2016
ACTR-12. PHASE I/II STUDY OF SINGLE AGENT IBRUTINIB IN RECURRENT/REFRACTORY PRIMARY (PCNSL) AND SECONDARY CNS LYMPHOMA (SCNSL)
Grommes C, Gavrilovic I, Kaley T, Nolan C, Omuro A, Wolfe J, Pentsova E, Hatzoglou V, Mellinghoff I, DeAngelis L. ACTR-12. PHASE I/II STUDY OF SINGLE AGENT IBRUTINIB IN RECURRENT/REFRACTORY PRIMARY (PCNSL) AND SECONDARY CNS LYMPHOMA (SCNSL). Neuro-Oncology 2016, 18: vi3-vi4. DOI: 10.1093/neuonc/now212.011.Peer-Reviewed Original ResearchSecondary CNS lymphomaCNS lymphomaPhase I/II studyRecurrent/refractory diseaseAggressive primary brain tumorCerebrospinal fluid involvementCNS lymphoma patientsGrade 4 toxicityGrade 3 toxicityEnd-organ functionNormal end-organ functionSingle-agent ibrutinibPrimary brain tumorsPromising clinical responsesB-cell malignanciesCommon toxicitiesEligible patientsFungal encephalitisManageable toxicityMedian PFSMethotrexate regimensPrior therapySCNSL patientsClinical responseII study
2015
Phase I Study of Single Agent Ibrutinib in Recurrent/Refractory Primary and Secondary CNS Lymphoma
Christian G, Thomas K, Abdel-Wahab O, Omuro A, Ingo M, DeAngelis L. Phase I Study of Single Agent Ibrutinib in Recurrent/Refractory Primary and Secondary CNS Lymphoma. Blood 2015, 126: 3960. DOI: 10.1182/blood.v126.23.3960.3960.Peer-Reviewed Original ResearchRefractory primary CNS lymphomaPrimary CNS lymphomaSecondary CNS lymphomaDose level 2CNS lymphomaCommon grade 2 toxicityRecurrent primary CNS lymphomaRecurrent/refractory diseaseAggressive primary brain tumorCD20 antibody therapyCNS lymphoma patientsDose of ibrutinibGrade 4 toxicityPrior treatment regimensDose level 1Grade 2 toxicityGrade 3 toxicityMethotrexate-based chemotherapyEnd-organ functionNormal end-organ functionSingle-agent ibrutinibPhase I trialPrimary brain tumorsPromising clinical responsesAlternative therapeutic approach
2014
PHASE II TRIAL OF THE PHOSPHATIDYINOSITOL-3 KINASE (PI3K) INHIBITOR BUPARLISIB (BKM120) IN RECURRENT GLIOBLASTOMA CONDUCTED BY THE IVY FOUNDATION EARLY PHASE CLINICAL TRIALS CONSORTIUM
Wen P, Wen P, Yung W, Mellinghoff I, Ramkissoon S, Alexander B, Rinne M, Colman H, Omuro A, DeAngelis L, Gilbert M, DeGroot J, Cloughesy T, Lee E, Nayak L, S. A, Batchelor T, Chang S, Prados M, Reardon D, Ligon K. PHASE II TRIAL OF THE PHOSPHATIDYINOSITOL-3 KINASE (PI3K) INHIBITOR BUPARLISIB (BKM120) IN RECURRENT GLIOBLASTOMA CONDUCTED BY THE IVY FOUNDATION EARLY PHASE CLINICAL TRIALS CONSORTIUM. Neuro-Oncology 2014, 16: iii47-iii47. PMCID: PMC4144634, DOI: 10.1093/neuonc/nou209.20.Peer-Reviewed Original ResearchPI3K pathwayCohort 2Cohort 1Pan-class I PI3K inhibitorEnzyme-inducing antiepileptic drugsAdequate bone marrowGrade 4 toxicityGrowth of U87K pathwayGrade 3 toxicityPhase II studyPhase II trialRecurrent GBM patientsAdditional eligibility criteriaALT/ASTSingle-agent efficacyPotential therapeutic targetPI3K mutationsReduction of pAKTPI3K inhibitorsEvaluable patientsMedian OSMedian PFSPrior bevacizumabRadiologic progression