JP5830005B2 - 癌および他の疾患を治療および管理するための免疫調節性化合物を用いた方法および組成物 - Google Patents
癌および他の疾患を治療および管理するための免疫調節性化合物を用いた方法および組成物 Download PDFInfo
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- JP5830005B2 JP5830005B2 JP2012273326A JP2012273326A JP5830005B2 JP 5830005 B2 JP5830005 B2 JP 5830005B2 JP 2012273326 A JP2012273326 A JP 2012273326A JP 2012273326 A JP2012273326 A JP 2012273326A JP 5830005 B2 JP5830005 B2 JP 5830005B2
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- A61K31/00—Medicinal preparations containing organic active ingredients
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Description
本発明は、免疫調節性化合物を単独でまたは他の治療剤と組み合わせて投与することにより、特定の癌および他の疾患(たとえば、限定されるものではないが、望ましくない血管新生に関連づけられるかまたはそれにより特性づけられる疾患)を治療、予防、および/または管理する方法に関する。とくに、本発明は、薬剤の特定の組合せまたは「カクテル」の使用およびこれらの特定の癌(たとえば、従来療法に不応性の癌)を治療するための放射線療法などの他の療法を包含する。本発明はまた、医薬組成物および投与レジメンに関する。
2.1 癌および他の疾患の病理生物学
癌は、主として、所与の正常組織に由来する異常細胞の数の増加、隣接する組織へのこれらの異常細胞の侵入、または所属リンパ節および遠隔部位への悪性細胞のリンパ行性または血行性の拡延(転移)により特性づけられる。臨床データおよび分子生物学的研究によると、癌は、特定の条件下で新形成に発展しうるわずかな前新生物変化から開始される多段階過程であることが示唆される。新生物病変は、とくに、新生物細胞が宿主の免疫監視を回避する条件下で、クローン的に発生し、侵入、増殖、転移、および異質化の能力を発揮する可能性がある。Roitt, I., Brostoff, J and Kale, D., Immunology, 17.1-17.12 (3rd ed., Mosby, St. Louis, Mo., 1993)。
現用の癌療法は、患者の新生物細胞を根絶するために、手術、化学療法、ホルモン療法、および/または放射線治療を必要とする可能性がある(たとえば、Stockdale, 1998, Medicine, vol. 3, Rubenstein and Federman, eds., Chapter 12, Section IVを参照されたい)。最近では、癌療法はまた、生物学的療法または免疫療法を必要とする可能性もある。これらの手法はすべて、患者にとって顕著な欠点を伴う。たとえば、手術は、患者の健康によっては禁忌になることもあるし、または患者に受け入れがたいこともある。さらに、手術では、新生物組織を完全に除去しえない可能性もある。放射線療法は、新生物組織が正常組織よりも放射線に高い感受性を呈する場合にのみ有効であるにすぎない。放射線療法はまた、多くの場合、重篤な副作用を誘発する可能性もある。ホルモン療法は、単一の作用因子として施されることはめったにない。ホルモン療法は、有効でありうるが、多くの場合、他の治療により癌細胞の大部分を除去した後、癌の再発を予防または遅延すべく用いられる。生物学的療法および免疫療法は、数が限られており、しかも皮疹もしくは腫脹、インフルエンザ様症候(たとえば、発熱、悪寒、および倦怠感)、消化管異常、またはアレルギー反応のような副作用を生じる可能性もある。
