HIGH-DOSE IFN-ALPHA-2B VS CISPLATIN, VINBLASTINE, DTIC + IL-2 & IFN IN 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。(来自国家癌症研究所PDQ数据库的临床试验摘要)干扰素α可能会干扰癌细胞的生长。化疗中使用的药物使用不同的方法来阻止肿瘤细胞分裂，从而停止生长或死亡。白介素2可以刺激人的白细胞杀死黑色素瘤细胞。目前尚不清楚，对于经过手术切除的高复发风险黑色素瘤患者，单独服用干扰素一年，还是联合化疗和白介素2超过9周，在预防复发方面是否更有效。这是一项随机的第三阶段试验，旨在比较单独使用α干扰素一年和接受9周治疗的有效性，这些治疗包括由顺铂、长春花碱和达卡巴津组成的化疗，以及白细胞介素2和干扰素α，用于治疗有高复发风险的手术切除的黑色素瘤患者。患者将随机分配到两组中的一组。第一组患者接受干扰素α静脉滴注，每周5天，共4周，然后每周3天，共48周。第二组患者在第1-4天接受顺铂和长春花碱的静脉滴注，在第一天开始接受达卡巴津的持续滴注，从第一天开始连续接受白细胞介素2的4天的输注。他们还将在第1-5、8、10和12天接受干扰素α的注射，在第6-15天接受非格列汀的注射。治疗可每3周重复一次，共三个疗程。患者将在2年内每3个月评估一次，3年每6个月评估一次，然后每年评估一次，为期5年。

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. (Clinical trial summary from the National Cancer Institute's PDQ database) Interferon alfa may interfere with the growth of cancer cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. It is not yet known whether interferon alfa is more effective at preventing recurrences for patients with surgically removed melanoma at high risk for recurrence if given alone for one year or if given with combination chemotherapy and interleukin-2 over a 9 week period of time. This is a randomized Phase III trial to compare the effectiveness of interferon alfa given alone for one year with a 9 week treatment including chemotherapy consisting of cisplatin, vinblastine, and dacarbazine, plus interleukin-2 and interferon alfa, for patients with surgically removed melanoma at high risk for recurrence. Patients will be randomly assigned to one of two groups. Patients in group one will receive infusions of interferon alfa 5 days a week for 4 weeks and then injections of interferon alfa 3 days a week for 48 weeks. Patients in group two will receive infusions of cisplatin and vinblastine on Days 1-4, an infusion of dacarbazine on Day 1, and a 4-day continuous infusion of interleukin-2 beginning on Day 1. They will also receive injections of interferon alfa on Days 1-5, 8, 10, and 12, and injections of filgrastim on Days 6-15. Treatment may be repeated every 3 weeks for three courses. Patients will be evaluated every 3 months for 2 years, every 6 months for 3 years, and then once a year for 5 years.