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1. Early phase clinical studies of AR‐42, a histone deacetylase inhibitor, for neurofibromatosis type 2‐associated vestibular schwannomas and meningiomas

Author

D. Bradley Welling, Katharine A. Collier, Sarah S. Burns, Janet L. Oblinger, Edina Shu, Beth A. Miles‐Markley, Craig C. Hofmeister, Mina S. Makary, H. Wayne Slone, Jaishri O. Blakeley, S. Alireza Mansouri, Brian A. Neff, Robert K. Jackler, Amir Mortazavi, and Long‐Sheng Chang

Subjects
AR‐42, histone deacetylase inhibitor, meningioma, neurofibromatosis type 2, vestibular schwannoma, Otorhinolaryngology, RF1-547, Surgery, RD1-811
Abstract

Abstract Objectives Two pilot studies of AR‐42, a pan‐histone deacetylase inhibitor, in human neurofibromatosis type 2 (NF2), vestibular schwannomas (VS), and meningiomas are presented. Primary endpoints included safety, and intra‐tumoral pharmacokinetics (PK) and pharmacodynamics (PD). Methods Pilot 1 is a subset analysis of a phase 1 study of AR‐42 in solid tumors, which included NF2 or sporadic meningiomas. Tumor volumes and treatment‐related adverse events (TRAEs) are reported (NCT01129193). Pilot 2 is a phase 0 surgical study of AR‐42 assessing intra‐tumoral PK and PD. AR‐42 was administered for 3 weeks pre‐operatively. Plasma and tumor drug concentrations and p‐AKT expression were measured (NCT02282917). Results Pilot 1: Five patients with NF2 and two with sporadic meningiomas experienced a similar incidence of TRAEs to the overall phase I trial. The six evaluable patients had 15 tumors (8 VS, 7 meningiomas). On AR‐42, tumor volume increased in six, remained stable in eight, and decreased in one tumor. The annual percent growth rate decreased in eight, remained stable in three, and increased in four tumors. Pilot 2: Four patients with sporadic VS and one patient with meningioma experienced no grade 3/4 toxicities. Expression of p‐AKT decreased in three of four VS. All tumors had higher AR‐42 concentrations than plasma. Conclusions AR‐42 is safe. Tumor volumes showed a mixed response, but most slowed growth. On a 40‐mg regimen, drug concentrated in tumors and growth pathways were suppressed in most tumors, suggesting this may be a well‐tolerated and effective dose. A phase 2 study of AR‐42 for NF2‐associated tumors appears warranted. Level of Evidence 1b, 4.

Published
2021
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2. Early phase clinical studies of AR‐42, a histone deacetylase inhibitor, for neurofibromatosis type 2‐associated vestibular schwannomas and meningiomas

Author

Mina S. Makary, Long-Sheng Chang, Katharine Collier, D. Bradley Welling, Beth A. Miles-Markley, Edina Shu, Craig C. Hofmeister, H. Wayne Slone, S. Alireza Mansouri, Brian A. Neff, Janet L. Oblinger, Jaishri O. Blakeley, Robert K. Jackler, Sarah S. Burns, and Amir Mortazavi

Subjects
Subset Analysis, medicine.medical_specialty, neurofibromatosis type 2, RD1-811, Head and Neck, and Tumor Biology, Phases of clinical research, AR‐42, Gastroenterology, meningioma, Meningioma, Pharmacokinetics, vestibular schwannoma, Internal medicine, medicine, otorhinolaryngologic diseases, Neurofibromatosis type 2, Adverse effect, histone deacetylase inhibitor, Original Research, business.industry, General Medicine, medicine.disease, Regimen, Otorhinolaryngology, RF1-547, Pharmacodynamics, Surgery, business
Abstract

Objectives Two pilot studies of AR‐42, a pan‐histone deacetylase inhibitor, in human neurofibromatosis type 2 (NF2), vestibular schwannomas (VS), and meningiomas are presented. Primary endpoints included safety, and intra‐tumoral pharmacokinetics (PK) and pharmacodynamics (PD). Methods Pilot 1 is a subset analysis of a phase 1 study of AR‐42 in solid tumors, which included NF2 or sporadic meningiomas. Tumor volumes and treatment‐related adverse events (TRAEs) are reported (NCT01129193). Pilot 2 is a phase 0 surgical study of AR‐42 assessing intra‐tumoral PK and PD. AR‐42 was administered for 3 weeks pre‐operatively. Plasma and tumor drug concentrations and p‐AKT expression were measured (NCT02282917). Results Pilot 1: Five patients with NF2 and two with sporadic meningiomas experienced a similar incidence of TRAEs to the overall phase I trial. The six evaluable patients had 15 tumors (8 VS, 7 meningiomas). On AR‐42, tumor volume increased in six, remained stable in eight, and decreased in one tumor. The annual percent growth rate decreased in eight, remained stable in three, and increased in four tumors. Pilot 2: Four patients with sporadic VS and one patient with meningioma experienced no grade 3/4 toxicities. Expression of p‐AKT decreased in three of four VS. All tumors had higher AR‐42 concentrations than plasma. Conclusions AR‐42 is safe. Tumor volumes showed a mixed response, but most slowed growth. On a 40‐mg regimen, drug concentrated in tumors and growth pathways were suppressed in most tumors, suggesting this may be a well‐tolerated and effective dose. A phase 2 study of AR‐42 for NF2‐associated tumors appears warranted. Level of Evidence 1b, 4.

