› Forums › General Melanoma Community › Help AGAIN!
- This topic has 18 replies, 5 voices, and was last updated 10 years, 7 months ago by
katie1.
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- September 24, 2013 at 9:40 pm
If you read my past post my husband was diagnosed with Melanoma with an unknown primary Stage IIIc – IV back in June. Though he is currently NED the size and depth of the tumor was extremely large (15mm?). We opted to take part in a clinical trial at DFCI for Yervoy. He got the 10mg dose. He had his first infusion about 2 1./2 weeks ago and had no side effects. He was scheduled to go in for his second infusion next Tuesday. Now, guess what – they cancelled his arm of the trial! They had a few deaths in this arm of the study and decided against continuing this arm of the trial! There are two other arms – a 3 mg yervoy and inteferon. They will only allow the 10 mg to be transferred to the inteferon arm! Doesn't seem fair to us but, that's the only option! After only one dose of yervoy we are very confused on what to do! It was such a hard decision to go with the 10mg yervoy and now we are back to square one! Is it really worth doing the interferon at this point? Any advise would be appreciated.
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- September 25, 2013 at 3:24 am
Do you mean they closed the arm and won't transfer the people to the 3 mm arm? That's lousy and cruel.
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- September 25, 2013 at 1:28 pm
Sorry to hear you have been taken off of the 10 mg arm and not able to go into the 3 mg arm seems so cruel. My husband has been on the 10 mg since March 2011 and has been NED for about a year now. He had his last infusion in August 2013. He was stage IV so I don't understand why cutting it now. Something doesn't seem right. He also gets GM-CSF with his 10 mg and has done great. As a matter of fact the two arms they had when he started his was 10 mg alone or 10 mg with the GM-CSF.
Judy (loving wife of Gene Stage IV and now NED)
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- September 26, 2013 at 3:19 am
They had some recent deaths in the 10mg arm. Not sure what the cause was – so they discontinued. We were hoping they would let him go into the 3mg arm but they say his only option is interferon. Just don't feel it's as effective?? Of course he still is NED – so I guess we need to stay positive! It took a lot to decide to do the trial and we felt it was the right decision! Now the rug has been ripped from under us and we are back to deciding a treatment option!
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- September 26, 2013 at 3:19 am
They had some recent deaths in the 10mg arm. Not sure what the cause was – so they discontinued. We were hoping they would let him go into the 3mg arm but they say his only option is interferon. Just don't feel it's as effective?? Of course he still is NED – so I guess we need to stay positive! It took a lot to decide to do the trial and we felt it was the right decision! Now the rug has been ripped from under us and we are back to deciding a treatment option!
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- September 26, 2013 at 3:19 am
They had some recent deaths in the 10mg arm. Not sure what the cause was – so they discontinued. We were hoping they would let him go into the 3mg arm but they say his only option is interferon. Just don't feel it's as effective?? Of course he still is NED – so I guess we need to stay positive! It took a lot to decide to do the trial and we felt it was the right decision! Now the rug has been ripped from under us and we are back to deciding a treatment option!
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- September 26, 2013 at 11:12 am
I'm so sorry you're having to go through this. I agree with all the comments about this being a cruel thing to do. I'm sure that some folks dropped out of that trial when they found out they were on the Interferon arm so they may be having trouble getting people into that arm.
Based on the statistics that I was quoted Interferon is barely more effective than doing nothing at all. That being said, those who have done the interferon have no regrets.
But there are a couple of things in your favor. One, is that he is NED! Two, is that if you research "melanoma unknown primary" on line you will find several studies that would seem to indicate that it's not such a bad place to be. A substantial number of patients do well due to a "strong endogenous immune response".
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- September 26, 2013 at 11:12 am
I'm so sorry you're having to go through this. I agree with all the comments about this being a cruel thing to do. I'm sure that some folks dropped out of that trial when they found out they were on the Interferon arm so they may be having trouble getting people into that arm.
Based on the statistics that I was quoted Interferon is barely more effective than doing nothing at all. That being said, those who have done the interferon have no regrets.
But there are a couple of things in your favor. One, is that he is NED! Two, is that if you research "melanoma unknown primary" on line you will find several studies that would seem to indicate that it's not such a bad place to be. A substantial number of patients do well due to a "strong endogenous immune response".
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- September 26, 2013 at 11:12 am
I'm so sorry you're having to go through this. I agree with all the comments about this being a cruel thing to do. I'm sure that some folks dropped out of that trial when they found out they were on the Interferon arm so they may be having trouble getting people into that arm.
Based on the statistics that I was quoted Interferon is barely more effective than doing nothing at all. That being said, those who have done the interferon have no regrets.
But there are a couple of things in your favor. One, is that he is NED! Two, is that if you research "melanoma unknown primary" on line you will find several studies that would seem to indicate that it's not such a bad place to be. A substantial number of patients do well due to a "strong endogenous immune response".
