2nd thoughts about TIL – hmm

Forums General Melanoma Community 2nd thoughts about TIL – hmm

  • Post
    arthurjedi007
    Participant

      I'm having a lot of 2nd thoughts about TIL. It looks like if I do that treatment it excludes me from the Nivo/AntiLag3 trial. That trial seems to have the purpose of helping folks that have progressed while on pd1. I'm not sure how successful they are having but I'm traveling to Chicago to see the doc next Tuesday about it. It's the typical no slot available now but will be opening thing. I'm also not sure if I'm strong enough to make it through the TIL treatment if I go that route. I've been hearing a lot about TIL and you have to be physically strong which I'm not sure if I am. If I'm not strong enough I could end up depleted or worse. So I dunno. Just rambling to folks I know get it because you've been through so much too.

      Artie

    Viewing 11 reply threads
    • Replies
        RJoeyB
        Participant
          Hi Artie, you have very valid thoughts and concerns.  Let me start by saying that I don't know if what I'll write will persuade or dissuade you and my goal is to do neither, other than to perhaps give you more information about what's best for you.
           
          First, as far as TIL making you ineligible for the nivolumab/anti-LAG3 trial, I can't add much here as I don't know the details of the eligibility criteria for that trial (or frankly, much about anti-LAG3 at all).  But as you note, there aren't currently any slots available, and it's possible that a future trial could be started without the same criteria, perhaps before a slot opens on this one.  You probably know as well as any of us that navigating the timing and elgibility criteria of clinical trials is such a huge challenge without right or wrong answers.  Just to be sure, though, what exactly do the trial criteria say about TIL?  I only ask because many trial documents I've seen have been pretty clear about prior Yervoy, BRAF, etc., but when it comes to TIL and ACT, they're kind of vague.
           
          As far as being strong enough for TIL, I understand.  My opinion about the TIL treatment protocol is admittedly skewed because I was otherwise healthy going in, had relatively low tumor burden, and, all things considered, it went as well as it could have (knowing the possible complications).  In the year before my diagnosis, I had been working out every day, lost 70 pounds, managed my blood pressure, etc. — looking to the left at my heart health and then, bam, took a right hook with Stage IV melanoma.  But I have to believe it helped me get through IL-2 and TIL.  
           
          As I see it, there are two tough things about TIL:  the preparatory chemotherapy regimen, and the course of IL-2.  The chemo is 2 days of cyclophosphamide followed by 5 days of fludarabine.  I found it to not be as difficult physically as I expected.  Mentally, I was freaked out by just the idea of chemo, but I only had a little nausea during the cyclophosphamide.  To protect your bladder, they also wake you every 2 hours to go to the bathroom and are pumping you full of Lasix to make that happen, but in the grand scheme, it was an inconvenience.  And of course, my hair fell out, but again, inconsequential.  During the five days of fludarabine, I was even able to go out on pass for a few days after the daily infusion and we did touristy DC stuff.  However, the bigger consideration is what the chemotherapy is doing that you don't see or feel, i.e. wiping your immune system out, causing extreme neutropenia, taking that white blood cell count to zero.  The TIL cells themselves, the round of IL-2, the GM-CSF shots, etc. are all meant to help reconstitute the immune system, but if your tumor burden is high and you're not feeling strong, then I don't know.  I know that they wouldn't allow you to participate if they didn't think you were strong enough.
           
          The other tough thing is IL-2.  I've written elsewhere that it is probably the toughest thing I've ever done, melanoma or otherwise, but in hindsight, I would do it again if there was a chance it could help me.  They monitor and manage the dosing very closely and recovery was quick, with rapid improvement in the hours and days following the last dose, with the only lasting side effect for me being fatigue for a couple of weeks.  Again, I was otherwise healthy going in — by that point I was about three months removed from having my shoulder replaced — and still had low tumor burden, plus I had prior experience withe two rounds of IL-2 six months earlier.
           
