JP6320756B2 - 癌を治療するための化学および免疫療法を用いた癌細胞の代謝標的法 - Google Patents
癌を治療するための化学および免疫療法を用いた癌細胞の代謝標的法 Download PDFInfo
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Description
本出願は、2010年12月6日に出願された米国特許仮出願第61/420,208号(その内容は、本明細書で完全に説明されるかのように、参照によりその全体が本明細書に組み込まれる)の恩典を主張する。
癌治療はしばしば、化学療法を単独でまたは他の治療様式、例えば手術、放射線療法、標的療法および免疫療法と組み合わせて含む。化学療法は、任意の疾患を治療するための任意の薬物の使用を意味するために使用され得るが、しばしば、癌治療と関連する。癌の治療では、化学療法剤または化学療法薬はしばしば、抗新生物または抗癌剤と呼ばれる。多くの化学療法薬は、本質的には、細胞毒性または細胞増殖抑制性である。抗新生物化学療法薬は、因子、例えば、どのように働くか、それらの化学構造または起源、およびそれらの別の薬物との関係に基づき、複数の群に分割することができる。そのような群としては、アルキル化剤、代謝拮抗薬、抗腫瘍抗生剤、トポイソメラーゼ阻害薬、有糸分裂阻害剤ホルモン療法、標的治療薬および免疫治療薬が挙げられるが、それらに限定されない。いくつかの化学療法剤は、いずれのカテゴリにもうまく適合しない。いくつかの薬物は、1を超える様式で作用するので、1を超える群に属し得る。薬物がどのように働くかを知ることは、副作用を予測する際に重要である。
どのように癌が形成するかという一般的な定説は、一連の遺伝子変異であり、これにより、細胞が変化し、疾患に至る。多くの研究が、癌関連遺伝子の突然変異または異数性を引き起こす化学発癌物質および遺伝的不安定性に焦点を当ててきた。これらの突然変異は容易に観察されるが、癌のいくつかの形質、例えば無限の複製/自己再生、不均一な集団への分化、および転移において見られるような体内を通って移動し、異なる組織で生存する能力の原因ではない。これらは、癌幹細胞として説明されるものと関連する形質である。
癌は、細胞集団の不均一な混合物から構成される。細胞集団のほんの小さな構成成分であるが、癌幹細胞は、不均一な集団全体を繰り返すことができることが知られている。これは、腫瘍減量療法、例えば手術、化学療法および放射線後の癌再増殖により最もよく証明される。多くの報告により、CSCは、それらの非幹細胞対応物よりも化学療法薬に対してより耐性があることが証明されている。これは、一部分において、下記で詳細に記載される、薬物を細胞から多剤耐性ポンプの使用により流出させる能力による。
エネルギーのために解糖に依存するために、CSCは、解糖代謝のアンタゴニストにより、および/またはグルコースの有効性を制限することにより、解糖を標的にすることにより直接的にまたは間接的に死滅させることができる。さらに、CSC薬剤耐性は、前に記載されるように、ABCトランスポーターを移動させるのに必要なATP産生を阻害する機序により、解糖を制限することにより克服することができる。
FDG−PETは陽電子放出同位体放射線に基づく、一般に使用される腫瘍学のための走査技術である。X線に基づくコンピュータ断層撮影(CT)と組み合わせて、PET/CTは、生物化学系走査と重ねられた三次元解剖学的イメージングが可能である。Warburg効果に基づき、FDG−PETは、周囲組織よりも容易にグルコースを取込む癌を検出することができる。正常組織グルコース取込みと癌細胞グルコース取込みの間のこの比は、計算されて標準取込み値(SUV)とされ、ここで、高いSUV値は高いグルコース代謝と相関する。
1つの実施形態では、分割された用量の代謝標的化学療法プロトコルが提供される。そのようなプロトコルは下記工程を含み得る:
1.メトホルミンを含む合剤を、約250mg−2500mgのある用量で、経口により1日1回投与する工程。治療を通して摂取される。
2.患者を一晩中絶食させ、ベースライン血糖値、典型的には非糖尿病患者では約4.5−5.5mmol/Lに到達させる工程。糖尿病患者は14mmol/Lを軽く超える絶食血糖値を有してもよい。
3.第2日に、静脈内で、500cc生理食塩水を投与または注射する工程。静脈内インスリン(Humalog)は、血糖値がベースラインの大体半分まで、非糖尿病患者では約2.2−2.8mmol/Lに低減されるように体重に基づいて患者に注射される。典型的にはインスリンの用量は、0.1〜0.5単位/kgであり、平均は0.2単位/kgである。血糖値は、治療の期間中モニタされる。
4.各化学療法薬の投与または注射は所望の血糖値が達成された後、別々に注射される(遅いボーラス)。これは、生理食塩水を点滴することにより一般に投与される薬物、例えばシスプラチンを含む。各薬物の用量は、標準化学療法用量の典型的には約5−25である。
5.化学療法治療後、グルコース溶液、典型的には50mlの20%の静脈内注射を投与または注射し、低グルコースレベルから回復させ;生理食塩水および液体消費により患者に水分補給する工程。
6.患者は典型的には1週間に1度、2度、または3度化学療法により治療される。患者は、通常、総計12−24の治療を受けるが、この数は、臨床転帰または様々な他の因子により変動し得る。
悪性癌細胞は、幹細胞と非悪性細胞の間の融合から生じるので、幹細胞特徴を保持するという考えは、悪性癌細胞を抗原提示細胞(APC)に変え、それらを免疫系により検出可能にすることもできることを示唆する(図2)。
1つの実施形態では、癌を治療するための方法は免疫標的治療レジメンを含み得る。免疫標的治療レジメンは、1つ以上の免疫作用物質または免疫療法の投与を含み得る。
