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Revisiting the AL,A/N (a-Lipoic Acid/LowDose Naltrexone) Protocol for People With Metastatic and Nonmetastatic Pancreatic Cancer: A Report of 3 New Cases

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($JSAGE

Burton M. Berl(son, MD, 1"15, PhD,I,. Daniel M. Rubin, NO, FABNO,3 and Arthur J. Berkson, M[)i

Abstract The authors, 'Ill ~ pl'eviOUI al'tl~le, d.,cl'lbed the long-term $ul'vival of a mal1 with panu'e8tlc cancel' and l11etasta~lll W the liver, treated with Intravel10us a1phll-lipolc acid and ol'al low-dos. l1altrexone (ALAIN) wit:hout any adv.'-'. effact', ~I. Is alive ;:Inc! well 78 months (lftCf Initial t?t'J~scntation, TI1I-(;c additioM31 pancreatic C,'lrlC(:t' case 111'\E1 pna..slZ!rlccd 11"1 thL~ ~"'ticle,At th¢ timc of this wl'ltll1g, the fll',t p!lticnt, GB, is .livc and well 39 l110nths aftel' 1,,'e'.l1tlng wi~h ndel10Cal-clllol11a of thft1 f:lnncl'c;J,S with ji141tastnsas to th~ Iivcl'.The second patl'ent,Jl<., who presentGd to the cli'tllc with the satnti; dim,gllosls W("lS t,.eoted with the ALAIN pl"ocoeol and aftel' 5 l110nths of therapy, PET scan demonstrated 110 evid""~~ of third pntiGI"lt, RC, In udditiol1 to his panCI'Ci1tic: l.;;om;i:1!" with liver ~nd l'ctl"Operitone.aJ 111cta5t~$lt)$, has a histol7 of B~celllYl'rqdhornrl and p!'(J!';tntc ndenocar(;lnorna,After -4 l1'1onths of the ALAIN protocol his PET sClln d~~IllQllstrat~c:1 no signs of ~::II'ICCr. In tbls ",.ticlo, the (lllthOI" dl,cuss thG poly activity of ALA: as all agel1t that I'educe' oxldativelt;!'CSS, It, ability to stabilize NF".B, its ability ro stimLllate pro-oxidant ap~ll~tOSic activity, and It' discl'lmin.tlve ability to dl,cou,'oge I:he p,.olifel'''I;IOl1 of l11allgl",nl: cells, In additlol1, the ability or lowclose ,',altl'exon. to modul.te an endogenollS In1mUl1C re,ponse Is discusse~,Thls is th~ second f,rtlcle published 011 the ALAIN "rotocol and the a"th~I-' bollcv. the I""tocol w"mlnts clil1ic,,1 LI'iaL l(eywol"ds pl:Il"lt;;nZl;:ltlC canCEW, gcnlcltabine

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drilill \\'111, Ill'\ 1.'1 l'nll,;, l'IIIW[\(lII:'II, n:~lIl1il1g 111 11',lllli'1i1 Vpl\:llih", .. 1'\'111 I,;, 1,;1' \\'I,'II! III :1 iq flli.:dl\:iill.\'f1Iv,' 11'1 S(111 l)k~l;ll !"Ol' :1 ',c'I-I'lhl \ll'illilll1.'\ t T H:ill'l \'I'm; 1'(1'1\'1'111\.:11. Illld II d~I1WI1' ',!ml",1 IWlll'IVillll' !';Im'v,!". li\','1' !llvl:l~I!,l~l'~, and pl:l'il\)n ztd ' \,:11\·1111,111111<,1:,,1::, In', 111<", '-':11,; Ii Ill.! \11:,11 11\'l1\I1h.'n! \lilnlld 1'11l:'~1 111,1,1\ vivid lilllt: I 11l.'lllk h,.'m:l'il 1I11I11lrai 111,1 11'C'i1l111l:n! 111:I,V Iw II1\' l'I\'!'I,:\hl,· dji,il:C Ihl' him ,',wmll "II:.. l'lliill \'

