› Forums › General Melanoma Community › Great news but afraid husband could be taken out of trial- need advice please!
- This topic has 18 replies, 3 voices, and was last updated 11 years, 5 months ago by
Maureen038.
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- November 22, 2014 at 12:50 pm
Hi everyone,
It's been awhile since I've posted, but I do read MRF every day and my heart goes out to the people who have died or are struggling now. My prayers go out to everyone fighting this battle. It's so wonderful to know though that there are so many people who care and truly have wonderful knowledge on this board. Thanks Tim too for providing this format!
First, thanks Janner for your wonderful advice on my son. His three colorless bumps were nothing. It was incredible news for us!!!!
My husband had a PET/CT yesterday. He is on the phase one ipi/ nivo trial. He also had TIL therapy at NIH before this trial. We feel very strongly that the combination of the TIL therapy and the Ipi/nivo trail have worked together to help my husband have great results. If you look at Lion Biotechnologies they are running trials with TIL and nivolumbab and TIL with ipi. We truly feel Dr. Rosenberg's work has been groundbreaking in the melanoma world. My husband has been stage 4 for over two years with nine lung nodules. The scan showed nothing new, but his one nodule grew again from 2.8 x 2.1 to 3.3 x 2.4. cm. The SUV max is 19.2, There are two lung nodules that are about 7 mm with no FDG uptake. There are a few very tiny nodules that have a SUV max of 3.5. It seems that some nodules have disappeared. This is all fantastic news except for the one nodule. Our concern is that Dr. Kirkwood at UPMC has discussed before that he can have the one nodule taken out, but BMS has to agree to it for him to continue on the trial. My husband was almost taken off the trial in June and I want to make sure there's no problem at our appointment on Monday in Pittsburg. Does anyone have a scholarly article I can use in case we have to argue our case. Thanks from the bottom of my heart!!
Maureen
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- November 22, 2014 at 1:01 pm
Hi Maureen, it seems like overall good news, except for that one lung nodule. I'm not sure I follow your question… are you wondering if he'll be taken off the trial based on that lone tumor growing? Or are you planning to have it removed and concerned that BMS is going to preemptively take him off because you're considering it?
Joe
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- November 22, 2014 at 3:18 pm
You can be taken off the trial for 20 percent growth which I am fairly certain he hasn't reached but I'm not positive. Also, to have the surgery for the one lung nodule requires permission fromBMS. Either issue could take him off trial, but it would not make sense to us because everything else is responding so well. We just want to make sure we are prepared for Monday just in case it's an issue. Thanks so much!
maureen
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- November 22, 2014 at 3:59 pm
Also if they take out the lung nodule which we definitely want done there won't be any nodule that's measurable because the only two measurable are 7 mm. We will probably try to have one more cycle of three infusions of nivolumbab and then have surgery and if he's taken off trial we should not have to wait that long we hope for nivolumbab to be FDA approved. The only problem would be paying for it but we will figure it out if we have to.
maureen
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- November 22, 2014 at 5:13 pm
Thanks for the clarification. The 20% likely is from a standard call "RECIST criteria" the defines the difference between "stable disease" and "progressive disease" — it should be documented in the trial enrollment signed before you started the trial. It also depends on which tumors/lesions were defined as "target lesions". I imagine that it wasn't solely that one lung nodule, and it how they choose to measure each lesion can vary with RECIST. There's a decent comparison of RECIST here:
Most trials use 1.1 these days. Long story short, even if that one growing lung tumor is included in the RECIST measurement and has grown by more than 20%, I suspect there were other targets included for your husband, too, which if they've shrunk, should counteract against the 20%.Also note that some tumors actually grow before they shrink with the checkpoint inhibitor immunotherapies like ipi and nivo. You can read about a number of people who have experienced that here on the forum. Point being is that the drug companies recognize this and I've heard are a bit more forgiving on the 20% to give things time to work, even if some tumors have already started to respond and shrink. However, if you decide to proactively remove that tumor and it's one of the targets, that would change things. Not to suggest that you shouldn't consider it, only that you should discuss it with your doctor and understand what it may mean moving forward.Hope that helps, wishing you both the best,Joe -
- November 22, 2014 at 5:13 pm
Thanks for the clarification. The 20% likely is from a standard call "RECIST criteria" the defines the difference between "stable disease" and "progressive disease" — it should be documented in the trial enrollment signed before you started the trial. It also depends on which tumors/lesions were defined as "target lesions". I imagine that it wasn't solely that one lung nodule, and it how they choose to measure each lesion can vary with RECIST. There's a decent comparison of RECIST here:
Most trials use 1.1 these days. Long story short, even if that one growing lung tumor is included in the RECIST measurement and has grown by more than 20%, I suspect there were other targets included for your husband, too, which if they've shrunk, should counteract against the 20%.Also note that some tumors actually grow before they shrink with the checkpoint inhibitor immunotherapies like ipi and nivo. You can read about a number of people who have experienced that here on the forum. Point being is that the drug companies recognize this and I've heard are a bit more forgiving on the 20% to give things time to work, even if some tumors have already started to respond and shrink. However, if you decide to proactively remove that tumor and it's one of the targets, that would change things. Not to suggest that you shouldn't consider it, only that you should discuss it with your doctor and understand what it may mean moving forward.Hope that helps, wishing you both the best,Joe -
- November 22, 2014 at 5:13 pm
Thanks for the clarification. The 20% likely is from a standard call "RECIST criteria" the defines the difference between "stable disease" and "progressive disease" — it should be documented in the trial enrollment signed before you started the trial. It also depends on which tumors/lesions were defined as "target lesions". I imagine that it wasn't solely that one lung nodule, and it how they choose to measure each lesion can vary with RECIST. There's a decent comparison of RECIST here:
Most trials use 1.1 these days. Long story short, even if that one growing lung tumor is included in the RECIST measurement and has grown by more than 20%, I suspect there were other targets included for your husband, too, which if they've shrunk, should counteract against the 20%.Also note that some tumors actually grow before they shrink with the checkpoint inhibitor immunotherapies like ipi and nivo. You can read about a number of people who have experienced that here on the forum. Point being is that the drug companies recognize this and I've heard are a bit more forgiving on the 20% to give things time to work, even if some tumors have already started to respond and shrink. However, if you decide to proactively remove that tumor and it's one of the targets, that would change things. Not to suggest that you shouldn't consider it, only that you should discuss it with your doctor and understand what it may mean moving forward.Hope that helps, wishing you both the best,Joe -
- November 22, 2014 at 3:59 pm
Also if they take out the lung nodule which we definitely want done there won't be any nodule that's measurable because the only two measurable are 7 mm. We will probably try to have one more cycle of three infusions of nivolumbab and then have surgery and if he's taken off trial we should not have to wait that long we hope for nivolumbab to be FDA approved. The only problem would be paying for it but we will figure it out if we have to.
