMT status is captured on tumor tissue which, given the difficulty in acquisition, limits the use of this molecular feature for treatment monitoring. MGMT protein expression levels may offer additional insights into the mechanistic understanding of MGMT but, currently, they correlate poorly to promoter methylation. The difficulty of acquiring tumor tissue for MGMT testing drives the need for non-invasive methods to predict MGMT status. Feature selection aims to identify the most informative features to build accurate and interpretable prediction models. This study explores the new application of a combined feature selection (i.e., LASSO and mRMR) and the rank-based weighting method (i.e., MGMT ProFWise) to non-invasively link MGMT promoter methylation status and serum protein expression in patients with GBM. Our method provides promising results, reducing dimensionality (by more than 95%) when employed on two large-scale proteomic datasets (7k SomaScan® panel and CPTAC) for all our analyses. The computational results indicate that the proposed approach provides 14 shared serum biomarkers that may be helpful for diagnostic, prognostic, and/or predictive operations for GBM-related processes, given further validation. [ABSTRACT FROM AUTHOR]

Published
2024
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15. Use, access, and initial outcomes of off-label ivosidenib in patients with IDH1 mutant glioma.

Author

Peters, Katherine B, Alford, Candice, Heltemes, Amy, Savelli, Alicia, Landi, Daniel B, Broadwater, Gloria, Desjardins, Annick, Johnson, Margaret O, Low, Justin T, Khasraw, Mustafa, Ashley, David M, Friedman, Henry S, and Patel, Mallika P

Subjects
OFF-label use (Drugs), GLIOMAS, ISOCITRATE dehydrogenase, ACUTE myeloid leukemia, CREATINE kinase, EPILEPSY, PATIENTS' attitudes
Abstract

Background Isocitrate dehydrogenase (IDH) is commonly mutated (mIDH) in gliomas, and this mutant enzyme produces the oncometabolite 2-hydroxyglutarate (2HG). 2HG promotes gliomagenesis and is implicated in epileptogenesis. Ivosidenib (IVO), a small molecule oral mIDH1 inhibitor, is FDA-approved for mIDH1 newly diagnosed and relapsed/refractory acute myeloid leukemia. Moreover, IVO has efficacy in clinical trials for recurrent mIDH1 gliomas. Given the lack of targeted treatments for gliomas, we initiated off-label IVO for mIDH glioma patients in October 2020. Methods Retrospectively, we sought to assess early outcomes in our patients and describe their experience on IVO from October 2020 through February 2022. Our objective was to report on the following variables of off-label use of IVO: radiographic response, seizure control, tolerability, and access to the medication. All patients initially received single-agent IVO dosed at 500 mg orally once daily. Results The cohort age range was 21–74 years. Tumor types included astrocytoma (n = 14) and oligodendroglioma (n = 16), with most being grade 2 (n = 21). The best radiographic response in nonenhancing disease (n = 22) was 12 stable diseases, 5 minor responses, 3 partial responses, and 2 progressive diseases. Seizure frequency was stable to improved for most patients (70%, n = 21). IVO was well-tolerated, with the most common toxicities being diarrhea, elevated creatine kinase, and QTc interval prolongation. Most patients (66.7%, n = 20) received drugs via the patient assistance program, with insurance initially covering a third of patients and with ongoing use, later covering 60%. Conclusions Targeted therapies like IVO are options for mIDH glioma patients and can provide positive oncologic and neurological outcomes. [ABSTRACT FROM AUTHOR]

Published
2024
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16. Evolving Barriers to Clinical Trial Enrollment and Clinical Care in Neuro-oncology in the Face of COVID-19.

Author

Grandhi, Nikhil, Zhou, Alice Y., Johnson, Margaret O., and Butt, Omar H.

Subjects
CLINICAL medicine, CLINICAL trials, COVID-19, COVID-19 pandemic, HEALTH equity, ONCOLOGY nursing, CLINICAL trials monitoring
Abstract

The lack of treatments with durable response in neuro-oncology highlights the critical need for clinical trials to advance patient care. The intersection of relatively low incidence, evolving classification schema, and entrenched community, healthcare provider, and organizational factors have been historic challenges against successful trial enrollment and implementation. The additional need for multidisciplinary, often tertiary-level care, further magnifies latent national and international health inequities with rural and under-served populations. The COVID-19 pandemic both unveiled fundamental weaknesses in historical approaches and prompted the necessity of new approaches and systems for conducting clinical trials. Here, we provide an overview of traditional barriers to clinical trial enrollment in neuro-oncology, the effect of COVID-19 on these barriers, and the discovery of additional systemic weaknesses. Finally, we discuss future directions by reflecting on lessons learned with strategies to broaden access of care and streamline clinical trial integration into clinical practice. [ABSTRACT FROM AUTHOR]

