Clinical trial: NCT02224599
Section: Alternatives
Subsections: W H At Ot H Er C H Oic Es D O I H A V E ?

If y o u d eci d e n ot t o b e i n t his st u d y, y o u h av e ot h er c h oic es, s uc h as:  
- Y o u m ay c h o os e t o h av e t h e st a n d ar d tr e at m e nt f or y o ur c a nc er.  
- Y o u m ay c h o os e t o b e i n a diff er e nt r es e arc h st u d y if o n e is av ail a bl e.  
- Y o u m ay c h o os e n ot t o b e tr e at e d ( wit h c ar e t o m a k e y o u f e el m or e c o mf ort a bl e). If y o u c h o os e n ot t o g et tr e at m e nt, y o u c a n g et c o mf ort c ar e, als o c all e d p alli ati v e c ar e. T his t y p e of c ar e h el ps r e d uc e p ai n, tir e d n ess, a p p etit e pr o bl e ms, a n d ot h er pr o bl e ms c a us e d by t h e c a nc er. It d o es n ot tr e at t h e c a nc er dir ectl y, b ut i nst e a d tri es t o i m pr ov e h o w y o u f e el.  
C o mf ort c ar e tri es t o k e e p y o u as acti v e a n d c o mf ort a bl e as p ossi bl e.  
Y o u c a n g et tr e at m e nt f or y o ur c a nc er w h et h er y o u ar e i n t his st u d y , or n ot. Y o u s h o ul d t al k t o y o ur o w n d oct or a b o ut e ac h of t h es e c h oic es b ef or e y o u d eci d e if y o u will t a k e p art i n t his st u d y.
Clinical trial: NCT02224599
Section: Confidentiality
Subsections: Not Recontacting Participants|Future Contact

It is possible that, in studying tissue samples and data from you and others, researchers may discover information that would be potentially relevant to your future health.  If this occurs, there are no plans to make this information available to you. This is because the tissue samples may have been coded or de-identified in a way that makes it difficult to trace the result back to a specific person, and because the results of research often are too uncertain to be used as specific medical information. Your signature below indicates that you understand this to be true. Please V check one:
[] Yes
[] No

Please indicate whether you would or would not be willing to let our researchers get in touch with you in the future, to ask whether you would be willing to contribute more tissue samples or data or participate in another study at that time: Please V check one:
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[] No
Clinical trial: NCT02224599
Section: Duration of Study Involvement
Subsections: B Ef Or E Y O U B E Gi N T H E St U D Y:|D Uri N G T H E St U D Y:

- Y o u will h av e a t est t h at will l o o k at y o ur t u m or c ells t o s e e if t h ey h av e at l e ast o n e of s ev er al s u bst a nc es t h at m ay c a us e y o ur b o d y t o m a k e a s p ecific i m m u n e r es p o ns e r el at e d t o t h e c a nc er v acci n e. To p erf or m s uc h a t est, y o ur d oct or mi g ht r e q uir e t a ki n g a s m all s a m pl e of y o ur t u m or fr o m a n e asy t o r e ac h sit e, usi n g mi ni m all y-i nv asi v e pr oc e d ur es.  
W hil e t his pr oc e d ur e, c all e d a bi o psy, o nl y c arri es mi ni m al ris k, it m ay b e n e e d e d t o pr ov e if t h e v acci n e is eff ecti v e.  
B ef or e y o u r ec ei v e t h e v acci n e y o u will n e e d t o h av e t h e f oll o wi n g extr a t ests a n d pr oc e d ur es:  
- A b o ut a pi nt of bl o o d will b e dr a w n fr o m a v ei n i n y o ur ar m vi a p hl e b ot o my. H o w ev er, if f or s o m e r e as o n, y o u ar e i n eli gi bl e f or p hl e b ot o my, y o u m ay u n d er g o a n F D A- a p pr ov e d pr oc e d ur e c all e d a l e u k a p h er esis. T his pr oc e d ur e is us e d t o r e m ov e t h e bl o o d fr o m y o ur b o d y t o c oll ect s p ecific bl o o d c ells. T h e n t h e r e m ai ni n g bl o o d is r et ur n e d t o t h e b o d y. Y o u will b e as k e d t o si g n a s e p ar at e c o ns e nt t h at will ex pl ai n t h e pr oc e d ur e i n m or e d et ail. T h e c ells r e m ov e d fr o m y o ur b o d y by eit h er pr oc ess will b e us e d t o m a k e t h e st u d y v acci n e f or y o u.  
- A s ki n t est will b e d o n e t o c h ec k y o u f or i m m u n e r e acti o ns as w ell.

