2017
A phase 1 study of bortezomib and romidepsin in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma, indolent B-cell lymphoma, peripheral T-cell lymphoma, or cutaneous T-cell lymphoma
Holkova B, Yazbeck V, Kmieciak M, Bose P, Ma S, Kimball A, Tombes MB, Shrader E, Wan W, Weir-Wiggins C, Singh A, Hogan KT, Conine S, Sankala H, Roberts JD, Shea TC, Grant S. A phase 1 study of bortezomib and romidepsin in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma, indolent B-cell lymphoma, peripheral T-cell lymphoma, or cutaneous T-cell lymphoma. Leukemia & Lymphoma 2017, 58: 1349-1357. PMID: 28103725, PMCID: PMC5817887, DOI: 10.1080/10428194.2016.1276287.Peer-Reviewed Original ResearchConceptsT-cell lymphomaMaximum-tolerated doseDose-limiting toxicityPhase 1 studyStable diseaseChronic lymphocytic leukemia/small lymphocytic lymphomaRefractory CLL/SLLPeripheral T-cell lymphomaCutaneous T-cell lymphomaIndolent B-cell lymphomaGrade 3 fatigueMedian treatment durationCLL/SLLSingle-agent bortezomibSmall lymphocytic lymphomaExpression of NFB-cell lymphomaRefractory CLLMedian durationPartial responseProgressive diseaseSafety profileLymphocytic lymphomaTreatment durationDay 1
2014
Phase I Trial of Bortezomib (PS-341; NSC 681239) and “Nonhybrid” (Bolus) Infusion Schedule of Alvocidib (Flavopiridol; NSC 649890) in Patients with Recurrent or Refractory Indolent B-cell Neoplasms
Holkova B, Kmieciak M, Perkins EB, Bose P, Baz RC, Roodman GD, Stuart RK, Ramakrishnan V, Wan W, Peer CJ, Dawson J, Kang L, Honeycutt C, Tombes MB, Shrader E, Weir-Wiggins C, Wellons M, Sankala H, Hogan KT, Colevas AD, Doyle LA, Figg WD, Coppola D, Roberts JD, Sullivan D, Grant S. Phase I Trial of Bortezomib (PS-341; NSC 681239) and “Nonhybrid” (Bolus) Infusion Schedule of Alvocidib (Flavopiridol; NSC 649890) in Patients with Recurrent or Refractory Indolent B-cell Neoplasms. Clinical Cancer Research 2014, 20: 5652-5662. PMID: 25248382, PMCID: PMC4233160, DOI: 10.1158/1078-0432.ccr-14-0805.Peer-Reviewed Original ResearchConceptsDose-limiting toxicityCombination of bortezomibCommon hematologic toxicityCommon nonhematologic toxicitiesIndolent B-cell neoplasmsRefractory multiple myelomaDose-escalation designNon-Hodgkin lymphomaTotal response rateB-cell malignanciesB-cell neoplasmsPharmacodynamic study resultsNonhematologic toxicitySchedule regimenStable diseaseComplete remissionHematologic toxicityPartial remissionClinical responseInvestigator's discretionDosing regimenI trialPharmacokinetic findingsSensory neuropathyInfusion schedule
2003
RTOG 97-06: Initial report of a Phase I–II trial of selective bladder conservation using TURBT, twice-daily accelerated irradiation sensitized with cisplatin, and adjuvant MCV combination chemotherapy
Hagan MP, Winter KA, Kaufman DS, Wajsman Z, Zietman AL, Heney NM, Toonkel LM, Jones CU, Roberts JD, Shipley WU. RTOG 97-06: Initial report of a Phase I–II trial of selective bladder conservation using TURBT, twice-daily accelerated irradiation sensitized with cisplatin, and adjuvant MCV combination chemotherapy. International Journal Of Radiation Oncology • Biology • Physics 2003, 57: 665-672. PMID: 14529770, DOI: 10.1016/s0360-3016(03)00718-1.Peer-Reviewed Original ResearchMeSH KeywordsAlgorithmsAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Transitional CellChemotherapy, AdjuvantCisplatinCombined Modality TherapyConfidence IntervalsCystectomyFemaleHumansMaleMethotrexateMiddle AgedMultivariate AnalysisNeoplasm Recurrence, LocalNeoplasm StagingRadiation-Sensitizing AgentsRadiotherapyRemission InductionUrinary Bladder NeoplasmsVinblastineConceptsGrade 3 toxicityAdjuvant chemotherapyInduction therapyOverall survivalResidual diseaseAdditional adjuvant chemotherapyBladder-sparing treatmentCycles of methotrexateGrade 4 hydronephrosisGrade 4 neutropeniaSelective bladder conservationEvidence of diseaseClinical T stagePositive cytologic findingsAggressive transurethral resectionRTOG 97Surgery specimenKarnofsky scoreLocoregional controlLocoregional failureCombination cisplatinMost patientsPathologic reviewProtocol treatmentVinblastine chemotherapy