CLINICAL TRIAL: ON 01910NA 3 DAY CONTINUOUS INFUSION IN PATIENTS WITH ADVANCED

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 假设：On 01910.Na对培养和动物模型中广泛的肿瘤细胞系，包括许多耐药细胞系的抗肿瘤作用，以及其高的治疗指数，为癌症患者的临床研究提供了强有力的理论基础。这项研究是为那些被诊断为晚期癌症的患者进行的，目前的知识无法治愈这种癌症，而且目前还没有其他疗法对这种癌症持续有效。这项研究将使用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进行研究，但尚未上市)。 这是一项开放标签、剂量递增的On 01910.Na第一阶段研究，用于符合本方案中列举的纳入/排除标准的晚期癌症门诊患者。患者将于01910接受Na3天持续输注，每2周一次，直到发现疾病进展的证据，国家癌症研究所建立的量表量化的特定不良事件，在4至6名患者中有2名患者达到3级(满分4)，或撤回患者同意。在确定了推荐的第二阶段剂量后，最多可以再增加12名患者，以确认建议的第二阶段剂量是否合适。 这种每2周连续输注3天的方案是一种有趣和适当的替代剂量方案，与每周2次、持续3周、恢复10天的输液方案相比，该方案目前正在约翰霍普金斯大学肿瘤学中心根据不同的方案(04-01)进行研究。已对5名患者进行了最多6剂的研究。发生的唯一毒副作用是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).