- P ati e nts will t a k e a l o w d os e of a F D A a p pr ov e d c h e m ot h er a py dr u g c all e d c ycl o p h os p h a mi d e by m o ut h f or 5 d ays b ef or e r ec ei vi n g t h e st u d y v acci n e. St u di es i n a ni m als a n d ot h er c a nc er v acci n e tri als s u g g est t h at c ycl o p h os p h a mi d e m ay m a k e t u m or v acci n es m or e p ot e nt. It is ex p ect e d t h at t his dr u g will i ncr e as e t h e c h a nc es of h avi n g a r es p o ns e t o t h e st u d y c anc er v acci n e.  
- T h e st u d y v acci n e will b e gi v e n i n 4 s m all i nj ecti o ns u n d er t h e s ki n. T h e st u d y v acci n e will b e r e p e at e d ev er y 7 d ays f or u p t o 3 d os es.  
- Aft er t h e v acci n e, y o u will r ec ei v e t o pic al I mi q ui m o d cr e a m, a dr u g t o h el p b o ost y o ur i m m u n e syst e m.  
- A s ki n t est will b e d o n e t o c h ec k f or i m m u n e r e acti o n t o st u d y v acci n e c o m p o n e nts b ef or e a n d aft er t h e st u d y v acci n e as s p ecifi e d i n t h e st u d y.  
- Bl o o d t ests will b e d o n e t h at c a n pr ovi d e i nf or m ati o n t o t h e st u d y d oct or a b o ut y o ur i m m u n e syst e m. F or t h es e t ests, u p t o 7 - 1 4 t a bl es p o o ns of bl o o d will b e t a k e n as dir ect e d by t h e st u d y c al e n d ar.  
W h e n y o u ar e fi nis h e d t a ki n g t h e v acci n e:  
- Bl o o d t ests will b e d o n e t h at c a n pr ovi d e i nf or m ati o n t o t h e st u d y d oct ors a b o ut y o ur i m m u n e syst e m. F or t h es e t ests, u p t o 7 t a bl es p o o ns of bl o o d will b e t a k e n as dir ect e d by t h e st u d y c al e n d ar.  
- A s ki n t est will b e d o n e t o c h ec k f or i m m u n e r e acti o n t o t h e v acci n e at as dir ect e d by t h e st u d y c al e n d ar.  
A st u d y c al e n d ar will b e pr ovi d e d t o y o u, s h o wi n g h o w oft e n t h es e pr oc e d ur es will b e d o n e.  
If y o u d eci d e t o b e i n t his st u d y, y o u will b e as k e d t o r e a d a n d si g n t his c o ns e nt f or m a n d t h at will t a k e a b o ut 3 0-6 0 mi n ut es. T his is a n av er a g e ti m e. It m ay t a k e l o n g er d e p e n di n g o n h o w m a ny q u esti o ns y o u h av e a b o ut t his r es e arc h st u d y. Y o u m ay t a k e t his c o ns e nt f or m h o m e wit h y o u if y o u w o ul d li k e m or e ti m e t o r e a d it a n d t hi n k a b o ut y o ur d ecisi o n.  
If y o u n e e d t o h av e l e u k a p h er esis t o c oll ect y o ur bl o o d c ells, t h at pr oc e d ur e m ay t a k e u p t o 8 h o urs.  
Y o u will r ec ei v e t h e st u d y v acci n e o nc e ev er y w e e k. Aft er y o u fi nis h t h e st u d y v acci n e, y o u will r et ur n t o t h e cli nic as p er t h e st u d y c al e n d ar, s o t h e st u d y d oct or c a n w atc h y o u f or si d e eff ects a n d f oll o w y o ur c o n diti o n. At t h at ti m e, y o u will h av e s o m e of t h e t ests a n d pr oc e d ur es d escri b e d a b ov e t o c h ec k y o ur h e alt h.
Clinical trial: NCT02224599
Section: Participant's Rights
Subsections: W H At Ar E M Y Ri G Hts I N T His St U D Y ?

T a ki n g p art i n t his st u d y is y o ur c h oic e. N o m att er w h at d ecisi o n y o u m a k e, a n d e v e n if y o ur d ecisi o n c h a n g es, t h er e will b e n o p e n alt y t o y o u. Y o u will n ot l os e m e dic al c ar e or a n y l e g al ri g hts.  
F or q u esti o ns a b o ut y o ur ri g hts as a r es e arc h p artici p a nt, or if y o u h a v e c o m pl ai nts, c o nc er ns, or q u esti o ns a b o ut t h e r es e arc h, pl e as e c o nt act [I R B C o nt act I nf or m ati o n] . Y o u m a y als o c o nt act t h e [ A d diti o n al Sit e C o nt act I nf or m ati o n, if a p plic a bl e]. T h e r es e arc h t e a m will t a k e pr o p er pr ec a uti o ns t o e ns ur e t h at a n y i nf or m ati o n r e g ar di n g y o ur i d e ntit y o bt ai n e d i n c o n n ecti o n wit h t his r es e arc h will r e m ai n c o nfi d e nti al; h o w e v er, c o nfi d e nti alit y c a n n ot b e g u ar a nt e e d.  
A d escri pti o n of t his cli nic al tri al will b e a v ail a bl e o n htt p:// w w w. Cli nic al Tri als. g o v , as r e q uir e d b y U. S. L a w. T his W e b sit e will n ot i ncl u d e i nf or m ati o n t h at c a n i d e ntif y y o u. At m ost, t h e W e b sit e will i ncl u d e a s u m m ar y of t h e r es ults. Y o u c a n s e arc h t his W e b sit e at a ny ti m e. ( 2 1 C F R 5 0. 2 5(c))
Clinical trial: NCT02224599
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: W H At Ris Ks Will I F Ac E B Y T A Ki N G P Art I N T H E St U D Y A N D H O W Will R Es E Arc H Ers Pr Ot Ect M E Fr O M|P Ossi Bl E Si D E Eff Ects Of D E N Dritic T H Er A P Y/ Vacci N E|R A R E, A N D S E Ri O U S|R A R E, A N D S E Ri O U S|P Ossi Bl E Si D E Eff Ects Of I Mi Q Ui M O D C O M M O N, S O M E M Ay B E S E Ri O U S|O C C A Si O N Al, S O M E M Ay B E S E Ri O U S|R A R E, A N D S E Ri O U S|R A R E, A N D S E Ri O U S|P Ossi Bl E Si D E Eff Ects Of C Ycl O P H Os P H A Mi D E C O M M O N, S O M E M Ay B E S E Ri O U S|G E N Er Al|U Nf Or Es E E A Bl E Ris Ks|Pr E G N A Nc Y/ Birt H C O Ntr Ol|Will T H Er E B E A N Y A D D E D Ris Ks Fr O M T His St U D Y If Y O U Ar E A F E M Al E ?

