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3. Phase II study of monthly pasireotide LAR (SOM230C) for recurrent or progressive meningioma

Author

Norden, A. D., primary, Ligon, K. L., additional, Hammond, S. N., additional, Muzikansky, A., additional, Reardon, D. A., additional, Kaley, T. J., additional, Batchelor, T. T., additional, Plotkin, S. R., additional, Raizer, J. J., additional, Wong, E. T., additional, Drappatz, J., additional, Lesser, G. J., additional, Haidar, S., additional, Beroukhim, R., additional, Lee, E. Q., additional, Doherty, L., additional, Lafrankie, D., additional, Gaffey, S. C., additional, Gerard, M., additional, Smith, K. H., additional, McCluskey, C., additional, Phuphanich, S., additional, and Wen, P. Y., additional

Published
2014
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4. SM-03 * A RANDOMIZED, PLACEBO-CONTROLLED PILOT TRIAL OF ARMODAFINIL FOR FATIGUE IN PATIENTS WITH GLIOMAS UNDERGOING RADIOTHERAPY

Author

Lee, E., primary, Muzikansky, A., additional, Kesari, S., additional, Wong, E., additional, Fadul, C., additional, Reardon, D., additional, Norden, A., additional, Nayak, L., additional, Rinne, M., additional, Alexander, B., additional, Arvold, N., additional, Doherty, L., additional, LaFrankie, D., additional, Pulverenti, J., additional, Smith, K., additional, Gaffey, S., additional, Kenney, A., additional, Hammond, S., additional, Drappatz, J., additional, and Wen, P., additional

Published
2014
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5. Retrospective study of carmustine or lomustine with bevacizumab in recurrent glioblastoma patients who have failed prior bevacizumab

Author

Rahman, R., primary, Hempfling, K., additional, Norden, A. D., additional, Reardon, D. A., additional, Nayak, L., additional, Rinne, M. L., additional, Beroukhim, R., additional, Doherty, L., additional, Ruland, S., additional, Rai, A., additional, Rifenburg, J., additional, LaFrankie, D., additional, Alexander, B. M., additional, Huang, R. Y., additional, Wen, P. Y., additional, and Lee, E. Q., additional

Published
2014
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6. MEDICAL RADIATION THERAPIES

