HIGH-DOSE IFN-ALPHA-2B VS CISPLATIN, VINBLASTINE, DTIC + IL-2 & IFN IN MELANOMA

高剂量 IFN-ALPHA-2B 与顺铂、长春碱、DTIC IL-2

• 批准号: 7375486
• 负责人: MARK R ALBERTINI
• 金额: $ 1.02万
• 依托单位: UNIVERSITY OF WISCONSIN-MADISON
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-12-01 至 2006-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7375486
• 关键词: DOSE; IFN; ALPHA; 2B; VS

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.

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。（来自国家癌症研究所PDQ数据库的临床试验总结）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式来阻止肿瘤细胞分裂，使它们停止生长或死亡。白细胞介素-2可以刺激一个人的白色血细胞杀死黑色素瘤细胞。目前尚不清楚是否干扰素α是更有效地预防复发的患者手术切除黑色素瘤复发的高风险，如果单独给予一年或如果联合化疗和白细胞介素-2超过9周的时间内。 这是一项随机III期临床试验，旨在比较干扰素α单独给药1年与9周治疗（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）对手术切除的高复发风险黑素瘤患者的有效性。 患者将被随机分配至两组之一。第一组患者将接受干扰素α输注，每周5天，持续4周，然后每周3天注射干扰素α，持续48周。第二组患者将在第1-4天接受顺铂和长春碱输注，第1天接受达卡巴嗪输注，第1天开始连续4天输注白细胞介素-2。他们还将在第1-5、8、10和12天接受干扰素α注射，并在第6- 1 - 5天接受非格司亭注射。治疗可以每3周重复一次，共3个疗程。患者将每3个月接受一次评价，持续2年，每6个月接受一次评价，持续3年，然后每年接受一次评价，持续5年。