NSCLC--COMBINED CHEMOTHERAPY & RADIOIMMUNOTUNOTHERAPY

非小细胞肺癌--联合化疗

• 批准号: 2733406
• 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 2001-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2733406
• 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 这项提议寻求支持，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。方法是 使用非清髓性放射免疫疗法(RAIT)与 紫杉醇铂为主的联合放化疗。放射免疫疗法 提出了一种I-131标记的抗CEA抗体。符合条件的患者将是 那些不能切除的I期到III期非小细胞肺癌。 这项研究的细节将确定剂量限制毒性和 放射免疫疗法的最大耐受量与 顺铂/紫杉醇联合化疗单周期化疗 将在一个完整的放化疗疗程后给予。一个 放射免疫治疗前的影像研究将作为一项比较 同步化疗一个周期的疗效观察 放射免疫治疗对后续正常器官和肿瘤药代动力学的影响 剂量学。此外，该药的安全性、耐受性和治疗效果 将对这一联合多模式疗法进行评估。 作为次要目标，这项研究将跟踪可能 为随后的第二阶段试验奠定基础。不存在随机化 这项试验的治疗部分。入院的患者将接受 紫杉醇和卡铂联合同期放射治疗 累积剂量为60Gy.放射治疗结束后， 紫杉醇/卡铂化疗剂量相同 通过注射针对CEA特异性的131I标记抗体 表位。