Published
2021

3. CLIN-NEURO/MEDICAL ONCOLOGY

Author

F. Girardi, C. Braun, Dennis C. Shrieve, Wei Chen, D. Kita, M. F. Fanelli, David Schiff, Sunyoung Ahn, Elizabeth Vera-Bolanos, J. Carrasquillo, S. Singer, James G. Herman, C. Bosa, Julia Selfridge, V. Tohidi, B.-A. Millar, M. Benavides, M. I. D. L. Fuente, Phioanh L. Nghiemphu, Kristin R. Swanson, John P. Kirkpatrick, Jonathan P.S. Knisely, Jörg C. Tonn, Kenneth Aldape, J. C. Streeter, R. Ruda, Seung Hong Choi, R. Curry, J. Yu, Ryo Nishikawa, E. Garoufalis, A. H. Friedman, Kurt A. Jaeckle, W. Zhang, Maryam Fouladi, Y. Odia, Arthur P. Chou, S. Sahebjam, E. Pentsova, Luis Souhami, Y. Yuan, F. N. Santos, C. Mesia, H. Friedman, Jennifer Linn, J. E. Adair, Yong Hwy Kim, Athanasios P. Kyritsis, Zvi Ram, M. G. Muhonen, Tracy T. Batchelor, Alissa A. Thomas, Stuart A. Grossman, M. Nasseri, Pedro Pérez Segura, S. Lacey, S. D. Bell, Helen A. Shih, E. Bit-Ivan, Timothy A. Chan, H. Pentsova, H. Wilson, Fumiko Shimizu, M. Forbes, L. Randolph, S. Kim, Amit Bhatt, Sabina Eigenbrod, T. Seigal, P. Dall'Occa, F. McSherry, R. M. Green, Michael D. Prados, Camilo E. Fadul, A. Guevarra, J.-Y. Han, Guido Reifenberger, E. Franceschi, D. Sageser, Jennie Taylor, Kevin Petrecca, M. K. Nicholas, Teresa Ribalta, Morris D. Groves, J.-Y. Blay, B. C. Beard, C. F. La, A. A. da Costa, K. Murillo-Medina, W. Pfisterer, R. Chu, Nan Lin, M. Ermani, A. J. Neuwelt, Samuel T. Chao, T. Ranjan, W. Taki, Hendrik Janssen, R. Agati, A. Mahta, T. N. Kreisl, E. Perez, J. Fuster, B. D. Fu, David M. Peereboom, N. Gresa-Arribas, Georg Widhalm, M. D'Apuzzo, J. Steinbach, Tom Mikkelsen, Michael Platten, R. Poggi, Sandra Ictech, I. Craven, A. Raghunathan, John B. Fiveash, N. L. Jansen, Rupert Egensperger, B. Badie, S. Medrano, Chul-Kee Park, K. Wong, Tae Min Kim, M. Bartolotti, M. Alejandro, T. Rosser, H.-P. Kiem, Marie-Christine Guiot, S. Gonzalez, J. Ljubimova, T. Furuta, J. Herndon, J. Finlay, Vivian Tabar, M. Hadjivassiliou, Christine Marosi, D. Hammoud, K. Black, S. K. Anderson, F. Bach, Gregory N. Fuller, N. Kased, S. Shpigel, Gianluca Marucci, Michael A. Vogelbaum, S. Bluml, J. Joo, M. D. Groves, X. Ye, Adam L. Cohen, J. A. Butman, M. D. Prados, X. Perez-Martin, R. Sharma, G. Colon-Otero, Richard M. Green, Paul D. Brown, Cornelia Sax, Robert J. Weil, J. Connelly, S. Burri, M. R. Welch, Marc K. Rosenblum, Minesh P. Mehta, Shlomit Yust-Katz, J. Canellas, Ulrich Bogdahn, S. Liker, P. U. Kumthekar, F. Gilles, M. Brock, Aaron T. Wild, A. Guerrero-Maldonado, Janet M. Bruner, A. Balmanoukian, E. Kitzweger, B. Schuknecht, Ayman I. Omar, J. Sampson, R. F. Del Maestro, W. Hruby, Niklas Thon, S. Zhao, F. Aboul-Enein, L. M. Alderson, J. McClain, J. Rudnick, J. Dorr, Vinay K. Puduvalli, Sonia Partap, Y. Hayashi, A. Kessinger, N. A. Shonka, T. Minamoto, D. Z. Lee, L. G. Berriel, T. Xie, J. Shih, J. S. Bubalo, Oscar Lin, J. E. Herndon, Michael Glantz, A. Gupta, H. Sabit, H. Heinrichs, Hans A. Kretzschmar, A. Asher, T. M. Bhavsar, A. Coan, V. A. Levin, M. Landeros, A. K. Choucair, D. Garbossa, G. Stockhammer, Jian Campian, C. J. Vecht, C. Ausch, Linda M. Liau, H. I. Farhat, M. Richards, H. I. Robins, R. Chaudhary, Agnieszka Korfel, Marta Penas-Prado, A. Jensen, I. Lolli, Amar J. Gajjar, K. Papsdorf, L. DeAngelis, Kathryn Beal, L. Phishniak, J. Joyce, Arnab Chakravarti, J. J. Vredenburgh, C. Dealis, A. F. Campos-Gines, Peter Hau, J.-I. Hamada, R. A. Gilbert, T. J. Kaley, Eric T. Wong, Ian F. Pollack, T. Gajewski, A. C. Levy, L. R. Bressler, X. Chen, C. Bernadette, O. Etxaniz, N. Antony, Birgit Flechl, D. Levacic, Byung Se Choi, J. I. Stenner, F. Pinto, Sandra K. Johnston, M. M. Mrugala, David Roberge, M. Wang, P. J. Anderson, H. A. Fine, M. J. Glantz, Alfred Yung, L. Alderson, M. Chamberlain, R. Naor, Jaume Capellades, Se-Hoon Lee, D. G. Brackman, Nathalie Jansen, T. Synold, Terri S. Armstrong, J. Pichler, X.