Author

Ahmed, I., primary, Biswas, A., additional, Krishnamurthy, S., additional, Julka, P., additional, Rath, G., additional, Back, M., additional, Huang, D., additional, Gzell, C., additional, Chen, J., additional, Kastelan, M., additional, Gaur, P., additional, Wheeler, H., additional, Badiyan, S. N., additional, Robinson, C. G., additional, Simpson, J. R., additional, Tran, D. D., additional, Rich, K. M., additional, Dowling, J. L., additional, Chicoine, M. R., additional, Leuthardt, E. C., additional, Kim, A. H., additional, Huang, J., additional, Michaelsen, S. R., additional, Christensen, I. J., additional, Grunnet, K., additional, Stockhausen, M.-T., additional, Broholm, H., additional, Kosteljanetz, M., additional, Poulsen, H. S., additional, Tieu, M., additional, Lovblom, E., additional, Macnamara, M., additional, Mason, W., additional, Rodin, D., additional, Tai, E., additional, Ubhi, K., additional, Laperriere, N., additional, Millar, B.-A., additional, Menard, C., additional, Perkins, B., additional, Chung, C., additional, Clarke, J., additional, Molinaro, A., additional, Phillips, J., additional, Butowski, N., additional, Chang, S., additional, Perry, A., additional, Costello, J., additional, DeSilva, A., additional, Rabbitt, J., additional, Prados, M., additional, Cohen, A. L., additional, Anker, C., additional, Shrieve, D., additional, Hall, B., additional, Salzman, K., additional, Jensen, R., additional, Colman, H., additional, Farber, O., additional, Weinberg, U., additional, Palti, Y., additional, Fisher, B., additional, Chen, H., additional, Macdonald, D., additional, Lesser, G., additional, Coons, S., additional, Brachman, D., additional, Ryu, S., additional, Werner-Wasik, M., additional, Bahary, J.-P., additional, Chakravarti, A., additional, Mehta, M., additional, Gupta, T., additional, Nair, V., additional, Epari, S., additional, Godasastri, J., additional, Moiyadi, A., additional, Shetty, P., additional, Juvekar, S., additional, Jalali, R., additional, Herrlinger, U., additional, Schafer, N., additional, Steinbach, J., additional, Weyerbrock, A., additional, Hau, P., additional, Goldbrunner, R., additional, Kohnen, R., additional, Urbach, H., additional, Stummer, W., additional, Glas, M., additional, Houillier, C., additional, Ghesquieres, H., additional, Chabrot, C., additional, Soussain, C., additional, Ahle, G., additional, Choquet, S., additional, Faurie, P., additional, Bay, J.-O., additional, Vargaftig, J., additional, Gaultier, C., additional, Nicolas-Virelizier, E., additional, Hoang-Xuan, K., additional, Iskanderani, O., additional, Izar, F., additional, Benouaich-Amiel, A., additional, Filleron, T., additional, Moyal, E., additional, Iweha, C., additional, Jain, S., additional, Melian, E., additional, Sethi, A., additional, Albain, K., additional, Shafer, D., additional, Emami, B., additional, Kong, X.-T., additional, Green, S., additional, Filka, E., additional, Green, R., additional, Yong, W., additional, Nghiemphu, P., additional, Cloughesy, T., additional, Lai, A., additional, Mallick, S., additional, Roy, S., additional, Purkait, S., additional, Gupta, S., additional, Julka, P. K., additional, Rath, G. K., additional, Marosi, C., additional, Thaler, J., additional, Ay, C., additional, Kaider, A., additional, Reitter, E.-M., additional, Haselbock, J., additional, Preusser, M., additional, Flechl, B., additional, Zielinski, C., additional, Pabinger, I., additional, Miyatake, S.-I., additional, Furuse, M., additional, Miyata, T., additional, Yoritsune, E., additional, Kawabata, S., additional, Kuroiwa, T., additional, Muragaki, Y., additional, Maruyama, T., additional, Iseki, H., additional, Akimoto, J., additional, Ikuta, S., additional, Nitta, M., additional, Maebayashi, K., additional, Saito, T., additional, Okada, Y., additional, Kaneko, S., additional, Matsumura, A., additional, Karasawa, K., additional, Nakazato, Y., additional, Kayama, T., additional, Nabors, L. B., additional, Fink, K. L., additional, Mikkelsen, T., additional, Grujicic, D., additional, Tarnawski, R., additional, Nam, D.-H., additional, Mazurkiewicz, M., additional, Salacz, M., additional, Ashby, L., additional, Thurzo, L., additional, Zagonel, V., additional, Depenni, R., additional, Perry, J. R., additional, Henslee-Downey, J., additional, Picard, M., additional, Reardon, D. A., additional, Nambudiri, N., additional, Nayak, L., additional, LaFrankie, D., additional, Wen, P., additional, Ney, D., additional, Carlson, J., additional, Damek, D., additional, Blatchford, P., additional, Gaspar, L., additional, Kavanagh, B., additional, Waziri, A., additional, Lillehei, K., additional, Reddy, K., additional, Chen, C., additional, Rashed, I., additional, Barton, K., additional, Anderson, D., additional, Prabhu, V., additional, Rusch, R., additional, Belongia, M., additional, Maheshwari, M., additional, Firat, S., additional, Schiff, D., additional, Desjardins, A., additional, Glantz, M., additional, Chamberlain, M., additional, Shapiro, W., additional, Gopal, S., additional, Judy, K., additional, Patel, S., additional, Mahapatra, A., additional, Shan, J., additional, Gupta, D., additional, Shih, K., additional, Bacha, J. A., additional, Brown, D., additional, Garner, W. J., additional, Steino, A., additional, Schwart, R., additional, Kanekal, S., additional, Li, M., additional, Lopez, L., additional, Burris, H. A., additional, Soderberg-Naucler, C., additional, Rahbar, A., additional, Stragliotto, G., additional, Song, A. J., additional, Kumar, A. M. S., additional, Murphy, E. S., additional, Tekautz, T., additional, Suh, J. H., additional, Recinos, V., additional, Chao, S. T., additional, Spoor, J., additional, Korami, K., additional, Kloezeman, J., additional, Balvers, R., additional, Dirven, C., additional, Lamfers, M., additional, Leenstra, S., additional, Sumrall, A., additional, Haggstrom, D., additional, Crimaldi, A., additional, Symanowski, J., additional, Giglio, P., additional, Asher, A., additional, Burri, S., additional, Sunkersett, G., additional, Khatib, Z., additional, Prajapati, C. M., additional, Magalona, E. E., additional, Mariano, M., additional, Sih, I. M., additional, Torcuator, R., additional, Taal, W., additional, Oosterkamp, H., additional, Walenkamp, A., additional, Beerenpoot, L., additional, Hanse, M., additional, Buter, J., additional, Honkoop, A., additional, Boerman, D., additional, de Vos, F., additional, Jansen, R., additional, van der Berkmortel, F., additional, Brandsma, D., additional, Enting, R., additional, Kros, J., additional, Bromberg, J., additional, van Heuvel, I., additional, Smits, M., additional, van der Holt, R., additional, Vernhout, R., additional, van den Bent, M., additional, Wick, W., additional, Suarez, C., additional, Rodon, J., additional, Forsyth, P., additional, Gueorguieva, I., additional, Cleverly, A., additional, Burkholder, T., additional, Desaiah, D., additional, Lahn, M., additional, Zach, L., additional, Guez, D., additional, Last, D., additional, Daniels, D., additional, Nissim, O., additional, Grober, Y., additional, Hoffmann, C., additional, Nass, D., additional, Talianski, A., additional, Spiegelmann, R., additional, Cohen, Z., additional, and Mardor, Y., additional

Published
2013
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7. Phase 2 study of dose-intense temozolomide in recurrent glioblastoma

Author

Norden, A. D., primary, Lesser, G. J., additional, Drappatz, J., additional, Ligon, K. L., additional, Hammond, S. N., additional, Lee, E. Q., additional, Reardon, D. R., additional, Fadul, C. E., additional, Plotkin, S. R., additional, Batchelor, T. T., additional, Zhu, J.-J., additional, Beroukhim, R., additional, Muzikansky, A., additional, Doherty, L., additional, Lafrankie, D., additional, Smith, K., additional, Tafoya, V., additional, Lis, R., additional, Stack, E. C., additional, Rosenfeld, M. R., additional, and Wen, P. Y., additional

Published
2013
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8. Interim Analysis of a Randomized Placebo-Controlled Pilot Trial of Armodafinil for Fatigue in Patients with Malignant Gliomas Undergoing Radiotherapy with or without Standard Chemotherapy Treatment (P07.104)

