2013
Phase I trial of bortezomib and dacarbazine in melanoma and soft tissue sarcoma
Poklepovic A, Youseffian L, Winning M, Birdsell CA, Crosby NA, Ramakrishnan V, Ernstoff MS, Roberts JD. Phase I trial of bortezomib and dacarbazine in melanoma and soft tissue sarcoma. Investigational New Drugs 2013, 31: 937-942. PMID: 23315028, PMCID: PMC3844155, DOI: 10.1007/s10637-012-9913-8.Peer-Reviewed Original ResearchConceptsSoft tissue sarcomasPhase I trialTissue sarcomasPartial responseI trialPhase II dosesDurable complete responseAmine precursor uptakeTwenty-eight patientsProteasome inhibitor bortezomibHuman melanoma cell linesMurine xenograft tumor modelXenograft tumor modelCKIT mutationsDecarboxylation (APUD) tumorsProphylactic antiemeticsRECIST v1.0Eight patientsComplete responseMelanoma cell linesWeekly dosesDose escalationAgent dacarbazinePreclinical studiesDose levels
2012
Phase I trial of the combination of flavopiridol and imatinib mesylate in patients with Bcr-Abl+ hematological malignancies
Bose P, Perkins EB, Honeycut C, Wellons MD, Stefan T, Jacobberger JW, Kontopodis E, Beumer JH, Egorin MJ, Imamura CK, Douglas Figg W, Karp JE, Koc ON, Cooper BW, Luger SM, Colevas AD, Roberts JD, Grant S. Phase I trial of the combination of flavopiridol and imatinib mesylate in patients with Bcr-Abl+ hematological malignancies. Cancer Chemotherapy And Pharmacology 2012, 69: 1657-1667. PMID: 22349810, PMCID: PMC3365614, DOI: 10.1007/s00280-012-1839-5.Peer-Reviewed Original ResearchConceptsTyrosine kinase inhibitorsCombination of flavopiridolStable diseasePhase I dose-escalation studyPhiladelphia chromosome-positive acute leukemiaSecond-generation BCR-ABL tyrosine kinase inhibitorBone marrow blast countI dose-escalation studyBCR-ABL tyrosine kinase inhibitorsKinase inhibitorsImatinib-resistant diseaseIntravenous infusion weeklyPhase II dosesDose-escalation studyMarrow blast countPhase I trialNovel combination regimenMajor pharmacokinetic interactionsBCR-ABL tyrosine kinaseChronic myelogenous leukemiaInfusion weeklyCyclin-dependent kinase inhibitorBlast countCombination regimenComplete response
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
2009
Phase I study of bryostatin 1, a protein kinase C modulator, preceding cisplatin in patients with refractory non-hematologic tumors
Pavlick AC, Wu J, Roberts J, Rosenthal MA, Hamilton A, Wadler S, Farrell K, Carr M, Fry D, Murgo AJ, Oratz R, Hochster H, Liebes L, Muggia F. Phase I study of bryostatin 1, a protein kinase C modulator, preceding cisplatin in patients with refractory non-hematologic tumors. Cancer Chemotherapy And Pharmacology 2009, 64: 803. PMID: 19221754, PMCID: PMC3901370, DOI: 10.1007/s00280-009-0931-y.Peer-Reviewed Original ResearchConceptsPeripheral blood mononuclear cellsPhase INon-hematologic tumorsPhase II dosesPhase II doseDose-limiting toxicityResultsFifty-three patientsBlood mononuclear cellsNon-hematologic malignanciesBryostatin 1Cytotoxicity of cisplatinCisplatin 50PurposePreclinical dataObjective responseContinuous infusionMononuclear cellsTolerable dosesProtein kinase C modulatorsCisplatin effectComputerized tomographyPatientsConsistent inhibitionCisplatin cytotoxicityCisplatinMinimal toxicity
2006
Phase I Study of Bryostatin 1 and Fludarabine in Patients with Chronic Lymphocytic Leukemia and Indolent (Non-Hodgkin's) Lymphoma
Roberts JD, Smith MR, Feldman EJ, Cragg L, Millenson MM, Roboz GJ, Honeycutt C, Thune R, Padavic-Shaller K, Carter WH, Ramakrishnan V, Murgo AJ, Grant S. Phase I Study of Bryostatin 1 and Fludarabine in Patients with Chronic Lymphocytic Leukemia and Indolent (Non-Hodgkin's) Lymphoma. Clinical Cancer Research 2006, 12: 5809-5816. PMID: 17020988, DOI: 10.1158/1078-0432.ccr-05-2730.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBryostatinsDose-Response Relationship, DrugDrug Administration ScheduleFemaleHumansLeukemia, Lymphocytic, Chronic, B-CellLymphoma, Non-HodgkinMacrolidesMaleMaximum Tolerated DoseMiddle AgedPrognosisSurvival RateVidarabineConceptsChronic lymphocytic leukemiaIndolent lymphomaLymphocytic leukemiaBryostatin 1Dose-limiting toxic eventsTreatment of CLLMonoclonal antibodiesPhase II dosePhase II dosesPhase II studyCD20 monoclonal antibodyII studyPersistent diseaseSuccessive patientsSingle doseContinuous infusionI studiesHematologic malignanciesPreclinical studiesTherapeutic effectFludarabinePatientsPrior treatmentLymphomaPhase I