t h es e ris ks ?  
If y o u c h o os e t o t a k e p art i n t his st u d y, t h er e is a ris k t h at y o u m ay:  
- L os e ti m e at w or k or h o m e a n d s p e n d m or e ti m e i n t h e h os pit al or d oct or's offic e t h a n us u al  
- B e as k e d s e nsiti v e or pri v at e q u esti o ns w hic h y o u n or m all y d o n ot disc uss  
T h e st u d y v acci n e us e d i n t his st u d y m ay aff ect h o w diff er e nt p arts of y o ur b o d y w or k s uc h as y o ur li v er, ki d n eys, h e art, a n d bl o o d. T h e st u d y d oct or will b e t esti n g y o ur bl o o d a n d will l et y o u k n o w if c h a n g es occ ur t h at m ay aff ect y o ur h e alt h.  
T h er e is als o a ris k t h at y o u c o ul d h av e si d e eff ects. Vacci n es li k e t h e o n e us e d i n t his st u d y h av e b e e n us e d i n ot h er r es e arc h st u di es. T h er e h av e b e e n f e w si d e eff ects o bs er v e d a n d v acci n es ar e g e n er ally w ell t ol er at e d a n d mil d.  
H er e ar e i m p ort a nt p oi nts a b o ut si d e eff ects:  
- T h e st u d y d oct or d o es n ot k n o w w h o will or w h o will n ot h av e si d e eff ects.  
- S o m e si d e eff ects m ay g o a w ay s o o n, s o m e m ay l ast a l o n g ti m e, or s o m e m ay n ev er g o a w ay.  
- S o m e si d e eff ects m ay i nt erf er e wit h y o ur a bilit y t o h av e c hil dr e n .  
- S o m e si d e eff ects m ay b e s eri o us a n d m ay ev e n r es ult i n d e at h.  
H er e ar e s o m e i m p ort a nt p oi nts a b o ut h o w y o u a n d t h e st u d y d oct or c a n m a k e si d e eff ects l ess of a pr o bl e m:  
- Tell t h e st u dy d oct or if y o u n otic e or f e el a nyt hi n g diff er e nt s o t h ey c a n s e e if y o u ar e h avi n g a si d e eff ect.  
- T h e st u d y d oct or m ay b e a bl e t o tr e at s o m e si d e eff ects.  
- T h e st u d y d oct or m ay a dj ust t h e st u d y dr u gs t o tr y t o r e d uc e si d e eff ects.  
Y o u m ust t ell t h e st u d y d oct or or st u d y st aff a b o ut all si d e eff ects t h at y o u h av e. If y o u a r e n ot h o n est a b o ut y o ur si d e eff ects, it m ay n ot b e s af e f or y o u t o st ay i n t h e st u d y.  
T h e t a bl es b el o w s h o w t h e m ost c o m m o n si d e eff ects t h at r es e arc h ers k n o w a b o ut. B ec a us e t his st u d y v acci n e is i nv esti g ati o n al, t h er e mi g ht b e ot h er si d e eff ects t h at r es e arc h ers d o n ot y et k n o w a b o ut. If i m p ort a nt n e w si d e eff ects ar e f o u n d, t h e st u d y d oct or will disc uss t h es e wit h y o u.

C O M M O N, S O M E M AY B E S E RI O U S  
Fl u -li k e sy m pt o ms t h at i ncl u d e:  
- F ev er  
- C hills  
- F ati g u e  
- B ac k a n d j oi nt p ai n  
- N a us e a  
- H e a d ac h e L oc al r e acti o n at t h e sit e of t h e i nj ecti o n t h at m ay i ncl u d e:  
- R e d d e ni n g of t h e s ki n or irrit ati o n  
- S w elli n g  
- Ar e a of h ar d e n e d/t hic k e n e d tiss u e  
- Ulc er ati o n/ n ecr osis  
- Itc hi n g O C C A SI O N AL, S O M E M AY B E S E RI O U S  
- Sli g ht e nl ar g e m e nt i n t h e l y m p h n o d e(s) i n t h e i nj ect e d ar e a aft er t h e v acci n e i nj ecti o n

- Vitili g o, a s ki n c o n diti o n t h at c a us es t h e p atc hy l oss of s ki n c ol or h as b e e n s e e n i n p ati e nts w h o h a d m el a n o m a.  
- N or m al f u ncti o n of t h e t esticl es m ay b e aff ect e d i n m e n.  
- T h e v acci n e m ay c a us e t h e d ev el o p m e nt of a c o n diti o n i n w hic h t h e b o d y r ec o g niz es its o w n tiss u es as f or ei g n a n d dir ects a n i m m u n e r es p o ns e a g ai nst t h e m.  
- It is p ossi bl e t h at t h e v acci n e m ay sti m ul at e t h e gr o wt h of y o ur t u m ors t h us m a ki n g y o ur c a nc er w ors e.

I n 1 0 0 p e o pl e r ec ei vi n g I mi q ui m o d, 1 or f e w er m ay h av e:  
- N o s eri o us e v e nts r e p ort e d.  
T h e a b ov e si d e eff ects w er e r ec or d e d i n p ati e nts u n d er g oi n g a st a n d ar d Al d ar a t h er a py, w hic h i n m ost c as es c o nsists of 5 a p plic ati o ns p er w e e k, f or a t ot al of 6 w e e ks. I nst e a d, i n t his st u d y y o u will b e gi v e n Al d ar a cr e a m o nl y o nc e aft er e ac h v acci n e i nj ecti o n, f or a t ot al of t hr e e ( 3) a p plic ati o ns, o n e  
( 1) w e e k a p art. Si nc e y o u will r ec eiv e o nl y 1 0 % of t h e st a n d ar d d os e, t h e pr o b a bilit y of a n y si d e eff ect fr o m Al d ar a is v er y l o w, b ut still p ossi bl e.

