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Leukine question at Stage IIIa

Forums General Melanoma Community Leukine question at Stage IIIa

  • Post
    davekarrie
    Participant

      Good morning all,

      Good morning all,

      Just a quick update on myself.  Initial tumor 1.5mm, mitotic rate 4, non brisk TIL on center of sternum/chest.  Had the WLE, about a 7 inch scar, and SLNB under both armpits.  1 was positive under left arm, then complete Lymph node disection of 41 nodes.  The drain comes out tomorrow and had stitches out of WLE 2 days ago and healing very well.  PET scans negative so for now NED. Met with oncologist at Mayo clinic and she said there is really no approved treatments for IIIa, but she did recomend Leukine if my insurance would cover it.  I have blue cross/shield.  I will be calling them today, but my question is for all out there who have tried Leukine.  What are side effects, how long is treatment, can it be done from home and any other things that you can tell me.

      Thank you so much for any info and god bless and happy holidays.

      Dave

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    • Replies
        lhaley
        Participant

          Dave,

          I did Leukine in 06 on a double blind trial. Because of recurrance 2 years later the trial was unblinded for me and I did receive the drug like I thought.  Once the archives are working you need to search for GMCSF.  I also have BCBS mine is from the State of Delaware.  Once on the trial I then heard that many were doing it off trial. I looked into it and found I would have been covered.  However, I was being covered through the prescription part which for me was Medco.  But, at the time since I was in a trial no one would prescribe it off label for me.

          I had 13 cycles.  14 shots then 14 days off. Gave myself the shots rotating each night – arms, thighs, stomach.  For me the major side effect was itching and welts. Very doable!!!  I was a sp. ed. k teacher at the time and 53 year old. I continud working everyday except for the once a month that I had to drive 6 hours round trip to pick up the meds!  I did have some bone pain and Naxaproxin took those issues away. There were other little things but all in all not difficult. 

          Some on the board have taken the drug for more than 3 years!  If you decided to do it please repost. We've all come up with many suggestions to make the shots easier and to lessen the side effects.

          Did the drug work for me?  Not sure. I have now had 5 recurrances and we're waiting to determine if I have a tumor in my lung. However when the tumors appear they are doing so 1 at a time. Was this from the leukine or would my body have presented this way by itself?  I'll never know.  As I get further away from my initial year my recurrances are coming closer together so maybe it did help initially. If insurance pays, and your Dr. is willing, and you have no better choices why not try it! 

          Wishing you the best,

          Linda

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          lhaley
          Participant

            Dave,

            I did Leukine in 06 on a double blind trial. Because of recurrance 2 years later the trial was unblinded for me and I did receive the drug like I thought.  Once the archives are working you need to search for GMCSF.  I also have BCBS mine is from the State of Delaware.  Once on the trial I then heard that many were doing it off trial. I looked into it and found I would have been covered.  However, I was being covered through the prescription part which for me was Medco.  But, at the time since I was in a trial no one would prescribe it off label for me.

            I had 13 cycles.  14 shots then 14 days off. Gave myself the shots rotating each night – arms, thighs, stomach.  For me the major side effect was itching and welts. Very doable!!!  I was a sp. ed. k teacher at the time and 53 year old. I continud working everyday except for the once a month that I had to drive 6 hours round trip to pick up the meds!  I did have some bone pain and Naxaproxin took those issues away. There were other little things but all in all not difficult. 

            Some on the board have taken the drug for more than 3 years!  If you decided to do it please repost. We've all come up with many suggestions to make the shots easier and to lessen the side effects.

            Did the drug work for me?  Not sure. I have now had 5 recurrances and we're waiting to determine if I have a tumor in my lung. However when the tumors appear they are doing so 1 at a time. Was this from the leukine or would my body have presented this way by itself?  I'll never know.  As I get further away from my initial year my recurrances are coming closer together so maybe it did help initially. If insurance pays, and your Dr. is willing, and you have no better choices why not try it! 

            Wishing you the best,

            Linda

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              davekarrie
              Participant

                Linda,

                Thanks for the info.  I wil most likely be trying Leukine if my insurance will cover it.  I would hope they would.  It makes sense to boost the immune system since that is what has failed us in the first place for not recognizing the cancer cells, so I can see only benefits for trying it. thanks again and I will keep you all posted.

