2024
A Phase 1 Dose-escalation and Expansion Study of CUE-101, Given As Monotherapy in 3rd Line and in Combination with Pembrolizumab in 1st Line Recurrent/Metastatic (R/M) HPV16+ Head and Neck Cancer Patients
Colevas A, Chung C, Adkins D, Rodriguez C, Park J, Gibson M, Sukari A, Burtness B, Johnson F, Julian R, Saba N, Worden F, Dunn L, Seiwert T, Jotte R, Haddad R, Gabrail N, Bauman J, Margossian S, Pai S. A Phase 1 Dose-escalation and Expansion Study of CUE-101, Given As Monotherapy in 3rd Line and in Combination with Pembrolizumab in 1st Line Recurrent/Metastatic (R/M) HPV16+ Head and Neck Cancer Patients. International Journal Of Radiation Oncology • Biology • Physics 2024, 118: e87. DOI: 10.1016/j.ijrobp.2024.01.192.Peer-Reviewed Original ResearchCD8+ T cellsR/M HNSCCHuman leukocyte antigenT cellsHLA-A*0201Phase 1 dose-escalationTumor antigen-specific CD8First-in-human studyHead and neck cancer patientsTargeted delivery of cytokinesHLA-A*0201 patientsHPV16 E7 peptidesRecurrent/metastatic (R/MData cut-offInfusion-related reactionsT-cell engagersDelivery of cytokinesNeck cancer patientsTreatment of patientsPembrolizumab combinationDose escalationEscalating dosesComplete responseMaculopapular rashLeukocyte antigen
2012
A phase I evaluation of vandetanib plus paclitaxel, carboplatin, 5-fluorouracil, and XRT induction therapy followed by surgery for previously untreated locally advanced cancer of the esophagus and GE junction.
Astsaturov I, Meyer J, Cheng J, Olszanski A, Dushkin H, Berger A, Davey M, Cohen S, Burtness B, Scott W. A phase I evaluation of vandetanib plus paclitaxel, carboplatin, 5-fluorouracil, and XRT induction therapy followed by surgery for previously untreated locally advanced cancer of the esophagus and GE junction. Journal Of Clinical Oncology 2012, 30: 74-74. DOI: 10.1200/jco.2012.30.4_suppl.74.Peer-Reviewed Original ResearchSquamous carcinomaGrade 3 non-hematological toxicityOpen-label phase IOperable esophagealFox Chase Cancer CenterNon-hematological toxicitiesPathologic complete responsePhase I evaluationAST/ALTPromising clinical activityEsophageal squamous carcinomaPET/CTCarboplatin AUC5Male ptsAbdominal painCurative intentGI hemorrhageInduction chemoradiotherapyInduction therapyDistant recurrenceInduction chemoradiationMedian followupComplete responseAdvanced cancerDose escalation
2000
Dose escalation and pharmacokinetic study of irinotecan in combination with paclitaxel in patients with advanced cancer
Murren J, Peccerillo K, DiStasio S, Li X, Leffert J, Pizzorno G, Burtness B, McKeon A, Cheng Y. Dose escalation and pharmacokinetic study of irinotecan in combination with paclitaxel in patients with advanced cancer. Cancer Chemotherapy And Pharmacology 2000, 46: 43-50. PMID: 10912577, DOI: 10.1007/s002800000115.Peer-Reviewed Original ResearchConceptsDose of irinotecanElimination of irinotecanDrug AdministrationAdvanced cancerFirst cycle patientsChemotherapy-related toxicityDose of paclitaxelClinical side effectsSequence of administrationBlood cell elementsNonhematologic toxicityReversible neutropeniaFirst doseMost patientsPartial responseCycle patientsDose escalationMild diarrheaPreclinical dataPlasma concentrationsSide effectsIrinotecanPatientsPharmacokinetic parametersWeekly scheduleA phase I study of the antimetabolite (E)-2'-fluoromethylene-2'-deoxycytidine (MDL 101,731) administered as a twice-weekly infusion.
Burtness B, Belker M, Stoltz M, Peccerillo KM, Lamb LA, Chmael SE, McKeon A, Clark MB, Winship J, Marsh JC, Pizzorno G, DeVita VT. A phase I study of the antimetabolite (E)-2'-fluoromethylene-2'-deoxycytidine (MDL 101,731) administered as a twice-weekly infusion. The Cancer Journal 2000, 6: 309-15. PMID: 11079170.Peer-Reviewed Original ResearchConceptsDose-limiting toxicityRest weekNovel antimetaboliteWeekly scheduleHuman tumor xenograft modelsWeeks of therapyLife-threatening toxicityPhase I trialFrequent dosing scheduleTumor xenograft modelIndicator lesionsNoninfectious feverPersistent neutropeniaStable diseaseWeekly infusionsDose escalationDosing schedulesI trialRectal cancerAdvanced cancerInitial doseMonths durationXenograft modelPatientsPreclinical tests
1999
A phase I study of paclitaxel for mobilization of peripheral blood progenitor cells
Burtness B, Psyrri A, Rose M, D’Andrea E, Staugaard-Hahn C, Henderson-Bakas M, Clark M, Mechanic S, Krause D, Snyder E, Cooper R, Abrantes J, Corringham R, Deisseroth A, Cooper D. A phase I study of paclitaxel for mobilization of peripheral blood progenitor cells. Bone Marrow Transplantation 1999, 23: 311-315. PMID: 10100573, DOI: 10.1038/sj.bmt.1701589.Peer-Reviewed Original ResearchConceptsSchedule of paclitaxelDose escalationH infusionPeripheral blood progenitor cellsDose of paclitaxelPhase I trialBlood progenitor cellsStem cell yieldStem cellsTolerable toxicityI trialInfusion scheduleDose levelsPhase IPaclitaxelDoseProgenitor cellsCells/NeuropathyFilgrastimInfusionEscalation