HIGH-DOSE IFN-ALPHA-2B VS CISPLATIN, VINBLASTINE, DTIC + IL-2 & IFN IN 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。（临床试验总结来自国家癌症研究所的PDQ数据库）干扰素可能会干扰癌细胞的生长。化疗中使用的药物通过不同的方式阻止肿瘤细胞分裂，从而使它们停止生长或死亡。白细胞介素-2可以刺激人的白细胞杀死黑色素瘤细胞。目前尚不清楚，对于手术切除的黑色素瘤复发风险较高的患者，单独使用干扰素一年或与化疗和白细胞介素-2联合使用超过9周的时间，干扰素在预防复发方面是否更有效。这是一项随机III期试验，比较干扰素α α单独给予1年与9周治疗的有效性，包括顺铂、长春碱和达卡巴嗪组成的化疗，加上白细胞介素-2和干扰素α α，用于手术切除黑色素瘤复发风险高的患者。患者将被随机分为两组。第一组患者每周5天输注α干扰素，连续4周，然后每周3天注射α干扰素，连续48周。第二组患者在第1-4天输注顺铂和长春碱，第1天输注达卡巴嗪，第1天开始连续输注白细胞介素-2，持续4天。在第1-5天、第8天、第10天和第12天注射干扰素，在第6-15天注射非格拉西汀。治疗可每3周重复3个疗程。患者每3个月评估一次，为期2年，每6个月评估一次，为期3年，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.