Published
2024
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17. Use, Access, and Initial Outcomes of Off-Label Ivosidenib in Patients with IDH1 Mutant Glioma

Author

Peters, Katherine B, primary, Alford, Candice, additional, Heltemes, Amy, additional, Savelli, Alicia, additional, Landi, Daniel B, additional, Broadwater, Gloria, additional, Desjardins, Annick, additional, Johnson, Margaret O, additional, Low, Justin T, additional, Khasraw, Mustafa, additional, Ashley, David M, additional, Friedman, Henry S, additional, and Patel, Mallika P, additional

Published
2023
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20. Racial disparities in inpatient clinical presentation, treatment, and outcomes in brain metastasis

Author

McCray, Edwin, primary, Waguia, Romaric, additional, de la Garza Ramos, Rafael, additional, Price, Meghan J, additional, Williamson, Theresa, additional, Dalton, Tara, additional, Sciubba, Daniel M, additional, Yassari, Reza, additional, Goodwin, Andrea N, additional, Fecci, Peter, additional, Johnson, Margaret O, additional, Chaichana, Kaisorn, additional, and Goodwin, C Rory, additional

Published
2022
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22. A phase 1 trial of D2C7-it in combination with an Fc-engineered anti-CD40 monoclonal antibody (2141-V11) administered intratumorally via convection-enhanced delivery for adult patients with recurrent malignant glioma (MG).

Author

Desjardins, Annick, primary, Chandramohan, Vidyalakshmi, additional, Landi, Daniel B, additional, Johnson, Margaret O., additional, Khasraw, Mustafa, additional, Peters, Katherine B., additional, Low, Justin, additional, Herndon, James Emmett, additional, Threatt, Stevie, additional, Bullock, Chevelle A., additional, Lipp, Eric S., additional, Sampson, John H., additional, Friedman, Allan H., additional, Friedman, Henry S., additional, Ashley, David M., additional, Knorr, David, additional, and Bigner, Darell D., additional

Published
2022
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23. A phase 0/surgical window-of-opportunity study in progress, evaluating evolocumab in patients with high-grade glioma or glioblastoma.

Author

Singh, Kirit, primary, Foster, Matthew, additional, Miller, Elizabeth S., additional, Gregory, Simon, additional, Weinhold, Kent J., additional, Ashley, David M., additional, Desjardins, Annick, additional, Low, Justin, additional, Peters, Katherine B., additional, Severance, Erin, additional, Jaggers, Denise, additional, Friedman, Henry S., additional, Johnson, Margaret O., additional, Friedman, Allan H., additional, Keir, Stephen T., additional, Herndon, James Emmett, additional, Li, Chuan-Yuan, additional, Fecci, Peter E., additional, Sampson, John H., additional, and Khasraw, Mustafa, additional

Published
2022
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24. Racial disparities in inpatient clinical presentation, treatment, and outcomes in brain metastasis.

Author

McCray, Edwin, Waguia, Romaric, Ramos, Rafael de la Garza, Price, Meghan J, Williamson, Theresa, Dalton, Tara, Sciubba, Daniel M, Yassari, Reza, Goodwin, Andrea N, Fecci, Peter, Johnson, Margaret O, Chaichana, Kaisorn, and Goodwin, C Rory

Subjects
BRAIN metastasis, RACIAL inequality, SYMPTOMS, RACE, BLACK people, COLOR blindness
Abstract

Background Few studies have assessed the impact of race on short-term patient outcomes in the brain metastasis population. The goal of this study is to evaluate the association of race with inpatient clinical presentation, treatment, in-hospital complications, and in-hospital mortality rates for patients with brain metastases (BM). Method Using data collected from the National Inpatient Sample between 2004 and 2014, we retrospectively identified adult patients with a primary diagnosis of BM. Outcomes included nonroutine discharge, prolonged length of stay (pLOS), in-hospital complications, and mortality. Results Minority (Black, Hispanic/other) patients were less likely to receive surgical intervention compared to White patients (odds ratio [OR] 0.70; 95% confidence interval [CI] 0.66–0.74, p  < 0.001; OR 0.88; 95% CI 0.84–0.93, p  < 0.001). Black patients were more likely to develop an in-hospital complication than White patients (OR 1.35, 95% CI 1.28–1.41, p  < 0.001). Additionally, minority patients were more likely to experience pLOS than White patients (OR 1.48; 95% CI 1.41–1.57, p  < 0.001; OR 1.34; 95% CI 1.27–1.42, p  < 0.001). Black patients were more likely to experience a nonroutine discharge (OR 1.25; 95% CI 1.19–1.31, p  < 0.001) and higher in-hospital mortality than White (OR 1.13; 95% CI 1.03–1.23, p  = 0.008). Conclusion Our analysis demonstrated that race is associated with disparate short-term outcomes in patients with BM. More efforts are needed to address these disparities, provide equitable care, and allow for similar outcomes regardless of care. [ABSTRACT FROM AUTHOR]

