TREATMENT OF RELAPSED T CELL LYMPHOMAS WITH RECOMBINANT LEUKOCYTE A INTERFERON

用重组白细胞 A 干扰素治疗复发性 T 细胞淋巴瘤

• 批准号: 3916673
• 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/3916673
• 关键词: dosage; drug adverse effect; drug delivery systems; human subject; human therapy evaluation; human tissue; interferons; lymphoma; mycosis fungoides lymphoma; neoplasm /cancer immunotherapy; neoplasm /cancer relapse /recurrence; remission /regression

Previous trials have demonstrated significant antitumor activity of interferon alfa in patients with cutaneous T-cell lymphomas. The dose used in the original trial was the maximally tolerated dose of 50 million units per meter squared given intramuscularly three times per week. The response rate in that trial was approximately 50 percent, and all responses were partial responses. All patients required dose reductions because of progressive interferon-related toxic side effects. In this protocol, we attempted to administer interferon cyclically at a dose of 50 million units per meter squared intramuscularly daily for four consecutive days (following an initial dose of 10 million units/m2 on day 1) every third week. The hope was that patients would recover from interferon-related side effects and that the amount of interferon actually delivered to patients might be increased by administering the therapy in this manner. If this was possible, higher response rates might be attained. Twenty-four patients were entered of whom 22 are evaluable for response. There was one complete remission lasting 7+ months, six partial remissions lasting a median of 7.5 months, six minor responses, and nine patients without response. In the first twelve weeks of therapy, 94.5 percent of the projected total dose of interferon had been administered reflecting reasonable patient tolerance to this different schedule of interferon administration. This compares to a less than 50 percent projected delivery of drug in patients treated with 50 million units intramuscularly three times per week on the older protocol. The similar overall response rate to the original study suggests that there is no dose-response relationship of this disease with interferon alfa at least over the dose range examined.

先前的试验已经证明了显著的抗肿瘤活性 干扰素α在皮肤T细胞淋巴瘤患者中的作用。 最初试验中使用的剂量是最大耐受剂量 每平方米肌肉注射5000万单位的剂量 每周三次。 该试验的应答率为 大约50%，所有的回答都是部分回答。 所有患者均因进行性 干扰素相关的毒副作用。 在本协议中，我们 试图以50 每平方米100万单位，每天肌肉注射， 连续几天（初始剂量为1000万单位/m2后 第1天）每三周。 希望病人能 从干扰素相关的副作用中恢复过来，并且数量 干扰素实际输送到患者的可能会增加， 以这种方式进行治疗。 如果这是可能的， 可以达到更高的答复率。 24例患者 其中22名患者可评价应答。 有一 完全缓解持续7个月以上，6次部分缓解 持续时间中位数为7.5个月，6次轻微反应，9次轻微反应。 患者无反应。 在治疗的前12周， 94.5干扰素的预计总剂量的百分比已经 反映了患者对此的合理耐受性 不同的干扰素给药时间表。 相比之下 在患者体内的药物输送量预计不到50%， 每周三次肌肉注射5000万单位 旧的协议。 类似的总体响应率， 最初的研究表明，没有剂量反应关系， 至少在一定剂量范围内， 考察