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

本研究的目的是在放射治疗前2 - 5小时连续10天（不包括周末和节假日）使用钆Texaphyrin （PCI-0120）注射治疗转移性脑肿瘤患者；建立适当的静脉注射剂量的头孢西林钆（PCI-0120）；测定脑转移性肿瘤姑息性放射治疗中钆Texaphyrin （PCI-0120）注射液的最大耐受总剂量（MTD）；在MTD对另外20名患者进行评估，以确定Gadolinium Texaphyrin （PCI-0120）注射液的安全性；评估转移灶内Texaphyrin Gadolinium （PCI-0120）注射液的蓄积和肿瘤体积的变化（即对治疗的反应）；确定重复剂量的钆Texaphyrin （PCI-0120）注射液的剂量限制毒性，每次剂量后进行放射治疗，用于脑转移性癌症患者；利用MRI和高（白色）信号强度的钆Texaphyrin （PCI-0120）注射剂在MRI扫描上产生的肿瘤（如脑转移）和正常组织（如脑组织）中的生物定位，以及肿瘤体积的变化；并确定在MTD治疗的患者体内药物动力学的钆Texaphyrin （PCI-0120）注射液。

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.