I n 1 0 0 p e o pl e r ec ei vi n g I mi q ui m o d, m or e t h a n 2 0 m ay h av e:  
- Itc hi n g  
- s w elli n g  
- b ur ni n g  
- s ki n t h at b ec o m es h ar d or t hic k e n e d  
- r e d n ess  
- fl a ki n g a n d sc ali n g - s or es, blist ers, or ulc ers  
- dr y n ess  
- c h a n g es i n s ki n c ol or t h at d o n ot al w a ys g o a w a y  
- sc a b bi n g a n d cr usti n g

I n 1 0 0 p e o pl e r ec ei vi n g I mi q ui m o d, fr o m 4 t o 2 0 m ay h av e:  
- Fl u -li k e sy m pt o ms: tir e d n ess, f ev er, n a us e a, m uscl e p ai n a n d c hills.

- Vitili g o, a s ki n c o n diti o n t h at c a us es t h e p atc hy l oss of s ki n c ol or h as b e e n s e e n i n p ati e nts w h o h a d m el a n o m a.  
- N or m al f u ncti o n of t h e t esticl es m ay b e aff ect e d i n m e n.  
- T h e v acci n e m ay c a us e t h e d ev el o p m e nt of a c o n diti o n i n w hic h t h e b o d y r ec o g niz es its o w n tiss u es as f or ei g n a n d dir ects a n i m m u n e r es p o ns e a g ai nst t h e m.  
- It is p ossi bl e t h at t h e v acci n e m ay sti m ul at e t h e gr o wt h of y o ur t u m ors t h us m a ki n g y o ur c a nc er w ors e.

I n 1 0 0 p e o pl e r ec ei vi n g I mi q ui m o d, 1 or f e w er m ay h av e:  
- N o s eri o us e v e nts r e p ort e d.  
T h e a b ov e si d e eff ects w er e r ec or d e d i n p ati e nts u n d er g oi n g a st a n d ar d Al d ar a t h er a py, w hic h i n m ost c as es c o nsists of 5 a p plic ati o ns p er w e e k, f or a t ot al of 6 w e e ks. I nst e a d, i n t his st u d y y o u will b e gi v e n Al d ar a cr e a m o nl y o nc e aft er e ac h v acci n e i nj ecti o n, f or a t ot al of t hr e e ( 3) a p plic ati o ns, o n e  
( 1) w e e k a p art. Si nc e y o u will r ec eiv e o nl y 1 0 % of t h e st a n d ar d d os e, t h e pr o b a bilit y of a n y si d e eff ect fr o m Al d ar a is v er y l o w, b ut still p ossi bl e.

- N a us e a, v o miti n g  
- Di arr h e a  
- F e eli n g w e a k  
- C o nf usi o n  
- S h ort n ess of br e at h  
- R as h or dr y, itc hy s ki n  
- L o w uri n e o ut p ut  
- A b n or m al bl o o d t ests w hic h s u g g est t h at t h e dr u g is aff ecti n g t h e li v er or ki d n eys O C C A SI O N AL, S O M E M AY B E S E RI O U S  
- F e eli n g dizzy  
- F e eli n g dr o wsy  
- S or es i n t h e m o ut h or o n t h e li ps  
- L oss of a p p etit e  
- A b d o mi n al (st o m ac h ar e a) p ai n  
- I ncr e as e d h e art r at e or c h a n g e i n h e art r hyt h m  
- S w elli n g i n t h e f ac e, h a n ds, or f e et  
- Tr o u bl e sl e e pi n g  
- Tr o u bl e c o nc e ntr ati n g  
- R u n ny n os e  
- L o w pl at el et c o u nt wit h i ncr e as e d ris k of bl e e di n g  
- L o w r e d bl o o d c ell c o u nt ( a n e mi a) wit h sy m pt o ms li k e tir e d n ess, w e a k n ess, s h ort n ess of br e at h  
| -   | L o w w hit e bl o o d c ell c o u nt wit h i ncr e as e d ris k of i nf ecti o n   |
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R A R E A N D S E RI O U S  
| -   | All er gic r e acti o n                                           |
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| -   | D a m a g e t o b o w el, r u pt ur e d or bl e e di n g b o w el |
| -   | S eri o us i nf ecti o n                                          |
| -   | Ki d n ey f ail ur e                                              |  
It is p ossi bl e t h at t h e c o m bi n ati o n of t h e dr u gs will i ncr e as e t h e n u m b er or s ev erity of si d e eff ects or c a us e diff er e nt si d e eff ects t h a n t h e o n es m e nti o n e d f or eit h er dr u g al o n e.

