ipilimumab 10 mg/kg dosage – Side effects question

Hello,

We were told that, when my husband started on this, it depends mostly on how your health is when you start and the stress.  He has been on the 10mg/kg for 2 years now.  He had the itching which was very intense at times and he is still itching on the maintenance phase of it and he is also getting injections of GMCSF for 14 days then 7 days off.  After the initial 4 doses every three weeks he has been getting a dose every 12 weeks.

He worked during the treatment until he had detached retina and then he was off for 1 year on sick leave as he had 5 eye surgeries and needed time to heal and was in a face down situation for a good deal of that year because of the retina.  If it hadn't have been for that he would have probably worked through it.

He had no diarrhea issues.  He was in good health otherwise and the oncology nurse told him he was more like the athlete then someone who was sickly.  He had lesions in the liver, lung and one unresectable as it was on the spine in the neck area and he had 4 sub q's as well.  We literally watched the sub q's shrink in the first 12 weeks and continue until they were all gone.  He is now NED (no evidence of disease) for about 6 months and is still receiving both of the drugs the same as when the clinical trial started.

So I wouldn't worry about the 10mg being any worse than the 3mg.  He started this clinical trial about 3 weeks before the drug was FDA approved at the 3 mg.  You need to concentrate on some outside factors such as your diet and also have your Vitamin D3 levels checked.  Sugar is the main item that needs to be eliminated from your diet.  Artificial sugar is really bad.  Meat and dairy digestions is also very hard for a cancer patient.  Try to drink as much good water as possible especially if you can locate some spring water.  

You can read more on his profile page if you wish.  Good luck and best wishes.

Judy (loving wife of Gene Stage IV and now NED)

Hello,

We were told that, when my husband started on this, it depends mostly on how your health is when you start and the stress.  He has been on the 10mg/kg for 2 years now.  He had the itching which was very intense at times and he is still itching on the maintenance phase of it and he is also getting injections of GMCSF for 14 days then 7 days off.  After the initial 4 doses every three weeks he has been getting a dose every 12 weeks.

He worked during the treatment until he had detached retina and then he was off for 1 year on sick leave as he had 5 eye surgeries and needed time to heal and was in a face down situation for a good deal of that year because of the retina.  If it hadn't have been for that he would have probably worked through it.

He had no diarrhea issues.  He was in good health otherwise and the oncology nurse told him he was more like the athlete then someone who was sickly.  He had lesions in the liver, lung and one unresectable as it was on the spine in the neck area and he had 4 sub q's as well.  We literally watched the sub q's shrink in the first 12 weeks and continue until they were all gone.  He is now NED (no evidence of disease) for about 6 months and is still receiving both of the drugs the same as when the clinical trial started.

So I wouldn't worry about the 10mg being any worse than the 3mg.  He started this clinical trial about 3 weeks before the drug was FDA approved at the 3 mg.  You need to concentrate on some outside factors such as your diet and also have your Vitamin D3 levels checked.  Sugar is the main item that needs to be eliminated from your diet.  Artificial sugar is really bad.  Meat and dairy digestions is also very hard for a cancer patient.  Try to drink as much good water as possible especially if you can locate some spring water.  

You can read more on his profile page if you wish.  Good luck and best wishes.

Judy (loving wife of Gene Stage IV and now NED)

Hello,

We were told that, when my husband started on this, it depends mostly on how your health is when you start and the stress.  He has been on the 10mg/kg for 2 years now.  He had the itching which was very intense at times and he is still itching on the maintenance phase of it and he is also getting injections of GMCSF for 14 days then 7 days off.  After the initial 4 doses every three weeks he has been getting a dose every 12 weeks.

He worked during the treatment until he had detached retina and then he was off for 1 year on sick leave as he had 5 eye surgeries and needed time to heal and was in a face down situation for a good deal of that year because of the retina.  If it hadn't have been for that he would have probably worked through it.

He had no diarrhea issues.  He was in good health otherwise and the oncology nurse told him he was more like the athlete then someone who was sickly.  He had lesions in the liver, lung and one unresectable as it was on the spine in the neck area and he had 4 sub q's as well.  We literally watched the sub q's shrink in the first 12 weeks and continue until they were all gone.  He is now NED (no evidence of disease) for about 6 months and is still receiving both of the drugs the same as when the clinical trial started.

So I wouldn't worry about the 10mg being any worse than the 3mg.  He started this clinical trial about 3 weeks before the drug was FDA approved at the 3 mg.  You need to concentrate on some outside factors such as your diet and also have your Vitamin D3 levels checked.  Sugar is the main item that needs to be eliminated from your diet.  Artificial sugar is really bad.  Meat and dairy digestions is also very hard for a cancer patient.  Try to drink as much good water as possible especially if you can locate some spring water.  

You can read more on his profile page if you wish.  Good luck and best wishes.

