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1. A randomised phase II trial of a trivalent ganglioside vaccine targeting GM2, GD2 and GD3 combined with immunological adjuvant OPT-821 versus OPT-821 alone in metastatic sarcoma patients rendered disease-free by surgery

Author

Rosenbaum, Evan, Chugh, Rashmi, Ryan, Christopher W., Agulnik, Mark, Milhem, Mohammed M., George, Suzanne, Jones, Robin L., Chmielowski, Bartosz, Van Tine, Brian A., Tawbi, Hussein, Elias, Anthony D., Read, William L., Budd, G. Thomas, Qin, Li-Xuan, Rodler, Eve T., Hirman, Joe, Weiden, Paul, Bennett, Cathryn M., Livingston, Philip O., Ragupathi, Govind, Hansen, David, D'Angelo, Sandra P., Tap, William D., Schwartz, Gary K., Maki, Robert G., and Carvajal, Richard D.

Published
2022
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3. Atezolizumab for Advanced Alveolar Soft Part Sarcoma

Author

Chen, Alice P., primary, Sharon, Elad, additional, O’Sullivan-Coyne, Geraldine, additional, Moore, Nancy, additional, Foster, Jared C., additional, Hu, James S., additional, Van Tine, Brian A., additional, Conley, Anthony P., additional, Read, William L., additional, Riedel, Richard F., additional, Burgess, Melissa A., additional, Glod, John, additional, Davis, Elizabeth J., additional, Merriam, Priscilla, additional, Naqash, Abdul R., additional, Fino, Kristin K., additional, Miller, Brandon L., additional, Wilsker, Deborah F., additional, Begum, Asma, additional, Ferry-Galow, Katherine V., additional, Deshpande, Hari A., additional, Schwartz, Gary K., additional, Ladle, Brian H., additional, Okuno, Scott H., additional, Beck, Jill C., additional, Chen, James L., additional, Takebe, Naoko, additional, Fogli, Laura K., additional, Rosenberger, Christina L., additional, Parchment, Ralph E., additional, and Doroshow, James H., additional

Published
2023
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8. Phase II study of atezolizumab in advanced alveolar soft part sarcoma (ASPS).

Author

Naqash, Abdul Rafeh, primary, O'Sullivan Coyne, Geraldine Helen, additional, Moore, Nancy, additional, Sharon, Elad, additional, Takebe, Naoko, additional, Fino, Kristin K., additional, Ferry-Galow, Katherine V., additional, Hu, James S., additional, Van Tine, Brian Andrew, additional, Burgess, Melissa Amber, additional, Read, William L., additional, Riedel, Richard F., additional, George, Suzanne, additional, Glod, John, additional, Conley, Anthony Paul, additional, Foster, Jared C., additional, Fogli, Laura K., additional, Parchment, Ralph E., additional, Doroshow, James H., additional, and Chen, Alice P., additional

Published
2021
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9. A randomized, open‐label, phase 2, multicenter trial of gemcitabine with pazopanib or gemcitabine with docetaxel in patients with advanced soft‐tissue sarcoma

Author

Somaiah, Neeta, primary, Van Tine, Brian Andrew, additional, Wahlquist, Amy E., additional, Milhem, Mohammed M., additional, Hill, Elizabeth G., additional, Garrett‐Mayer, Elizabeth, additional, Armeson, Kent E., additional, Schuetze, Scott M., additional, Meyer, Christian F., additional, Reuben, Daniel Y., additional, Elias, Anthony D., additional, Read, William L., additional, Chawla, Sant P., additional, and Kraft, Andrew S., additional

Published
2020
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14. A blueprint for document control: how to develop, maintain and improve the system

Author

Fine, Debra L. and Read, William L.

Subjects
Document management systems -- Analysis, Quality control -- Management, Business, Economics, Engineering and manufacturing industries
Abstract

A document control system ensures that information is available to users, up-to-date, altered in a controlled way, approved by proper authority, monitored and archived. Basic requirements to properly control a document should be detailed in a procedure. The key elements of a system for document control include identification of the need for documentation, periodic auditing and resources to support the actions required to implement and maintain quality system documentation. The main factors in assessing documentation needs are business goals, regulatory mandates and customer requirements. Effective quality system documentation is determined by management's allocation of appropriate resources and active involvement.

Published
2000

17. Phase II trial of gemcitabine (G) with pazopanib (P) or gemcitabine with docetaxel (T) in advanced soft tissue sarcoma (STS).

Author

Somaiah, Neeta, primary, Van Tine, Brian Andrew, additional, Hill, Elizabeth Goodwin, additional, Milhem, Mohammed M., additional, Schuetze, Scott, additional, Meyer, Christian Frederick, additional, Reuben, Daniel Y., additional, Elias, Anthony D., additional, Read, William L., additional, Chawla, Sant P., additional, Wahlquist, Amy E., additional, Garrett-Mayer, Elizabeth, additional, and Kraft, Andrew S., additional

Published
2019
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18. A randomized, open‐label, phase 2, multicenter trial of gemcitabine with pazopanib or gemcitabine with docetaxel in patients with advanced soft‐tissue sarcoma.

Author

Somaiah, Neeta, Van Tine, Brian Andrew, Wahlquist, Amy E., Milhem, Mohammed M., Hill, Elizabeth G., Garrett‐Mayer, Elizabeth, Armeson, Kent E., Schuetze, Scott M., Meyer, Christian F., Reuben, Daniel Y., Elias, Anthony D., Read, William L., Chawla, Sant P., and Kraft, Andrew S.