- Ris k/si d e -eff ects of i ntr av e n o us (i n t h e v ei n) i nj ecti o n/i nf usi o n:  
T h er e m ay b e s w elli n g or s or e n ess at t h e ar e a of t h e i nj ecti o n. It is p ossi bl e t h at l oc al br uisi n g m ay d ev el o p at t h e pl ac e w h er e t h e st u d y dr u g is gi v e n, a n d t h er e is a r ar e ris k of i nf ecti o n at t h at l oc ati o n.  
- V e ni p u nct ur e ( bl o o d dr a w):  
T h e ris ks a n d disc o mf orts ass oci at e d wit h h avi n g y o ur bl o o d dr a w n ar e p ai n at t h e sit e, bl e e di n g, i nf ecti o n, br uisi n g, p ossi bl e f ai nti n g a n d a dr o p i n bl o o d pr ess ur e.  
- I nj ecti o n: Ris ks fr o m a n i nj ecti o n i ncl u d e p ai n at t h e sit e of t h e i nj ecti o n; bl e e di n g; br uisi n g; s or e n ess; s w elli n g; r e d n ess ar o u n d t h e C e ntr al Li n e or C at h et er (if us e d t o c oll ect bl o o d c ells t o pr e p ar e v acci n e).  
- C at h et er pl ac e m e nt if n e e d e d f or l e u k a p h er esis: O n e ris k of t h e c at h et er (s m all t u b e)  
b ei n g pl ac e d i n a v ei n i n y o ur c h est is t h e c oll a ps e of t h e l u n g. If t his s h o ul d h a p p e n, a n ot h er s p eci al t u b e w o ul d h av e t o b e pl ac e d i nt o t h e c h est f or s ev er al d ays t o r e - ex p a n d t h e l u n g. T h er e is als o a c h a nc e t h at i nf ecti o n will d ev el o p at t his sit e, w hic h w o ul d r e q uir e t h e t u b e b e r e m ov e d a n d r e pl ac e d a n d p ossi bl e tr e at m e nt wit h a nti bi otics. S uc h a n i nf ecti o n c a n c a us e ot h er si d e eff ects l e a di n g t o l o n g er h os pit aliz ati o n; h o w ev er, wit h t h e us e of or al a nti bi otics, us e d t o pr ev e nt t h es e ki n ds of pr o bl e ms, t h e c h a nc e of i nf ecti o n is u nc o m m o n. T h er e is a ris k of air i n y o ur c h est d u e t o a p u nct ur e d l u n g. Bl e e di n g i n t h e c h est a n d i nt o a n d u n d er t h e s ki n is p ossi bl e. It is p ossi bl e y o u will h av e s o m e p ai n or disc o mf ort w h e n t h e c e ntr al li n e is pl ac e d.  
L et y o ur st u d y d oct or k n o w of a ny q u esti o ns y o u h av e a b o ut p ossi bl e si d e eff ects. Y o u c a n as k t h e st u d y d oct or q u esti o ns a b o ut si d e eff ects at a ny ti m e.  
As wit h a ny r es e arc h st u dy, t h er e m ay b e a d diti o n al risks t h at ar e u nk n o w n or u n ex p ect e d. If t h es e b ec o m e k n o w n, t h e st u dy t e a m will n otify y o u i n a ti m ely m a n n er of a ny c h a n g es t h at m ay c h a n g e y o ur willi n g n ess t o p artici p at e. If n e w i nf or m ati o n is pr ovi d e d t o y o u aft er y o u h av e j oi n e d t h e st u dy, it is p ossi bl e t h at y o u m ay b e ask e d t o si g n a n e w c o ns e nt f or m t h at i ncl u d es t h e n e w i nf or m ati o n. Pl e as e t ell t h e r es e arc h ers i n t h e c o nt act s ecti o n a b o ut a ny i nj uri es, si d e eff ects, or ot h er pr o bl e ms t h at y o u h av e d uri n g t his st u dy. Y o u s h o ul d als o t ell y o ur r e g ul ar d oct ors.

B ec a us e t his v acci n e is i nv esti g ati o n al, all its si d e eff ects m ay n ot b e k n o w n. T h er e m ay b e r ar e or u nk n o w n si d e eff ects t h at c o ul d p ossi bly occ ur, i ncl u di n g lif e -t hr e at e ni n g r e acti o ns.

B ec a us e t h e dr u gs i n t his st u d y c a n aff ect a n u n b or n b a by, y o u s h o ul d n ot b ec o m e pr e g n a nt or f ath er a b a by w hil e o n t his st u d y. W o m e n s h o ul d n ot br e astf e e d a b a by w hil e o n t his st u d y.  
Eit h er a f e m al e or a m al e wis hi n g t o b e i n t his st u d y m ust b e usi n g o n e or m or e t y p es of birt h c o ntr ol d uri n g t h e e ntir e st u d y a n d f or 6 m o nt hs aft er c o m pl eti n g t h e st u d y. Birt h c o ntr ol m et h o ds m ay i ncl u d e c o n d o ms, di a p hr a g m, birt h c o ntr ol pills, s p er mici d al g els or f o a ms, i nj ecti o ns, i ntr a ut eri n e d evic es (I U D), s ur gic al st eriliz ati o n, or s u bc ut a n e o us i m pl a nts. A n ot h er c h oic e is f or y o ur s ex u al p art n er t o us e o n e of t h es e birt h c o ntr ol m et h o ds.  
If y o u f e el y o u h av e ex p eri e nc e d a si d e eff ect or a n u n us u al sy m pt o m t o t h e st u d y dr u g or a ny pr oc e d ur es d uri n g t his st u d y, y o u s h o ul d c all t h e st u d y d oct or a n d t h e r es e arc h st aff at t h e p h o n e n u m b ers list e d o n p a g e o n e of t his c o ns e nt f or m.

If y o u ar e a w o m a n w h o c a n b ec o m e pr e g n a nt, y o u m ust h av e a n e g ati v e pr e g n a ncy t est b ef or e y o u st art t h e st u d y. If y o u ar e a n ursi n g m ot h er a n d wis h t o b e i n t his st u d y, y o u m ust st o p br e astf e e di n g. Y o u c a n n ot b e i n t h e st u d y if y o u ar e pr e g n a nt or br e astf e e di n g. E v e n if y o u us e a m e dic ally acc e pt a bl e birt h c o ntr ol m et h o d, y o u c o ul d still b ec o m e pr e g n a nt. N ot h a vi n g s ex  
( a bsti n e nc e) is t h e o nl y c ert ai n w a y t o pr e v e nt pr e g n a ncy. If y o u b ec o m e pr e g n a nt d uri n g t h e st u d y, st o p t a ki n g t h e st u d y dr u gs a n d c all t h e st u d y d oct or.  
If y o u ar e pr e g n a nt or b ec o m e pr e g n a nt d uri n g t h e st u d y, t h e st u d y dr u g or pr oc e d ur es m a y i n v ol v e ris ks t o t h e u n b or n b a b y, w hic h ar e c urr e ntl y unf or es e e a bl e. T h e eff ects of t h e st u dy dr u g o n a n u n b or n b a by or br e astf e d b a by ar e u nk n o w n. If y o u b ec o m e pr e g n a nt w hil e o n t his st u d y, y o u will n o l o n g er b e eli gi bl e t o b e i n t h e st u d y a n d y o ur st u d y dr u gs will b e st o p p e d.
Clinical trial: NCT02224599
Section: Procedures
Subsections: W H At E Xtr A T Est A N D Pr Oc E D Ur Es Will I H A V E If I T A K E P Art I N T H E St U D Y ?