                Dave

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                davekarrie
                Participant

                  Linda,

                  Thanks for the info.  I wil most likely be trying Leukine if my insurance will cover it.  I would hope they would.  It makes sense to boost the immune system since that is what has failed us in the first place for not recognizing the cancer cells, so I can see only benefits for trying it. thanks again and I will keep you all posted.

                  Dave

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                Jim in Denver
                Participant

                  Hi Dave,

                  I have read here, just as the above poster wrote, that there are no other treatments except lukine available for Phase III.   That is not the case.  There is a largePhase III clinical trial involving Ipilimumab for Stage III mel for which you would appear to be eligible, at least you could look into it.  It is for Stage III patients who have had  "complete resection".   It is randomized, as are the other Phase III trials, which presents serious issues to consider.  But given the dearth of other good options, you may want to consider the trial. 

                   http://clinicaltrials.gov/ct2/show/NCT00636168

                  IIf you had "unresectable" Stage II mel, then this Phase I trial would be an option to consider.  It involves a promising combiniation of Ipilimumab and and "Anti PD1" drug MDX 1106:

                  http://clinicaltrials.gov/ct2/show/NCT00636168

                  You will see a range of opinions about lukine efficacy in the archives here or if you google around for more information.  Stage III patients need more treatment options, to be sure, and maybe Ipi will become available for you and others once it is approved this year, because it has been shown to be one of the best treatments ever developed.  That would be something to discuss with your Melanoma Specialist at Mayo.  The above trial are not available at Mayo, so you would need to pursue them at whatever sites they are available and are least inconvenient for you.  Hope that helps a little.

                  Best Wishes,

                  Jim

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                  Jim in Denver
                  Participant

                    Hi Dave,

                    I have read here, just as the above poster wrote, that there are no other treatments except lukine available for Phase III.   That is not the case.  There is a largePhase III clinical trial involving Ipilimumab for Stage III mel for which you would appear to be eligible, at least you could look into it.  It is for Stage III patients who have had  "complete resection".   It is randomized, as are the other Phase III trials, which presents serious issues to consider.  But given the dearth of other good options, you may want to consider the trial. 

                     http://clinicaltrials.gov/ct2/show/NCT00636168

                    IIf you had "unresectable" Stage II mel, then this Phase I trial would be an option to consider.  It involves a promising combiniation of Ipilimumab and and "Anti PD1" drug MDX 1106:

                    http://clinicaltrials.gov/ct2/show/NCT00636168

                    You will see a range of opinions about lukine efficacy in the archives here or if you google around for more information.  Stage III patients need more treatment options, to be sure, and maybe Ipi will become available for you and others once it is approved this year, because it has been shown to be one of the best treatments ever developed.  That would be something to discuss with your Melanoma Specialist at Mayo.  The above trial are not available at Mayo, so you would need to pursue them at whatever sites they are available and are least inconvenient for you.  Hope that helps a little.

                    Best Wishes,

                    Jim

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                      Jim in Denver
                      Participant

                        I meant unresectable Stage III. 

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                        Jim in Denver
                        Participant

                          I meant unresectable Stage III. 

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                        Julie in SoCal
                        Participant

                          Hi Dave,

                          I am also stage 3A (and currently NED!!). I did 1 month of high dose INF and then 11 months of Leukine (also known as GM-CSF) 14 days on 14 days off.  The GM-CSF is very doable.  I had the characteristic red itchy welts and bone pain and a bit of fatigue, but this was very manageable with OTC pain meds and creams.

                          I was encouraged to do GM-CSF by my Dr. who said that it was being studied, but looked promising.  So I did it.

                          Now that study has come out and and GM-CSF was not shown to be effective.  Here's the abstract and the data:

                          E4697: Phase III cooperative group study of yeast-derived granulocyte macrophage colony-stimulating factor (GM-CSF) versus placebo as adjuvant treatment of patients with completely resected stage III-IV melanoma.

                          This is an ECOG study begun in 2006 to see if SQ GM-CSF is an effective adjuvant treatment in patients with resectable metastatic disease, after surgery. The primary endpoint was overall survival which at the time of the abstract’s writing (updates for ASCO are suggested in the text) was NOT met, meaning that overall the drug was not effective. PFS (progression free survival) was positive statistically but only 3 months difference.

                          full abstract link:
                          http://abstract.asco.org/AbstView_74_49374.html

                           E4697: Phase III cooperative group study of yeast-derived granulocyte macrophage colony-stimulating factor (GM-CSF) versus placebo as adjuvant treatment of patients with completely resected stage III-IV melanoma.

