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Nanoliposomal Irinotecan and Metronomic Temozolomide for Patients With Recurrent Glioblastoma: BrUOG329, A Phase I Brown University Oncology Research Group Trial

Elinzano, Heinrich ; Toms, Steven ; Robison, Jordan ; Mohler, Alex ; Carcieri, Arieana ; Cielo, Deus ; Donnelly, Jennifer ; Disano, Dylan ; Vatketich, John ; Baekey, John ; Sturtevant, Ashlee ; MacKinnon, Kelsey ; Wood, Roxanne ; Safran, Howard

American journal of clinical oncology, 2021-02, Vol.44 (2), p.49-52 [Periódico revisado por pares]

United States

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Título:
Nanoliposomal Irinotecan and Metronomic Temozolomide for Patients With Recurrent Glioblastoma: BrUOG329, A Phase I Brown University Oncology Research Group Trial
Autor: Elinzano, Heinrich ; Toms, Steven ; Robison, Jordan ; Mohler, Alex ; Carcieri, Arieana ; Cielo, Deus ; Donnelly, Jennifer ; Disano, Dylan ; Vatketich, John ; Baekey, John ; Sturtevant, Ashlee ; MacKinnon, Kelsey ; Wood, Roxanne ; Safran, Howard
Assuntos: Administration, Metronomic ; Adult ; Aged ; Anorexia - chemically induced ; Antineoplastic Combined Chemotherapy Protocols - administration & dosage ; Antineoplastic Combined Chemotherapy Protocols - adverse effects ; Brain Neoplasms - drug therapy ; Brain Neoplasms - mortality ; Brain Neoplasms - pathology ; Diarrhea - chemically induced ; Drug Delivery Systems - methods ; Female ; Glioblastoma - drug therapy ; Glioblastoma - mortality ; Glioblastoma - pathology ; Humans ; Irinotecan - administration & dosage ; Liposomes - administration & dosage ; Male ; Maximum Tolerated Dose ; Middle Aged ; Nanostructures - administration & dosage ; Nanostructures - chemistry ; Neutropenia - chemically induced ; Temozolomide - administration & dosage
É parte de: American journal of clinical oncology, 2021-02, Vol.44 (2), p.49-52
Descrição: Liposomal formulations may improve the solubility and bioavailability of drugs potentially increasing their ability to cross the blood-brain barrier. We performed a phase I study to determine the maximum tolerated dose and preliminary efficacy of pegylated nanoliposomal irinotecan (nal-IRI)+metronomic temozolomide (TMZ) in patients with recurrent glioblastoma. Patients with glioblastoma who progressed after at least 1 line of therapy were eligible. All patients received TMZ 50 mg/m2/d until disease progression. Three dose levels of nal-IRI were planned, 50, 70, and 80 mg/m2, intravenously every 2 weeks. Patients were accrued in a 3+3 design. The study included a preliminary assessment after the first 13 evaluable patients. The trial would be terminated early if 0 or 1 responses were observed in these patients. Twelve patients were treated over 2 dose levels (nal-IRI 50 and 70 mg/m2). At dose level 2, nal-IRI 70 mg/m2, 2 of 3 patients developed dose-limiting toxicities including 1 patient who developed grade 4 neutropenia and grade 3 diarrhea and anorexia and 1 patient with grade 3 diarrhea, hypokalemia fatigue, and anorexia. Accrual to dose level 1 was expanded to 9 patients. The Drug Safety Monitoring Board (DSMB) reviewed the data of the initial 12 patients-there were 0/12 responses (0%) and the median progression-free survival was 2 months and accrual was halted. The maximum tolerated dose of nal-IRI was 50 mg/m2 every 2 weeks with TMZ 50 mg/m2/d. The dose-limiting toxicities were diarrhea and neutropenia. No activity was seen at interim analysis and the study was terminated.
Editor: United States
Idioma: Inglês

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Nanoliposomal Irinotecan and Metronomic Temozolomide for Patients With Recurrent Glioblastoma: BrUOG329, A Phase I Brown University Oncology Research Group Trial

Elinzano, Heinrich ; Toms, Steven ; Robison, Jordan ; Mohler, Alex ; Carcieri, Arieana ; Cielo, Deus ; Donnelly, Jennifer ; Disano, Dylan ; Vatketich, John ; Baekey, John ; Sturtevant, Ashlee ; MacKinnon, Kelsey ; Wood, Roxanne ; Safran, Howard

United States

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