M a ny of t h e ex a ms, t ests, a n d pr oc e d ur es y o u will h av e ar e p art of t h e us u al a p pr o ac h f or y o ur c a nc er. H o w ev er, t h er e ar e s o m e extr a t ests a n d/ or pr oc e d ur es t h at y o u will n e e d t o h av e if y o u t a k e p art i n t his st u d y.
Clinical trial: NCT02224599
Section: Voluntary Participation
Subsections: I Nf Or M E D C O Ns E Nt F Or P Artici P Ati O N I N R Es E Arc H P Artici P A Nt'S N A M E: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ S U Bj Ect I D N U M B Er: _ _ _ _ _ _ _ _ _ _ _ _ _ _|If I T A K E P Art I N T His St U D Y, C A N I Als O P Artici P At E I N Ot H Er St U Di Es ?

Offici al St u d y Titl e: Pr ot oc ol Kir o V ax 0 0 3; P h as e I/II St u d y of L o w-D os e C ycl o p h os p h a mi d e, T u m or Ass oci at e d P e pti d e A nti g e n -P uls e d D e n dritic C ell T h er a p y a n d I mi q ui m o d, i n P ati e nts wit h Pr o gr essi v e a n d/ or R efr act or y S oli d M ali g n a nci es

B ei n g i n m or e t h a n o n e r es e arc h st u d y at t h e s a m e ti m e, or e v e n at diff er e nt ti m es, m a y i ncr e as e t h e ris ks t o y o u. It m ay als o aff ect t h e r es ults of t h e st u di es. Y o u s h o ul d n ot t a k e p art i n m or e t h a n o n e st u d y wit h o ut a p pr o v al fr o m t h e r es e arc h ers i n v ol v e d i n e ac h st u d y.
Clinical trial: NCT02224599
Section: Withdrawal from Study
Subsections: If I W A Nt T O St O P P Artici P Ati N G I N T H E St U D Y, W H At S H O Ul D I D O ?|C O Ul D T H E R Es E Arc H Ers T A K E M E O Ut Of T H E St U D Y E V E N If I W A Nt T O C O Nti N U E T O P Artici P At E ?

If y o u wis h t o st o p y o ur p artici p ati o n i n t his r es e arc h st u dy f or a ny r e as o n y o u s h o ul d l et t h e pri nci p al i nv esti g at or/st u dy c o or di n at or k n o w as s o o n as p ossi bl e s o t h at y o u c a n st o p s af ely . Y o u m a y b e as k e d w h y y o u ar e l e a vi n g t h e st u d y a n d y o ur r e as o ns f or l e a vi n g m a y b e k e pt as p ar t of t h e st u d y r ec or d. If y o u d eci d e t o l e a v e t h e st u d y b ef or e it is fi nis h e d, pl e as e t ell o n e of t h e p ers o ns list e d i n " C o nt act I nf or m ati o n".  
If y o u st o p y o ur p artici p ati o n i n t his st u d y, y o u c a n d eci d e w h et h er t o l et t h e st u d y d oct or c o nti n u e t o pr ovi d e y o ur m e dic al i nf or m ati o n t o t h e or g a niz ati o n r u n ni n g t h e st u d y.  
It is i m p ort a nt f or y o u t o t ell t h e st u d y d oct or if y o u ar e t hi n ki n g a b o ut st o p pi n g s o h e/s h e c a n ev al u at e a ny ris ks fr o m t h e st u d y dr u g. A n ot h er r e as o n t o t ell y o ur o w n d oct or t h at y o u ar e t hi n ki n g a b o ut st o p pi n g is t o disc uss w h at f oll o w-u p c ar e a n d t esti n g c o ul d b e m ost h el pf ul f or y o u.  
If y o u l e av e t h e st u d y, y o ur ri g ht t o st a n d ar d m e dic al c ar e will c o nti n u e.  
If y o u l e av e t h e st u d y, w e c a n n ot r e m ov e a ny i nf or m ati o n w e h av e c oll ect e d t o t h at p oi nt.