                          I don't regret doing GM-CSF.  I wanted to do something as I'm not sure I could have sat back and done the watch and wait very well.  It was the best guess at the time.  If I was in the same position now, I wouldn't do GM-CSF, but rather try to get on an IPI trial.

                          Just my 2 cents.  Do what you think is best.  Research your options, make your decision, and then don't look back.

                          Blessings,

                          Julie

                           

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                          Julie in SoCal
                          Participant

                            Hi Dave,

                            I am also stage 3A (and currently NED!!). I did 1 month of high dose INF and then 11 months of Leukine (also known as GM-CSF) 14 days on 14 days off.  The GM-CSF is very doable.  I had the characteristic red itchy welts and bone pain and a bit of fatigue, but this was very manageable with OTC pain meds and creams.

                            I was encouraged to do GM-CSF by my Dr. who said that it was being studied, but looked promising.  So I did it.

                            Now that study has come out and and GM-CSF was not shown to be effective.  Here's the abstract and the data:

                            E4697: Phase III cooperative group study of yeast-derived granulocyte macrophage colony-stimulating factor (GM-CSF) versus placebo as adjuvant treatment of patients with completely resected stage III-IV melanoma.

                            This is an ECOG study begun in 2006 to see if SQ GM-CSF is an effective adjuvant treatment in patients with resectable metastatic disease, after surgery. The primary endpoint was overall survival which at the time of the abstract’s writing (updates for ASCO are suggested in the text) was NOT met, meaning that overall the drug was not effective. PFS (progression free survival) was positive statistically but only 3 months difference.

                            full abstract link:
                            http://abstract.asco.org/AbstView_74_49374.html

                             E4697: Phase III cooperative group study of yeast-derived granulocyte macrophage colony-stimulating factor (GM-CSF) versus placebo as adjuvant treatment of patients with completely resected stage III-IV melanoma.

                            I don't regret doing GM-CSF.  I wanted to do something as I'm not sure I could have sat back and done the watch and wait very well.  It was the best guess at the time.  If I was in the same position now, I wouldn't do GM-CSF, but rather try to get on an IPI trial.

                            Just my 2 cents.  Do what you think is best.  Research your options, make your decision, and then don't look back.

                            Blessings,

                            Julie

                             

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                            MaryBZ
                            Participant

                              Hi Dave,

                              I just finished my year long treatment of Leukine. My insurance did cover all but a $20 monthly copay (I am told these year long injections are about $30,000).  It is not packaged like interferon where it is premixed and measured for you to just inject.  You have to mix saline with the dry Leukine.  Luckily CareMark pharmacy was able to ship me my monthly package of saline, Leukine, needles, syringes, alcohol pads, and a Sharps container.  I just had to call each month to make sure they new when my next cycle of injections was. 

                              I was diagnosed at stage IIb in Feb '09 and did high dose interferon and only 3 weeks of low dose (mentally could not handle it).  I had a local recurrence in July 2009 and after seeing my local oncologist about a treatment plan, to which he replied, "There isn't any, we wait and watch."  I went to a melanoma specialist who suggested the Leukine to "boost my immune system" .  It was very "doable".  I had redness and swelling at the injection site (even though I iced the site before and after injecting and made sure the dose sat at room temperature for an hour prior to injecting) and mild fatigue (nothing even near to that of interferon). No problems will daily functioning like work, family commitments etc.   I was told to expect bone pain but I guess I am one of the lucky ones and did not have that reaction.  I will have a PET scan Feb 5 and am praying my system has been able to ward off any nasty melanoma cells.

                              I am always looking ahead to see what possibilities are out there should my disease progress.  I waver back and forth about if I would ever try IL-2 (if I couldn't handle low dose interferon I don't imagine I would fair well with IL-2).  IPI seems to be an option.

                               

                              Good luck and God bless!

                               

                              Mary

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                              MaryBZ
                              Participant

                                Hi Dave,

                                I just finished my year long treatment of Leukine. My insurance did cover all but a $20 monthly copay (I am told these year long injections are about $30,000).  It is not packaged like interferon where it is premixed and measured for you to just inject.  You have to mix saline with the dry Leukine.  Luckily CareMark pharmacy was able to ship me my monthly package of saline, Leukine, needles, syringes, alcohol pads, and a Sharps container.  I just had to call each month to make sure they new when my next cycle of injections was. 

