2013
Prostate-specific membrane antigen antibody drug conjugate (PSMA ADC): A phase I trial in metastatic castration-resistant prostate cancer (mCRPC) previously treated with a taxane.
Petrylak D, Kantoff P, Mega A, Vogelzang N, Stephenson J, Fleming M, Stambler N, Petrini M, Blattman S, Israel R. Prostate-specific membrane antigen antibody drug conjugate (PSMA ADC): A phase I trial in metastatic castration-resistant prostate cancer (mCRPC) previously treated with a taxane. Journal Of Clinical Oncology 2013, 31: 5018-5018. DOI: 10.1200/jco.2013.31.15_suppl.5018.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerProstate-specific membrane antigenProgressive metastatic castration-resistant prostate cancerMonomethyl auristatin ELiver function testsFree MMAEPhase 1 dose-escalation studyCastration-resistant prostate cancerTaxane-containing chemotherapyAntitumor activityDose-escalation studyPhase 2 trialPhase I trialCancer cellsProstate cancer cellsSpecific membrane antigenECOG statusLFT abnormalitiesPrior docetaxelAdverse eventsEscalation studyI trialPeripheral neuropathyAntibody therapyFunction testsProstate-specific membrane antigen antibody drug conjugate (PSMA ADC): A phase I trial in metastatic castration-resistant prostate cancer (mCRPC) previously treated with a taxane.
Petrylak D, Kantoff P, Mega A, Vogelzang N, Stephenson J, Fleming M, Stambler N, Petrini M, Huang K, Israel R. Prostate-specific membrane antigen antibody drug conjugate (PSMA ADC): A phase I trial in metastatic castration-resistant prostate cancer (mCRPC) previously treated with a taxane. Journal Of Clinical Oncology 2013, 31: 119-119. DOI: 10.1200/jco.2013.31.6_suppl.119.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerProstate-specific membrane antigenMonomethyl auristatin EFree MMAEProstate cancer cellsProgressive metastatic castration-resistant prostate cancerDose levelsPhase 1 dose-escalation studyLiver function test elevationsCastration-resistant prostate cancerTaxane-containing chemotherapyAntitumor activityDose-escalation studyPhase 2 trialPhase I trialCancer cellsClinical disease progressionHighest dose levelSpecific membrane antigenECOG statusLFT abnormalitiesPrior docetaxelAdverse eventsEscalation studyI trial
2012
Prostate-specific membrane antigen antibody drug conjugate (PSMA ADC): A phase I trial in metastatic castration-resistant prostate cancer (mCRPC) previously treated with a taxane.
Mega A, Petrylak D, Kantoff P, Stephenson J, Vogelzang N, Dreicer R, Shore N, Stambler N, Carpenito J, D'Ambrosio P, Israel R. Prostate-specific membrane antigen antibody drug conjugate (PSMA ADC): A phase I trial in metastatic castration-resistant prostate cancer (mCRPC) previously treated with a taxane. Journal Of Clinical Oncology 2012, 30: 4662-4662. DOI: 10.1200/jco.2012.30.15_suppl.4662.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerMonomethyl auristatin EHighest dose levelFree MMAEProstate cancer cellsDose levelsAdverse eventsProgressive metastatic castration-resistant prostate cancerPhase 1 dose-escalation studyCastration-resistant prostate cancerTumor cellsHigh-dose cohortTaxane-containing chemotherapyAntitumor activityCommon laboratory abnormalitiesDose-escalation studyLiver function testsPhase I trialCancer cellsClinical disease progressionDose cohortsECOG statusEscalation studyLaboratory abnormalitiesDose escalationProstate-specific membrane antigen antibody drug conjugate (PSMA ADC): A phase I trial in men with prostate cancer previously treated with taxane.