Published
2023
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25. Validation of an Online Calculator to Predict Short-term Postoperative Outcomes in Patients with Metastatic Brain Tumors

Author

Kang, Jennifer H., primary, Murphy, Kelly Ryan, additional, McCray, Edwin, additional, Ramirez, Luis, additional, Price, Meghan, additional, Dalton, Tara E., additional, Peters, Katherine B., additional, Desjardins, Annick, additional, Johnson, Margaret O., additional, Friedman, Allan H., additional, Cook, Steven, additional, Codd, Patrick J., additional, Sampson, John H., additional, Zomorodi, Ali R., additional, Fecci, Peter E., additional, and Goodwin, C. Rory, additional

Published
2021
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26. Primary brain tumor patients admitted to a US intensive care unit: a descriptive analysis

Author

Kang, Jennifer H, primary, Swisher, Christa B, additional, Buckley, Evan D, additional, Herndon, James E, additional, Lipp, Eric S, additional, Kirkpatrick, John P, additional, Desjardins, Annick, additional, Friedman, Henry S, additional, Johnson, Margaret O, additional, Randazzo, Dina M, additional, Ashley, David M, additional, and Peters, Katherine B, additional

Published
2021
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28. The mutational landscape of older patients with IDH wild-type glioblastoma (GBM).

Author

Johnson, Margaret O, primary, Xiu, Joanne, additional, Glantz, Michael J., additional, Zeng, Jia, additional, Chen, Clark C, additional, Dunbar, Erin M., additional, Fonkem, Ekokobe, additional, Kesari, Santosh, additional, Brenner, Andrew J., additional, Newton, Herbert B., additional, Low, Justin, additional, Sumrall, Ashley Love, additional, Korn, Wolfgang Michael, additional, and Ashley, David M., additional

Published
2021
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29. Adjuvant radiation in older patients with glioblastoma: a retrospective single institution analysis

Author

Lee, Jessica W, Kirkpatrick, John P, McSherry, Frances, Herndon, James E, Lipp, Eric S, Desjardins, Annick, Randazzo, Dina M, Friedman, Henry S, Ashley, David M, Peters, Katherine B, Johnson, Margaret O, Lee, Jessica W, Kirkpatrick, John P, McSherry, Frances, Herndon, James E, Lipp, Eric S, Desjardins, Annick, Randazzo, Dina M, Friedman, Henry S, Ashley, David M, Peters, Katherine B, and Johnson, Margaret O

Abstract

Objectives Standard 6-week and hypofractionated 3-week courses of adjuvant radiation therapy (RT) are both options for older patients with glioblastoma (GBM), but deciding the optimal regimen can be challenging. This analysis explores clinical factors associated with selection of RT course, completion of RT, and outcomes following RT. Materials and Methods This IRB-approved retrospective analysis identified patients ≥70 years old with GBM who initiated adjuvant RT at our institution between 2004 and 2016. We identified factors associated with standard or hypofractionated RT using the Cochran-Armitage trend test, estimated time-to-event endpoints using the Kaplan-Meier method, and found predictors of overall survival (OS) using Cox proportional hazards models. Results Sixty-two patients with a median age of 74 (range 70–90) initiated adjuvant RT, with 43 (69%) receiving standard RT and 19 (31%) receiving hypofractionated RT. Selection of short-course RT was associated with older age (p = 0.04) and poor KPS (p = 0.03). Eight (13%) patients did not complete RT, primarily for hospice care due to worsening symptoms. After a median follow-up of 37 months, median OS was 12.3 months (95% CI 9.0–15.1). Increased age (p < 0.05), poor KPS (p < 0.0001), lack of MGMT methylation (p < 0.05), and lack of RT completion (p < 0.0001) were associated with worse OS on multivariate analysis. In this small cohort, GTV size and receipt of standard or hypofractionated RT were not associated with OS. Conclusions In this cohort of older patients with GBM, age and KPS was associated with selection of short-course or standard RT. These regimens had similar OS, though a subset of patients experienced worsening symptoms during RT and discontinued treatment. Further investigation into predictors of RT completion and survival may help guide adjuvant therapies and supportive care for older patients.

