IMMUNOMODULATION BY IMIQUIMOD IN PRIMARY MELANOMA

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。 这项试验性的临床研究是为了确定5%咪喹莫特乳膏(Aldara，3M PharmPharmticals)是否可以用于诱导原发性黑色素瘤皮肤癌患者的免疫反应。符合条件的受试者将从港湾-加州大学洛杉矶分校皮肤科诊所或外科肿瘤学服务机构转介进行研究评估。患者将接受外科肿瘤学副教授赫尔南·瓦尔加斯博士的护理，并将接受目前标准的原发性黑色素瘤皮肤癌治疗--手术切除。这项研究将在目前的护理标准基础上增加额外的干预措施。患者将有50%的机会接受安慰剂或药物治疗。患者将在他们通常等待预定手术的时间内，在黑色素瘤皮肤癌部位应用研究药物，一种局部乳膏，为期两周。患者将来港湾-加州大学洛杉矶分校的普通临床研究中心进行初步访问。在这里，他们将与研究人员会面，以获得研究风险和收益的全面披露，并同意纳入研究。纳入或排除在研究之外绝不会影响他们是否得到标准的护理。在知情同意后，将完成初步检查，对患者的皮肤癌进行拍照，并收集初始100cc(约7汤匙)的血液。研究药房将为患者提供研究用药。

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. This pilot clinical study is to determine if 5% imiquimod cream (Aldara, 3M Pharmaceuticals), an FDA-approved drug for use in other skin cancers, can be used to induce an immune response in patients with primary melanoma skin cancers. Eligible subjects will be referred from the Harbor-UCLA Dermatology Clinic or Surgical Oncology service for study evaluation. Patients will be under the care of Dr. Hernan Vargas, associate professor of Surgical Oncology and will receive the current standard of care for primary melanoma skin cancer-surgical removal. This study will add an additional intervention to the current standard of care. Patients will have a 50-50 chance of receiving placebo or medication. Patients will apply the study medication, a topical cream, to the site of the melanoma skin cancer for 2 weeks during the time they would normally wait for their scheduled surgery. Patients will come for an initial visit to the General Clinical Research Center at Harbor-UCLA. Here they will meet with the research fellow to obtain full disclosure of the study risks and benefits and consent to inclusion in the study. Inclusion or exclusion from the study will in no way affect whether they receive the standard of care. After informed consent, an initial examination will be completed, the patient's skin cancer will be photographed and an initial 100cc (approximately 7 tablespoons) of blood will be collected. Patients will be given the study medication by the investigational pharmacy.