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- September 26, 2013 at 12:23 pm
My husband is in the same trial (3mg arm). I know he had to sign a new consent just before randomization because of a “safety update.” This was in June. There had been 3 deaths in the 10mg arm. I can’t remember the details at this point. I don’t think all three were clearly linked to Ipi. So I know there were some issues. Since it is an adjuvant trial, it must have reached a threshold (10mg has been used in many trials for metastatic disease). I know in our Center Interferon has had people drop out due to toxic side effects (nobody has dropped out of Ipi). I’m sure you looked into the Interferon prior to deciding on the trial, but it may be worth discussing with your oncologist (and doing your own research) based on your husband’s pathology. My understanding is that studies have shown some types have better response (ulcerated, micro lymph involvement). Studies do seem to show an improvement in relapse free survival (though some feel at too high a cost from side effects) but no statistically significant change in OS. Given how quickly the landscape of treatment options is changing, RFS may be a great benefit. You will figure out what is best for you guys.
It seems they have closed the arm entirely from what you said, but you might confirm if there is an option to transfer centers?
Good luck with your decision,
Katie -
- September 26, 2013 at 12:23 pm
My husband is in the same trial (3mg arm). I know he had to sign a new consent just before randomization because of a “safety update.” This was in June. There had been 3 deaths in the 10mg arm. I can’t remember the details at this point. I don’t think all three were clearly linked to Ipi. So I know there were some issues. Since it is an adjuvant trial, it must have reached a threshold (10mg has been used in many trials for metastatic disease). I know in our Center Interferon has had people drop out due to toxic side effects (nobody has dropped out of Ipi). I’m sure you looked into the Interferon prior to deciding on the trial, but it may be worth discussing with your oncologist (and doing your own research) based on your husband’s pathology. My understanding is that studies have shown some types have better response (ulcerated, micro lymph involvement). Studies do seem to show an improvement in relapse free survival (though some feel at too high a cost from side effects) but no statistically significant change in OS. Given how quickly the landscape of treatment options is changing, RFS may be a great benefit. You will figure out what is best for you guys.
It seems they have closed the arm entirely from what you said, but you might confirm if there is an option to transfer centers?
Good luck with your decision,
Katie -
- September 26, 2013 at 12:23 pm
My husband is in the same trial (3mg arm). I know he had to sign a new consent just before randomization because of a “safety update.” This was in June. There had been 3 deaths in the 10mg arm. I can’t remember the details at this point. I don’t think all three were clearly linked to Ipi. So I know there were some issues. Since it is an adjuvant trial, it must have reached a threshold (10mg has been used in many trials for metastatic disease). I know in our Center Interferon has had people drop out due to toxic side effects (nobody has dropped out of Ipi). I’m sure you looked into the Interferon prior to deciding on the trial, but it may be worth discussing with your oncologist (and doing your own research) based on your husband’s pathology. My understanding is that studies have shown some types have better response (ulcerated, micro lymph involvement). Studies do seem to show an improvement in relapse free survival (though some feel at too high a cost from side effects) but no statistically significant change in OS. Given how quickly the landscape of treatment options is changing, RFS may be a great benefit. You will figure out what is best for you guys.
It seems they have closed the arm entirely from what you said, but you might confirm if there is an option to transfer centers?
Good luck with your decision,
Katie -
- September 25, 2013 at 1:28 pm
Sorry to hear you have been taken off of the 10 mg arm and not able to go into the 3 mg arm seems so cruel. My husband has been on the 10 mg since March 2011 and has been NED for about a year now. He had his last infusion in August 2013. He was stage IV so I don't understand why cutting it now. Something doesn't seem right. He also gets GM-CSF with his 10 mg and has done great. As a matter of fact the two arms they had when he started his was 10 mg alone or 10 mg with the GM-CSF.
Judy (loving wife of Gene Stage IV and now NED)
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- September 25, 2013 at 1:28 pm
Sorry to hear you have been taken off of the 10 mg arm and not able to go into the 3 mg arm seems so cruel. My husband has been on the 10 mg since March 2011 and has been NED for about a year now. He had his last infusion in August 2013. He was stage IV so I don't understand why cutting it now. Something doesn't seem right. He also gets GM-CSF with his 10 mg and has done great. As a matter of fact the two arms they had when he started his was 10 mg alone or 10 mg with the GM-CSF.
Judy (loving wife of Gene Stage IV and now NED)
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- September 25, 2013 at 3:24 am
Do you mean they closed the arm and won't transfer the people to the 3 mm arm? That's lousy and cruel.
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- September 25, 2013 at 3:24 am
Do you mean they closed the arm and won't transfer the people to the 3 mm arm? That's lousy and cruel.
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