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l,IililllY dli'lill 1\1 I\Lirvh l11' :::007, i'lL' WI:li,> G\l1I'n i 1'1 cd by II !m;d· 11.:(11 oI'IL:ull1,",i~1 who 1:\\1111'11!.il1kd II1I11 (II (ldH pl,lll\!. IH" hnd rdllll\\'ly Utili: 111 111I,~ t'l I~ lilI1 (lllilllt::, Tlli' Inll:I'" Ilill17Lllil'l1l <:d'lhi:; hil drHI11 WII~ p".1'1\1I"l1Wd. lind lIll hii'

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III'


421 VVl'l1l~ thnl :lL'li\':lIc I.ral'l:-:(TlptiOl'l I"Flctnr NI~ 10::13," Becilllse

nf'll1is, NI 1..:I'll11uys n signilicnili. role 1l1lhc 1'Cl~1IIntli)n (If iilf1i1ll'1llwlnry illdll,,~t1 !iCIH; lill1diol1, HIlih drl,lcs "f Al.A, Whl~11 lIdded I~l (.'ell l'ullUrc have l'ccil ~llCWI'11 to inhihil thl,:~ dL,tivullll1llirNF I<ltl I\IlJ\I1i",~I' nnil:k: slH1wi,:d l,witll~l1t:v nf t\ 11'H.::chLI\11sm by wlll('h AL.A 1I',;ghl he hc'lpl'ul in CIl11Cel' therapy bc,",I."" of Ihe 1',,"llh'" it "lin sliIIIUI"i(', prl1(!,xidllnH(l'iven ~11,,'pl()',S 111 1111111:11'1 cnlnl1 1.:\1111.,'1;:1" cl'lh'" This l1ml~css is tlctivutl.'Jd by lIll II'll.,,'n;:lsl,:d tlll(nkc: (11' I.'l;,dl'1i~,<'lblc ~l.Ih~[rnl,i;i'1 Into th(~ 111ilo~ l'h\1IHld\ln,~~ 111 UIH'1111l:1" I"ludy, ALA was showl1 to jll~rl!:rti'H: \1(111'\l~~y:-:l\;lll(,' ~lml'Clllmli01IF wilhin CnnCl:l" c¢\ls in ccrlflil1 l'slilhli~hL~d L'UIICln' L~l~11 Illles,l) Tile lllcrctisod htnnocyslL':i11c ri,lt1t;l:l1lr:lli()n~~ \'VL;I'C (I)xil: 1~)1' (he 111ldi!~l1nl1l cc\L~, All

Liddiffl

others Wt~l'e rCplJI'IN! to clos0 lt1 1\'lrds~il)n" 1:1

hHV!ll Llchil.rvcd n:Il1i."s(O!l N W(,,1t'L:

ZnBon and M,I.,ilughlin lJ rcpol'leclthal LDN slowed Ihe gl'(,1w(.h ofl1(~uJt)I)ltl;;tllllHl cellK II, ('ultun: ulid I"tlggl;)~IL~d

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l.;t1l1i,iL:TS,

MallgnHllt nS[I'(lc)J1'OI1UIt: tll'~ nul bclh:)vcd (tl h",~ ~urUl"'Jh.1,

,111(1 t1"1:" In1"111 i, II Il110d al' pall in t I" n, Li "so 11 I C1,,1 " 1', ported 011 the 11\\:r(mel11 \11' Ih,s l11nlignill1cy with IHlllrcXi.1I1(' pillS !"Hc!iolhernpy (In), '1"110 tum"r regressiol1 nile in j1"lictil~ IMlted wilh Rt' pil" I'InIIT8X1.J1IC WI1,' ""lllcwhlli higher Ihnll Iho,e tl'l~lIt,1d witll RT "I(mc, 11l1d Ille pCI'CCl1ta!:l" (!I' Ilm,e SLlI'vivlllg 1.11' [ yeti I' was slgnif1c~llll1y higlwl' in pntk~nls

l,"e"led with [{T pi", 11,i1ITO",lI'," Ihlln il1 111o," Il'enled with RT "h'11e,

II'."" II'I ill Ikul iUlI ,'ol1""lc,d l'h"l A L/\ I1dl'cd Iho 111"0111'01'1111,," 1l\1I'lllill hl\l11;lll lytll11[,(lcytCb: lIl,1t:1 ~1l)\'Vl;d down the: pro'" lil'-:l'il 1il,111 I'll':: k~1IIwI11lt: 'r~~cll lill~~l-l,11I Thl1 discrl111innlillg lo:d\,'ily llr /\1./\ W:IS hC'L;(ll\,L.;I,: of Ihe inductioll of L1PlJplo~iN