Judy (loving wife of Gene Stage IV and now NED)

At one point I went for a second opinion (and attempt to get into a TIL trial) at MD Anderson, after finishing up a standard FDA approved IPI schedule (4 doses at 3 mg/kg, each 3 weeks apart). For what it's worth, the MDA oncologist said to keep a lookout for any IPI trials at the higher 10 mg/kg dosage, because IPI seemed to bit more effective at those levels.

I hadn't had any major side effects at the lower dose, which may have been part of her reasoning. But I haven't had progression since, so far, so I haven't had to follow her up on her advice to this point.

Congratulations for getting INTO a trial, and I hope it proves effective and without major side effects. I'm sure as a clinical trial site they'll be immediately on top of symptoms that occur, and they'll tell your husband to be on top of any symptoms as well, especially to report any GI / diarrhea symptoms if they do occur, even seemingly mild ones, right away. That's the IPI side anyway, I don't know what they'll say for the VER side. 

Good luck to your husband on the IPI/ver trial, and let us know how it's going.

– Kyle

At one point I went for a second opinion (and attempt to get into a TIL trial) at MD Anderson, after finishing up a standard FDA approved IPI schedule (4 doses at 3 mg/kg, each 3 weeks apart). For what it's worth, the MDA oncologist said to keep a lookout for any IPI trials at the higher 10 mg/kg dosage, because IPI seemed to bit more effective at those levels.

I hadn't had any major side effects at the lower dose, which may have been part of her reasoning. But I haven't had progression since, so far, so I haven't had to follow her up on her advice to this point.

Congratulations for getting INTO a trial, and I hope it proves effective and without major side effects. I'm sure as a clinical trial site they'll be immediately on top of symptoms that occur, and they'll tell your husband to be on top of any symptoms as well, especially to report any GI / diarrhea symptoms if they do occur, even seemingly mild ones, right away. That's the IPI side anyway, I don't know what they'll say for the VER side. 

Good luck to your husband on the IPI/ver trial, and let us know how it's going.

– Kyle

At one point I went for a second opinion (and attempt to get into a TIL trial) at MD Anderson, after finishing up a standard FDA approved IPI schedule (4 doses at 3 mg/kg, each 3 weeks apart). For what it's worth, the MDA oncologist said to keep a lookout for any IPI trials at the higher 10 mg/kg dosage, because IPI seemed to bit more effective at those levels.

I hadn't had any major side effects at the lower dose, which may have been part of her reasoning. But I haven't had progression since, so far, so I haven't had to follow her up on her advice to this point.

Congratulations for getting INTO a trial, and I hope it proves effective and without major side effects. I'm sure as a clinical trial site they'll be immediately on top of symptoms that occur, and they'll tell your husband to be on top of any symptoms as well, especially to report any GI / diarrhea symptoms if they do occur, even seemingly mild ones, right away. That's the IPI side anyway, I don't know what they'll say for the VER side. 

Good luck to your husband on the IPI/ver trial, and let us know how it's going.

– Kyle

I was on the MDX-010 (ipi 10 mg/kg)  trial a few years ago –  before the FDA approved Yervoy at the 3 mg/kg dose.  I had some autoimmune issues (thyroid = turned into eye issues), but they were eventually cleared up with some high dose steroids.  .. I had a complete response and have been NED since that maintenance dose almost 4 years ago.   My symptoms while on the drug included only a very faint rash on my upper back – that's it.  I had some VERY rare – like no one else one the trial had this – auto-immune issue with my eyes (Graves disease without the thryoid issues).  Recently I was diagnosed with Graves disease (hyper-thryoid issues).  Our best guess is that Ipi or not I would have likely gotten Graves. 

My best to you and your husband. 

Rocco, Stage IV in 2005, Ipi responder, NED

I was on the MDX-010 (ipi 10 mg/kg)  trial a few years ago –  before the FDA approved Yervoy at the 3 mg/kg dose.  I had some autoimmune issues (thyroid = turned into eye issues), but they were eventually cleared up with some high dose steroids.  .. I had a complete response and have been NED since that maintenance dose almost 4 years ago.   My symptoms while on the drug included only a very faint rash on my upper back – that's it.  I had some VERY rare – like no one else one the trial had this – auto-immune issue with my eyes (Graves disease without the thryoid issues).  Recently I was diagnosed with Graves disease (hyper-thryoid issues).  Our best guess is that Ipi or not I would have likely gotten Graves. 

My best to you and your husband. 

Rocco, Stage IV in 2005, Ipi responder, NED

I was on the MDX-010 (ipi 10 mg/kg)  trial a few years ago –  before the FDA approved Yervoy at the 3 mg/kg dose.  I had some autoimmune issues (thyroid = turned into eye issues), but they were eventually cleared up with some high dose steroids.  .. I had a complete response and have been NED since that maintenance dose almost 4 years ago.   My symptoms while on the drug included only a very faint rash on my upper back – that's it.  I had some VERY rare – like no one else one the trial had this – auto-immune issue with my eyes (Graves disease without the thryoid issues).  Recently I was diagnosed with Graves disease (hyper-thryoid issues).  Our best guess is that Ipi or not I would have likely gotten Graves. 