TNF-αの異常産生に関連づけられる疾患を治療すべく安全かつ効果的に使用することのできる化合物を提供する目的で、いくつかの研究が行われてきた。たとえば、Marriott, J.B., et al., Expert Opin. Biol. Ther. 1(4):1-8 (2001); G.W. Muller, et al., Journal of Medicinal Chemistry 39(17): 3238-3240 (1996);およびG.W. Muller, et al., Bioorganic & Medicinal Chemistry Letters 8: 2669-2674 (1998)を参照されたい。いくつかの研究では、LPSにより刺激されたPBMCによるTNF-αの産生を強力に阻害する機能に関して選択された化合物群に焦点があてられてきた。L.G. Corral, et al., Ann. Rheum. Dis. 58:(Suppl I) 1107-1113 (1999)。IMiDTM(Celgene Corporation)または免疫調節性薬剤と呼ばれるこれらの化合物は、TNF-αの強力な阻害だけでなくLPSにより誘発される単球のIL1βおよびIL12産生の顕著な阻害をも示す。LPS誘導IL6もまた、免疫調節性化合物により阻害されるが、ただし、部分的な阻害である。これらの化合物は、LPS誘導IL10の強力な刺激剤である。同上。IMiDTMの特定例としては、米国特許第6,281,230号および同第6,316,471号(両方ともG.W. Mullerらに付与された)に記載されている置換2-(2,6-ジオキソピペリジン-3-イル)フタルイミドおよび置換2-(2,6-ジオキソピペリジン-3-イル)-1-オキソイソインドールが挙げられるが、これらに限定されるものではない。
本発明は、特定のタイプの癌、たとえば、原発性および転移性の癌ならびに従来の化学療法に不応性または耐性である癌を治療および予防する方法を包含する。この方法には、そのような治療または予防の必要な患者に治療上または予防上有効な量の免疫調節性化合物またはその製薬上許容される塩、溶媒和物、水和物、立体異性体、包接体、もしくはプロドラッグを投与することが含まれる。本発明はまた、特定の癌を管理する(たとえば、それらの再発を予防もしくは遅延したりまたは寛解期を延長したりする)方法を包含する。この方法には、そのような管理の必要な患者に予防上有効な量の本発明の免疫調節性化合物またはその製薬上許容される塩、溶媒和物、水和物、立体異性体、包接体、もしくはプロドラッグ投与することが含まれる。
本発明の第1の実施形態は、癌を治療、管理、または予防する方法を包含する。この方法には、そのような治療または予防の必要な患者に治療上または予防上有効な量の本発明の免疫調節性化合物またはその製薬上許容される塩、溶媒和物、水和物、立体異性体、包接体、もしくはプロドラッグを投与することが含まれる。
本発明に使用される化合物には、ラセミ体であるか、ステレオマー的に富化されているか、またはステレオマー的に純粋である免疫調節性化合物、ならびにそれらの製薬上許容される塩、溶媒和物、水和物、立体異性体、包接体、およびプロドラッグが包含される。本発明に使用される好ましい化合物は、約1,000g/mol以下の分子量を有する小有機分子であり、タンパク質でもペプチドでもオリゴヌクレオチドでもオリゴ糖でも他の巨大分子でもない。
を有する。特定の免疫調節性化合物としては、以下の化合物が挙げられるが、これらに限定されるものではない:
1-オキソ-2-(2,6-ジオキソピペリジン-3-イル)-4-アミノイソインドリン;
1-オキソ-2-(2,6-ジオキソピペリジン-3-イル)-5-アミノイソインドリン;
1-オキソ-2-(2,6-ジオキソピペリジン-3-イル)-6-アミノイソインドリン;
1-オキソ-2-(2,6-ジオキソピペリジン-3-イル)-7-アミノイソインドリン;
1,3-ジオキソ-2-(2,6-ジオキソピペリジン-3-イル)-4-アミノイソインドリン;および
1,3-ジオキソ-2-(2,6-ジオキソピペリジン-3-イル)-5-アミノイソインドリン。
で示される。別の実施形態では、本発明は、これらの化合物のエナンチオマー的に純粋な形態(たとえば、光学的に純粋な(R)または(S)エナンチオマー)の使用を包含する。