患者.以前、1つ以上の化学療法薬、放射線、手術または他の治療様式による標準治療に無応答性であった、様々な転移性後期癌(すなわち、IIIB/IV期)を有する6人の患者を選択し、下記で記載されるように、治療を受けさせた。
患者.Xi’an Xingcheng Borui病院(西安新城博瑞医院西安長纓東路383号)およびYangling Demonstration Zone病院(楊凌示范区医院)で治療された、様々な転移性後期癌(すなわち、IIIB/IV期;下記表4において示される癌型)を有し、1つ以上の化学療法薬、放射線、手術または治療様式による標準治療に対し以前は無応答性であった患者を選択し、下記で記載される治療を受けさせた。
下記で列挙される参考文献全ておよび上記明細書において引用されるもの全ては、本明細書で完全に説明されるかのように、参照によりその全体が本明細書に組み込まれる。
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Claims (12)
- 癌患者の治療において使用するための代謝標的化学免疫療法キットであって、
免疫応答を刺激するための治療的有効用量の1つ以上の免疫作用物質;および、
治療的有効用量の1つ以上の化学療法薬;
を含み、
前記1つ以上の免疫作用物質および前記1つ以上の化学療法薬の治療的有効用量は標準用量より低く、さらに、前記治療的有効用量の1つ以上の化学療法薬は、血糖低減治療の後で、該治療によって誘導された低血糖の間に前記患者に投与され、
前記低血糖の間の前記患者の血糖値は、前記癌患者に対するベースライン血糖値又は空腹時血糖値の約半分であり、
前記血糖低減治療は、1回以上のインスリンの投与であり、さらに、
前記癌患者は非糖尿病患者である、代謝標的化学免疫療法キット。 - 前記1つ以上の免疫作用物質は、1つ以上の治療抗体、ビタミン、ミネラル、栄養分、ハーブ、植物由来物質、真菌、動物または昆虫由来物質、アジュバント、抗酸化剤、アミノ酸、サイトカイン、ケモカイン、ホルモン、T細胞共刺激分子、全身的免疫刺激ペプチド、遺伝子治療、および免疫細胞由来療法を含む、請求項1に記載の代謝標的化学免疫療法キット。
- 1つ以上のブースター量の、前記1つ以上の治療抗体をさらに含む、請求項1に記載の代謝標的化学免疫療法キット。
- 血糖の低減は長期間維持される、請求項1に記載の代謝標的化学免疫療法キット。
- 前記1つ以上の化学療法薬は、高頻度で投与される、請求項1に記載の代謝標的化学免疫療法キット。
- 癌患者の治療において使用するための代謝標的化学免疫療法キットであって、
治療的有効用量の1つ以上の化学療法薬;
を含み、
前記1つ以上の化学療法薬の治療的有効用量は標準用量より低く、さらに、前記治療的有効用量の1つ以上の化学療法薬は、癌幹細胞の集団において発現されるMDRポンプを標的にするインスリン非依存血糖低減治療の後で、該治療によって誘導された低血糖の間に前記患者に投与され、
前記低血糖の間の前記患者の血糖値は、前記癌患者に対するベースライン血糖値又は空腹時血糖値の約半分であり、さらに、
前記癌患者は非糖尿病患者である、代謝標的化学免疫療法キット。 - 前記インスリン非依存血糖低減治療は、αグルコシダーゼ阻害薬、MDRポンプ阻害薬、ビグアナイド薬、またはその組み合わせから選択される、請求項6に記載の代謝標的化学免疫療法キット。
- a)前記1つ以上の化学療法薬は、アルキル化剤、代謝拮抗薬、抗腫瘍抗生剤、トポイソメラーゼ阻害薬、有糸分裂阻害剤、ホルモン療法、解糖阻害薬、標的治療薬および免疫治療薬からなる群より選択される;または、
b)前記1つ以上の化学療法薬は、複数の化学療法薬を含み、各々が細胞周期の異なる点を標的にする、請求項1又は6に記載の代謝標的化学免疫療法キット。 - 免疫応答を刺激するための治療的有効用量の1つ以上の免疫作用物質をさらに含み、前記1つ以上の化学療法薬の治療的有効用量は標準用量よりも低く、さらに、前記1つ以上の免疫作用物質は、治療抗体、ビタミン、ミネラル、栄養分、ハーブ、植物由来物質、真菌、動物または昆虫由来物質、アジュバント、抗酸化剤、アミノ酸、サイトカイン、ケモカイン、ホルモン、T細胞共刺激分子、全身的免疫刺激ペプチド、遺伝子治療、および免疫細胞由来療法からなる群より選択される、請求項6に記載の代謝標的化学免疫療法キット。
- 前記代謝標的化学免疫療法は、健康な細胞よりも、癌細胞の集団を選択的に標的にする、請求項1または6に記載の代謝標的化学免疫療法キット。
- その後の用量のインスリンをさらに含む、請求項6に記載の代謝標的化学免疫療法キット。
- 前記代謝標的化学免疫療法は、食道癌、乳癌、肺癌、骨癌、膀胱癌、脳癌、尿路癌、細胞腫、子宮頸癌、結腸癌、胃癌、頭頸部癌、肝細胞癌、肝癌、リンパ腫および白血病、メラノーマ、卵巣癌、膵癌、下垂体癌、前立腺癌、直腸癌、腎臓癌、肉腫、精巣癌、甲状腺癌、および子宮癌からなる群より選択される癌を治療するために使用される、請求項1または6に記載の代謝標的化学免疫療法キット。
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WO2014052305A2 (en) * | 2012-09-26 | 2014-04-03 | Thomas Jefferson University | Method for treating breast cancer using mitochondrial poisons that interfere with over-expressed mitochondrial proteins |
WO2014130313A2 (en) * | 2013-02-19 | 2014-08-28 | The Brigham And Women's Hospital, Inc. | Methods and compositions relating to the treatment of cancer |
CN112023054A (zh) | 2013-04-12 | 2020-12-04 | 内德生物系统有限公司 | 癌症的治疗 |