          I don't know if they are still ongoing, but at one point, NIH had trials of two different variants of the protocol:  one looking at reducing the chemo in the preparatory regimen, and the other looking at not using IL-2 after the TIL infusion for patients who might not tolerate it well.  You might want to inquire about these.  As I said, I don't think they're going to enroll you in a trial that they think you aren't strong enough to endure, but it's completely valid for you to question it.  I don't know how much I'm helping, but my suggestion would be to perhaps let it play out and go through with the evaluation process.  It's not an easy decision, I know.  Please don't hesitate to ask if you have any other questions; continuing to keep you in my prayers.
           
          Best,
          Joe
          RJoeyB
          Participant
            Hi Artie, you have very valid thoughts and concerns.  Let me start by saying that I don't know if what I'll write will persuade or dissuade you and my goal is to do neither, other than to perhaps give you more information about what's best for you.
             
            First, as far as TIL making you ineligible for the nivolumab/anti-LAG3 trial, I can't add much here as I don't know the details of the eligibility criteria for that trial (or frankly, much about anti-LAG3 at all).  But as you note, there aren't currently any slots available, and it's possible that a future trial could be started without the same criteria, perhaps before a slot opens on this one.  You probably know as well as any of us that navigating the timing and elgibility criteria of clinical trials is such a huge challenge without right or wrong answers.  Just to be sure, though, what exactly do the trial criteria say about TIL?  I only ask because many trial documents I've seen have been pretty clear about prior Yervoy, BRAF, etc., but when it comes to TIL and ACT, they're kind of vague.
             
            As far as being strong enough for TIL, I understand.  My opinion about the TIL treatment protocol is admittedly skewed because I was otherwise healthy going in, had relatively low tumor burden, and, all things considered, it went as well as it could have (knowing the possible complications).  In the year before my diagnosis, I had been working out every day, lost 70 pounds, managed my blood pressure, etc. — looking to the left at my heart health and then, bam, took a right hook with Stage IV melanoma.  But I have to believe it helped me get through IL-2 and TIL.  
             
            As I see it, there are two tough things about TIL:  the preparatory chemotherapy regimen, and the course of IL-2.  The chemo is 2 days of cyclophosphamide followed by 5 days of fludarabine.  I found it to not be as difficult physically as I expected.  Mentally, I was freaked out by just the idea of chemo, but I only had a little nausea during the cyclophosphamide.  To protect your bladder, they also wake you every 2 hours to go to the bathroom and are pumping you full of Lasix to make that happen, but in the grand scheme, it was an inconvenience.  And of course, my hair fell out, but again, inconsequential.  During the five days of fludarabine, I was even able to go out on pass for a few days after the daily infusion and we did touristy DC stuff.  However, the bigger consideration is what the chemotherapy is doing that you don't see or feel, i.e. wiping your immune system out, causing extreme neutropenia, taking that white blood cell count to zero.  The TIL cells themselves, the round of IL-2, the GM-CSF shots, etc. are all meant to help reconstitute the immune system, but if your tumor burden is high and you're not feeling strong, then I don't know.  I know that they wouldn't allow you to participate if they didn't think you were strong enough.
             
            The other tough thing is IL-2.  I've written elsewhere that it is probably the toughest thing I've ever done, melanoma or otherwise, but in hindsight, I would do it again if there was a chance it could help me.  They monitor and manage the dosing very closely and recovery was quick, with rapid improvement in the hours and days following the last dose, with the only lasting side effect for me being fatigue for a couple of weeks.  Again, I was otherwise healthy going in — by that point I was about three months removed from having my shoulder replaced — and still had low tumor burden, plus I had prior experience withe two rounds of IL-2 six months earlier.
             