Subjects
DOCETAXEL, DRUG efficacy, SARCOMA, LOG-rank test, PROGRESSION-free survival
Abstract

Background: Therapeutic options for patients with advanced soft‐tissue sarcoma (STS) are limited. The goal of the current phase 2 study was to examine the clinical activity and safety of the combination of gemcitabine plus pazopanib, a multityrosine kinase inhibitor with activity in STS. Methods: The current randomized, phase 2 trial enrolled patients with advanced nonadipocytic STS who had received prior anthracycline‐based therapy. Patients were assigned 1:1 to receive gemcitabine at a dose of 1000 mg/m2 on days 1 and 8 with pazopanib at a dose of 800 mg daily (G+P) or gemcitabine at a dose of 900 mg/m2 on days 1 and 8 and docetaxel at a dose of 100 mg/m2 on day 8 (G+T) every 3 weeks. Crossover was allowed at the time of disease progression. The study used a noncomparative statistical design based on the precision of 95% confidence intervals for reporting the primary endpoints of median progression‐free survival (PFS) and rate of grade ≥3 adverse events (AEs) for these 2 regimens based on the intent‐to‐treat patient population (AEs were graded using version 4.0 of the National Cancer Institute Common Terminology Criteria for Adverse Events). Results: A total of 90 patients were enrolled: 45 patients on each treatment arm. The median PFS was 4.1 months for each arm (P =.3, log‐rank test). The best overall response of stable disease or better (complete response + partial response + stable disease) was the same for both treatment arms (64% for both the G+T and G+P arms). The rate of related grade ≥3 AEs was 82% for the G+T arm and 78% for the G+P arm. Related grade ≥3 AEs occurring in ≥10% of patients in the G+T and G+P arms were anemia (36% and 20%, respectively), fatigue (29% and 13%, respectively), thrombocytopenia (53% and 49%, respectively), neutropenia (20% and 49%, respectively), lymphopenia (13% and 11%, respectively), and hypertension (2% and 20%, respectively). Conclusions: The data from the current study have demonstrated the safety and efficacy of G+P as an alternative to G+T for patients with nonadipocytic STS. The results of the current trial suggest similar efficacy and tolerability when comparing the gemcitabine and pazopanib (G+P) regimen with the gemcitabine and docetaxel (G+T) regimen. In patients who are not suitable for treatment with G+T, the G+P regimen is a reasonable alternate for the second‐line treatment of patients with metastatic nonadipocytic sarcomas. [ABSTRACT FROM AUTHOR]

Published
2021
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19. Response assessment of meningioma: 1D, 2D, and volumetric criteria for treatment response and tumor progression

Author

Huang, Raymond Y, primary, Unadkat, Prashin, additional, Bi, Wenya Linda, additional, George, Elizabeth, additional, Preusser, Matthias, additional, McCracken, Jay D, additional, Keen, Joseph R, additional, Read, William L, additional, Olson, Jeffrey J, additional, Seystahl, Katharina, additional, Le Rhun, Emilie, additional, Roelcke, Ulrich, additional, Koeppen, Susanne, additional, Furtner, Julia, additional, Weller, Michael, additional, Raizer, Jeffrey J, additional, Schiff, David, additional, and Wen, Patrick Y, additional

Published
2018
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24. Timed sequential therapy of the selective T-type calcium channel blocker mibefradil and temozolomide in patients with recurrent high-grade gliomas

Author

Holdhoff, Matthias, primary, Ye, Xiaobu, additional, Supko, Jeffrey G., additional, Nabors, Louis B., additional, Desai, Arati S., additional, Walbert, Tobias, additional, Lesser, Glenn J., additional, Read, William L., additional, Lieberman, Frank S., additional, Lodge, Martin A., additional, Leal, Jeffrey, additional, Fisher, Joy D., additional, Desideri, Serena, additional, Grossman, Stuart A., additional, Wahl, Richard L., additional, and Schiff, David, additional

Published
2017
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30. Trivalent ganglioside vaccine and immunologic adjuvant versus adjuvant alone in metastatic sarcoma patients rendered disease-free by surgery: A randomized phase 2 trial.

Author

Carvajal, Richard D., primary, Agulnik, Mark, additional, Ryan, Christopher W., additional, Milhem, Mohammed M., additional, George, Suzanne, additional, Jones, Robin Lewis, additional, Chmielowski, Bartosz, additional, Van Tine, Brian Andrew, additional, Tawbi, Hussein Abdul-Hassan, additional, Elias, Anthony D., additional, Read, William L., additional, Budd, G. Thomas, additional, Hirman, Joe, additional, Weiden, Paul, additional, Bennett, Cathryn M., additional, Livingston, Philip O., additional, Hansen, David, additional, Maki, Robert G., additional, Schwartz, Gary K., additional, and Chugh, Rashmi, additional

Published
2014
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32. Using proton MRSI to predict response to vorinostat treatment in recurrent GBM.

Author

Shim, Hyunsuk, primary, Voloschin, Alfredo Daniel, additional, Wei, Li, additional, Hwang, Scott N, additional, Miller, Andrew H., additional, Guo, Ying, additional, Brat, Daniel, additional, Holder, Chad A, additional, Read, William L., additional, Kopcewicz, Katarzyna, additional, Harvey, R. Donald, additional, Barker, Peter, additional, Shu, Hui-Kuo George, additional, Hu, Xioaping P, additional, and Olson, Jeffrey J., additional

Published
2012
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