                                I was diagnosed at stage IIb in Feb '09 and did high dose interferon and only 3 weeks of low dose (mentally could not handle it).  I had a local recurrence in July 2009 and after seeing my local oncologist about a treatment plan, to which he replied, "There isn't any, we wait and watch."  I went to a melanoma specialist who suggested the Leukine to "boost my immune system" .  It was very "doable".  I had redness and swelling at the injection site (even though I iced the site before and after injecting and made sure the dose sat at room temperature for an hour prior to injecting) and mild fatigue (nothing even near to that of interferon). No problems will daily functioning like work, family commitments etc.   I was told to expect bone pain but I guess I am one of the lucky ones and did not have that reaction.  I will have a PET scan Feb 5 and am praying my system has been able to ward off any nasty melanoma cells.

                                I am always looking ahead to see what possibilities are out there should my disease progress.  I waver back and forth about if I would ever try IL-2 (if I couldn't handle low dose interferon I don't imagine I would fair well with IL-2).  IPI seems to be an option.

                                 

                                Good luck and God bless!

                                 

                                Mary

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                                  davekarrie
                                  Participant

                                    Thanks to everyone for the responses.  To me the Leukine makes sense since it boosts the immune system, but nothing is foolproof especially with melanoma.  So many trials that I don't fully understand at all yet to be honest so still learning.

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                                    davekarrie
                                    Participant

                                      Thanks to everyone for the responses.  To me the Leukine makes sense since it boosts the immune system, but nothing is foolproof especially with melanoma.  So many trials that I don't fully understand at all yet to be honest so still learning.

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                                      Jim in Denver
                                      Participant

                                        You can learn if you want to – I have had to learn, otherwise I might not be writing this.  You asked for info and are getting some here that is useful – if you want it to be.  Relying on any one Doc, unless they are one of the leading melanoma specialists in the country, is a risky proposition, unfortunately.  Ther are many of them out there who really don't know about all treatment options and who would never refer a patient to another Doc or hospital.  I won't give you my details, but I know from experience that you need to become an expert and make informed decisions after understanding all your options.  Best wishes to you both.

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                                        Jim in Denver
                                        Participant

                                          You can learn if you want to – I have had to learn, otherwise I might not be writing this.  You asked for info and are getting some here that is useful – if you want it to be.  Relying on any one Doc, unless they are one of the leading melanoma specialists in the country, is a risky proposition, unfortunately.  Ther are many of them out there who really don't know about all treatment options and who would never refer a patient to another Doc or hospital.  I won't give you my details, but I know from experience that you need to become an expert and make informed decisions after understanding all your options.  Best wishes to you both.

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                                        King
                                        Participant

                                          Hi Dave,

                                           

                                          I don't know if I'm not reading this correctly or what.  There is a FDA approved treatment for Stage IIIA and that is Interferon.

                                           

                                          I have done both Interferon and Leukine.  I did 12 months of Interferon when I was Stage III and after my LND (lymph node dissection) so I was NED (had no evidence of disease) when starting Interferon.

                                           

                                          I did Leukine in a Phase II clinical trial in 2005-2006. I did 13 cycles of 14 days of injections and 14 days of no injections.  At the time I had advanced to Stage IV with a liver metastasis.  I had a liver resection and started the Leukine trial when I was NED as well.  One can't really determine if a treatment is effective, if one is NED when starting the treatment and remains that way while receiving the treatment.

                                           

                                          Leukine's side effects for me were bone burning and the itchy hives at the injection site.

                                           

                                          Stay Strong
                                          King

                                          Stage IV 7/05 Liver mets

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                                          King
                                          Participant

                                            Hi Dave,

                                             

                                            I don't know if I'm not reading this correctly or what.  There is a FDA approved treatment for Stage IIIA and that is Interferon.

                                             

                                            I have done both Interferon and Leukine.  I did 12 months of Interferon when I was Stage III and after my LND (lymph node dissection) so I was NED (had no evidence of disease) when starting Interferon.

                                             

                                            I did Leukine in a Phase II clinical trial in 2005-2006. I did 13 cycles of 14 days of injections and 14 days of no injections.  At the time I had advanced to Stage IV with a liver metastasis.  I had a liver resection and started the Leukine trial when I was NED as well.  One can't really determine if a treatment is effective, if one is NED when starting the treatment and remains that way while receiving the treatment.

                                             

                                            Leukine's side effects for me were bone burning and the itchy hives at the injection site.

                                             

                                            Stay Strong
                                            King

                                            Stage IV 7/05 Liver mets

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