EFFECT OF INDOMETHECIN WITH IFN ALPHA FOR METASTATIC MALIGNANT MELANOMA

据报道，吲哚美辛可防止在 接受重组α干扰素治疗的患者。对此一无所知 这种药物的潜力也抑制或可能增强 这种药的抗肿瘤作用。在这项研究中，一种已知的疾病是 对α干扰素的反应，恶性黑色素瘤将被用来治疗 中等剂量的重组α干扰素。会是 随机接受任何其他治疗或吲哚美辛 剂量为25毫克，每天三次。血液学 在治疗过程中进行监测，以确定是否 吲哚美辛对干扰素介导的生物效应有什么影响 回应。此外，将监测急性和慢性毒性，以 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。曾经有过一个 完全缓解，1例部分缓解，14例患者病情稳定 疾病，13名患者有进展性疾病，并从 研究，四名患者因进展性疾病而被排除在研究之外 毒性不能通过减少干扰素剂量来补救。吲哚美辛做的 似乎在预防相关的一些副作用方面有效 使用干扰素。17名未接受吲哚美辛治疗的患者中有7名患者发冷 而接受吲哚美辛治疗的16人中只有1人有寒战症状。发烧发生在 16名接受吲哚美辛治疗的患者中有7名，17名未接受治疗的患者中有14名 吲哚甲素。然而，在接受治疗的16名患者中，有7名出现了疲劳。 消炎痛，17例中有4例未服用消炎痛。恶心和呕吐 4名接受吲哚美辛治疗的患者和6名未接受治疗的患者发生 吲哚甲素。体重下降超过患者身体的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 吲哚甲素。由此可见，干扰素的抗肿瘤作用 并不是通过同时服用吲哚美辛而减少的，但 毒性有所降低。不幸的是，这件事的应答率很低 研究将很难得出干扰素不会干扰的结论 干扰素的治疗活性。

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.