XおよびYのうちの一方はC=Oであり、かつ他方はCH2またはC=Oであり;
R1は、H、(C1〜C8)アルキル、(C3〜C7)シクロアルキル、(C2〜C8)アルケニル、(C2〜C8)アルキニル、ベンジル、アリール、(C0〜C4)アルキル-(C1〜C6)ヘテロシクロアルキル、(C0〜C4)アルキル-(C2〜C5)ヘテロアリール、C(O)R3、C(S)R3、C(O)OR4、(C1〜C8)アルキル-N(R6)2、(C1〜C8)アルキル-OR5、(C1〜C8)アルキル-C(O)OR5、C(O)NHR3、C(S)NHR3、C(O)NR3R3'、C(S)NR3R3'、または(C1〜C8)アルキル-O(CO)R5であり;
R2は、H、F、ベンジル、(C1〜C8)アルキル、(C2〜C8)アルケニル、または(C2〜C8)アルキニルであり;
R3およびR3'は、独立して、(C1〜C8)アルキル、(C3〜C7)シクロアルキル、(C2〜C8)アルケニル、(C2〜C8)アルキニル、ベンジル、アリール、(C0〜C4)アルキル-(C1〜C6)ヘテロシクロアルキル、(C0〜C4)アルキル-(C2〜C5)ヘテロアリール、(C0〜C8)アルキル-N(R6)2、(C1〜C8)アルキル-OR5、(C1〜C8)アルキル-C(O)OR5、(C1〜C8)アルキル-O(CO)R5、またはC(O)OR5であり;
R4は、(C1〜C8)アルキル、(C2〜C8)アルケニル、(C2〜C8)アルキニル、(C1〜C4)アルキル-OR5、ベンジル、アリール、(C0〜C4)アルキル-(C1〜C6)ヘテロシクロアルキル、または(C0〜C4)アルキル-(C2〜C5)ヘテロアリールであり;
R5は、(C1〜C8)アルキル、(C2〜C8)アルケニル、(C2〜C8)アルキニル、ベンジル、アリール、または(C2〜C5)ヘテロアリールであり;
R6は、それぞれ独立して、H、(C1〜C8)アルキル、(C2〜C8)アルケニル、(C2〜C8)アルキニル、ベンジル、アリール、(C2〜C5)ヘテロアリール、もしくは(C0〜C8)アルキル-C(O)O-R5であるか、またはR6基は、連結してヘテロシクロアルキル基を形成し;
nは、0または1であり;そして
*は、キラル炭素中心を表す。
R2は、Hまたは(C1〜C8)アルキルであり;そして
R3は、(C1〜C8)アルキル、(C3〜C7)シクロアルキル、(C2〜C8)アルケニル、(C2〜C8)アルキニル、ベンジル、アリール、(C0〜C4)アルキル-(C1〜C6)ヘテロシクロアルキル、(C0〜C4)アルキル-(C2〜C5)ヘテロアリール、(C5〜C8)アルキル-N(R6)2;(C0〜C8)アルキル-NH-C(O)O-R5;(C1〜C8)アルキル-OR5、(C1〜C8)アルキル-C(O)OR5、(C1〜C8)アルキル-O(CO)R5、またはC(O)OR5であり;そして他の変数は、同一の定義を有する。
である。
XおよびYのうちの一方はC=Oであり、かつ他方はCH2またはC=Oであり;
Rは、HまたはCH2OCOR'であり;
(i) R1、R2、R3、もしくはR4は、それぞれ互いに独立して、ハロ、1〜4個の炭素原子のアルキル、もしくは1〜4個の炭素原子のアルコキシであるか、または(ii) R1、R2、R3、もしくはR4のうちの1つは、ニトロもしくは-NHR5であり、かつR1、R2、R3、もしくはR4の残りは、水素であり;
R5は、水素または1〜8個の炭素のアルキルであり;
R6は、水素、1〜8個の炭素原子のアルキル、ベンゾ、クロロ、またはフルオロであり;
R'は、R7-CHR10-N(R8R9)であり;
R7は、m-フェニレンまたはp-フェニレンまたは-(CnH2n)-(ここで、nは、0〜4の値を有する)であり;
R8およびR9は、それぞれ互いに独立して、水素もしくは1〜8個の炭素原子のアルキルであるか、またはR8およびR9は、一緒になって、テトラメチレン、ペンタメチレン、ヘキサメチレン、もしくは-CH2CH2[X]X1CH2CH2-(ここで、[X]X1は、-O-、-S-、もしくは-NH-である)であり;
R10は、水素、8個までの炭素原子のアルキル、またはフェニルであり;そして
*は、キラル炭素中心を表す。