Petrylak D, Kantoff P, Mega A, Dreicer R, Frank R, Shore N, Morris S, Olson W, Israel R. Prostate-specific membrane antigen antibody drug conjugate (PSMA ADC): A phase I trial in men with prostate cancer previously treated with taxane. Journal Of Clinical Oncology 2012, 30: 107-107. DOI: 10.1200/jco.2012.30.5_suppl.107.Peer-Reviewed Original ResearchMonomethyl auristatin EFree MMAEProstate cancer cellsAdverse eventsProstate cancerMetastatic castration-resistant prostate cancerPhase 1 dose-escalation studyCastration-resistant prostate cancerTumor cellsHigh-dose cohortTaxane-containing regimenAntitumor activityCommon laboratory abnormalitiesDose-escalation studyPhase I trialCancer cellsClinical disease progressionHighest dose levelBone painDose cohortsECOG statusEscalation studyLaboratory abnormalitiesI trialThird doses
2011
Preliminary Results of An Ongoing Phase I Trial of Oral Belinostat a Novel Histone Deacetylase Inhibitor in Patients with Lymphoid Malignancies,
Zain J, Foss F, Diefenbach C, Petrylak D, Narwal A, Neylon E, Knoblauch P, O'Connor O. Preliminary Results of An Ongoing Phase I Trial of Oral Belinostat a Novel Histone Deacetylase Inhibitor in Patients with Lymphoid Malignancies,. Blood 2011, 118: 3710. DOI: 10.1182/blood.v118.21.3710.3710.Peer-Reviewed Original ResearchHistone deacetylase inhibitorsTumor shrinkageSolid tumorsDeacetylase inhibitorsIntra-patient dose escalationOngoing phase I trialClass I/II histone deacetylase inhibitorEarly tumor shrinkageGrade 3 diarrheaMedian age 48Frequent adverse eventsNovel histone deacetylase inhibitorPhase I trialHighest dose levelMantle cell lymphomaAnorexia/Dose cohortsEvaluable diseaseQ3w scheduleStable diseaseAdverse eventsDaily doseDose escalationI trialNHL patientsProstate-specific membrane antigen antibody–drug conjugate (PSMA ADC): A phase I trial in taxane-refractory prostate cancer.
Petrylak D, Kantoff P, Frank R, Shore N, Rotshteyn Y, Israel R, Olson W, Ramakrishna T, Morris S. Prostate-specific membrane antigen antibody–drug conjugate (PSMA ADC): A phase I trial in taxane-refractory prostate cancer. Journal Of Clinical Oncology 2011, 29: 4650-4650. DOI: 10.1200/jco.2011.29.15_suppl.4650.Peer-Reviewed Original ResearchProstate-specific membrane antigen antibody drug conjugate (PSMA ADC): A phase I trial in taxane-refractory prostate cancer.
Petrylak D, Kantoff P, Rotshteyn Y, Israel R, Olson W, Ramakrishna T, Morris S. Prostate-specific membrane antigen antibody drug conjugate (PSMA ADC): A phase I trial in taxane-refractory prostate cancer. Journal Of Clinical Oncology 2011, 29: 158-158. DOI: 10.1200/jco.2011.29.7_suppl.158.Peer-Reviewed Original ResearchMonomethyl auristatin EFree MMAEProstate cancer cellsProstate cancerRefractory metastatic prostate cancerDose-proportional PKTaxane-containing regimenCommon laboratory abnormalitiesDose-proportional mannerPhase I trialCancer cellsClinical disease progressionMetastatic prostate cancerOngoing phase IEnzyme-linked immunosorbent assay (ELISA) methodPotential clinical utilityImmunosorbent assay (ELISA) methodECOG statusAdverse eventsEscalation studyLaboratory abnormalitiesI trialThird dosesAntibody therapyLiquid chromatography/mass spectrometry/mass spectrometry method
2010
Phase I trial of intravesical nanoparticle albumin-bound paclitaxel in the treatment of BCG-refractory non-muscle-invasive bladder cancer.
Barlow L, Laudano M, Mann M, Desai M, Petrylak D, Benson M, McKiernan J. Phase I trial of intravesical nanoparticle albumin-bound paclitaxel in the treatment of BCG-refractory non-muscle-invasive bladder cancer. Journal Of Clinical Oncology 2010, 28: 4542-4542. DOI: 10.1200/jco.2010.28.15_suppl.4542.Peer-Reviewed Original ResearchFirst-in-human phase I trial of prostate-specific membrane antigen antibody drug conjugate (PSMA ADC) in taxane-refractory prostate cancer.