Author

Hammond, S., primary, Drappatz, J., additional, Lee, E., additional, Muzikansky, A., additional, Weiss, S., additional, Kesari, S., additional, Wong, E., additional, Fadul, C., additional, Norden, A., additional, Beroukhim, R., additional, Alexander, B., additional, Ruland, S., additional, Ciampa, A., additional, Lafrankie, D., additional, Doherty, L., additional, McCluskey, C., additional, Smith, K., additional, Gerard, M., additional, and Wen, P., additional

Published
2012
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9. Phase I study of panobinostat in combination with bevacizumab for recurrent high-grade glioma

Author

Drappatz, J., primary, Lee, E. Q., additional, Hammond, S., additional, Grimm, S. A., additional, Norden, A. D., additional, Beroukhim, R., additional, Gerard, M., additional, Schiff, D., additional, Chi, A. S., additional, Batchelor, T. T., additional, Doherty, L. M., additional, Ciampa, A. S., additional, LaFrankie, D. C., additional, Ruland, S., additional, Snodgrass, S. M., additional, Raizer, J. J., additional, and Wen, P. Y., additional

Published
2011
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11. A phase I trial of LBH589 and bevacizumab for recurrent high-grade glioma (HGG).

Author

Drappatz, J., primary, Raizer, J. J., additional, Schiff, D., additional, Chi, A. S., additional, Batchelor, T., additional, Snodgrass, S. M., additional, Quant, E. C., additional, Norden, A. D., additional, Beroukhim, R., additional, Grimm, S. A., additional, Doherty, L. M., additional, Ciampa, A. S., additional, LaFrankie, D. C., additional, Ruland, S., additional, Gerard, M., additional, Hammond, S., additional, and Wen, P. Y., additional

Published
2011
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12. Phase II study of dose-intense temozolomide in recurrent glioblastoma.

Author

Hammond, S., primary, Norden, A. D., additional, Lesser, G. J., additional, Drappatz, J., additional, Fadul, C. E., additional, Batchelor, T., additional, Quant, E. C., additional, Beroukhim, R., additional, Muzikansky, A., additional, Ciampa, A. S., additional, Doherty, L. M., additional, LaFrankie, D. C., additional, Ruland, S., additional, Bochacki, C. A., additional, Griffin, K., additional, Gerard, M., additional, Sceppa, C., additional, Rosenfeld, M. R., additional, and Wen, P. Y., additional

Published
2011
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14. Ongoing Clinical Trials