免疫調節性化合物は、本発明の方法および組成物において、他の薬理学的に活性な化合物(「第2の活性剤」)と組み合わせることができる。特定のタイプの癌ならびに望ましくない血管新生に関連づけられるかまたはそれにより特性づけられる特定の疾患および症状の治療において特定の組合せが相乗的に作用すると考えられる。免疫調節性化合物はまた、特定の第2の活性剤に関連づけられる有害作用を軽減するように作用することができ、いくつかの第2の活性剤は、免疫調節性化合物に関連づけられる有害作用を軽減するように使用することができる。
本発明の方法は、種々のタイプの癌ならびに望ましくない血管新生に関連づけられるかまたはそれにより特性づけられる疾患および障害を治療、予防、および/または管理する方法を包含する。本明細書中で使用する場合、別段の記載がないかぎり、「治療」という用語は、特定の疾患または障害の症候の発症後に本発明の化合物または他のさらなる活性剤を投与することを意味する。本明細書中で使用する場合、別段の記載がないかぎり、「予防」という用語は、とくに、癌ならびに望ましくない血管新生に関連づけられるかまたはそれにより特性づけられる他の疾患および障害を患う危険性のある患者に、症候の発症前に投与を行うことを意味する。「予防」という用語には、特定の疾患または障害の症候を抑制することが包含される。癌ならびに望ましくない血管新生に関連づけられるかまたはそれにより特性づけられる疾患および障害の病歴をもつ家族のいる患者は、予防レジメンを施すのに好ましい候補である。本明細書中で使用する場合、とくに明示されていないかぎり、「管理」という用語には、特定の疾患もしくは障害を患ったことのある患者における該疾患もしくは障害の再発を防止することおよび/または該疾患または障害を患ったことのある患者が寛解状態で生存し続ける期間を延長することが包含される。
本発明の特定の方法には、1種以上の第2の活性剤と併用して、および/または放射線療法、輸血、もしくは手術と併用して、本発明の免疫調節性化合物またはその製薬上許容される塩、溶媒和物、水和物、立体異性体、包接体、もしくはプロドラッグを投与することが含まれる。本発明の免疫調節性化合物の例は、本明細書に開示されている(たとえば、第5.1節を参照されたい)。第2の活性剤の例も、本明細書に開示される(たとえば、第5.2節を参照されたい)。
本発明の化合物を用いれば、移植片対宿主疾患(GVHD)のリスクを減少させることができる。したがって、本発明には、癌を治療、予防、および/または管理する方法であって、移植療法と組み合わせて、本発明の免疫調節性化合物またはその製薬上許容される塩、溶媒和物、水和物、立体異性体、包接体、もしくはプロドラッグを投与することを含む上記方法が包含される。
特定の実施形態では、本発明の予防剤または治療剤は、患者に周期的に投与される。サイクル療法では、ある期間にわたり活性剤の投与を行った後で残りの期間にわたり投与を行い、この逐次的投与を繰り返す。サイクル療法を行うことにより、1つ以上の療法に対する耐性の発生を軽減したり、1つの療法の副作用を回避もしくは軽減したり、および/または治療の効力を向上させたりすることができる。
医薬組成物は、個別の単回投与製剤の調製に使用することができる。本発明の医薬組成物および製剤には、本発明の免疫調節性化合物またはその製薬上許容される塩、溶媒和物、水和物、立体異性体、包接体、もしくはプロドラッグが含まれる。本発明の医薬組成物および製剤は、1種以上の賦形剤をさらに含むことができる。
経口投与に好適な本発明の医薬組成物は、個別の製剤として、たとえば、限定されるものではないが、錠剤(たとえば、咀嚼錠剤)、キャプレット剤、カプセル剤、および液剤(たとえば、香味シロップ剤)として、提示することができる。そのような製剤は、所定量の活性成分を含有しており、当業者に周知の製剤学的方法により調製可能である。概要については、Remington's Pharmaceutical Sciences, 18th ed., Mack Publishing, Easton PA (1990)を参照されたい。