            I don't know if they are still ongoing, but at one point, NIH had trials of two different variants of the protocol:  one looking at reducing the chemo in the preparatory regimen, and the other looking at not using IL-2 after the TIL infusion for patients who might not tolerate it well.  You might want to inquire about these.  As I said, I don't think they're going to enroll you in a trial that they think you aren't strong enough to endure, but it's completely valid for you to question it.  I don't know how much I'm helping, but my suggestion would be to perhaps let it play out and go through with the evaluation process.  It's not an easy decision, I know.  Please don't hesitate to ask if you have any other questions; continuing to keep you in my prayers.
             
            Best,
            Joe
            RJoeyB
            Participant
              Hi Artie, you have very valid thoughts and concerns.  Let me start by saying that I don't know if what I'll write will persuade or dissuade you and my goal is to do neither, other than to perhaps give you more information about what's best for you.
               
              First, as far as TIL making you ineligible for the nivolumab/anti-LAG3 trial, I can't add much here as I don't know the details of the eligibility criteria for that trial (or frankly, much about anti-LAG3 at all).  But as you note, there aren't currently any slots available, and it's possible that a future trial could be started without the same criteria, perhaps before a slot opens on this one.  You probably know as well as any of us that navigating the timing and elgibility criteria of clinical trials is such a huge challenge without right or wrong answers.  Just to be sure, though, what exactly do the trial criteria say about TIL?  I only ask because many trial documents I've seen have been pretty clear about prior Yervoy, BRAF, etc., but when it comes to TIL and ACT, they're kind of vague.
               
              As far as being strong enough for TIL, I understand.  My opinion about the TIL treatment protocol is admittedly skewed because I was otherwise healthy going in, had relatively low tumor burden, and, all things considered, it went as well as it could have (knowing the possible complications).  In the year before my diagnosis, I had been working out every day, lost 70 pounds, managed my blood pressure, etc. — looking to the left at my heart health and then, bam, took a right hook with Stage IV melanoma.  But I have to believe it helped me get through IL-2 and TIL.  
               
              As I see it, there are two tough things about TIL:  the preparatory chemotherapy regimen, and the course of IL-2.  The chemo is 2 days of cyclophosphamide followed by 5 days of fludarabine.  I found it to not be as difficult physically as I expected.  Mentally, I was freaked out by just the idea of chemo, but I only had a little nausea during the cyclophosphamide.  To protect your bladder, they also wake you every 2 hours to go to the bathroom and are pumping you full of Lasix to make that happen, but in the grand scheme, it was an inconvenience.  And of course, my hair fell out, but again, inconsequential.  During the five days of fludarabine, I was even able to go out on pass for a few days after the daily infusion and we did touristy DC stuff.  However, the bigger consideration is what the chemotherapy is doing that you don't see or feel, i.e. wiping your immune system out, causing extreme neutropenia, taking that white blood cell count to zero.  The TIL cells themselves, the round of IL-2, the GM-CSF shots, etc. are all meant to help reconstitute the immune system, but if your tumor burden is high and you're not feeling strong, then I don't know.  I know that they wouldn't allow you to participate if they didn't think you were strong enough.
               
              The other tough thing is IL-2.  I've written elsewhere that it is probably the toughest thing I've ever done, melanoma or otherwise, but in hindsight, I would do it again if there was a chance it could help me.  They monitor and manage the dosing very closely and recovery was quick, with rapid improvement in the hours and days following the last dose, with the only lasting side effect for me being fatigue for a couple of weeks.  Again, I was otherwise healthy going in — by that point I was about three months removed from having my shoulder replaced — and still had low tumor burden, plus I had prior experience withe two rounds of IL-2 six months earlier.
               
              I don't know if they are still ongoing, but at one point, NIH had trials of two different variants of the protocol:  one looking at reducing the chemo in the preparatory regimen, and the other looking at not using IL-2 after the TIL infusion for patients who might not tolerate it well.  You might want to inquire about these.  As I said, I don't think they're going to enroll you in a trial that they think you aren't strong enough to endure, but it's completely valid for you to question it.  I don't know how much I'm helping, but my suggestion would be to perhaps let it play out and go through with the evaluation process.  It's not an easy decision, I know.  Please don't hesitate to ask if you have any other questions; continuing to keep you in my prayers.
               