Author

Clarke, J. L., primary, Ennis, M. M., additional, Lamborn, K. R., additional, Prados, M. D., additional, Puduvalli, V. K., additional, Penas-Prado, M., additional, Gilbert, M. R., additional, Groves, M. D., additional, Hess, K. R., additional, Levin, V. A., additional, de Groot, J., additional, Colman, H., additional, Conrad, C. A., additional, Loghin, M. E., additional, Hunter, K., additional, Yung, W. K., additional, Chen, C., additional, Damek, D., additional, Liu, A., additional, Gaspar, L. E., additional, Waziri, A., additional, Lillehei, K., additional, Kavanagh, B., additional, Finlay, J. L., additional, Haley, K., additional, Dhall, G., additional, Gardner, S., additional, Allen, J., additional, Cornelius, A., additional, Olshefski, R., additional, Garvin, J., additional, Pradhan, K., additional, Etzl, M., additional, Goldman, S., additional, Atlas, M., additional, Thompson, S., additional, Hirt, A., additional, Hukin, J., additional, Comito, M., additional, Bertolone, S., additional, Torkildson, J., additional, Joyce, M., additional, Moertel, C., additional, Letterio, J., additional, Kennedy, G., additional, Walter, A., additional, Ji, L., additional, Sposto, R., additional, Dorris, K., additional, Wagner, L., additional, Hummel, T., additional, Drissi, R., additional, Miles, L., additional, Leach, J., additional, Chow, L., additional, Turner, R., additional, Gragert, M. N., additional, Pruitt, D., additional, Sutton, M., additional, Breneman, J., additional, Crone, K., additional, Fouladi, M., additional, Friday, B. B., additional, Buckner, J., additional, Anderson, S. K., additional, Giannini, C., additional, Kugler, J., additional, Mazurczac, M., additional, Flynn, P., additional, Gross, H., additional, Pajon, E., additional, Jaeckle, K., additional, Galanis, E., additional, Badruddoja, M. A., additional, Pazzi, M. A., additional, Stea, B., additional, Lefferts, P., additional, Contreras, N., additional, Bishop, M., additional, Seeger, J., additional, Carmody, R., additional, Rance, N., additional, Marsella, M., additional, Schroeder, K., additional, Sanan, A., additional, Swinnen, L. J., additional, Rankin, C., additional, Rushing, E. J., additional, Hutchins, L. F., additional, Damek, D. M., additional, Barger, G. R., additional, Norden, A. D., additional, Lesser, G., additional, Hammond, S. N., additional, Drappatz, J., additional, Fadul, C. E., additional, Batchelor, T. T., additional, Quant, E. C., additional, Beroukhim, R., additional, Ciampa, A., additional, Doherty, L., additional, LaFrankie, D., additional, Ruland, S., additional, Bochacki, C., additional, Phan, P., additional, Faroh, E., additional, McNamara, B., additional, David, K., additional, Rosenfeld, M. R., additional, Wen, P. Y., additional, Phuphanich, S., additional, Reardon, D., additional, Wong, E. T., additional, Plotkin, S. R., additional, Mintz, A., additional, Raizer, J. J., additional, Kaley, T. J., additional, Smith, K. H., additional, Chamberlain, M. C., additional, Graham, C., additional, Mrugala, M., additional, Johnston, S., additional, Kreisl, T. N., additional, Smith, P., additional, Iwamoto, F., additional, Sul, J., additional, Butman, J. A., additional, Fine, H. A., additional, Westphal, M., additional, Heese, O., additional, Warmuth-Metz, M., additional, Pietsch, T., additional, Schlegel, U., additional, Tonn, J.-C., additional, Schramm, J., additional, Schackert, G., additional, Melms, A., additional, Mehdorn, H. M., additional, Seifert, V., additional, Geletneky, K., additional, Reuter, D., additional, Bach, F., additional, Khasraw, M., additional, Abrey, L. E., additional, Lassman, A. B., additional, Hormigo, A., additional, Nolan, C., additional, Gavrilovic, I. T., additional, Mellinghoff, I. K., additional, Reiner, A. S., additional, DeAngelis, L., additional, Omuro, A. M., additional, Burzynski, S. R., additional, Weaver, R. A., additional, Janicki, T. J., additional, Burzynski, G. S., additional, Szymkowski, B., additional, Acelar, S. S., additional, Mechtler, L. L., additional, O'Connor, P. C., additional, Kroon, H.-A., additional, Vora, T., additional, Kurkure, P., additional, Arora, B., additional, Gupta, T., additional, Dhamankar, V., additional, Banavali, S., additional, Moiyadi, A., additional, Epari, S., additional, Merchant, N., additional, Jalali, R., additional, Moller, S., additional, Grunnet, K., additional, Hansen, S., additional, Schultz, H., additional, Holmberg, M., additional, Sorensen, M. M., additional, Poulsen, H. S., additional, Lassen, U., additional, Reardon, D. A., additional, Vredenburgh, J. J., additional, Desjardins, A., additional, Janney, D. E., additional, Peters, K., additional, Sampson, J., additional, Gururangan, S., additional, Friedman, H. S., additional, Jeyapalan, S., additional, Constantinou, M., additional, Evans, D., additional, Elinzano, H., additional, O'Connor, B., additional, Puthawala, M. Y., additional, Goldman, M., additional, Oyelese, A., additional, Cielo, D., additional, Dipetrillo, T., additional, Safran, H., additional, Anan, M., additional, Seyed Sadr, M., additional, Alshami, J., additional, Sabau, C., additional, Seyed Sadr, E., additional, Siu, V., additional, Guiot, M.-C., additional, Samani, A., additional, Del Maestro, R., additional, Bogdahn, U., additional, Stockhammer, G., additional, Mahapatra, A. K., additional, Venkataramana, N. K., additional, Oliushine, V. E., additional, Parfenov, V. E., additional, Poverennova, I. E., additional, Hau, P., additional, Jachimczak, P., additional, Heinrichs, H., additional, Schlingensiepen, K.-H., additional, Shibui, S., additional, Kayama, T., additional, Wakabayashi, T., additional, Nishikawa, R., additional, de Groot, M., additional, Aronica, E., additional, Vecht, C. J., additional, Toering, S. T., additional, Heimans, J. J., additional, Reijneveld, J. C., additional, Batchelor, T., additional, Mulholland, P., additional, Neyns, B., additional, Nabors, L. B., additional, Campone, M., additional, Wick, A., additional, Mason, W., additional, Mikkelsen, T., additional, Ashby, L. S., additional, DeGroot, J. F., additional, Gattamaneni, H. R., additional, Cher, L. M., additional, Rosenthal, M. A., additional, Payer, F., additional, Xu, J., additional, Liu, Q., additional, van den Bent, M., additional, Nabors, B., additional, Fink, K., additional, Chan, M., additional, Trusheim, J., additional, Raval, S., additional, Hicking, C., additional, Henslee-Downey, J., additional, Picard, M., additional, Schiff, D., additional, Karimi, S., additional, DeAngelis, L. M., additional, Nolan, C. P., additional, Omuro, A., additional, Gavrilovic, I., additional, Norden, A., additional, Purow, B. W., additional, Lieberman, F. S., additional, Hariharan, S., additional, Perez-Larraya, J. G., additional, Honnorat, J., additional, Chinot, O., additional, Catry-Thomas, I., additional, Taillandier, L., additional, Guillamo, J. S., additional, Campello, C., additional, Monjour, A., additional, Tanguy, M. L., additional, Delattre, J. Y., additional, Franz, D. N., additional, Krueger, D. A., additional, Care, M. M., additional, Holland-Bouley, K., additional, Agricola, K., additional, Tudor, C., additional, Mangeshkar, P., additional, Byars, A. W., additional, Sahmoud, T., additional, Alonso-Basanta, M., additional, Lustig, R. A., additional, Dorsey, J. F., additional, Lai, R. K., additional, Recht, L. D., additional, Paleologos, N., additional, Groves, M., additional, Meech, S., additional, Davis, T., additional, Pavlov, D., additional, Marshall, M. A., additional, Slot, M., additional, Peerdeman, S. M., additional, Beauchesne, P. D., additional, Faure, G., additional, Noel, G., additional, Schmitt, T., additional, Kerr, C., additional, Jadaud, E., additional, Martin, L., additional, Carnin, C., additional, Peters, K. B., additional, Herndon, J. E., additional, Kirkpatrick, J. P., additional, Nayak, L., additional, Panageas, K. S., additional, and Deangelis, L. M., additional

Published
2010
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19. Activity of PD-1 blockade with nivolumab among patients with recurrent atypical/anaplastic meningioma: phase II trial results.

