PHASE IB/II TRIAL OF PC 0120AS RADIOSENSITIZER IN METASTATIC BRAIN CANCER

PC 0120AS 放射增敏剂治疗转移性脑癌的 IB/II 期试验

• 批准号: 6121724
• 负责人: MINESH P. MEHTA
• 金额: $ 3.35万
• 依托单位: UNIVERSITY OF WISCONSIN-MADISON
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6121724
• 关键词: brain neoplasms; clinical research; clinical trial phase I; dosage; drug adverse effect; drug screening /evaluation; gadolinium; human subject; human therapy evaluation; injection /infusion; magnetic resonance imaging; metastasis; neoplasm /cancer radiation therapy; pharmacokinetics; radiosensitizer

The purpose of this study is to treat patients with metastatic brain tumors using Gadolinium Texaphyrin (PCI-0120) injection two to five hours before radiation treatments for ten consecutive days (excluding weekends and holidays); to establish an appropriate intravenous dose of Gadolinium Texaphyrin (PCI-0120) Injection; to determine the maximum tolerated total dose (MTD) of Gadolinium Texaphyrin (PCI-0120) Injection for palliative radiation therapy of metastases to the brain; to evaluate an additional 20 patients at the MTD to establish the safety profile of Gadolinium Texaphyrin (PCI-0120) Injection; to evaluate accumulation of Gadolinium Texaphyrin (PCI-0120) Injection in metastases and changes in tumor volume (i.e., response to treatment); to determine the dose limiting toxicity of repetitive doses of Gadolinium Texaphyrin (PCI-0120) Injection, where each dose is followed by a radiation treatment, in patients with metastatic cancer to the brain; to determine the biolocalization of Gadolinium Texaphyrin (PCI-0120) Injection in cancer (e.g., brain metastases) and normal tissue(s) (e.g., brain tissue), and the change in cancer volume, using MRI and the high (white) signal intensity Gadolinium Texaphyrin (PCI-0120) Injection produces on MRI scans; and to determine the in vivo pharmacokinetics of Gadolinium Texaphyrin (PCI-0120) injection in patients treated at the MTD.

本研究的目的是在连续10天(不包括周末和节假日)的放射治疗前2~5小时注射葛根素(PCI-0120)治疗脑转移瘤；建立合适的静脉注射葛根素(PCI-0120)剂量；确定姑息性放射治疗脑转移瘤的最大耐受总剂量(MTD)；评估另外20例患者在MTD处的安全性；本研究的目的是评估葛根素(PCI-0120)在转移瘤中的蓄积和肿瘤体积的变化(即对治疗的反应)；确定在脑转移癌患者中多次注射葛根素(PCI-0120)的剂量限制性毒性，每次剂量后再进行放射治疗；目的：利用磁共振成像技术及磁共振成像所显示的高(白)信号载体