My best to you and your husband. 

Rocco, Stage IV in 2005, Ipi responder, NED

I was on the MDX-010 (ipi 10 mg/kg)  trial a few years ago –  before the FDA approved Yervoy at the 3 mg/kg dose.  I had some autoimmune issues (thyroid = turned into eye issues), but they were eventually cleared up with some high dose steroids.  .. I had a complete response and have been NED since that maintenance dose almost 4 years ago.   My symptoms while on the drug included only a very faint rash on my upper back – that's it.  I had some VERY rare – like no one else one the trial had this – auto-immune issue with my eyes (Graves disease without the thryoid issues).  Recently I was diagnosed with Graves disease (hyper-thryoid issues).  Our best guess is that Ipi or not I would have likely gotten Graves. 

My best to you and your husband. 

Rocco, Stage IV in 2005, Ipi responder, NED

I was on the MDX-010 (ipi 10 mg/kg)  trial a few years ago –  before the FDA approved Yervoy at the 3 mg/kg dose.  I had some autoimmune issues (thyroid = turned into eye issues), but they were eventually cleared up with some high dose steroids.  .. I had a complete response and have been NED since that maintenance dose almost 4 years ago.   My symptoms while on the drug included only a very faint rash on my upper back – that's it.  I had some VERY rare – like no one else one the trial had this – auto-immune issue with my eyes (Graves disease without the thryoid issues).  Recently I was diagnosed with Graves disease (hyper-thryoid issues).  Our best guess is that Ipi or not I would have likely gotten Graves. 

My best to you and your husband. 

Rocco, Stage IV in 2005, Ipi responder, NED

I was on the MDX-010 (ipi 10 mg/kg)  trial a few years ago –  before the FDA approved Yervoy at the 3 mg/kg dose.  I had some autoimmune issues (thyroid = turned into eye issues), but they were eventually cleared up with some high dose steroids.  .. I had a complete response and have been NED since that maintenance dose almost 4 years ago.   My symptoms while on the drug included only a very faint rash on my upper back – that's it.  I had some VERY rare – like no one else one the trial had this – auto-immune issue with my eyes (Graves disease without the thryoid issues).  Recently I was diagnosed with Graves disease (hyper-thryoid issues).  Our best guess is that Ipi or not I would have likely gotten Graves. 

My best to you and your husband. 

Rocco, Stage IV in 2005, Ipi responder, NED

I was on the MDX-010 (ipi 10 mg/kg)  trial a few years ago –  before the FDA approved Yervoy at the 3 mg/kg dose.  I had some autoimmune issues (thyroid = turned into eye issues), but they were eventually cleared up with some high dose steroids.  .. I had a complete response and have been NED since that maintenance dose almost 4 years ago.   My symptoms while on the drug included only a very faint rash on my upper back – that's it.  I had some VERY rare – like no one else one the trial had this – auto-immune issue with my eyes (Graves disease without the thryoid issues).  Recently I was diagnosed with Graves disease (hyper-thryoid issues).  Our best guess is that Ipi or not I would have likely gotten Graves. 

My best to you and your husband. 

Rocco, Stage IV in 2005, Ipi responder, NED

I was on the MDX-010 (ipi 10 mg/kg)  trial a few years ago –  before the FDA approved Yervoy at the 3 mg/kg dose.  I had some autoimmune issues (thyroid = turned into eye issues), but they were eventually cleared up with some high dose steroids.  .. I had a complete response and have been NED since that maintenance dose almost 4 years ago.   My symptoms while on the drug included only a very faint rash on my upper back – that's it.  I had some VERY rare – like no one else one the trial had this – auto-immune issue with my eyes (Graves disease without the thryoid issues).  Recently I was diagnosed with Graves disease (hyper-thryoid issues).  Our best guess is that Ipi or not I would have likely gotten Graves. 

My best to you and your husband. 

Rocco, Stage IV in 2005, Ipi responder, NED

I was on the MDX-010 (ipi 10 mg/kg)  trial a few years ago –  before the FDA approved Yervoy at the 3 mg/kg dose.  I had some autoimmune issues (thyroid = turned into eye issues), but they were eventually cleared up with some high dose steroids.  .. I had a complete response and have been NED since that maintenance dose almost 4 years ago.   My symptoms while on the drug included only a very faint rash on my upper back – that's it.  I had some VERY rare – like no one else one the trial had this – auto-immune issue with my eyes (Graves disease without the thryoid issues).  Recently I was diagnosed with Graves disease (hyper-thryoid issues).  Our best guess is that Ipi or not I would have likely gotten Graves. 

My best to you and your husband. 

Rocco, Stage IV in 2005, Ipi responder, NED