Ill'

",,'k

il1 Illc k,d'''I"lu ALA "I,,) "()Ii,,eubly il1c\"l;uscd Ihe IlId""I;',,, I!I' 1"'''I'(''L1klll-2 (I ) I11RNA nnd I 11\"l1lclrl ,('(:I','lillll ill ,'11110"1" l'C' II." The 111111101', ,ll1lcd Lhnt Ille diflcrL'llli:i\ cITI..:L'I~ (11' 1\1 l11ity

Nlll~l~il'y

\1

.1\ ~1I1 Ilf,lI" I11nI ,Ind ll:llklt.:1l11c lyl1'!1'll1oeylcs I"tllhwny Imvnrd thl~ develol"'Jll'lcllt of

IIV"\'

tlll'nq1i,;\III't: ilgL'11\~ I~,'ll' L'nl1l'l'I', M:ll1lnvill,i :md Mt'H:l'io " dClTll'll'l~lTi.'l(l::t1lhQ l'.1hHHy of ;\LA ((I \"\l1'1'lJC( 1'1I111:11l'11'11:'1I dcfl':\.,:1:.; in Ill;l'ipl1crnI hlood 111(,,1n(111U~

"kill' ('c'lI, i:;,.IIlrc'(1

n'()111

(l(lv'1I1c,,'<I

cancer l'aLielll",

T\\'\"I\\)' pnllen!.': ''''ilh mIV:llll:cd Ct'lllL:Cl'1-; of l'he lung. (,vary,

HIHlll01\t! n\ld 1'\eck \Vcl"t~ C;,\(1111\11C(], The ~Cl'UI11 11,-", IIA" TNI'-iJ" "'1(\ sIL-2R were ,ig. t'lll'i~"01l1lly hi~h(.'r in t:Lllll',l~r rHlt1cI1IN l'h~lt'l in paliclIt8 with 110 kl1!!\\11 "illll.'"r', '1'1,(: "ddili,1!'1 "I' ALA inlll ti,e cell eullures ,'i 1j~ll I Ih:llllil Y I lll~I\";(:.:;(,d Ihl:: rcsp()j)sl.' Ofl,;'ill1CDr P~ll'it~111I1H.nw~ lilleklll' L'ell" I'hl, I'cporl dCI'I1l111SII'IIl"d Ihnl ALA h", :r hL'tH::rit.'inl (,;1'1\:(:1 elll i1l'11'1l1l1l(~ cell 1\I11dlnn In nrlval'l(;~d~~tt'\gc l'lldll1111:1ntll'll,

11\

bc'ls ,ii' II

Conc;lusion Wl.~ nrc not ~~~rtt:lill jl'l'I'lI.'::rc is \'l syllcrgist.ic: nr mklilivc rdill'iol1sl1i'l bcl.weel1 ALA ond LDN, As the lil11e of Ihis Wrtlil'lg" Ihl.lrc dl,'1L:~ nOl ~,com III be (Illy dil'ljt;tly CCll'lll11l'l1 biochcmicallnllbwny, 'It i~ n.:::a:-;lll1ClblL; lo (hil1k tllnt there illdc~d IN ;,It lt~I:1SI' (,111(; (ll'thl:~(" (:ffcds 1lI'I'hnl' their l;mltlinil'liR1Julion illiHtlt~8 :1 lHWt.:! ~11NCndt~ 01' bl't11t\lji(:nI cnb;ht (( i::< i'C1.\!4(lI1ub!i;! t(,"l bl::lil~V8 ilS w!,';!! that on~; CUl11POllClll or 1:l1c AL.AiN pl"\)lOl.::ol bears gl'l-~illcr l'lICl';:lpCuliL' \,:fl'icacy thnn l'h~ nl'llcl', It is I'cusl)m:lblc 1'11,1( l,:cnuin 111::';1\')1 (1g1C<\1 1)'pl,;S lif P<1l1Cl\~IHic ClII'Icor will 1'~'p(111d 10 ALAIN, Thi, is the "ccol1lllll'ticlo pub(i$l1~~d 011 this slIbjcd, nnd Wl' bcllcv!; tlHl!' thlr: t1(1l,~~ Wtll'~ n1111. deepcr elil1ien( invoslig,'li<1I1 vil1 11 clil11clIi Il'i:1l, especially givel'l the PO(ll' clil1ielll cour,e ol'lel1 experienced

or

by

tho!:lc dingnol)ct!