maureen
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- November 22, 2014 at 3:59 pm
Also if they take out the lung nodule which we definitely want done there won't be any nodule that's measurable because the only two measurable are 7 mm. We will probably try to have one more cycle of three infusions of nivolumbab and then have surgery and if he's taken off trial we should not have to wait that long we hope for nivolumbab to be FDA approved. The only problem would be paying for it but we will figure it out if we have to.
maureen
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- November 22, 2014 at 5:45 pm
Maureen,
I'm in an immunotherapy trial too. They are using the same RECIST criteria your trial is using, it sounds like.
My trial coordinator told me that if the target lesion grows by more than 20%, they then call that "unconfirmed progression". At that point, they would proceed with 1 more cycle. If it is still bigger they would then call that "confirmed progression" and at that point they could decide to take me off the trial.
So that might be something to ask about — unconfirmed progression vs confirmed progression — whether or not (and knock on wood, it's *not*) the 20% mark might be breached.
I'll have to ask my coordinator next time if there's any discretion or wiggle room on the part of the drug company, and if so what kinds of things they look at.
Good luck Monday!
– Kyle
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- November 22, 2014 at 10:38 pm
Thank you Joe and Kyle for your help! We will just have to wait unti Monday to see what happens.
Maureen
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- November 22, 2014 at 10:38 pm
Thank you Joe and Kyle for your help! We will just have to wait unti Monday to see what happens.
Maureen
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- November 22, 2014 at 10:38 pm
Thank you Joe and Kyle for your help! We will just have to wait unti Monday to see what happens.
Maureen
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- November 22, 2014 at 5:45 pm
Maureen,
I'm in an immunotherapy trial too. They are using the same RECIST criteria your trial is using, it sounds like.
My trial coordinator told me that if the target lesion grows by more than 20%, they then call that "unconfirmed progression". At that point, they would proceed with 1 more cycle. If it is still bigger they would then call that "confirmed progression" and at that point they could decide to take me off the trial.
So that might be something to ask about — unconfirmed progression vs confirmed progression — whether or not (and knock on wood, it's *not*) the 20% mark might be breached.
I'll have to ask my coordinator next time if there's any discretion or wiggle room on the part of the drug company, and if so what kinds of things they look at.
Good luck Monday!
– Kyle
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- November 22, 2014 at 5:45 pm
Maureen,
I'm in an immunotherapy trial too. They are using the same RECIST criteria your trial is using, it sounds like.
My trial coordinator told me that if the target lesion grows by more than 20%, they then call that "unconfirmed progression". At that point, they would proceed with 1 more cycle. If it is still bigger they would then call that "confirmed progression" and at that point they could decide to take me off the trial.
So that might be something to ask about — unconfirmed progression vs confirmed progression — whether or not (and knock on wood, it's *not*) the 20% mark might be breached.
I'll have to ask my coordinator next time if there's any discretion or wiggle room on the part of the drug company, and if so what kinds of things they look at.
Good luck Monday!
– Kyle
-
- November 22, 2014 at 3:18 pm
You can be taken off the trial for 20 percent growth which I am fairly certain he hasn't reached but I'm not positive. Also, to have the surgery for the one lung nodule requires permission fromBMS. Either issue could take him off trial, but it would not make sense to us because everything else is responding so well. We just want to make sure we are prepared for Monday just in case it's an issue. Thanks so much!
maureen
-
- November 22, 2014 at 3:18 pm
You can be taken off the trial for 20 percent growth which I am fairly certain he hasn't reached but I'm not positive. Also, to have the surgery for the one lung nodule requires permission fromBMS. Either issue could take him off trial, but it would not make sense to us because everything else is responding so well. We just want to make sure we are prepared for Monday just in case it's an issue. Thanks so much!
maureen
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- November 22, 2014 at 1:01 pm
Hi Maureen, it seems like overall good news, except for that one lung nodule. I'm not sure I follow your question… are you wondering if he'll be taken off the trial based on that lone tumor growing? Or are you planning to have it removed and concerned that BMS is going to preemptively take him off because you're considering it?
Joe
-
- November 22, 2014 at 1:01 pm
Hi Maureen, it seems like overall good news, except for that one lung nodule. I'm not sure I follow your question… are you wondering if he'll be taken off the trial based on that lone tumor growing? Or are you planning to have it removed and concerned that BMS is going to preemptively take him off because you're considering it?
Joe
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