ON 01910NA 3 DAY CONTINUOUS INFUSION IN PATIENTS WITH ADVANCED CANCER

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。假设：on01910的抗肿瘤作用。Na对肿瘤细胞系的广谱培养和动物模型，包括许多耐药细胞系，以及其较高的治疗指数，为临床研究治疗癌症患者提供了强有力的理论依据。这项研究是针对那些被诊断为晚期癌症的患者，这些患者目前的知识无法治愈，也没有其他治疗方法可以持续有效。本研究将使用ON01910。Na，一种新的抗癌药物，正在研究中（已被食品和药物管理局批准用于研究，但不用于销售）。这是一项开放标签、剂量递增的I期研究。满足本方案中列出的纳入/排除标准的晚期癌症门诊患者。患者将接受ON 01910。钠静脉滴注3天，每2周持续输注一次，直到有证据表明疾病进展，特定不良事件由美国国家癌症研究所（National Cancer Institute）的既定量表量化，达到3级（4级）水平，或在4至6例患者中有2例患者撤回患者同意。在确定推荐的II期剂量后，最多可增加12名患者，以确认推荐的II期剂量的适宜性。这种每2周连续输注3天的方案，是一种有趣且合适的替代剂量方案，每周2次，每次2小时输注，持续3周，10天恢复，目前正在约翰霍普金斯大学肿瘤中心根据不同的方案进行研究（04-01）。对5名患者进行了多达6次剂量的研究。唯一发生的毒副作用是1例患者出现1级腹泻（可能与药物有关）。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Hypothesis: The antitumor effects of ON 01910.Na on a broad spectrum of tumor cell lines in culture and animal models, including many drug resistant cell lines, and its high therapeutic index, provide a strong rationale for clinical studies in the treatment of cancer patients. This study is for patients who have a diagnosis of an advanced cancer, which cannot be cured with present knowledge and for which no other therapy is known to be consistently effective. This research study will use ON01910.Na, a new anticancer agent, which is investigational (has been approved by the Food and Drug Administration for study but not for sale). This is an open-label, dose-escalating Phase I study of ON 01910.Na in ambulatory patients with advanced cancers, who have satisfied the inclusion/exclusion criteria enumerated in this protocol. Patients will receive ON 01910.Na intravenously by 3-day continuous infusion every 2 weeks, until evidence of disease progression, specific adverse events quantified by an established scale of the National Cancer Institute to reach a level of grade 3 (out of 4) in two patients in a cohort of 4 to 6 patients, or withdrawal of patient consent. After the Recommended Phase II Dose has been determined, up to an additional 12 patients may be added to confirm the appropriateness of the Recommended Phase II Dose. This regimen of a 3-day continuous infusion every 2 weeks, is an interesting and appropriate alternative dose regimen to the 2-hour, twice a week infusion schedule for 3 weeks with 10 days recovery, that is currently under investigation under a different protocol (04-01) at The Johns Hopkins University Oncology Center. Five patients have been studied for up to six doses. The only toxic side effect that has occurred was grade 1 diarrhea in one patient (possibly drug related).