EP3008212A4 (en) * | 2013-06-10 | 2017-05-24 | Millennium Pharmaceuticals, Inc. | Methods of treatment of cancer |
BR112015032889B1 (pt) | 2013-07-01 | 2021-06-15 | University Of Southern California | Método para identificar um sintoma de diabetes; método para aliviar ou prevenir resistência à insulina e/ou hiperglicemia; e método para aliviar ou prevenir síndrome metabólica |
CN104513297B (zh) * | 2013-09-27 | 2018-12-04 | 李光辉 | 用于筛选抗癌症医药组合物的多肽分子及其应用 |
GB201322626D0 (en) * | 2013-12-19 | 2014-02-05 | Immutep S A | Combined preparations for the treatment of cancer |
GB201500374D0 (en) | 2015-01-09 | 2015-02-25 | Immutep S A | Combined preparations for the treatment of cancer |
CN107613979A (zh) * | 2015-04-16 | 2018-01-19 | 南加利福尼亚大学 | 响应于雷帕霉素和地塞米松诱导的标准和高葡萄糖条件禁食模仿膳食(fmd)和降葡萄糖药物保护正常细胞并产生癌症敏感条件 |
WO2016172494A2 (en) | 2015-04-23 | 2016-10-27 | The Johns Hopkins University | Combination of immunotherapy with local chemotherapy for the treatment of malignancies |
WO2018102393A1 (en) * | 2016-11-30 | 2018-06-07 | Cure Cancer Worldwide Llc | System for chemotherapy delivery and method of the same |
US20200121716A1 (en) * | 2017-04-22 | 2020-04-23 | Caidong Qin | Method for Inhibiting Both Glycolysis and Glutamine Metabolism in Cells and Use Thereof |
RU2020133020A (ru) * | 2018-03-14 | 2022-04-14 | Мерк Патент Гмбх | Соединения и их применения для лечения опухолей у субъекта |
US20220211822A1 (en) * | 2019-05-15 | 2022-07-07 | The University Of Chicago | Lactate response system and methods |
CN110339350A (zh) | 2019-07-25 | 2019-10-18 | 广州中科蓝华生物科技有限公司 | 一种抗肿瘤的联合用药物组合物及其应用 |
WO2022155311A1 (en) * | 2021-01-14 | 2022-07-21 | The Regents Of The University Of California | Methods and systems for analysis of drug target engagement and treatment of cancer |
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CN101273124B (zh) | 2005-08-25 | 2013-05-08 | 亚利桑那大学董事会 | 干细胞融合癌发生模型 |
AU2007213920B2 (en) * | 2006-02-09 | 2013-08-29 | Amgen Research (Munich) Gmbh | Treatment of metastatic breast cancer |
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EP2648734A1 (en) | 2013-10-16 |
BR112013014076A2 (pt) | 2016-11-22 |
EP2648734B1 (en) | 2019-02-13 |
CN103347521B (zh) | 2018-05-25 |
AU2011339929A1 (en) | 2013-07-25 |
US20140056844A1 (en) | 2014-02-27 |
SG10201510009YA (en) | 2016-01-28 |
CA2820384A1 (en) | 2012-06-14 |
SG191048A1 (en) | 2013-07-31 |
WO2012075679A1 (en) | 2012-06-14 |
EP2648734A4 (en) | 2014-04-09 |
AU2011339929B2 (en) | 2017-05-11 |
CN103347521A (zh) | 2013-10-09 |
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