              Best,
              Joe
                tschmith
                Participant

                  Hi Artie!  I agree with Joe.  They won't let you in the trial if they think you aren't up to it.  I was wiped out  for a couple of months after I got out of NIH, but I'm 59 and had surgery on my spine and brain within one year so…that probably didn't help.  I really didn't have much trouble with the week of chemo or the IL-2 but  I only had 6 bags of IL-2 because an infection developed and I was running a fever.  It's a difficult decision but you have a lot of knowledge.  Plus, Keytruda seems to be working for you… at least partially.  I guess I don't have much advice, but I know what you're going through!  Stupid Melanoma!  

                  Take care,

                  Terrie

                  tschmith
                  Participant

                    Hi Artie!  I agree with Joe.  They won't let you in the trial if they think you aren't up to it.  I was wiped out  for a couple of months after I got out of NIH, but I'm 59 and had surgery on my spine and brain within one year so…that probably didn't help.  I really didn't have much trouble with the week of chemo or the IL-2 but  I only had 6 bags of IL-2 because an infection developed and I was running a fever.  It's a difficult decision but you have a lot of knowledge.  Plus, Keytruda seems to be working for you… at least partially.  I guess I don't have much advice, but I know what you're going through!  Stupid Melanoma!  

                    Take care,

                    Terrie

                    tschmith
                    Participant

                      Hi Artie!  I agree with Joe.  They won't let you in the trial if they think you aren't up to it.  I was wiped out  for a couple of months after I got out of NIH, but I'm 59 and had surgery on my spine and brain within one year so…that probably didn't help.  I really didn't have much trouble with the week of chemo or the IL-2 but  I only had 6 bags of IL-2 because an infection developed and I was running a fever.  It's a difficult decision but you have a lot of knowledge.  Plus, Keytruda seems to be working for you… at least partially.  I guess I don't have much advice, but I know what you're going through!  Stupid Melanoma!  

                      Take care,

                      Terrie

                      arthurjedi007
                      Participant

                        Yeah this anti-lag NCT01968109 seems to say the last treatment has to be either ctla4,pd1,pdl. But I could be reading it wrong cause I'm in a lot of pain with my knee and hip and these stupid pain pills don't seem to do anything.

                        I guess with that chemo regimen your stomach is probably a mess so you can't eat or drink good? I assume the same or worse for the IL-2?

                        Artie

                         

                        arthurjedi007
                        Participant

                          Yeah this anti-lag NCT01968109 seems to say the last treatment has to be either ctla4,pd1,pdl. But I could be reading it wrong cause I'm in a lot of pain with my knee and hip and these stupid pain pills don't seem to do anything.

                          I guess with that chemo regimen your stomach is probably a mess so you can't eat or drink good? I assume the same or worse for the IL-2?

                          Artie

                           

                          arthurjedi007
                          Participant

                            Yeah this anti-lag NCT01968109 seems to say the last treatment has to be either ctla4,pd1,pdl. But I could be reading it wrong cause I'm in a lot of pain with my knee and hip and these stupid pain pills don't seem to do anything.

                            I guess with that chemo regimen your stomach is probably a mess so you can't eat or drink good? I assume the same or worse for the IL-2?

                            Artie

                             

                            RJoeyB
                            Participant

                              Artie, it's probably a moot point now given your more recent posts, but I took a look at the trial description for NCT01968109 at:

                               
                              Given the multiple cohorts, possible prior treatment options, and multiple tumor types, it is very vague and confusing when it comes to the eligibility criteria (it's not you or the pain medication ;-).  I don't see anything that says outright that TIL cell therapy would exclude you. The only thing that comes close, and isn't specific to TIL, is for Part B participants with NSCLC (lung cancer), but not melamoma, that an anti-PD-1 has to be the most recent treatment prior to the trial.  Regardless, though, it's all pretty vague and I'd definitely ask (multiple times) for clarification or confirmation before making any decision.
                               