Author

Bi WL, Nayak L, Meredith DM, Driver J, Du Z, Hoffman S, Li Y, Lee EQ, Beroukhim R, Rinne M, McFaline-Figueroa R, Chukwueke U, McCluskey C, Gaffey S, Cherniack AD, Stefanik J, Doherty L, Taubert C, Cifrino M, LaFrankie D, Graillon T, Wen PY, Ligon KL, Al-Mefty O, Huang RY, Muzikansky A, Chiocca EA, Santagata S, Dunn IF, and Reardon DA

Subjects
B7-H1 Antigen, Humans, Neoplasm Recurrence, Local drug therapy, Nivolumab therapeutic use, Programmed Cell Death 1 Receptor, Meningeal Neoplasms drug therapy, Meningioma drug therapy
Abstract

Background: Programmed death ligand 1 (PD-L1) contributes to tumor immunosuppression and is upregulated in aggressive meningiomas. We performed a phase II study of nivolumab, a programmed death 1 (PD-1) blocking antibody among patients with grade ≥2 meningioma that recurred after surgery and radiation therapy., Methods: Twenty-five patients received nivolumab (240 mg biweekly) until progression, voluntary withdrawal, unacceptable toxicity, or death. Tumor mutational burden (TMB) and quantification of tumor-infiltrating lymphocytes (TIL) were evaluated as potential immunocorrelative biomarkers. Change in neurologic function was prospectively assessed using the Neurologic Assessment in Neuro-Oncology (NANO) scale., Results: Enrolled patients had multiple recurrences including ≥3 prior surgeries and ≥2 prior courses of radiation in 60% and 72%, respectively. Nivolumab was well tolerated with no unexpected adverse events. Six-month progression-free survival (PFS-6) rate was 42.4% (95% CI: 22.8, 60.7) and the median OS was 30.9 months (95% CI: 17.6, NA). One patient achieved radiographic response (ongoing at 4.5 years). TMB was >10/Mb in 2 of 15 profiled tumors (13.3%). Baseline TIL density was low but increased posttreatment in 3 patients including both patients with elevated TMB. Most patients who achieved PFS-6 maintained neurologic function prior to progression as assessed by NANO., Conclusion: Nivolumab was well tolerated but failed to improve PFS-6, although a subset of patients appeared to derive benefit. Low levels of TMB and TIL density were typically observed. NANO assessment of neurologic function contributed to outcome assessment. Future studies may consider rationally designed combinatorial regimens., (© The Author(s) 2021. Published by Oxford University Press on behalf of the Society for Neuro-Oncology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Published
2022
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20. Phase II trial of ponatinib in patients with bevacizumab-refractory glioblastoma.

Author

Lee EQ, Muzikansky A, Duda DG, Gaffey S, Dietrich J, Nayak L, Chukwueke UN, Beroukhim R, Doherty L, Laub CK, LaFrankie D, Fontana B, Stefanik J, Ruland S, Caruso V, Bruno J, Ligon K, Reardon DA, and Wen PY

Subjects
Adult, Aged, Biomarkers blood, Brain Neoplasms blood, Brain Neoplasms mortality, Cytokines blood, Drug Resistance, Neoplasm drug effects, Female, Glioblastoma blood, Glioblastoma mortality, Humans, Imidazoles adverse effects, Imidazoles pharmacology, Karnofsky Performance Status, Male, Middle Aged, Progression-Free Survival, Protein Kinase Inhibitors adverse effects, Pyridazines adverse effects, Pyridazines pharmacology, Receptor, TIE-2 blood, Vascular Endothelial Growth Factor A blood, Vascular Endothelial Growth Factor Receptor-1 blood, Vascular Endothelial Growth Factor Receptor-2 blood, Angiogenesis Inhibitors therapeutic use, Bevacizumab therapeutic use, Brain Neoplasms drug therapy, Glioblastoma drug therapy, Imidazoles therapeutic use, Protein Kinase Inhibitors therapeutic use, Pyridazines therapeutic use
Abstract

Background: Responses to bevacizumab in glioblastoma (GBM) are not durable. Plasma levels of basic fibroblast growth factor (bFGF) increase at the time of tumor progression. By targeting vascular endothelial growth factor receptor (VEGFR), platelet-derived growth factor receptor, Src, and FGF receptor pathways, ponatinib may potentially help to overcome some of the putative mechanisms of adaptive resistance., Methods: We performed a phase II trial of ponatinib in patients with bevacizumab-refractory GBM and variants. Adult patients with Karnofsky performance score (KPS) ≥60, measurable disease, and normal organ and marrow function received 45 mg ponatinib daily. No limit on the number of prior therapies but only one prior bevacizumab-containing regimen was allowed. Primary endpoint was 3-month progression-free survival. Plasma biomarkers of angiogenesis and inflammation were evaluated before and after treatment., Results: The study closed after the first stage. Fifteen patients enrolled: median age 61 [27-74]; median KPS 80 [70-90]; median number of prior relapses 2 [2-4]. Three-month progression-free survival rate was 0, median overall survival was 98 days [95% CI 56, 257], and median PFS was 28 days [95% CI 27, 30]. No responses were seen. The most common grade ≥3 adverse events included fatigue (n = 3), hypertension (2), and lipase elevation (2). Ponatinib treatment significantly increased plasma VEGF, soluble (s)VEGFR1, sVEGFR2, sTIE2, interferon gamma (IFNγ), tumor necrosis factor alpha (TNF-α), interleukin (IL)-6, IL-8, and IL-10 and decreased sVEGFR2., Conclusions: Ponatinib was associated with minimal activity in bevacizumab-refractory GBM patients. Circulating biomarker data confirmed pharmacodynamic changes and suggested that resistance to ponatinib may be related to an increase in inflammatory cytokines., (© 2019 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.)

