First-in-Human Phase 1 Trial of Agarose Beads Containing Murine RENCA Cells in Advanced Solid Tumors.

Cancer growth and metastasis Pub Date : 2016-08-02 eCollection Date: 2016-01-01 DOI:10.4137/CGM.S39442

Barry H Smith, Tapan Parikh, Zoe P Andrada, Thomas J Fahey, Nathaniel Berman, Madeline Wiles, Angelica Nazarian, Joanne Thomas, Anna Arreglado, Eugene Akahoho, David J Wolf, Daniel M Levine, Thomas S Parker, Lawrence S Gazda, Allyson J Ocean

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引用次数: 8

Abstract

Purpose: Agarose macrobeads containing mouse renal adenocarcinoma cells (RMBs) release factors, suppressing the growth of cancer cells and prolonging survival in spontaneous or induced tumor animals, mediated, in part, by increased levels of myocyte-enhancing factor (MEF2D) via EGFR-and AKT-signaling pathways. The primary objective of this study was to determine the safety of RMBs in advanced, treatment-resistant metastatic cancers, and then its efficacy (survival), which is the secondary objective.

Methods: Thirty-one patients underwent up to four intraperitoneal implantations of RMBs (8 or 16 macrobeads/kg) via laparoscopy in this single-arm trial (FDA BB-IND 10091; NCT 00283075). Serial physical examinations, laboratory testing, and PET-CT imaging were performed before and three months after each implant.

Results: RMBs were well tolerated at both dose levels (mean 660.9 per implant). AEs were (Grade 1/2) with no treatment-related SAEs.

Conclusion: The data support the safety of RMB therapy in advanced-malignancy patients, and the preliminary evidence for their potential efficacy is encouraging. A Phase 2 efficacy trial is ongoing.

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含有小鼠RENCA细胞的琼脂糖珠在晚期实体瘤中的首次人体1期试验。

目的:琼脂糖大珠含有小鼠肾腺癌细胞(RMBs)释放因子，在自发或诱导的肿瘤动物中抑制癌细胞的生长并延长生存时间，部分是通过egfr和akt信号通路中肌细胞增强因子(MEF2D)水平的增加介导的。本研究的主要目的是确定RMBs在晚期，治疗耐药转移性癌症中的安全性，然后是其有效性(生存期)，这是次要目标。方法:在这项单臂试验中，31名患者通过腹腔镜接受了多达4次RMBs(8或16巨珠/kg)腹腔内植入(FDA BB-IND 10091;NCT 00283075)。在每次种植前和种植后3个月进行一系列体检、实验室检查和PET-CT成像。结果:两种剂量水平的RMBs耐受性良好(平均660.9个植入物)。ae为(1/2级)，无治疗相关的sae。结论:这些数据支持人民币治疗晚期恶性肿瘤患者的安全性，初步证据表明其潜在疗效令人鼓舞。2期疗效试验正在进行中。

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Cancer growth and metastasis

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