EVALUATION OF 2'-DCF IN RECOMBINANT LEUKOCYTE IFN ALPHA IN HAIRY CELL LEUKEMIA

毛细胞白血病重组白细胞 IFN α 中 2-DCF 的评估

• 批准号: 3916671
• 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/3916671
• 关键词: adenosine deaminase; antileukemic agent; antineoplastic antibiotics; antineoplastics; combination cancer therapy; combination chemotherapy; deoxycoformycin; drug adverse effect; enzyme inhibitors; hairy cell leukemia; human subject; human therapy evaluation; human tissue; immunosuppressive; interferons; lymphatic disorder; lymphoma; metastasis; neoplasm /cancer chemotherapy; neoplasm /cancer immunotherapy

Because we have previously observed substantial responses to deoxycoformycin in hairy cell leukemia after failure of interferon, we began this pilot protocol to evaluate the efficacy and toxicity of combined recombinant interferon alfa-2a and 2'deoxycoformycin. Response criteria in this protocol were more strict than other studies in that we required absence of hairy cells from bilateral iliac crest bone marrow biopsies obtained twice at approximately two month intervals and improvement of the peripheral blood hemoglobin to greater than 12 grams percent, granulocyte count to greater than 1500 per cubic millimeter, and platelet count to greater than 100,000 per cubic millimeter. Most previous studies using deoxycoformycin have declared patients complete responders on the basis of a single unilateral bone marrow biopsy. Of 15 patients, 13 are evaluable for response with one patient being inevaluable because of a diffuse bony sclerosis and consequent inability to provide marrow for assessment of the marrow response, and one patient continues on therapy. All 13 patients had partial responses with small numbers of residual hairy cells remaining in the bone marrow. Had standard criteria for complete remission been used, we would have had 10 complete responses based on only a single unilateral bone marrow biopsy. It appears that the combination of deoxycoformycin plus interferon provides no substantial improvement in complete response rate over dCF alone. At present, therefore, the combination of deoxycoformycin and recombinant interferon alfa-2a cannot be recommended over either agent alone.

因为我们之前观察到了对 干扰素治疗失败后毛细胞白血病中的脱氧考福霉素， 我们开始这个试验方案来评估其疗效和毒性。 联合应用重组干扰素α-2a和2‘-脱氧康福霉素。 此协议中的响应标准比其他协议更严格 研究中，我们要求双侧无毛细胞 两次取自髂冠的骨髓活检 间隔两个月和改善外周血 血红蛋白大于12克百分比，粒细胞计数至 每立方毫米超过1500，血小板计数达到 每立方毫米超过100,000。大多数先前的研究 使用脱氧考福霉素的患者已宣布完全有效 在单侧骨髓活检的基础上。共15个 13名患者，其中1名患者的反应可评估 由于弥漫性骨硬化症和随之而来的 无法提供用于评估骨髓反应的骨髓， 还有一名患者继续接受治疗。所有13名患者都有部分 剩余少量毛细胞的应答 骨髓。如果完全缓解的标准是 使用，我们将有10个完整的回复，仅基于一个 单侧骨髓活检。看起来好像是 脱氧考福霉素和干扰素的联合治疗不会 与仅使用DCF相比，完全应答率有显著提高。 因此，目前脱氧辅酶A和阿司匹林的联合应用 不能推荐使用重组干扰素α-2a 只有探员一个人。