Published
2019
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21. Phase I and Biomarker Study of Plerixafor and Bevacizumab in Recurrent High-Grade Glioma.

Author

Lee EQ, Duda DG, Muzikansky A, Gerstner ER, Kuhn JG, Reardon DA, Nayak L, Norden AD, Doherty L, LaFrankie D, Stefanik J, Vardam T, Smith KH, McCluskey C, Gaffey S, Batchelor TT, Jain RK, and Wen PY

Subjects
Adult, Aged, Benzylamines, Bevacizumab administration & dosage, Bevacizumab pharmacokinetics, Biomarkers, Tumor blood, Biomarkers, Tumor cerebrospinal fluid, Cyclams, Dose-Response Relationship, Drug, Drug Resistance, Neoplasm genetics, Female, Gene Expression Regulation, Neoplastic, Glioma blood, Glioma cerebrospinal fluid, Glioma genetics, Hepatocyte Growth Factor blood, Hepatocyte Growth Factor cerebrospinal fluid, Heterocyclic Compounds administration & dosage, Heterocyclic Compounds pharmacokinetics, Humans, Male, Middle Aged, Neoplasm Recurrence, Local blood, Neoplasm Recurrence, Local cerebrospinal fluid, Neoplasm Recurrence, Local genetics, Neoplastic Cells, Circulating metabolism, Progression-Free Survival, Proto-Oncogene Proteins c-met blood, Proto-Oncogene Proteins c-met cerebrospinal fluid, Receptors, CXCR4 genetics, Signal Transduction drug effects, Vascular Endothelial Growth Factor A genetics, Glioma drug therapy, Neoplasm Recurrence, Local drug therapy, Receptors, CXCR4 antagonists & inhibitors, Vascular Endothelial Growth Factor A antagonists & inhibitors
Abstract

Purpose: Although antiangiogenic therapy for high-grade glioma (HGG) is promising, responses are not durable. Correlative clinical studies suggest that the SDF-1α/CXCR4 axis may mediate resistance to VEGFR inhibition. Preclinical data have demonstrated that plerixafor (a reversible CXCR4 inhibitor) could inhibit glioma progression after anti-VEGF pathway inhibition. We conducted a phase I study to determine the safety of plerixafor and bevacizumab in recurrent HGG. Patients and Methods: Part 1 enrolled 23 patients with a 3 × 3 dose escalation design to a maximum planned dose of plerixafor 320 μg/kg subcutaneously on days 1 to 21 and bevacizumab 10 mg/kg intravenously on days 1 and 15 of each 28-day cycle. Cerebrospinal fluid (CSF) and plasma samples were obtained for pharmacokinetic analyses. Plasma and cellular biomarkers were evaluated before and after treatment. Part 2 enrolled 3 patients and was a surgical study to determine plerixafor's penetration in tumor tissue. Results: In Part 1, no dose-limiting toxicities were seen at the maximum planned dose of plerixafor + bevacizumab. Treatment was well tolerated. After plerixafor 320 μg/kg treatment, the average CSF drug concentration was 26.8 ± 19.6 ng/mL. Plerixafor concentration in resected tumor tissue from patients pretreated with plerixafor was 10 to 12 μg/g. Circulating biomarker data indicated that plerixafor + bevacizumab induces rapid and persistent increases in plasma SDF-1α and placental growth factor. Progression-free survival correlated with pretreatment plasma soluble mesenchymal-epithelial transition receptor and sVEGFR1, and overall survival with the change during treatment in CD34 + progenitor/stem cells and CD8 T cells. Conclusions: Plerixafor + bevacizumab was well tolerated in HGG patients. Plerixafor distributed to both the CSF and brain tumor tissue, and treatment was associated with biomarker changes consistent with VEGF and CXCR4 inhibition. Clin Cancer Res; 24(19); 4643-9. ©2018 AACR ., (©2018 American Association for Cancer Research.)

Published
2018
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22. A randomized, placebo-controlled pilot trial of armodafinil for fatigue in patients with gliomas undergoing radiotherapy.

Author

Lee EQ, Muzikansky A, Drappatz J, Kesari S, Wong ET, Fadul CE, Reardon DA, Norden AD, Nayak L, Rinne ML, Alexander BM, Arvold ND, Doherty L, Stefanik J, LaFrankie D, Ruland SF, Pulverenti J, Smith KH, Gaffey SC, Hammond S, and Wen PY

Subjects
Adult, Aged, Aged, 80 and over, Double-Blind Method, Fatigue etiology, Female, Humans, Male, Middle Aged, Modafinil, Pilot Projects, Radiotherapy adverse effects, Treatment Outcome, Benzhydryl Compounds therapeutic use, Fatigue drug therapy, Glioma radiotherapy, Wakefulness-Promoting Agents therapeutic use
Abstract