Published
2021

31. Glioblastoma as an age-related neurological disorder in adults

Author

Kim, Miri, primary, Ladomersky, Erik, additional, Mozny, Andreas, additional, Kocherginsky, Masha, additional, O’Shea, Kaitlyn, additional, Reinstein, Zachary Z, additional, Zhai, Lijie, additional, Bell, April, additional, Lauing, Kristen L, additional, Bollu, Lakshmi, additional, Rabin, Erik, additional, Dixit, Karan, additional, Kumthekar, Priya, additional, Platanias, Leonidas C, additional, Hou, Lifang, additional, Zheng, Yinan, additional, Wu, Jennifer, additional, Zhang, Bin, additional, Hrachova, Maya, additional, Merrill, Sarah A, additional, Mrugala, Maciej M, additional, Prabhu, Vikram C, additional, Horbinski, Craig, additional, James, Charles David, additional, Yamini, Bakhtiar, additional, Ostrom, Quinn T, additional, Johnson, Margaret O, additional, Reardon, David A, additional, Lukas, Rimas V, additional, and Wainwright, Derek A, additional

Published
2021
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32. Phase I trial of D2C7 immunotoxin (D2C7-IT) administered intratumorally via convection-enhanced delivery (CED) for recurrent malignant glioma (MG).

Author

Desjardins, Annick, primary, Randazzo, Dina, additional, Chandramohan, Vidyalakshmi, additional, Peters, Katherine B., additional, Johnson, Margaret O, additional, Threatt, Stevie, additional, Bullock, Chevelle A, additional, Herndon, James Emmett, additional, Healy, Patrick, additional, Lipp, Eric S, additional, Sampson, John H., additional, Friedman, Allan H., additional, Friedman, Henry S., additional, Ashley, David M., additional, and Bigner, Darell D., additional

Published
2020
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33. Patterns of relapse after successful completion of initial therapy in primary central nervous system lymphoma: a case series

Author

Patel, Mallika P., primary, Kirkpatrick, John P., additional, Johnson, Margaret O., additional, Healy, Patrick, additional, Herndon, James E., additional, Lipp, Eric S., additional, Miller, Elizabeth S., additional, Desjardins, Annick, additional, Randazzo, Dina, additional, Friedman, Henry S., additional, Ashley, David M., additional, and Peters, Katherine B., additional

Published
2020
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36. Oncolytic polio/rhinovirus recombinant (PVSRIPO) against WHO grade IV malignant glioma (MG): Experience with retreatment of survivors from the phase I trial.

Author

Desjardins, Annick, primary, Gromeier, Matthias, additional, Herndon, James Emmett, additional, Randazzo, Dina, additional, Threatt, Stevie, additional, Lipp, Eric S., additional, Miller, Elizabeth S., additional, Jackman, Jennifer, additional, Bolognesi, Dani P., additional, Friedman, Allan H., additional, Friedman, Henry S., additional, McSherry, Frances, additional, Peters, Katherine B., additional, Johnson, Margaret O, additional, Sampson, John H., additional, Ashley, David M., additional, and Bigner, Darell D., additional

Published
2019
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38. An adult with recurrent atypical teratoid rhabdoid tumor of the spine

Author

Charles, Antoinette J, Smith, Vanessa L, Goodwin, C Rory, and Johnson, Margaret O

Abstract

Atypical teratoid rhabdoid tumors (AT/RT) are rare and highly malignant CNS neoplasms primarily affecting children. Adult cases are extremely uncommon, with only approximately 92 reported. Spinal AT/RT in adults is particularly rare. Here, we present the case of a 50-year-old patient diagnosed with AT/RT of the spine. Initially, they were diagnosed and treated for a spinal ependymoma. However, after 10 years, a recurrence was detected through magnetic resonance imaging (MRI) and the tumor was reclassified as AT/RT. We discuss the significance of SMARCB1gene mutations in diagnosing AT/RT and describe our unique treatment approach involving surgery, radiation and anti-PD1 therapy in this patient.

Published
2024
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41. 19-Year-Old Male with Headaches and a Possible Seizure

Author

Nasrallah, MacLean P., primary, Nasrallah, Ilya M., additional, Prelack, Marisa S., additional, Johnson, Margaret O., additional, Lewis, Travis B., additional, Rubenstein, Michael, additional, Minturn, Jane E., additional, Desai, Arati, additional, Marcotte, Paul, additional, Santi, Mariarita, additional, and Martinez-Lage, Maria, additional

Published
2017
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42. Bibliography.

Subjects
CEREBRAL ischemia treatment, HEART failure treatment, FECAL incontinence -- Risk factors, TREATMENT of lung tumors, STROKE treatment, BEREAVEMENT, CANCER patient medical care, CANCER treatment, CANCER pain, HEALTH care teams, HOME care services, HOSPICE care, OUTPATIENT services in hospitals, MEDICAID, MUSIC therapy, PALLIATIVE treatment, TERMINAL care, TUMOR classification, ADVANCE directives (Medical care), SPECIALTY hospitals, IDIOPATHIC pulmonary fibrosis, HOSPITAL mortality
Published
2019
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