Leukine question at Stage IIIa

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

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

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

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

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:

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:

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

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

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

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