-T. Kong, T. Cloughesy, P. Frankel, R. Valdez-Vazquez, Mathias Kunz, J. Dalmau, A. Baldock, Stewart Goldman, K. Rizzo, M. Nakada, Christoph Meisner, Ryan Merrell, C. Bomprezzi, Tomokazu Aoki, M. R. Gilbert, Jason K. Rockhill, Benjamin Ellezam, C. Sebastian, O. Arrieta, N. Wu, M. Magistrello, T. Patel, Adelheid Wöhrer, M. Sabel, F. Bokstein, V. Gomez-Molinar, S. Yovino, A. Kheder, Gaspar Reynes, R. Packer, M. Ronellenfitsch, Sasan Karimi, David Piccioni, J. M. Stachnik, C. Sebesta, Ryan Shanley, L. T. Chinen, H.-S. Gwak, E. A. Woyshner, D. Reuter, S. Bekker, K. Hunter, B. Haghighi, G. Poepperl, M. C. Chamberlain, W. Massey, M. A. Hamza, R. Cavaliere, Sichen Li, Daniela A. Bota, S. Spiegl-Kreinecker, G. Tatzreiter, Sigmund Hsu, M. Westphal, T. Pietsch, P. D. Barnes, C. Arango, G. Cervantes-Sanchez, C. Grommes, W. Brick, Vera Graute, M. P. Gabay, L. Bertero, Friedrich W. Kreth, F. M. Iwamoto, D. T. Blumenthal, M. Matsutani, K. B. Peters, S. F. Shakur, E. Flanagan, H. T. Kim, M. Simon, Michael Ackerl, Nadia N. Laack, J. Portnow, R. Ruckser, T. F. Cloughesy, H. Wayne Slone, A. A. Erazo-Valle-Solis, Karin Dieckmann, J. Baerhing, R. Soffietti, N. Laperriere, M. J. Gil, R. Fisher, Thierry Muanza, Reema R. Mody, W. Kim, L. Droms, Fabio M. Iwamoto, J. Grimm, Robert B. Jenkins, M. R. Aizenberg, E. Lipp, M. J. Taphoorn, V. Garcia-Navarro, J. H. Suh, Peter Bartenstein, E. Bourekas, Brett Theeler, W. G. Watkin, R. M. Tyson, Mira Zurayk, D. Alexandru, N. Uchiyam, J. Gilreath, A. J. Ramiro, R. Rockne, R. Naruse, M. Krieger, A. Kloet, Petr Kavan, E. Jaffe, D. A. Reardon, Jochen Herms, A. Willson, H. Zwinkels, M. Faedi, A. Moreno-Aspitia, J. Vredenburgh, Herbert H. Engelhard, C. Bridge, Paul W. Sperduto, H. Yoo, P. Friedman, N. Letarte, Tetsuya Ueba, Lisa M. DeAngelis, C. Nolan, Michael Weller, H. Colman, Jürgen Lutz, H. Ian Robins, J. McGregor, Pankaj Jalan, Joseph Landolfi, M. Di Battista, Bogdana Suchorska, Manuela Caroli, G. Nikkhah, A. Leibetseder, K. Aboody, V. Liu, Albert Lai, Yoshiki Arakawa, Kazuhiko Nozaki, G. Dhall, Kenneth R. Hess, Oscar Gallego, A. Naomi, A. Pace, T. M. Nguyen, K. Kawakami, K. DeBraganca, A. A. Brandes, V. K. Puduvalli, Lakshmi Nayak, Charles A. Conrad, Laurie E. Gaspar, P. J. Flynn, S. Ruiz-Gonzalez, Carmen Balana, J. Lange, T. Kaley, Vijay Pandav, J. Herrada, Eugenia Verger, S. Honigschnabel, M. Chen, C. A. Bridge, Yu Jung Kim, Mary Jo T. Necesito-Reyes, Bettina Hentschel, Victor A. Levin, J. Hu, K. Hoang-Xuan, Chae-Yong Kim, W. Sherman, L. Armbruster, T. Yun, C. Carapella, E. L. Diamond, A. Mahapatra, Warren P. Mason, X. Luo, R. C. Rockne, S. G. Crasto, L. Bailey, K. Sanghee, Matthias Preusser, R. Mathew, Jaclyn Wu, D. White, Susumu Miyamoto, A. Omuro, A. Desjardins, P.H. Gutin, J. S. Lee, Andrew D. Trister, Maxwell Lewis Neal, W. Zaky, A. L. Sumrall, C. M. Sperduto, A. L. Baldock, S. Phuphanich, J. Sul, S. H. Shin, E. A. Neuwelt, Heinrich Elinzano, C. Huang, H. S. Friedman, Laura Guyman, Sean Grimm, C. Sanchez, H. Newton, G. Oberhauser, Chunyue Yin, Wolfgang Wick, Caterina Giannini, Veronica Chiang, C. LaFougere, P. Metellus, A. Krauthammer, M. Kinoshita, J. Sheehan, Miguel J. Gil, E. Trevisan, J. Raizer, Shin-Ichi Miyatake, A. Olch, Jin Wook Kim, John L. Villano, Patricia Sneed, Brian P. O'Neill, A. Sahgal, Il Han Kim, A. Brickhouse, K. Herath, C. Zoccoli, M. J. van den Bent, T. Tsukahara, M. Heaney, B. Hassanzadeh, J. Quan, David R. Macdonald, Percy Ivy, D. Liue, John H. Suh, K. Miyashita, T. J. Fraum, W. A. Yung, I. Melguizo-Gavilanes, Maciej M. Mrugala, Matthew J. Matasar, and P. Garciarena

