PHII: A PHASE II STUDY OF UCN-01 IN METASTATIC MELANOMA

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。这项研究的目的是找出调查剂UCN01对黑色素瘤的活性，并获得关于其副作用的进一步信息。这项研究的第二个目的是通过对血液和唾液等身体分泌物的测试，更多地了解这种药物对黑色素瘤细胞和身体不同部位的正常细胞的直接影响。这项研究的治疗可以继续进行，只要受试者没有出现无法控制的副作用，并且他们从治疗中获得了一些好处，这表明他们没有肿瘤生长或对治疗的反应。治疗结束后，医疗情况将继续无限期跟踪。转移性黑色素瘤对大多数化疗或生物治疗药物不太敏感。大多数患者并没有从治疗中获得重大好处。因此，研究人员寻找不同的治疗方法是至关重要的。一种可能性是在实验室研究中使用与现有药物不同的方法杀死黑色素瘤细胞的药物。UCN01就是这样一种药物，在实验室实验中已经显示出对多种肿瘤细胞的抗癌活性。这种药物似乎通过干扰癌细胞中的重要蛋白质的功能来发挥作用，并阻止细胞的生长和繁殖。出于这个原因，人们正在研究它对抗黑色素瘤。已经为这项研究选择了一个剂量和时间表，在癌症受试者的早期研究中没有引起无法控制的副作用。

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. The purpose of this study is to find out how active the investigational agent UCN01 is against melanoma and to obtain further information about its side effects. A secondary purpose of the study is to learn more about the direct effects of this drug on cells from melanoma tumor and normal cells from various parts of the body using tests on body secretions, such as blood and saliva. Treatment on this study may be continued as long as the subjects do not experience unmanageable side effects and they are receiving some benefit from treatment as demonstrated by either lack of tumor growth or response to treatment. After treatment is over, medical condition will continue to be followed indefinitely. Metastatic melanoma is not very responsive to most chemotherapy or biological therapy drugs. Most patients do not achieve a major benefit from treatment. Therefore, it is essential that researchers look for different treatments. One possibility is drugs that kill melanoma cells in laboratory studies by different methods than currently available drugs. UCN01 is one such drug that has shown anti-cancer activity against a number of tumor cell types in laboratory experiments. It appears that this drug works by interfering with the function of important proteins found in cancer cells and prevents growth and multiplication of the cells. For this reason, it is being studied against melanoma. A dose and schedule has been selected for this study that did not cause unmanageable side effects in earlier studies in subjects with cancer.