PHASE I--TREATMENT WITH I-131 METAIODOBENZYLGUANIDINE IN METASTATIC CARCINOID

I 期——用 I-131 间碘苄基胍治疗转移性类癌

• 批准号: 5215612
• 负责人: JON P GOCKERMAN
• 金额: --
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/5215612
• 关键词: clinical research; clinical trial phase I; contrast media; dosage; drug screening /evaluation; endocrine disorder; gastrointestinal neoplasms; guanidines; halohydrocarbon; human subject; human therapy evaluation; iodine; metastasis; neoplasm /cancer chemotherapy; neoplasm /cancer radionuclide therapy

This is a Phase I study for treatment with I-131 Metaiodobenzylguanidine (MIBG) in patients with metastatic carcinoid. The primary objective of the study is to determine the maximum tolerated dose of I-131 MIBG in patients with untreated metastatic carcinoid. There is documentation in the literature that patients with metastatic carcinoid that uptake MIBG can obtain at least subjective improvement in their disease related symptomatology with treatment using I-131 MIBG. The maximum tolerated dose has not yet been determined and that is the goal of the current study. We hope that higher doses will improve response, both subjectively and objectively. The most recent cohort being treated is at 400 mCi of I-131 MIBG and the one patient in this cohort, at this time is eight weeks out, has shown both subjective and objective improvement without bone marrow toxicity. This is the third cohort with dose increases at 50 mCi per cohort. No dose limiting toxicities have been seen yet. Two more subjects are needed for the current cohort and we hope to continue enrolling patients to determine a maximum tolerated dose.

这是I-131间碘苄胍治疗的I期研究 （MIBG）在转移性类癌患者中的应用。 的主要目的 本研究旨在确定I-131 MIBG的最大耐受剂量， 未经治疗的转移性类癌患者。 文件中有 文献表明，吸收MIBG的转移性类癌患者 至少可以在他们的疾病相关的主观改善， 使用I-131 MIBG进行治疗的放射学。 最大耐受 剂量尚未确定，这是目前的目标 study. 我们希望更高的剂量将改善反应， 主观和客观。 最近接受治疗的队列为400 mCi的I-131 MIBG， 这个队列中的一个病人，在这个时候是8周，已经显示出 主观和客观改善，无骨髓毒性。 这是第三个剂量增加至50 mCi/队列的队列。 没有 剂量限制性毒性已经观察到。 另外两个主题是 我们希望继续招募患者 以确定最大耐受剂量。