U n d er c ert ai n circ u mst a nc es, y o ur st u d y d oct or m ay d eci d e t o t a k e y o u o ut of t h e st u d y. T his mi g ht h a p p e n b ec a us e:  
- Y o ur h e alt h c h a n g es a n d t h e st u d y ar e n o l o n g er i n y o ur b est i nt er est.  
- Y o ur dis e as e g ets w ors e d es pit e t h e c a nc er v acci n e;  
- T h e si d e eff ects of t h e c a nc er v acci n e ar e t o o d a n g er o us f or y o u;  
- N e w i nf or m ati o n a b o ut t h e c a nc er v acci n e b ec o m es av ail a bl e a n d t his i nf or m ati o n s u g g ests t h e c a nc er v acci n e will b e i n eff ecti v e or u ns af e f or y o u;  
- It is u nli k el y, b ut t h e st u d y m ay b e st o p p e d e arl y d u e t o l ac k of v acci n e s u p pl y or l ac k of f u n di n g. S h o ul d t h e st u d y b e st o p p e d e arly f or a ny r e as o n, y o u will c o nti n u e t o b e tr e at e d f or y o ur c a nc er. Y o ur o w n d oct or will disc uss all tr e at m e nt o pti o ns wit h y o u at t h at ti m e .  
Y o ur p art i n t his st u dy m ay b e st o p p e d at a ny ti m e wit h o ut y o ur p er missi o n. T h e f oll o wi n g p e o pl e c a n st o p y o ur p artici p ati o n a n d/ or t h e st u dy its elf:  
- St u d y D oct or  
- S p o ns or C o m p a ny  
- I R B  
- T h e U nit e d St at es F o o d a n d Dr u g A d mi nistr ati o n ( F D A)  
- Ot h er St at e a n d F e d er al R e g ul at or y A g e nci es If y o u wit h dr a w fr o m t h e st u d y, n o n e w d at a a b o ut y o u will b e c oll ect e d f or st u d y p ur p os es. All d at a t h at h av e alr e a d y b e e n c oll ect e d f or st u d y p ur p os es will b e s h ar e d wit h t h e st u d y s p o ns or.  
W h at h a p p e ns if I g et h urt, m y c o n diti o n w ors e ns, or h a v e ot h er pr o bl e ms b ec a us e of t his r es e arc h ?  
If y o u ar e i nj ur e d as a dir ect r es ult of t his st u d y, m e dic al c ar e is a v ail a bl e. I n g e n er al, n o l o n gt er m m e dic al c ar e or fi n a nci al c o m p e ns ati o n f or r es e arc h-r el at e d i nj uri es will b e pr o vi d e d b y [ Sit e N a m e] . Y o u d o n ot w ai v e ( gi v e u p) a n y l e g al ri g hts b y si g ni n g t his i nf or m e d c o ns e nt f or m.  
Kir o mic , I nc a n d its affili at es d o n ot off er t o p ay f or or c ov er t h e c ost of m e dic al tr e at m e nt f or r es e arc h r el at e d ill n ess or i nj ur y. N o f u n ds h av e b e e n s et asi d e t o p ay or r ei m b urs e y o u i n t h e ev e nt of s uc h i nj ur y or ill n ess u nl ess s p ecific ally st at e d.  
If y o u h av e a r es e arc h r el at e d ill n ess or i nj ur y, c ar e will b e av ail a bl e t o y o u as us u al, b ut y o u a n d/ or y o ur m e dic al or h os pit al i ns ur a nc e c o m p a ny will b e bill e d f or t h e c ost of tr e at m e nt. Y o ur i ns ur a nc e c o m p a ny m ay n ot b e willi n g t o p ay f or st u d y-r el at e d i nj ur y. If y o u h av e n o i ns ur a nc e c ov er a g e, y o u w o ul d b e bill e d f or a ny c osts. B ef or e e nt eri n g t his st u d y, y o u s h o ul d c h ec k w h et h er y o ur i ns ur a nc e c o m p a ny mi g ht li mit y o ur i ns ur a nc e c ov er a g e if y o u t a k e p art i n a r es e arc h st u d y.  
W h at i nf or m ati o n a b o ut m e c o ul d b e s e e n b y t h e r es e arc h ers or b y ot h er p e o pl e ? W h y ?  
W h o mi g ht s e e it ? H o w will it b e pr ot ect e d ?  
R el e as e of H e alt h I nf or m ati o n - If y o u d eci d e t o p artici p at e i n t his st u d y, i nf or m ati o n a b o ut y o ur h e alt h m a y b e us e d or discl os e d (s h ar e d o utsi d e of t h e H os pit al) f or t h e p ur p os es of c o n d ucti n g t his st u d y. T his i nf or m ati o n m ay i ncl u d e i nf or m ati o n fr o m y o ur m e dic al r ec or d t h at is r el e v a nt t o t his st u d y, s uc h as y o ur m e dic al hist or y, m e dic ati o ns, t est r es ults, di a g n os es, tr e at m e nts, o p er ati v e r e p orts ( r e p orts fr o m o p er ati o ns t h at y o u h a v e u n d er g o n e), a n d disc h ar g e s u m m ari es.  
It m a y als o i ncl u d e i nf or m ati o n r el ati n g t o: H u m a n I m m u n o d efici e ncy Vir us (" HI V") i nf ecti o n or Ac q uir e d I m m u n o d efici e ncy Sy n dr o m e (" AI D S"); tr e at m e nt f or or hist ory of dr u g or alc o h ol a b us e; or m e nt al or b e h avi or al h e alt h or psyc hi atric c ar e. I nf or m ati o n c oll ect e d b y t h e st u d y d oct or a n d/ or r es e arc h st aff s p ecific all y f or t his st u d y, s uc h as t est r es ults, bl o o d s a m pl es, p h ysic al ex a mi n ati o ns, i nf or m ati o n a b o ut p ossi bl e si d e eff ects, a n d s ur v e ys y o u mi g ht b e as k e d t o c o m pl et e c o ul d als o b e us e d or discl os e d.  
I n di vi d u als t h at m a y us e or r el e as e t his i nf or m ati o n i ncl u d e: p h ysici a ns, p h ysici a ns' offic e st aff, h os pit al st aff, t h e st u d y d oct or, a n d a ut h oriz e d m e m b ers of t h e st u d y d oct or's r es e arc h st aff.  
T h es e i n di vi d u als m a y r el e as e t his i nf or m ati o n t o t h e st u d y d oct or, a ut h oriz e d m e m b ers of t h e st u d y d oct or's st aff, t h e f u n di n g a g e nc y of t h e st u d y Kir o mic, I nc as w ell as its a g e nts or c o ntr act ors, ot h er r es e arc h ers, t h e I nstit uti o n al R e vi e w B o ar d (I R B), t h e U nit e d St at es F o o d a n d Dr u g A d mi nistr ati o n ( F D A) a n d its r e pr es e nt ati v es, a n d ot h er g o v er n m e nt a g e nci es.  
