A phase I clinical trial for [131I]meta-iodobenzylguanidine therapy in patients with refractory pheochromocytoma and paraganglioma : a study protocol

Objective Pheochromocytoma and paraganglioma (PPGLs) are rare neuroendocrine tumors derived from the adrenal medulla or extra-adrenal paraganglioma from extra-adrenal chromaffin tissue. Although malignant PPGLs has miserable prognosis, the treatment strategy remains to be established. An internal radiation therapy using [131I]meta-iodobenzylguanidine (131I-mIBG) called MIBG therapy has been attempted as one of the systemic treatment of malignant PPGLs. The aim of this study is therefore to evaluate the safety and the efficacy of MIBG therapy for refractory PPGLs. Methods Patients with refractory PPGLs will be enrolled in this study. The total number of patients for registration is 20. The patients receive a fixed dose of 7,400 MBq of 131I-mIBG. Adverse events are surveyed during 20 weeks after 131I-mIBG injection and all severe adverse events will be documented and reported in detail in accordance with the Common Terminology Criteria for Adverse Events (CTCAE). Examination and imaging diagnosis are performed in 12 weeks after 131I-mIBG injection for the evaluation of therapeutic effect in accordance with the Response Evaluation in Solid Tumours (RECIST). Conclusion The current study is the first multi-institutional prospective study of MIBG therapy and thereby will play a significant role in improving the patients’ prognosis of refractory PPGLs

Phase I/II study of alectinib in lung cancer with RET fusion gene : study protocol

Background : The rearranged during transfection (RET) fusion gene was discovered as a driver oncogene in 1-2% of non-small cell lung cancers (NSCLCs). Alectinib is an approved anaplastic lymphoma kinase (ALK) inhibitor that may also be effective for RET fusion-positive NSCLC. Methods/Design : RET fusion-positive NSCLC patients treated with at least one regimen of chemotherapy are being recruited. In step 1, alectinib (600 or 450 mg, twice daily) will be administered following a 3+3 design. The primary endpoint is safety. In step 2, alectinib will be administered at the recommended dose (RD) defined by step 1. The primary endpoint is the response rate of RET inhibitor treatment-naïve patients. Conclusion : This is the first study to investigate the safety and preliminary efficacy of alectinib in RET fusion-positive NSCLC patients. If successful, alectinib treatment may lead to substantial and important changes in the management of NSCLC with RET fusion genes

Comptes rendus des séances de l'Académie des Inscriptions et Belles-Lettres, 128ᵉ année, N. 2, 1984

金沢大学附属病院2015年4月に「人を対象とする医学系研究に関する倫理指針」が施行され、一部の研究を除いてモニタリングが必須となった。本研究は、人的・経費的資源が少なく、かつモニタリング経験の乏しいアカデミア等において、効率よく信頼性の高いモニタリングに貢献できるクラウドシステムの構築を目標とした。その結果、これまでの実施内容や、今後のタスクの確認が容易にできる省力化機能をはじめ、人為的ミスを防ぐ対策や、モニタリング報告書の自動作成、モニタリング進捗の確認が容易にできるシステムの構築に成功した。本システムは、我が国のアカデミア等におけるモニタリング業務を容易にし、臨床研究の質の向上に貢献するものと考える。Since the "Ethical Guidelines for Medical and Health Research Involving Human Subjects" become into force in April 2015, clinical monitoring has been essential except for some research.In this project, we investigated to construct an efficient and highly reliable cloud system in the clinical monitoring, because academia has not been experiencing in the clinical monitoring as well as they have not had much resources and research budget.As a result, we could succeed in constructing the efficient and reliable cloud system in the clinical monitoring system. The system has tremendous features that would contribute to improving the quality of the research and development in the clinical study in Japan. We found the system would achieve the efficient task management, prevention of the human errors and status update checking of the clinical monitoring system.研究課題/領域番号:16K15390, 研究期間(年度):2016-04-01 - 2019-03-3

Feasibility of high-dose iodine-131-metaiodobenzylguanidine therapy for high-risk neuroblastoma preceding myeloablative chemotherapy and hematopoietic stem cell transplantation: a study protocol

Objective(s): High-risk neuroblastoma is a childhood cancer with poorprognosis despite modern multimodality therapy. Internal radiotherapy using131I-metaiodobenzylguanidine (MIBG) is effective for treating the disease even if it isresistant to chemotherapy. The aim of this study is to evaluate the safety and efficacyof 131I-MIBG radiotherapy combined with myeloablative high-dose chemotherapyand hematopoietic stem cell transplantation.Methods: Patients with high-risk neuroblastoma will be enrolled in this study. A totalof 8 patients will be registered. Patients will receive 666 MBq/kg of 131I-MIBG andafter safety evaluation will undergo high-dose chemotherapy and hematopoietic stemcell transplantation. Autologous and allogeneic stem cell sources will be accepted.After engraftment or 28 days after hematopoietic stem cell transplantation, the safetyand response will be evaluated.Conclusion: This is the first prospective study of 131I-MIBG with high-dosechemotherapy and hematopoietic stem cell transplantation in Japan. The results willbe the basis of a future nationwide clinical trial

High Performance Liquid Chromatography of Phenols with a Four-Electrode Electrochemical Detector

小特集 環境工

Phase I/II study of alectinib in lung cancer with RET fusion gene: Study protocol

金沢大学附属病院がんセンターBackground: The rearranged during transfection (RET) fusion gene was discovered as a driver on-cogene in 1-2% of non-small cell lung cancers (NSCLCs). Alectinib is an approved anaplastic lymphoma kinase (ALK) inhibitor that may also be effective for RET fusion-positive NSCLC. Methods/Design: RET fusion-positive NSCLC patients treated with at least one regimen of chemotherapy are being recruited. In step 1, alectinib (600 or 450 mg, twice daily) will be administered following a 3+3 design. The primary endpoint is safety. In step 2, alectinib will be administered at the recommended dose (RD) defined by step 1. The primary endpoint is the response rate of RET inhibitor treatment-naïve patients. Conclusion: This is the first study to investigate the safety and preliminary efficacy of alectinib in RET fusion-positive NSCLC patients. If successful, alectinib treatment may lead to substantial and important changes in the management of NSCLC with RET fusion genes. © 2017, University of Tokushima. All rights reserved