Background: Fatigue is common among glioma patients undergoing radiotherapy (RT) and impacts quality of life (QOL). We evaluated whether armodafinil, a wakefulness-promoting medication, improves fatigue in glioma patients undergoing RT., Methods: Eligibility criteria included age ≥18 years, Karnofsky performance status ≥60, and grade 2-4 glioma undergoing RT to a total dose of 50-60 Gy. Patients were randomized 1:1 to armodafinil or placebo for 8 weeks beginning within 10 days of starting RT. Fatigue and QOL were assessed at baseline, day 22, day 43, and day 56 with the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F), the Functional Assessment of Cancer Therapy - General (FACT-G), the Brief Fatigue Inventory (BFI), and the Cancer Fatigue Scale (CFS). The primary aim was to detect a difference in the 42-day change in FACIT-F fatigue subscale between the 2 groups using a 2-sample Wilcoxon statistic., Results: We enrolled 81 patients total (42 armodafinil and 39 placebo). Armodafinil did not significantly improve fatigue or QOL based on the 42-day change in FACIT-F fatigue subscale, FACT-G, CFS, or BFI. Further analysis suggests no difference between the arms even after accounting for the potential bias of missing data. Treatment was well tolerated with few grade 3 or 4 toxicities., Conclusions: While treatment was well-tolerated, an 8-week course of armodafinil did not improve fatigue or QOL in glioma patients undergoing RT in this pilot study. Further studies are needed to determine whether pharmacologic treatment improves fatigue in glioma patients undergoing RT., (© The Author(s) 2016. Published by Oxford University Press on behalf of the Society for Neuro-Oncology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Published
2016
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23. Phase II study of monthly pasireotide LAR (SOM230C) for recurrent or progressive meningioma.

Author

Norden AD, Ligon KL, Hammond SN, Muzikansky A, Reardon DA, Kaley TJ, Batchelor TT, Plotkin SR, Raizer JJ, Wong ET, Drappatz J, Lesser GJ, Haidar S, Beroukhim R, Lee EQ, Doherty L, Lafrankie D, Gaffey SC, Gerard M, Smith KH, McCluskey C, Phuphanich S, and Wen PY

Subjects
Adult, Aged, Aged, 80 and over, Cohort Studies, Disease-Free Survival, Female, Humans, Insulin-Like Growth Factor I metabolism, Male, Middle Aged, Receptors, Somatostatin metabolism, Somatostatin therapeutic use, Antineoplastic Agents, Hormonal therapeutic use, Meningeal Neoplasms drug therapy, Meningioma drug therapy, Neoplasm Recurrence, Local drug therapy, Somatostatin analogs & derivatives
Abstract

Objective: A subset of meningiomas recur after surgery and radiation therapy, but no medical therapy for recurrent meningioma has proven effective., Methods: Pasireotide LAR is a long-acting somatostatin analog that may inhibit meningioma growth. This was a phase II trial in patients with histologically confirmed recurrent or progressive meningioma designed to evaluate whether pasireotide LAR prolongs progression-free survival at 6 months (PFS6). Patients were stratified by histology (atypical [World Health Organization grade 2] and malignant [grade 3] meningiomas in cohort A and benign [grade 3] in cohort B)., Results: Eighteen patients were accrued in cohort A and 16 in cohort B. Cohort A had median age 59 years, median Karnofsky performance status 80, 17 (94%) had previous radiation therapy, and 11 (61%) showed high octreotide uptake. Cohort B had median age 52 years, median Karnofsky performance status 90, 11 (69%) had previous radiation therapy, and 12 (75%) showed high octreotide uptake. There were no radiographic responses to pasireotide LAR therapy in either cohort. Twelve patients (67%) in cohort A and 13 (81%) in cohort B achieved stable disease. In cohort A, PFS6 was 17% and median PFS 15 weeks (95% confidence interval: 8-20). In cohort B, PFS6 was 50% and median PFS 26 weeks (12-43). Treatment was well tolerated. Octreotide uptake and insulin-like growth factor-1 levels did not predict outcome. Expression of somatostatin receptor 3 predicted favorable PFS and overall survival., Conclusions: Pasireotide LAR has limited activity in recurrent meningiomas. The finding that somatostatin receptor 3 is associated with favorable outcomes warrants further investigation., Classification of Evidence: This study provides Class IV evidence that in patients with recurrent or progressive meningioma, pasireotide LAR does not significantly increase the proportion of patients with PFS at 6 months., (© 2014 American Academy of Neurology.)

Published
2015
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24. Role of a second chemotherapy in recurrent malignant glioma patients who progress on bevacizumab.

Author

Quant EC, Norden AD, Drappatz J, Muzikansky A, Doherty L, Lafrankie D, Ciampa A, Kesari S, and Wen PY

Subjects
Adult, Aged, Antibodies, Monoclonal therapeutic use, Antibodies, Monoclonal, Humanized, Bevacizumab, Brain Neoplasms mortality, Brain Neoplasms pathology, Disease Progression, Disease-Free Survival, Female, Glioma mortality, Glioma pathology, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Neoplasm Recurrence, Local mortality, Neoplasm Recurrence, Local pathology, Retrospective Studies, Treatment Outcome, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Brain Neoplasms drug therapy, Glioma drug therapy, Neoplasm Recurrence, Local drug therapy
Abstract

Bevacizumab is a humanized monoclonal antibody against vascular endothelial growth factor (VEGF) that has efficacy in recurrent malignant gliomas, particularly in combination with irinotecan. However, responses are rarely durable. Continuation of bevacizumab in combination with another chemotherapeutic agent may demonstrate some activity. In this article we present a retrospective review of 54 patients with recurrent malignant gliomas who progressed on a bevacizumab-containing regimen and were then treated with an alternate bevacizumab-containing regimen. All patients received intravenous bevacizumab (5-10 mg/kg) every 2 weeks alone or in combination with an additional chemotherapeutic agent, such as irinotecan. There was no limit on the number of prior therapies. Clinical characteristics and outcomes were reviewed. Tumor progression was determined by a combination of clinical status and radiographic changes. Patients were 33 men, 21 women (median age, 50 years; range, 23-72 years) with a median KPS score of 80 prior to the first bevacizumab-containing regimen and 70 prior to the second regimen; median prior chemotherapy regimens including the first bevacizumab-containing regimen was 3 (range, 2-5). Median progression-free survival (PFS) on the first bevacizumab-containing regimen was 124 days (95% confidence interval [CI], 87-154 days); 6-month (6M)-PFS was 33%. Median PFS on the second bevacizumab-containing regimen was 37.5 days (95% CI, 34-42 days); 6M-PFS was 2%. Ten patients on the first regimen and 12 patients on the second regimen suffered grade 3/4 toxicities. Those patients with malignant gliomas who progressed despite a bevacizumab-containing regimen rarely responded to the second bevacizumab-containing chemotherapeutic regimen. In such patients, alternate therapies should be considered.