本発明の活性成分は、当業者に周知である制御放出手段または送達器具により投与することができる。例としては、米国特許第3,845,770号;同第3,916,899号;同第3,536,809号;同第3,598,123号;ならびに同第4,008,719号、同第5,674,533号、同第5,059,595号、同第5,591,767号、同第5,120,548号、同第5,073,543号、同第5,639,476号、同第5,354,556号、および同第5,733,566号(いずれも参照により本明細書に組み入れられるものとする)に記載のものが挙げられるが、これらに限定されるものではない。そのような製剤を用いれば、たとえば、ヒドロプロピルメチルセルロース、他のポリマーマトリクス、ゲル、透析膜、浸透系、多層コーティング、微粒子、リポソーム、マイクロスフェア、またはそれらの組合せを使用して、1つ以上の活性成分の徐放または制御放出を行うことにより、さまざまな割合で所望の放出プロファイルを得ることができる。本明細書に記載のものを含めて当業者に公知の好適な制御放出製剤は、本発明の活性成分と併用すべく容易に選択することができる。したがって、本発明は、経口投与に好適な単回投与製剤、たとえば、限定されるものではないが、制御放出に適した錠剤、カプセル剤、ゲルキャップ剤、およびキャプレット剤を包含する。
非経口製剤は、患者に対して、種々の経路により、たとえば、限定されるものではないが、皮下、静脈内(ボーラス注射を含めて)、筋肉内、および動脈内に、投与することができる。典型的には、それらの投与によって汚染物に対する患者の自然防御が働くことがないように、非経口製剤は、好ましくは、無菌であるかまたは患者に投与する前に滅菌可能である。非経口製剤の例としては、そのまま注射できる状態にある溶液剤、注射に供すべく製薬上許容される媒体に溶解もしくは懸濁させることができる状態にある乾燥製剤、そのまま注射できる状態にあるサスペンジョン剤、およびエマルジョン剤が挙げられるが、これらに限定されるものではない。
本発明の局所製剤および経粘膜製剤としては、スプレー剤、エーロゾル剤、溶液剤、エマルジョン剤、サスペンジョン剤、点眼剤もしくは他の眼科調剤、または当業者に既知の他の製剤が挙げられるが、これらに限定されるものではない。たとえば、Remington's Pharmaceutical Sciences, 16th and 18theds., Mack Publishing, Easton PA (1980 & 1990);およびIntroduction to Pharmaceutical Dosage Forms, 4th ed., Lea & Febiger, Philadelphia (1985)を参照されたい。口腔内の粘膜組織の治療に好適な製剤は、洗口剤または経口ゲルとして製剤化することができる。
典型的には、本発明の活性成分は、好ましくは、患者に同時に投与されるず、または同一の投与経路により投与されない。したがって、本発明は、医師が使用したときに患者への適正量の活性成分の投与を単純化できるキットを包含する。
以下の実施例により本発明の特定の実施形態について具体的に説明するが、これらの実施例に限定されるものではない。
ヒト被験者における本発明の免疫調節性化合物の臨床評価を裏づけるために、一連の非臨床薬理学的および毒性学的試験を行った。これらの試験は、別段の記載がないかぎり、国際的に公認された試験計画ガイドラインに従って、かつGood Laboratory Practice(GLP)の要求基準を満たすように行われた。
MM細胞系の増殖に及ぼす3-(4-アミノ-1-オキソ-1,3-ジヒドロ-イソインドール-2-イル)-ピペリジン-2,6-ジオン(RevimidTM)および比較用のサリドマイドの影響力をin vitro試験で調べた。さまざまなMM細胞系(MM.IS、Hs Sultan、U266、およびRPMI-8226)による[3H]-チミジン取込みを細胞増殖の指標として測定した。化合物の存在下で細胞を48時間インキュベートし;インキュベーション時間の最後の8時間で[3H]-チミジンを加えた。MM.1SおよびHs Sultan細胞への3-(4-アミノ-1-オキソ-1,3-ジヒドロ-イソインドール-2-イル)-ピペリジン-2,6-ジオンの添加により、それぞれ、0.4μmおよび1μmの濃度で細胞増殖の50%阻害を生じた。これに対して、100μmまでの濃度でサリドマイドを添加しても、MM.1SおよびHs Sultan細胞の細胞増殖は、それぞれ、15%および20%阻害されたにすぎなかった。これらのデータを図1にまとめる。
