IMMUNOMODULATION BY IMIQUIMOD IN PRIMARY MELANOMA

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 这项初步临床研究是为了确定5%咪喹莫特乳膏（Aldara，3 M Pharmaceuticals），一种FDA批准用于其他皮肤癌的药物，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。 合格受试者将从Harbor-UCLA皮肤科诊所或肿瘤外科服务处转诊，以进行研究评价。 患者将接受外科肿瘤学副教授Hernan Vargas博士的护理，并将接受原发性黑色素瘤皮肤癌手术切除的现行护理标准。 本研究将在当前标准治疗基础上增加额外干预。患者将有50%的机会接受安慰剂或药物治疗。 患者将在通常等待预定手术的时间内，在黑色素瘤皮肤癌部位涂抹研究药物（外用乳膏）2周。 患者将前往Harbor-UCLA的综合临床研究中心进行首次访问。 在此，他们将与研究员会面，以获得研究风险和获益的充分披露，并同意纳入研究。 入选或排除研究不会影响他们是否接受标准治疗。 知情同意后，将完成初步检查，拍摄患者的皮肤癌照片，并采集初始100 cc（约7汤匙）血液。患者将由研究药房给予研究药物。

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.