Kantoff P, Petrylak D, Pomerantz M, Israel R, Olson W, Ramakrishna T, Morris S. First-in-human phase I trial of prostate-specific membrane antigen antibody drug conjugate (PSMA ADC) in taxane-refractory prostate cancer. Journal Of Clinical Oncology 2010, 28: tps245-tps245. DOI: 10.1200/jco.2010.28.15_suppl.tps245.Peer-Reviewed Original Research
2009
A combined phase I/II trial of intravesical nanoparticle albumin-bound paclitaxel in the treatment of refractory non–muscle- invasive transitional cell bladder cancer
Barlow L, Laudano M, Mann M, Desai M, Petrylak D, Benson M, McKiernan J. A combined phase I/II trial of intravesical nanoparticle albumin-bound paclitaxel in the treatment of refractory non–muscle- invasive transitional cell bladder cancer. Journal Of Clinical Oncology 2009, 27: e16047-e16047. DOI: 10.1200/jco.2009.27.15_suppl.e16047.Peer-Reviewed Original ResearchPhase I trialPhase I/II trialIntravesical agentsNab-paclitaxelI trialII trialIntravesical therapyBladder cancerSystemic absorptionInvasive transitional cell bladder cancerResponse ratePhase II efficacy studyTis transitional cell carcinomaNanoparticle albumin-bound paclitaxelTransitional cell bladder cancerOngoing phase I trialDose-escalation modelDose-escalation trialEvidence of diseaseGrade 1 toxicityHigh-risk patientsHigh-grade TaInvasive bladder cancerAlbumin-bound paclitaxelTransitional cell carcinomaA phase I open-label study using lenalidomide and docetaxel in castration- resistant prostate cancer
Petrylak D, Resto-Garces K, Tibyan M, Mohile S. A phase I open-label study using lenalidomide and docetaxel in castration- resistant prostate cancer. Journal Of Clinical Oncology 2009, 27: 5156-5156. DOI: 10.1200/jco.2009.27.15_suppl.5156.Peer-Reviewed Original ResearchMeasurable diseaseDay 1Dose levelsPhase I open-label studyCastration-resistant prostate cancerGrade 3 neutropeniaGrade 3/4 toxicitiesGrade 4 neutropeniaMedian baseline PSAOpen-label studyPost-treatment PSAPrior chemotherapy regimensMetastatic pulmonary nodulesDeep venous thrombosisFurther dose escalationPhase I trialEfficacy of docetaxelNear complete resolutionCycle 1Derivative of thalidomideAntiandrogen withdrawalNCI trialProphylactic anticoagulationTreatment PSAChemotherapy regimens
2006
A phase I open-label, dose escalation study to determine the maximum tolerated dose and to evaluate the safety profile of lenalidomide with every three week docetaxel in subjects with androgen independent prostate cancer
Moss R, Shelton G, Melia J, Mohile S, Petrylak D. A phase I open-label, dose escalation study to determine the maximum tolerated dose and to evaluate the safety profile of lenalidomide with every three week docetaxel in subjects with androgen independent prostate cancer. Journal Of Clinical Oncology 2006, 24: 14618-14618. DOI: 10.1200/jco.2006.24.18_suppl.14618.Peer-Reviewed Original ResearchAndrogen-independent prostate cancerIndependent prostate cancerMeasurable diseaseProstate cancerSerum prostate-specific antigen levelProstate-specific antigen levelDose escalation schedulePrior chemotherapy regimensEvidence of progressionFurther dose escalationPhase I trialSpecific antigen levelsEfficacy of docetaxelDerivative of thalidomideAntiandrogen withdrawalL1 patientsPalliative RTPo bidStable diseaseChemotherapy regimensMedian PSARECIST criteriaEscalation studySerum PSABone metastasesA Phase I Trial of Pox PSA vaccines (PROSTVAC®-VF) with B7-1, ICAM-1, and LFA-3 co-stimulatory molecules (TRICOM™) in Patients with Prostate Cancer
DiPaola R, Plante M, Kaufman H, Petrylak D, Israeli R, Lattime E, Manson K, Schuetz T. A Phase I Trial of Pox PSA vaccines (PROSTVAC®-VF) with B7-1, ICAM-1, and LFA-3 co-stimulatory molecules (TRICOM™) in Patients with Prostate Cancer. Journal Of Translational Medicine 2006, 4: 1. PMID: 16390546, PMCID: PMC1360095, DOI: 10.1186/1479-5876-4-1.Peer-Reviewed Original ResearchProstate-specific antigenSerious adverse eventsAdverse eventsProstate cancerB7-1ICAM-1Co-stimulatory molecules B7-1Mean prostate-specific antigenRecombinant vaccinia virus vaccineAndrogen-independent prostate cancerFurther phase IIPreliminary clinical activityInjection site reactionsPhase I trialVaccinia virus vaccineCo-stimulatory moleculesIndependent prostate cancerFeasible therapeutic approachRecombinant fowlpox virusStable diseaseMetastatic diseaseProgressive diseaseI trialTherapeutic vaccinesSafety profile
1999
Phase I trial of docetaxel with estramustine in androgen-independent prostate cancer.
Petrylak D, Macarthur R, O'Connor J, Shelton G, Judge T, Balog J, Pfaff C, Bagiella E, Heitjan D, Fine R, Zuech N, Sawczuk I, Benson M, Olsson C. Phase I trial of docetaxel with estramustine in androgen-independent prostate cancer. Journal Of Clinical Oncology 1999, 17: 958-67. PMID: 10071290, DOI: 10.1200/jco.1999.17.3.958.Peer-Reviewed Original ResearchConceptsAndrogen-independent prostate cancerEPT patientsProstate cancerMPT patientsProgressive metastatic androgen-independent prostate cancerMetastatic androgen-independent prostate cancerDose-limiting myelosuppressionGrade 3/4 granulocytopeniaPSA response ratePhase II doseDoses of docetaxelPhase I trialPharmacokinetics of docetaxelBone painMeasurable diseaseOral estramustinePo tidPain medicationPartial responseSerum PSAI trialNarcotic analgesicsTime of entryPatientsDay 1