EFFECT OF INDOMETHECIN WITH IFN ALPHA FOR METASTATIC MALIGNANT MELANOMA

吲哚美辛联合 IFN α 对转移性恶性黑色素瘤的疗效

• 批准号: 3963353
• 负责人: R G STEIS
• 金额: --
• 依托单位: DIVISION OF CANCER TREATMENT
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/3963353
• 关键词: combination chemotherapy; drug adverse effect; human subject; human therapy evaluation; indomethacin; interferons; metastasis; neoplasm /cancer immunotherapy

Indomethecin has been reported to prevent the side effects observed in patients receiving recombinant alpha interferon. Nothing is known about the potential of this drug to also inhibit or possibly augment the antitumor effect of this drug. In this study with a disease known to be responsive to alpha interferon, malignant melanoma will be treated with moderately high doses of recombinant alpha interferon. It will be randomized to receive in addition either no other therapy or indomethecin at a dose of 25 milligrams given three times per day. Hematologic monitoring is carried out during the course of this therapy to determine if indomethecin will have any effect upon interferon mediated biological responses. In addition, acute and chronic toxicities will be monitored to determine if indomethecin can reduce these side effects. So far 33 patients have been entered on this trial. There has been one complete response, one partial response, 14 patients have had stable disease, 13 patients had progressive disease and were removed from the study, and four patients were removed from the study because of progressive toxicity not remedied by interferon dose reduction. Indomethecin did appear to be effective in preventing some of the side effects associated with interferon. Seven of 17 patients receiving no indomethecin had chills whereas only 1 of 16 receiving indomethecin had chills. Fevers occurred in 7 of 16 patients receiving indomethecin and 14 of 17 not receiving indomethecin. Fatigue, however, occurred in 7 of 16 patients receiving indomethecin and 4 of 17 not receiving indomethecin. Nausea and vomiting occurred in 4 patients receiving indomethecin and 6 not receiving indomethecin. Weight loss exceeding 10 percent of the patient's body weight occurred in one patient receiving indomethecin and one not receiving indomethecin. Thus, it appears that antitumor effectiveness of interferon is not reduced by concurrent administration of indomethecin but that toxicity is reduced somewhat. Unfortunately, the low response rate in this study will make it difficult to conclude that interferon does not interfer with the therapeutic acitivity of interferon.

据报道，吲哚美辛可以预防在治疗中观察到的副作用。 接受重组α干扰素治疗的患者。 没有人知道 这种药物抑制或可能增加 这种药物的抗肿瘤作用。 在这项研究中， 对α干扰素有反应的恶性黑色素瘤将用 中等剂量的重组α干扰素。 将 随机接受除此之外无其他治疗或吲哚美辛 每天三次，每次25毫克 血液学 在该治疗过程中进行监测以确定 吲哚美辛将对干扰素介导的生物学效应 应答 此外，还将监测急性和慢性毒性， 确定吲哚美辛是否可以减少这些副作用。 到目前为止，已有33名患者参加了这项试验。 曾经有一个 完全缓解，1例部分缓解，14例患者稳定 疾病，13例患者进行性疾病，并从 研究中，4名患者因进展性 毒性不能通过减少干扰素剂量来补救。 吲哚美辛 似乎能有效预防一些与之相关的副作用 干扰素 17名未接受吲哚美辛治疗的患者中有7名出现寒战 而接受吲哚美辛的16人中只有1人有寒战。 发烧发生在 接受吲哚美辛的16例患者中有7例，未接受吲哚美辛的17例患者中有14例 吲哚美辛 然而，16名接受治疗的患者中有7名发生疲劳， 吲哚美辛和17个未接受吲哚美辛的4个。 恶心和呕吐 4例接受吲哚美辛治疗的患者发生，6例未接受吲哚美辛治疗的患者发生 吲哚美辛 体重减轻超过患者身体的10% 一名接受吲哚美辛治疗的患者和一名未接受吲哚美辛治疗的患者发生体重增加。 吲哚美辛 因此，似乎干扰素的抗肿瘤效果 并不因同时给予吲哚美辛而降低， 毒性有所降低。 不幸的是，这方面的回复率很低 研究将很难得出结论，干扰素不干扰 干扰素的治疗活性。