Subjects
Cancer Research, medicine.medical_specialty, Abstracts, Oncology, business.industry, medicine, Medical physics, Neurology (clinical), business
Published
2012

4. Radiation necrosis mimicking rapid intracranial progression of melanoma metastasis in two patients treated with vemurafenib.

Author

Liebner DA, Walston SA, Cavaliere R, Powers CJ, Sauvageau E, Lehman NL, Wayne Slone H, Xu-Welliver M, Xia F, and Kendra KL

Subjects
Adult, Central Nervous System drug effects, Central Nervous System radiation effects, Diagnosis, Differential, Disease Progression, Disease-Free Survival, Female, Humans, Male, Melanoma diagnosis, Melanoma pathology, Mutation, Necrosis diagnosis, Radiation Dosage, Radiation Injuries chemically induced, Skin Neoplasms diagnosis, Skin Neoplasms pathology, Vemurafenib, Young Adult, Central Nervous System pathology, Indoles adverse effects, Indoles therapeutic use, Melanoma drug therapy, Melanoma radiotherapy, Radiation Injuries etiology, Skin Neoplasms drug therapy, Skin Neoplasms radiotherapy, Sulfonamides adverse effects, Sulfonamides therapeutic use
Abstract

Optimal treatment of metastases to the central nervous system (CNS) in patients with malignant melanoma remains a clinical challenge. In particular, for patients with BRAF-mutant melanoma and CNS metastases, much remains unknown about the safety and efficacy of the novel BRAF-targeted agents when administered in close sequence with radiation. We report two cases of rapid development of CNS radiation necrosis in patients with metastatic melanoma treated with the BRAF inhibitor, vemurafenib, closely sequenced with stereotactic radiosurgery or fractionated stereotactic radiation therapy. In the absence of prospective safety data from clinical trials, we advise vigilance in monitoring patients with BRAF-mutant melanoma whose treatment plan includes CNS radiation and vemurafenib and caution when assessing treatment response within the CNS in these patients.

Published
2014
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