will1

1l1t:mstol'ic rHll'lCl'l;':i1lic ('lmeel',

In SlImn111l"y, tllc inlcgr(llivc rhcntpy tk,,,:ribcd Il1ll1i, 1I1'licit: 1'I1(1y ht1v(~ the j10sSibilHy ol'cxtending the lil~ tll'u !~l1liC1l1

ill \hl~ therapy or thl;;

wh,\) I;:; ClIstCJl'I1i:ll'ily cOl1sidcl"cd h~I'1l1ilml, 1~hl.s wns lH:C(1Il1~ plir;h~d wIlh l\ pl'ngnt11'1 (If::tl1 an1'il)xidnI'H' lhnl ht:.,!.lt''i KnOwn l'111li!lIl11Ul' ~l(,~tivily (nIl11H:ly, }\LAl llnd nl1 llpi::llc bll)cknd~ ngcnt 1'\'0(: ('[II] 8j'iI11UI:;\(~ 1.111 undogl:ll0l\S il11111UIh.,~ l'e~pl'\nSQ, AB w~~ ,S[lltC('\ in Oltl' ~n.rlkl' I1I'fil~lc, W~' hi.;']ll'V1-1 th~ll bin1'1lcc1ical Bckncc \vill om:: d~)y (,'h::vcll;J):1 1'1 Cl1l"C !:l)1' Il1l'lnsl:nti(,; ptl\1cn.::r:dk Ct111('t)l" perlHI])S \'iu g\'~n(: thern!:'!)! (11' 11llOll'ir,:1' bl(l~

pilliCllI:i. Ntil'IUl'l1i'lIly dus('d I J)N hlockr; C!1(1(l~;l!:lln118 OpiLlIt:: n,'I,,'I,,'plOI'~~ l\\!' U \\:1)' ~~horlliilK', Dl1l'il11~ this 1"1::(,;(,'1'1'01' bll1tJl,;udc, Ihl: h(1\ly PI'\')dllt:l.:~ lill'~,~l.:: 1l1ll(1l111tS ufopii'llcK 1111'CSj1tl118C to 11lL' 110,"ilhiL: l\.'l'lIIHIl.::k, 'fIll' GlltlUgl'110l.1S upinllt.," bl::\,~(1I1H':

Il'InrkGt, ITI(lI\~OY{,;I' QVl1lv~ unci nrc l't;l1ll?:cd, Ihe ALAIN thcr~ tq,y ~hol1ld be c(ln~i(kl'ed, given il0lth:;k l)l"tuxicily i1\ k,vds I'CPI1l"lcli 11~I'c 111, Its l'c,,,ly 'I \'11 i I:II'i lily, (lml ii,' elTceL (111 1110 ,1

(I VLlIl:lhk' Hild !:'l'\1 \ (j'~dl' I"l~l..~(J'I:'! IU1'$ (111 ,":'\I;ioUN celLs in lhc 1!11f1rUnC

patients

\.'i\11L'1:1' p:ll1Vl'1lf.;.

Naltrexone L11t\1

\\'i\!4 Ih~ s(,~v(lll(l kl.:~Y illgrcdi~~I'd

logklil-iype plllllbrm, Blil L1111il silch pl'J.1I"eol,

di~c.\l;it.(l;d ill thi~~ ~1l1TC1,l

(:"l11e

I"

iI1'tielc,

!"1ybl '..:111.

II! 19 ', Illl1:I1"': !"irsl l.I"cd LDN 111 Ireul penl,k With " tl!licd l,DN for

P"d",",ltiQn of Conflicting Il1t".",.t.