                              As far as the chemotherapy regimen, my appetite wasn't too bad and I didn't have too much nausea — a little on the two days of cyclophosphamide, but none with the fludarabine.  I didn't have any nausea with IL-2 either, but some people do.  I did have a loss of appetite, though, but it was more like a loss of wanting to do anything, just feeling like I was run over by a truck, the worst case of the flu ever, times ten.  There are a few days during each round of IL-2 that, for me, are a haze, sort of "lost days".  My wife says I slept through most of them.  After that, my appetite came back, but slowly.
                               
                              Joe
                               
                               
                              RJoeyB
                              Participant

                                Artie, it's probably a moot point now given your more recent posts, but I took a look at the trial description for NCT01968109 at:

                                 
                                Given the multiple cohorts, possible prior treatment options, and multiple tumor types, it is very vague and confusing when it comes to the eligibility criteria (it's not you or the pain medication ;-).  I don't see anything that says outright that TIL cell therapy would exclude you. The only thing that comes close, and isn't specific to TIL, is for Part B participants with NSCLC (lung cancer), but not melamoma, that an anti-PD-1 has to be the most recent treatment prior to the trial.  Regardless, though, it's all pretty vague and I'd definitely ask (multiple times) for clarification or confirmation before making any decision.
                                 
                                As far as the chemotherapy regimen, my appetite wasn't too bad and I didn't have too much nausea — a little on the two days of cyclophosphamide, but none with the fludarabine.  I didn't have any nausea with IL-2 either, but some people do.  I did have a loss of appetite, though, but it was more like a loss of wanting to do anything, just feeling like I was run over by a truck, the worst case of the flu ever, times ten.  There are a few days during each round of IL-2 that, for me, are a haze, sort of "lost days".  My wife says I slept through most of them.  After that, my appetite came back, but slowly.
                                 
                                Joe
                                 
                                 
                                RJoeyB
                                Participant

                                  Artie, it's probably a moot point now given your more recent posts, but I took a look at the trial description for NCT01968109 at:

                                   
                                  Given the multiple cohorts, possible prior treatment options, and multiple tumor types, it is very vague and confusing when it comes to the eligibility criteria (it's not you or the pain medication ;-).  I don't see anything that says outright that TIL cell therapy would exclude you. The only thing that comes close, and isn't specific to TIL, is for Part B participants with NSCLC (lung cancer), but not melamoma, that an anti-PD-1 has to be the most recent treatment prior to the trial.  Regardless, though, it's all pretty vague and I'd definitely ask (multiple times) for clarification or confirmation before making any decision.
                                   
                                  As far as the chemotherapy regimen, my appetite wasn't too bad and I didn't have too much nausea — a little on the two days of cyclophosphamide, but none with the fludarabine.  I didn't have any nausea with IL-2 either, but some people do.  I did have a loss of appetite, though, but it was more like a loss of wanting to do anything, just feeling like I was run over by a truck, the worst case of the flu ever, times ten.  There are a few days during each round of IL-2 that, for me, are a haze, sort of "lost days".  My wife says I slept through most of them.  After that, my appetite came back, but slowly.
                                   
                                  Joe
                                   
                                   
                                JoshF
                                Participant

                                  Artie-

                                   

                                  Who you seeing in Chicago?

                                  JoshF
                                  Participant

                                    Artie-

                                     

                                    Who you seeing in Chicago?

                                    JoshF
                                    Participant

                                      Artie-

                                       

                                      Who you seeing in Chicago?

                                        arthurjedi007
                                        Participant

                                          They mentioned Dr Luke but on the papers they changed it to Dr Gajewski.

                                          Artie

                                          arthurjedi007
                                          Participant

                                            They mentioned Dr Luke but on the papers they changed it to Dr Gajewski.