I n m ost c as es, t h e i nf or m ati o n r el e as e d t o t h e a b o v e list e d i n di vi d u als or e ntiti es will n ot c o nt ai n y o ur n a m e, s oci al s ec urit y n u m b er, or a n y ot h er p ers o n al i nf or m ati o n. H o w e v er, a ut h oriz e d r e pr es e nt ativ es of y o ur st u d y d oct or, I R B, F D A, or ot h er g o v er n m e nt a g e nci es m a y r e vi e w r ec or ds c o nt ai ni n g p ers o n al i nf or m ati o n t o m a k e s ur e t h at t h e st u d y i nf or m ati o n is c orr ect.  
B e c a us e of t h e n e e d t o pr o vi d e i nf or m ati o n t o t h es e p arti es, a bs ol ut e c o nfi d e nti ality c a n n ot b e g u ar a nt e e d.  
Us e of I nf or m ati o n - T his i nf or m ati o n m ay b e us e d t o d et er mi n e w h et h er y o u m e et all r e q uir e m e nts f or p artici p ati o n i n t h e st u d y, t o m o nit or y o ur h e alt hc ar e d uri n g t h e st u d y, t o e n a bl e t h e s p o ns or t o a ns w er t h e sci e ntific q u esti o ns f or w hic h t h e st u d y w as d esi g n e d, a n d t o e ns ur e t h at t h e st u d y h as b e e n d o n e pr o p erl y. Ex a m pl es of t h e us e of t his i nf or m ati o n ar e as f oll o ws: t h e s p o ns or m a y us e t h e i nf or m ati o n i n s u b missi o ns t o g o v er n m e nt a g e nci es t hr o u g h o ut t h e w orl d, t o r e q u est a p pr o v al of t h e st u d y dr u g or d e vic e; t h e s p o ns or m a y us e t h e i nf or m ati o n f or r e p orti n g a d v ers e e v e nts t o g o v er n m e nt a g e nci es, s uc h as t h e F D A; t h e s p o ns or m a y als o tr a nsf er t h e i nf or m ati o n t o b usi n ess p art n ers or c o m p a ni es it hir es t o pr ovi d e st u d y -  
r el at e d s er vic es; t h e s p o ns or m a y als o pr o vi d e o v er all st u d y r es ults, i ncl u di n g y o ur i nf or m ati o n, t o ot h er st u d y d oct ors; a n d t h e s p o ns or m a y r e a n al yz e t h e d at a fr o m t his st u d y i n t h e f ut ur e or c o m bi n e it wit h d at a fr o m ot h er st u di es f or a n al ysis. I n a d diti o n, b ot h t h e s p o ns or a n d t h e st u d y d oct or m a y us e t h e i nf or m ati o n t o pr e p ar e r e p orts or p u blic ati o ns of t h e st u d y r es ults. H o w e v er, w h e n r es ults of t h e r es e arc h st u d y ar e r e p ort e d i n m e dic al j o ur n als or at sci e ntific m e eti n gs, t h e p e o pl e w h o w er e i n t h e st u d y ar e n ot n a m e d a n d i d e ntifi e d. T h er ef or e, y o ur n a m es w o ul d n ot b e discl os e d i n a n y pr es e nt ati o n or p u blic ati o n.  
Y o u n e e d t o u n d erst a n d t h at o nc e y o ur i nf or m ati o n h as b e e n r el e as e d, it m a y n o l o n g er b e pr ot ect e d by U S f e d er al r e g ul ati o ns r el ati n g t o d at a pri v acy a n d c o ul d b e us e d or r e -discl os e d i n w a ys ot h er t h a n t h os e list e d i n t his s ecti o n of t h e c o ns e nt f or m.  
Y o u h a v e t h e ri g ht t o s e e a n d c o p y y o ur m e dic al r ec or ds b ut i nf or m ati o n r el ati n g t o t his st u d y m a y b e wit h h el d u ntil t h e e n d of t his st u d y.  
W h at h a p p e ns t o i nf or m ati o n a b o ut m e aft er t h e st u d y is o v er or if I c a nc el m y p er missi o n ? If y o u st o p p artici p ati n g i n t his st u d y, y o u als o h a v e t h e ri g ht t o r e v o k e ( wit h dr a w) y o ur a ut h oriz ati o n t o discl os e a n d us e y o ur i nf or m ati o n. R e v o ki n g y o ur a ut h oriz ati o n m e a ns t a ki n g b ac k t h e p er missi o n y o u g a v e t h e st u d y d oct or t o s e n d i nf or m ati o n a b o ut y o u t o t h e s p o ns or or ot h er p e o pl e a n d e ntiti es. If y o u r ev o k e y o ur a ut h oriz ati o n, y o ur d oct or will n ot us e or r el e as e a n y m or e i nf or m ati o n a b o ut y o u aft er r ec ei vi n g y o ur r e q u est, exc e pt t o t ell t h e s p o ns or t h at y o u h a v e st o p p e d e arl y a n d h a v e r e v o k e d y o ur a ut h oriz ati o n. H o w e v er, t h e s p o ns or a n d t h e st u d y d oct or c a n k e e p a n d us e a n y i nf or m ati o n t h at it h as alr e a d y r ec ei v e d t o t h e ext e nt n ec ess ary t o pr es er v e t h e i nt e grity of t h e r es e arc h st u d y. T o r e v o k e t his a ut h oriz ati o n, c o nt act t h e r es e arc h t e a m. T h e r es e arc h t e a m will acc e pt eit h er a writt e n or v er b al r e q u est.  
Y o ur bl o o d/tiss u e s a m pl es a n d/ or cli nic al d at a m a y b e st or e d a n d s h ar e d f or f ut ur e r es e arc h wit h o ut a d diti o n al i nf or m e d c o ns e nt if i d e ntifi a bl e pri v at e i nf or m ati o n, s uc h as y o ur n a m e a n d m e dic al r ec or d n u m b er, ar e r e m o v e d. If y o ur i d e ntif yi n g i nf or m ati o n is r e m o v e d fr o m y o ur s a m pl es or d at a, w e will n o l o n g er b e a bl e t o i d e ntif y a n d d estr o y t h e m. T h e us e of y o ur s a m pl es m a y r es ult i n c o m m erci al pr ofit. Y o u will n ot b e c o m p e ns at e d f or t h e us e of y o ur s a m pl es ot h er t h a n w h at is d escri b e d i n t his c o ns e nt f or m. ( m a y b e r e m o v e d if n o s p eci m e ns ar e c oll ect e d)