2011
Phase I Trial of Belinostat and Bortezomib in Patients with Relapsed or Refractory Acute Leukemia, Myelodysplastic Syndrome, or Chronic Myelogenous Leukemia in Blast Crisis
Holkova B, Tombes M, Shrader E, Cooke S, Wan W, Sankala H, Kmieciak M, Roberts J, Garcia-Manero G, Grant S. Phase I Trial of Belinostat and Bortezomib in Patients with Relapsed or Refractory Acute Leukemia, Myelodysplastic Syndrome, or Chronic Myelogenous Leukemia in Blast Crisis. Blood 2011, 118: 2598. DOI: 10.1182/blood.v118.21.2598.2598.Peer-Reviewed Original ResearchRefractory acute leukemiaMyelodysplastic syndromeAcute leukemiaChronic myelogenous leukemiaMyelogenous leukemiaI trialCML-BCBlast crisisDay 1ECOG performance score 0Hematopoietic stem cell transplantationPerformance score 0Phase II dosesRecent preclinical findingsPeripheral sensory neuropathySerious adverse eventsMinute intravenous infusionPhase I trialPhase II evaluationPrimary acute myelogenous leukemiaSchedule of administrationStem cell transplantationBiphenotypic acute leukemiaCombination of bortezomibAcute myelogenous leukemia
2008
Phase I Trial of Bortezomib (NSC 681239) and Flavopiridol (NSC 649890) in Patients with Recurrent or Refractory Indolent B-Cell Neoplasms.
Grant S, Sullivan D, Roodman D, Stuart R, Perkins E, Kolla S, Ramakrishnan V, Wright J, Colevas A, Tombes M, Roberts J. Phase I Trial of Bortezomib (NSC 681239) and Flavopiridol (NSC 649890) in Patients with Recurrent or Refractory Indolent B-Cell Neoplasms. Blood 2008, 112: 1573. DOI: 10.1182/blood.v112.11.1573.1573.Peer-Reviewed Original ResearchB-cell neoplasmsDose levelsBolus scheduleI trialMinor responseNF-kappaB nuclear localizationIndolent B-cell neoplasmsPhase II evaluationPhase I trialPhospho-JNKCorrelative laboratory studiesNF-kappaB DNA bindingChronic lymphocytic leukemiaB-cell malignanciesBone marrow CD138Mcl-1Evaluable patientsStable diseaseEligible patientsPostural hypotensionHerpes zosterPartial responseRefractory diseaseStandard therapySystemic therapyPhase I Trial of Vorinostat (SAHA) in Combination with Alvocidib (Flavopiridol) in Patients with Relapsed, Refractory or (Selected) Poor Prognosis Acute Leukemia or Refractory Anemia with Excess Blasts-2 (RAEB-2)
Grant S, Kolla S, Sirulnik L, Shapiro G, Supko J, Cooper B, Perkins E, Ramakrishnan V, Espinoza-Delgado I, Tombes M, Roberts J. Phase I Trial of Vorinostat (SAHA) in Combination with Alvocidib (Flavopiridol) in Patients with Relapsed, Refractory or (Selected) Poor Prognosis Acute Leukemia or Refractory Anemia with Excess Blasts-2 (RAEB-2). Blood 2008, 112: 2986. DOI: 10.1182/blood.v112.11.2986.2986.Peer-Reviewed Original ResearchAcute leukemiaDose levelsStandard therapyI trialDay 1Grade 4 non-hematologic toxicityPoor-prognosis acute leukemiaDe novo acute leukemiaExcess blasts-2High-risk AMLNon-hematologic toxicitiesRemission induction failurePoor risk factorsImatinib-Refractory Chronic Myeloid LeukemiaPhase I trialPhase II evaluationAML/MDSCorrelative laboratory studiesNovo acute leukemiaChronic myeloid leukemiaHDAC inhibitor vorinostatCDK inhibitor flavopiridolAbsence of leukemiaPost-treatment effectsBolus schedule
2005
Phase I Trial of Bortezomib (NSC 681239) and Flavopiridol (NSC 649890) in Patients with Recurrent or Refractory Indolent B-Cell Neoplasms.
Grant S, Sullivan D, Roodman D, Stuart R, Perkins E, Ramakrishnan V, Wright J, Colevas A, Roberts J. Phase I Trial of Bortezomib (NSC 681239) and Flavopiridol (NSC 649890) in Patients with Recurrent or Refractory Indolent B-Cell Neoplasms. Blood 2005, 106: 3338. DOI: 10.1182/blood.v106.11.3338.3338.Peer-Reviewed Original ResearchI trialDose levelsPre-existing peripheral neuropathyIndolent B-cell lymphomaNF-kappaB nuclear localizationIndolent B-cell neoplasmsCase of exacerbationPhase I trialPhase II evaluationPhospho-JNKCorrelative laboratory studiesNF-kappaB DNA bindingB-cell lymphomaB-cell malignanciesBone marrow CD138B-cell neoplasmsMcl-1Eligible patientsStable diseaseHerpes zosterPartial responseRefractory diseaseStandard therapySystemic therapyComplete response
2000
Weekly lometrexol with daily oral folic acid is appropriate for phase II evaluation
Roberts J, Poplin E, Tombes M, Kyle B, Spicer D, Grant S, Synold T, Moran R. Weekly lometrexol with daily oral folic acid is appropriate for phase II evaluation. Cancer Chemotherapy And Pharmacology 2000, 45: 103-110. PMID: 10663624, DOI: 10.1007/s002800050017.Peer-Reviewed Original ResearchConceptsDaily oral folic acidOral folic acidDose omissionsFolic acidDose combinationWeekly scheduleEarlier Phase I trialPredose plasma samplesPhase II dosePhase II trialDose-limiting toxicityPhase I trialPhase II evaluationRed blood cell contentSevere toxic eventsRenal cell carcinomaDays of treatmentAppropriate dose combinationBlood cell contentInfusion weeklyStable diseaseII trialDose intensityPartial responseWeekly administration