Browsing by Author "Mohile, Nimish"

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    Epid-07. Access to Glioblastoma Clinical Trials for Rural Patients in the United States from 2010–2020
    (Oxford University Press, 2020-11) Nevel, Kathryn; Capouch, Samuel; Arnold, Lisa; Peters, Katherine; Mohile, Nimish; Thomas, Alissa; Neurology, School of Medicine
    Background: Patients in rural communities have less access to optimal cancer care and clinical trials. For GBM, access to experimental therapies, and consideration of a clinical trial is embedded in national guidelines. Still, the availability of clinical trials to rural communities, representing 20% of the US population, has not been described. Methods: We queried ClinicalTrials.gov for glioblastoma interventional treatment trials opened between 1/2010 and 1/2020 in the United States. We created a Structured Query Language database and leveraged Google application programming interfaces (API) Places to find name and street addresses for the sites, and Google’s Geocode API to determine the county location. Counties were classified by US Department of Agriculture Rural-Urban Continuum Codes (RUCC 1–3 = urban and RUCC 4–9 = rural). We used z-ratios for rural-urban statistical comparisons. Results: We identified 406 interventional treatment trials for GBM at 1491 unique sites. 8.7% of unique sites were in rural settings. Rural sites opened an average of 1.7 trials/site and urban sites 2.8 trials/site from 1/2010–1/2020. Rural sites offered more phase II trials (63% vs 57%, p= 0.03) and fewer phase I trials (22% vs 28%, p= 0.01) than urban sites. Rural locations were more likely to offer federally-sponsored trials (p< 0.002). There were no investigator-initiated or single-institution trials offered at rural locations, and only 1% of industry trials were offered rurally. Discussion: Clinical trials for GBM were rarely open in rural areas, and were more dependent on federal funding. Clinical trials are likely difficult to access for rural patients, and this has important implications for the generalizability of research as well as how we engage the field of neuro-oncology and patient advocacy groups in improving patient access to trials. Increasing the number of clinical trials in rural locations may enable more rural patients to access and enroll in GBM studies.
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    Prospective biomarker study in newly diagnosed glioblastoma: Cyto-C clinical trial
    (Oxford University Press, 2021-12-24) Griguer, Corinne E.; Oliva, Claudia R.; Coffey, Christopher S.; Cudkowicz, Merit E.; Conwit, Robin A.; Gudjonsdottir, Anna L.; Ecklund, Dixie J.; Fedler, Janel K.; Neill-Hudson, Tina M.; Nabors, Louis B.; Benge, Melanie; Hackney, James R.; Chase, Marianne; Leonard, Timothy P.; Patel, Toral; Colman, Howard; de la Fuente, Macarena; Chaudhary, Rekha; Marder, Karen; Kreisl, Teri; Mohile, Nimish; Chheda, Milan G.; McNeill, Katharine; Kumthekar, Priya; Dogan, Aclan; Drappatz, Jan; Puduvalli, Vinay; Kowalska, Agnes; Graber, Jerome; Gerstner, Elizabeth; Clark, Stephen; Salacz, Michael; Markert, James; Neurology, School of Medicine
    Background: Glioblastoma (GBM) has a 5-year survival rate of 3%-5%. GBM treatment includes maximal resection followed by radiotherapy with concomitant and adjuvant temozolomide (TMZ). Cytochrome C oxidase (CcO) is a mitochondrial enzyme involved in the mechanism of resistance to TMZ. In a prior retrospective trial, CcO activity in GBMs inversely correlated with clinical outcome. The current Cyto-C study was designed to prospectively evaluate and validate the prognostic value of tumor CcO activity in patients with newly diagnosed primary GBM, and compared to the known prognostic value of MGMT promoter methylation status. Methods: This multi-institutional, blinded, prospective biomarker study enrolled 152 patients with newly diagnosed GBM who were to undergo surgical resection and would be candidates for standard of care. The primary end point was overall survival (OS) time, and the secondary end point was progression-free survival (PFS) time. Tumor CcO activity and MGMT promoter methylation status were assayed in a centralized laboratory. Results: OS and PFS did not differ by high or low tumor CcO activity, and the prognostic validity of MGMT promoter methylation was confirmed. Notably, a planned exploratory analysis suggested that the combination of low CcO activity and MGMT promoter methylation in tumors may be predictive of long-term survival. Conclusions: Tumor CcO activity alone was not confirmed as a prognostic marker in GBM patients. However, the combination of low CcO activity and methylated MGMT promoter may reveal a subgroup of GBM patients with improved long-term survival that warrants further evaluation. Our work also demonstrates the importance of performing large, multi-institutional, prospective studies to validate biomarkers. We also discuss lessons learned in assembling such studies.