Selective Intra-arterial Injection of Peptide Receptor Radionuclide Therapy (PRRT) in Neuroendocrine Tumor Patients With Liver Metastases

Sandeep Laroia1 个研究点分布在 1 个国家目标入组 3 人开始时间: 2018年10月11日最近更新: 2023年11月28日

适应症

干预措施

试验速览

阶段: 早期 1 期
状态: 终止
发起方
入组人数: 3
试验地点: 1
主要终点: Change in absolute neutrophil count

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a safety study to determine the phase 1 starting dose of [90]Yttrium-DOTATOC when it is administered intravenously for patients with neuroendocrine tumors that have spread to the liver.

详细描述

[90]Yttrium-DOTATOC is a radioactive drug used for peptide receptor radionuclide therapy (PRRT). In other studies, 90Y-DOTATOC has been administered through a vein (IV) to target somatostatin receptor positive tumor tissue. The DOTATOC identifies the tumor through the somatostatin receptor and links to it, attaching the radioactive molecule 90Yttrium to the malignant cell.

This study expands the initial work to examine if administering the drug 90Y-DOTATOC directly to the liver is safe for patients with neuroendocrine tumors whose disease has spread to their tumor. We don't know how of the 90Y-DOTATOC is safe to administer. We want to learn what the maximum safe dose is and what the side effects are related to that dose.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Sequential
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Ability to understand and the willingness to provide informed consent
•Pathologically well-differentiated neuroendocrine tumor (i.e. grade 1 or grade 2).
•Primary tumor location should be known or believed to be midgut.
•At least one tumor in the liver that is positive with [68]Ga-DOTATATE (NETSPOT). Imaging must be performed within the past 6 months.
•Liver lesions not amendable to other therapies (surgery, ablation) and have progressed after treatment with octreotide/lanreotide and/or other treatments. (everolimus, sunitinib).
•Karnofsky performance status of at least 70
•Absolute neutrophil count of at least 1,000 cells/mm3
•Platelet count of at least 90,000 cells / mm3
•Total bilirubin ≤ 2 x the upper limit of normal when adjusted for age
•AST and ALT ≤ 5 x the upper limit of normal when adjusted for age
•Serum creatinine ≤ 1.2 mg/dl; if serum creatinine is >1.2 mg/dl nuclear GFR will used for potentially eligible participants.
•Agrees to contraception.
•Exclusion criteria:
•Liver tumor involvement greater than 70% by cross sectional imaging
•Extra-hepatic visceral and osseous metastases
•Concomitant therapy for tumor (except for somatostatin analogs or bisphosphonates)
•Previous PRRT or other liver directed therapy within 12 months of consent
•Women who are pregnant, breast feeding or breast pumping.
•Another concurrent malignancy on active therapy
•Previous external-beam radiation therapy to a kidney (including scatter dose)
•Therapeutic investigational drug within 4 weeks of therapy.
•Subjects for whom, in the opinion of their physician, a 24-hour discontinuation of somatostatin analogue therapy represents a health risk.
•Sandostatin LAR injection within 4 weeks or lanreotide injection within 8 weeks of proposed therapy.
•Inability to lie down supine for study procedure.
•Reaction to IV contrast used for the angiogram.
•Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring hospitalization, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

排除标准

未提供