NSCLC--COMBINED CHEMOTHERAPY & RADIOIMMUNOTUNOTHERAPY

非小细胞肺癌--联合化疗

• 批准号: 2440224
• 负责人: JACK D BURTON
• 金额: $ 10.75万
• 依托单位: CTR FOR MOLECULAR MEDICINE/IMMUNOLOGY
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-07-11 至 1999-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2440224
• 关键词: antitumor antibody; carcinoembryonal antigen; cis platinum compound; clinical research; clinical trial phase I; combination cancer therapy; combination chemotherapy; human subject; human therapy evaluation; iodine; neoplasm /cancer chemotherapy; neoplasm /cancer immunotherapy; neoplasm /cancer radionuclide therapy; nonsmall cell lung cancer; paclitaxel; radionuclides

DESCRIPTION This proposal seeks support to study a novel multimodal approach to treat patients with advanced non-small cell lung cancer (NSCLC). The approach is to use a combination of non-myelo ablative radioimmunotherapy (RAIT) with taxol platinum based combination chemoradiotherapy. The radioimmunotherapy proposed is an I-131 label anti-CEA antibody. Eligible patients will be those with unresectable Stage I through III non-small cell lung cancer. The specifics of the study will determine the dose limiting toxicities and maximum tolerated dose of the radioimmunotherapy in combination with the single consolidations cycle of cystoplatin/paclitaxel chemotherapy, which will be given after a full course of chemoradiation therapy. A preradioimmunotherapy imaging study will be performing as a comparative study to determine the effect of one concurrent cycle of chemotherapy and radioimmunotherapy on the subsequent pharmacokinetic normal organ and tumor dosimetry. Furthermore, the safety, tolerability and therapeutic impact of this combined multimodal therapy will be assessed. As a secondary objective, the study will follow tumor response that could form a basis for subsequent phase II trial. There is no randomization for the treatment portion of this trial. Patients entered will be treated with a combination of Paclitaxel and Carboplatin with concurrent radiotherapy to a cumulative dose of 60 Gy. Following completion of radiotherapy, paclitaxel/carboplatin chemotherapy will be given in the same doses followed by an injection of 131I labeled antibody directed against the CEA specific epitope.

描述 该提案寻求支持，以研究一种新的多模式方法来治疗 晚期非小细胞肺癌（NSCLC）患者。 该方法是 使用非骨髓消融性放射免疫治疗（赖特）与 紫杉醇铂联合放化疗。 放射免疫疗法 提出了一种I-131标记的抗CEA抗体。 符合条件的患者将被 那些患有不可切除的I期至III期非小细胞肺癌的患者。 研究的细节将决定剂量限制性毒性， 放射免疫疗法联合最大耐受剂量 单次巩固周期的顺铂/紫杉醇化疗， 将在一个完整的放化疗疗程后给予。 一 将进行放射免疫治疗前成像研究， 确定一个同步化疗周期效果的研究， 放射免疫治疗对随后的药代动力学正常器官和肿瘤的影响 剂量测定法 此外，安全性，耐受性和治疗效果， 将评估这种组合的多模式治疗。 作为次要目的，该研究将跟踪肿瘤反应， 为后续二期试验奠定基础。 没有随机化， 这个试验的治疗部分 入组患者将接受以下治疗： 紫杉醇和卡铂联合放疗， 累积剂量为60戈伊。放疗结束后， 紫杉醇/卡铂化疗将以相同的剂量给予， 通过注射131 I标记的抗CEA特异性抗体， 表位