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
1991
A phase i clinical trial of didemnin B
Stewart J, Low J, Roberts J, Blow A. A phase i clinical trial of didemnin B. Cancer 1991, 68: 2550-2554. PMID: 1933801, DOI: 10.1002/1097-0142(19911215)68:12<2550::aid-cncr2820681203>3.0.co;2-q.Peer-Reviewed Original ResearchConceptsM2/dDrug-induced liver dysfunctionPhase I clinical trialPhase II doseHepatic enzyme levelsDose-limiting toxicityComplete tumor responseCastor oil vehicleMurine B16 melanomaDidemnin BBolus scheduleClinical bleedingLiver dysfunctionAdvanced cancerAnaphylactic symptomsTumor responseClinical trialsDrug infusionL1210 growthOil vehicleM5076 sarcomaB16 melanomaDose levelsSporadic elevationsToxicologic tests