Published
2009
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25. Effect of adding temozolomide to radiation therapy on the incidence of pseudo-progression.

Author

Gerstner ER, McNamara MB, Norden AD, Lafrankie D, and Wen PY

Subjects
Aged, Combined Modality Therapy adverse effects, Dacarbazine adverse effects, Disease Progression, Disease-Free Survival, Female, Humans, Magnetic Resonance Imaging methods, Male, Middle Aged, Odds Ratio, Retrospective Studies, Temozolomide, Treatment Outcome, Antineoplastic Agents, Alkylating adverse effects, Brain Neoplasms drug therapy, Brain Neoplasms pathology, Brain Neoplasms radiotherapy, Dacarbazine analogs & derivatives, Glioblastoma drug therapy, Glioblastoma pathology, Glioblastoma radiotherapy, Radiotherapy, Adjuvant adverse effects
Abstract

Recently, there has been greater awareness that combination radiation and temozolomide used to treat glioblastomas may cause increased contrast enhancement on the first post radiation MRI scan. However, this increased enhancement may stabilize or decrease over time and represent pseudo-progression (psPD) rather than true progressive disease. It has never been shown that this phenomenon is greater with combination therapy than radiation alone. To address this question, we reviewed MRI scans in glioblastoma patients treated with radiation alone versus patients treated with radiation and concomitant temozolomide and compared the frequency of psPD in the two groups. Eighteen of 47 patients (38%) treated with radiation alone demonstrated enlargement on their first post-radiation MRI scan and 11 of these 18 (61%) proved to have psPD as defined by no further enlargement on stable therapy for 3 months following radiation. Twenty-four of 45 patients (53%) treated with radiation and temozolomide had enlargement on their first post-radiation MRI scan and 13 of these 24 (54%) had psPD. Median overall survival (OS) in patients with psPD treated with radiation alone was 15.6 versus 12.8 months in those without psPD. Median OS in patients treated with radiation and concomitant temozolomide who had psPD was 24.4 versus 15.9 months in those who did not have psPD. We were unable to detect a difference in OS between the four groups. Presence of psPD, independent of treatment, was associated with prolonged progression-free survival (P = 0.05) but not OS. psPD may be more common in combination therapy but most likely by a small margin.

Published
2009
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26. Phase II study of protracted daily temozolomide for low-grade gliomas in adults.

Author

Kesari S, Schiff D, Drappatz J, LaFrankie D, Doherty L, Macklin EA, Muzikansky A, Santagata S, Ligon KL, Norden AD, Ciampa A, Bradshaw J, Levy B, Radakovic G, Ramakrishna N, Black PM, and Wen PY

Subjects
Adult, Aged, Antineoplastic Agents, Alkylating adverse effects, Brain Neoplasms mortality, Brain Neoplasms pathology, DNA Methylation, DNA Modification Methylases genetics, DNA Repair Enzymes genetics, Dacarbazine administration & dosage, Dacarbazine adverse effects, Disease-Free Survival, Drug Administration Schedule, Female, Glioma mortality, Glioma pathology, Humans, Loss of Heterozygosity, Male, Middle Aged, Survival Analysis, Temozolomide, Tumor Suppressor Proteins genetics, Antineoplastic Agents, Alkylating administration & dosage, Brain Neoplasms drug therapy, Dacarbazine analogs & derivatives, Glioma drug therapy
Abstract

Purpose: Resistance to temozolomide chemotherapy is partly mediated by O(6)-methylguanine-DNA methlytransferase (MGMT). Protracted treatment with temozolomide potentially overcomes MGMT resistance and improves outcome. We conducted a phase II study of protracted daily temozolomide in adults with low-grade gliomas., Experimental Design: Patients with newly diagnosed oligodendroglioma or oligoastrocytoma with a MIB-1 index of >5% or recurrent low-grade gliomas received temozolomide (75 mg/m(2)/day in 11-week cycles of 7 weeks on/4 weeks off). Treatment continued for a total of six cycles or until tumor progression or unacceptable toxicity. Primary end point was best overall response rate; secondary end points were progression-free survival, overall survival, and toxicity. We correlated response with MGMT promoter methylation and chromosome 1p/19q deletion status., Results: Forty-four patients were treated (14 female, 30 male) with a median follow-up of 39.4 months. Median age was 43 years (range, 20-68 years) and median Karnofsky performance status was 90 (range, 70-100). The regimen was well tolerated. No patients had a complete response (0%), 9 had partial response (20%), 33 had stable disease (75%), and 2 had progressive disease (5%). A total of 21 patients eventually progressed with an overall median progression-free survival of 38 months. Patients with methylated MGMT promoter had a longer overall survival (P = 0.008). Deletion of either 1p or 19q chromosomes also predicted longer overall survival (hazard ratio, 0.17; 95% confidence interval, 0.03-0.93; log-rank P = 0.02)., Conclusions: A protracted course of daily temozolomide is a well-tolerated regimen and seems to produce effective tumor control. This compares favorably with historical data on the standard 5-day temozolomide regimen.

Published
2009
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