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

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。本研究的目的是找出研究药物UCN01对黑色素瘤的活性，并获得有关其副作用的进一步信息。这项研究的第二个目的是通过对身体分泌物（如血液和唾液）的测试，更多地了解这种药物对黑色素瘤细胞和身体各个部位的正常细胞的直接影响。只要受试者没有出现难以控制的副作用，并且他们从治疗中获得了一些益处，如没有肿瘤生长或对治疗有反应，则本研究的治疗可以继续进行。治疗结束后，医疗状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没有很好的反应。大多数患者没有从治疗中获得重大益处。因此，研究人员寻找不同的治疗方法至关重要。一种可能性是在实验室研究中用不同于现有药物的方法杀死黑色素瘤细胞。UCN01就是这样一种药物，在实验室实验中显示出对多种肿瘤细胞类型的抗癌活性。这种药物似乎是通过干扰癌细胞中发现的重要蛋白质的功能来起作用的，从而阻止细胞的生长和增殖。因此，人们正在研究它对黑色素瘤的治疗作用。本研究选择的剂量和时间表在早期的癌症研究中不会产生难以控制的副作用。

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.