心臓血管機能および呼吸機能に及ぼす3-(4-アミノ-1-オキソ-1,3-ジヒドロ-イソインドール-2-イル)-ピペリジン-2,6-ジオン(RevimidTM)の影響を、麻酔されたイヌで調べる。2グループのビーグル犬(2/性別/グループ)を使用する。一方のグループには、媒体のみを3回投与し、他方のグループには、3-(4-アミノ-1-オキソ-1,3-ジヒドロ-イソインドール-2-イル)-ピペリジン-2,6-ジオンを漸増量(2、10、および20mg/kg)で3回投与する。いずれの場合においても、少なくとも30分間の間隔をおいて頸静脈に注入することにより、所定用量の3-(4-アミノ-1-オキソ-1,3-ジヒドロ-イソインドール-2-イル)-ピペリジン-2,6-ジオンまたは媒体を逐次的に投与する。
特定の実施形態では、本発明の免疫調節性化合物は、周期的に癌患者に投与される。サイクル療法では、ある期間にわたり第1の作用剤の投与を行った後である期間にわたり休止期間を設け、この逐次的投与を繰り返す。サイクル療法を行うことにより、1つ以上の療法に対する耐性の発生を軽減したり、1つの療法の副作用を回避もしくは軽減したり、および/または治療の効力を向上させたりすることができる。
6.5.1 再発多発性骨髄腫の治療
4-(アミノ)-2-(2,6-ジオキソ(3-ピペリジル))-イソインドリン-1,3-ジオン(ActimidTM)を再発/不応性多発性骨髄腫の患者に投与した。Good Clinical Practicesに準拠して試験を行った。患者は、少なくとも18歳であり、多発性骨髄腫(血清中および/または尿中にパラプロテインを有する)と診断され、そして少なくとも2サイクルの治療の後で治療に不応性であるとみなされたかまたは2サイクルの治療の後で再発した。
3-(4-アミノ-1-オキソ-1,3-ジヒドロ-イソインドール-2-イル)-ピペリジン-2,6-ジオン(RevimidTM)の2つの第1相臨床試験を行い、不応性または再発多発性骨髄腫の患者における最大耐用量(MTD)を確定した。また、これらの試験により、漸増用量の3-(4-アミノ-1-オキソ-1,3-ジヒドロ-イソインドール-2-イル)-ピペリジン-2,6-ジオンを4週間まで経口投与したときの3-(4-アミノ-1-オキソ-1,3-ジヒドロ-イソインドール-2-イル)-ピペリジン-2,6-ジオンの安全性プロファイルの特性づけも行った。患者に対して5mg/日で3-(4-アミノ-1-オキソ-1,3-ジヒドロ-イソインドール-2-イル)-ピペリジン-2,6-ジオン治療を開始し、続いて、段階的に10、25、および50mg/日に増量した。28日間にわたり割り当てられた用量で患者を登録し、疾患進行を呈することも用量制限毒性(DLT)を経験することもなかった患者については長期治療を施した。各来院時に、患者の有害事象を評価し、National Cancer Institute (NCI) Common Toxicity Criteriaに従って、これらの事象の重症度の等級づけを行った。DLT(非血液学的毒性等級が3以上または血液学的毒性等級が4である)を経験した場合、その患者の試験は中断した。
悪性黒色腫(13名)、膵臓癌(2名)、未知の原発性癌(1名)、腎癌(1名)、乳癌(1名)、およびNSCLC(2名)を含むさまざまなタイプの充実性腫瘍の患者において、3-(4-アミノ-1-オキソ-1,3-ジヒドロ-イソインドール-2-イル)-ピペリジン-2,6-ジオン(RevimidTM)を用いた試験を行った。5mg/日の3-(4-アミノ-1-オキソ-1,3-ジヒドロ-イソインドール-2-イル)-ピペリジン-2,6-ジオンを患者に7日間投与し、続いて、7日間ごと10mg/日、25mg/日、および50mg/日に増量し、合計4週間の治療を行った。臨床的恩恵にあずかった患者は、特定患者として治療を継続させた。