                                            Artie

                                            arthurjedi007
                                            Participant

                                              They mentioned Dr Luke but on the papers they changed it to Dr Gajewski.

                                              Artie

                                            Bubbles
                                            Participant

                                              Oh, Artie,

                                              Wish I did have words of wisdom for you or some amazing data that would make the path clear.  But…I don't.  It all feels like a crap shoot doesn't it?  Hope just knowing that I think of you and wish you well helps…cause that's all I got!!!  ;>)  Hang in there.  I know you will make the decision that is best for you!  Love, C

                                              Bubbles
                                              Participant

                                                Oh, Artie,

                                                Wish I did have words of wisdom for you or some amazing data that would make the path clear.  But…I don't.  It all feels like a crap shoot doesn't it?  Hope just knowing that I think of you and wish you well helps…cause that's all I got!!!  ;>)  Hang in there.  I know you will make the decision that is best for you!  Love, C

                                                Bubbles
                                                Participant

                                                  Oh, Artie,

                                                  Wish I did have words of wisdom for you or some amazing data that would make the path clear.  But…I don't.  It all feels like a crap shoot doesn't it?  Hope just knowing that I think of you and wish you well helps…cause that's all I got!!!  ;>)  Hang in there.  I know you will make the decision that is best for you!  Love, C

                                                    arthurjedi007
                                                    Participant

                                                      Thanks Celeste. Yeah I'm hoping if I get to go the anti-lag route that it does work for those who progressed on pd1. I think I read something they are seeing some good results with it. But I'm especially hoping the tumors that never responded to pd1 will respond with anti-lag but I'm not sure about that part either because I've not seen anything about it.

                                                      Artie

                                                       

                                                      arthurjedi007
                                                      Participant

                                                        Thanks Celeste. Yeah I'm hoping if I get to go the anti-lag route that it does work for those who progressed on pd1. I think I read something they are seeing some good results with it. But I'm especially hoping the tumors that never responded to pd1 will respond with anti-lag but I'm not sure about that part either because I've not seen anything about it.

                                                        Artie

                                                         

                                                        arthurjedi007
                                                        Participant

                                                          Thanks Celeste. Yeah I'm hoping if I get to go the anti-lag route that it does work for those who progressed on pd1. I think I read something they are seeing some good results with it. But I'm especially hoping the tumors that never responded to pd1 will respond with anti-lag but I'm not sure about that part either because I've not seen anything about it.

                                                          Artie

                                                           

                                                          Bubbles
                                                          Participant

                                                            Yes, Artie!!!  I think that anti-LAG3 with or after anti-PD1 holds a great deal of promise!!!  Here's an overview and an article about it:  http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2014/06/how-to-make-anti-pd1-work-better-with.html

                                                            I'd certainly be up for trying it myself!  Hang in there.  C

                                                            Bubbles
                                                            Participant

                                                              Yes, Artie!!!  I think that anti-LAG3 with or after anti-PD1 holds a great deal of promise!!!  Here's an overview and an article about it:  http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2014/06/how-to-make-anti-pd1-work-better-with.html

                                                              I'd certainly be up for trying it myself!  Hang in there.  C

                                                              Bubbles
                                                              Participant

                                                                Yes, Artie!!!  I think that anti-LAG3 with or after anti-PD1 holds a great deal of promise!!!  Here's an overview and an article about it:  http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2014/06/how-to-make-anti-pd1-work-better-with.html

                                                                I'd certainly be up for trying it myself!  Hang in there.  C

                                                              JoshF
                                                              Participant

                                                                Gajewski is good…was on board at MRA. Does a lot of research in immunotherapy. 

                                                                JoshF
                                                                Participant

                                                                  Gajewski is good…was on board at MRA. Does a lot of research in immunotherapy. 

                                                                  JoshF
                                                                  Participant

                                                                    Gajewski is good…was on board at MRA. Does a lot of research in immunotherapy. 

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