1\11)~: 1;,h:i.~11 hlN )11\'In;sil1t~ \'Ct4Ii\\,,,, hI.; Inl'CI"

Tlw lHithors dl,)clnl'~~d

Ih\,~ tl\.'i\\111l'll1 ('ii' 1:'1I:\l!lIC'

ml j:hnl"",I1\p lInd/ur IJlIblil.:l.\liul'\ l\Hhl:i l1rtklc,

!1\,l1l\ini!411,'I'l~d

wilh \,:lIllccl", (Jvl;;r (he ycnl'~, h~ 1,I)N 10 ;;1,50 11liticnlhi with Ctlll!.~el', 111t1~l of

\\1\1(1111 1l:l1l ndk'~\ 11lL: ,"lIW'l(lnl'tl ll'l:t'ltinc:nls, A~~4nrdit1g 1'0 I~ill:lt'i, ql' 3,"1,4 ]lnli(:lils who [HId rl;.~gl,llur flllkl\v-l1IJS, 86

s!luw\\1 ill

llJ!l:~t n 7~Hi;) 1\;dllClj(111 in tumor

bulle tllld I

I1U 1:l)llflil~lS

nf inl'l:h::"l with rCbpecl tu \Iw

Funding Tht: uuthort< t'c0L:h'l~d

n(1

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dI'lLlII'!":;'I'ill';lli\111 \\ 1111:1 ~'111\I.'UI1Iil(1111 (,j.~",il_.:':\,'lll,'lilli\lll,

IhTblli'II\J '111l" 1i~111;'~hI'l11 ~\lr\'i\':,11

willi

111'111'1;111"111 \1,'111, 1":\111,',1'1.'1111,' L':II1\.'\:1

11\'~'1' :111,'1' 11\':IIIIIVill l\illl, ii'lL' 11'llrIl\.'l'I\llli~; :ill,llil-1i11tIlL ;1';'I'I!; 1I'li',d,,\V Il"IIIIV~('il1l.' pIUI'IVI"L

q

I [11!llwl',S H, l\ill,I\,llilIIII!1I1I,ll\':\!t;I\",~'IILlLII' l)o\lll(\~',v>,H'II1k: ~"IIIU'II" 11':IIII,il1 jlllnI11,,'II' n'111111L',:-;, ('lill ('funi II 'Iii, ,~(ltl,l",', 'Ill: 1:- I I ~iJ,

('~rJll'~'I' 'I'IiVI' :',\)(Hl;:~:

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!\,I

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\,\'I\I]'lIiilli'" liI"1 li",11 1-;'1'I1pll1.'11'1111 III :1 l'llll'le?I'1 i,l;',il1!~

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k'\lI~(\t.:111it.' II, t\'1Utllt'1l,,'Ulll

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lillllli:[':,

11."/1<, ii'

('llvll ,Ll..l, ,''';ivllliU 1<" ,:i d'11I,:III.!v111 l'L,11

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,'lln'~1 11'1 11i'i1HI';II'I~l'l1rllwd

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11,1\-'lIl,'11

t'd:-l,

(,:1'11 1'1'\ \.'1'11:"'·'III,III~:i,;\1

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~ llli~~h :~,

[\'\',11-'1111,11' 1i.'II'~(:I:;

ill,!, ',II. li11111; / I I yl 'I. I ,,1" i\I',}'.:il\1.I1

11111.1 L',llli:n,llilll, "\VI'1,'1oi:,l.'d

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Lhi'I'li1i P,

I:t

l.'lillwr

S,

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1'11\1 :lllIlilid 1,1\\

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\;::hlvlli\ 1,1'

V(ll'k, )\IY

.'\lplli\~III'IlIL' ,'11:1.1 i~':1

:1\'11'.,1111,111 ill IHlll1:,II~

11'1"1/)1'111 lilll/,/li'S /\'1', r. '"IIi!!/I!!!. I(lil,~ l:iilI711t),,17I,S,

I'

~:I:lh;,

Iii S,'\',.: ::i 1',iI ':; II' i 'il

111,-':'. 1,,'n'<:\;,lli V, ~'I ,ii, l't:ldiil~'llIlllt:llli\: Illn'i]\I' 1

111111.'1111111111111111' 1,1 ,1\11 "bllp:1

Ni:\\,

ill 111I!.'L' willi I'IL'I II'p1'd, I ~" 1(1111: I. S/ 11'1 In'

1:1,

I1lbl'llillllll1llll~, \\'111 IIIL' 11tll:kl.:r

Ii 1\\\.i.II'I\I'I!II-,\,'lliIIIIVWliV

I h\

1)I'\~'';L'III,·~I;lI

l'l1!liIn 11, kL'.Ylll'li'..' ilddl'l.'i,S,

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,.'llil":;~.ill:\ II,·I·IIN

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1 i'i,'

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