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Phase 1 trial of carfilzomib (PR-171) in combination with vorinostat (SAHA) in patients with relapsed or refractory B-cell lymphomas.
Holkova, Beata; Kmieciak, Maciej; Bose, Prithviraj; Yazbeck, Victor Y; Barr, Paul M; Tombes, Mary Beth; Shrader, Ellen; Weir-Wiggins, Caryn; Rollins, April D; Cebula, Erin M; Pierce, Emily; Herr, Megan; Sankala, Heidi; Hogan, Kevin T; Wan, Wen; Feng, Changyong; Peterson, Derick R; Fisher, Richard I; Grant, Steven; Friedberg, Jonathan W.
Affiliation
  • Holkova B; a Massey Cancer Center and Virginia Commonwealth University , Richmond , VA , USA .
  • Kmieciak M; b Department of Internal Medicine , Virginia Commonwealth University , Richmond , VA , USA .
  • Bose P; a Massey Cancer Center and Virginia Commonwealth University , Richmond , VA , USA .
  • Yazbeck VY; c University of Texas MD Anderson Cancer Center , Houston , TX , USA .
  • Barr PM; a Massey Cancer Center and Virginia Commonwealth University , Richmond , VA , USA .
  • Tombes MB; b Department of Internal Medicine , Virginia Commonwealth University , Richmond , VA , USA .
  • Shrader E; d James P. Wilmot Cancer Center, University of Rochester , Rochester , NY , USA .
  • Weir-Wiggins C; a Massey Cancer Center and Virginia Commonwealth University , Richmond , VA , USA .
  • Rollins AD; a Massey Cancer Center and Virginia Commonwealth University , Richmond , VA , USA .
  • Cebula EM; a Massey Cancer Center and Virginia Commonwealth University , Richmond , VA , USA .
  • Pierce E; a Massey Cancer Center and Virginia Commonwealth University , Richmond , VA , USA .
  • Herr M; d James P. Wilmot Cancer Center, University of Rochester , Rochester , NY , USA .
  • Sankala H; d James P. Wilmot Cancer Center, University of Rochester , Rochester , NY , USA .
  • Hogan KT; d James P. Wilmot Cancer Center, University of Rochester , Rochester , NY , USA .
  • Wan W; a Massey Cancer Center and Virginia Commonwealth University , Richmond , VA , USA .
  • Feng C; a Massey Cancer Center and Virginia Commonwealth University , Richmond , VA , USA .
  • Peterson DR; e Department of Biostatistics , Virginia Commonwealth University , Richmond , VA , USA .
  • Fisher RI; d James P. Wilmot Cancer Center, University of Rochester , Rochester , NY , USA .
  • Grant S; f Department of Biostatistics and Computational Biology , University of Rochester , Rochester , NY , USA .
  • Friedberg JW; f Department of Biostatistics and Computational Biology , University of Rochester , Rochester , NY , USA .
Leuk Lymphoma ; 57(3): 635-43, 2016.
Article in En | MEDLINE | ID: mdl-26284612
ABSTRACT
A phase 1 study with carfilzomib and vorinostat was conducted in 20 B-cell lymphoma patients. Vorinostat was given orally twice daily on days 1, 2, 3, 8, 9, 10, 15, 16, and 17 followed by carfilzomib (given as a 30-min infusion) on days 1, 2, 8, 9, 15, and 16. A treatment cycle was 28 days. Dose escalation initially followed a standard 3 + 3 design, but adapted a more conservative accrual rule following dose de-escalation. The maximum tolerated dose was 20 mg/m2 carfilzomib and 100 mg vorinostat (twice daily). The dose-limiting toxicities were grade 3 pneumonitis, hyponatremia, and febrile neutropenia. One patient had a partial response and two patients had stable disease. Correlative studies showed a decrease in NF-κB activation and an increase in Bim levels in some patients, but these changes did not correlate with clinical response.
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Antineoplastic Combined Chemotherapy Protocols / Lymphoma, B-Cell Type of study: Clinical_trials Limits: Adult / Aged / Female / Humans / Male / Middle aged Language: En Journal: Leuk Lymphoma Journal subject: HEMATOLOGIA / NEOPLASIAS Year: 2016 Document type: Article Affiliation country: United States
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Antineoplastic Combined Chemotherapy Protocols / Lymphoma, B-Cell Type of study: Clinical_trials Limits: Adult / Aged / Female / Humans / Male / Middle aged Language: En Journal: Leuk Lymphoma Journal subject: HEMATOLOGIA / NEOPLASIAS Year: 2016 Document type: Article Affiliation country: United States