この試験は、再発性高悪性度神経膠腫の患者において毒性を調べるために行ったものである。最大耐用量(MTD)が確定するまで、漸増用量の3-(4-アミノ-1-オキソ-1,3-ジヒドロイソインドール-2-イル)-ピペリジン-2,6-ジオンを患者に投与するように、試験をデザインする。3-(4-アミノ-1-オキソ-1,3-ジヒドロ-イソインドール-2-イル)-ピペリジン-2,6-ジオンの予備的毒性情報および薬物動態学的なデータを取得すること、さらには機能的神経画像処理試験および血清血管新生ペプチドのin vitroアッセイを用いてin vivo血管新生活性の代替エンドポイントに関する診査データを得ることも、この試験の目的である。
転移性黒色腫の患者に対して、3-(4-アミノ-1-オキソ-1,3-ジヒドロ-イソインドール-2-イル)-ピペリジン-2,6-ジオン(RevmidTM))を7日間にわたり5mg/日で投与することから開始した。次に、合計4週間の治療で、7日間ごとに用量を10mg/日、25mg/日、および50mg/日に増量した。このレジメンで治療された13名の黒色腫患者のうち5名は、最初の4週間の治療で疾患の安定化または部分寛解を示とた。腫瘍反応は、皮膚および皮下の病変(5名の患者)、リンパ節(2名の患者)、および肝臓(1名の患者)でみられた。反応の継続時間は、約6か月であった。この結果から、化合物は、外見上、有望な新しい抗癌剤であり、抗血管新生特性と免疫調節特性の両方を有することが示唆される。
少なくとも3つの以前のレジメンに失敗したかまたはパフォーマンスステータス不良、好中球減少、もしくは血小板減少を呈したかのいずれかである再発したおよび不応性のDune-Salmon第III期多発性骨髄腫の患者に対して、メルファラン(50mg、静脈内)、本発明の免疫調節性化合物(約1〜150mg、経口、毎日)、およびデキサメタゾン(40mg/日、経口、1〜4日目)を併用して4サイクルまで4〜6週間ごとに治療を施した。本発明の免疫調節性化合物を毎日およびデキサメタゾンを毎月投与することよりなる維持療法を、疾患進行の間、継続させた。メルファランおよびデキサメタゾンと組み合わせて本発明の免疫調節性化合物を用いた療法は、非常に活性が高く、一般的には、他の方法では予後不良である極度の前治療の施された多発性骨髄腫患者で許容されるものであった。
Claims (14)
- 治療上有効な量の化合物3-(4-アミノ-1-オキソ-1,3-ジヒドロ-イソインドール-2-イル)-ピペリジン-2,6-ジオンまたはその製薬上許容される塩もしくは溶媒和物を含む、再発した、不応性、または再発かつ不応性の非ホジキンリンパ腫(NHL)の治療のための医薬であって、前記医薬は前記化合物を1〜25mg/日の量で投与されるように製造される、医薬。
- 化合物が3-(4-アミノ-1-オキソ-1,3-ジヒドロ-イソインドール-2-イル)-ピペリジン-2,6-ジオンである、請求項1に記載の医薬。
- 化合物が製薬上許容される塩である、請求項1に記載の医薬。
- 化合物が製薬上許容される溶媒和物である、請求項1に記載の医薬。
- 治療上有効な量の第2の活性剤であって、造血増殖因子、サイトカイン、抗癌剤およびプロテインキナーゼ阻害剤からなる群より選択される第2の活性剤と組合せて投与される、請求項1〜4のいずれか1項に記載の医薬。
- 放射線療法、ホルモン療法、生物学的療法または免疫療法と組み合わせて投与される、請求項1〜5のいずれか1項に記載の医薬。
- 化合物が経口投与される、請求項1〜6のいずれか1項に記載の医薬。
- 化合物がカプセル剤または錠剤の形態である、請求項7に記載の医薬。
- 化合物が1〜25mg/日の量で投与される、請求項1〜8のいずれか1項に記載の医薬。
- 化合物が5〜25mg/日の量で投与される、請求項9に記載の医薬。
- 化合物が周期的に投与される、請求項1〜10のいずれか1項に記載の医薬。
- 1サイクルが4〜6週間を含む、請求項11に記載の医薬。
- 1サイクルが28日サイクル中、21日間の化合物の投与と7日間の休止期間を含む、請求項11に記載の医薬。
- 28日サイクルで、化合物が21日間にわたり1日当たり5〜25mgの量で投与され、7日間の休止期間が設けられる、請求項11に記載の医薬。
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