› Forums › General Melanoma Community › It’s not just the brain mets, it’s the prior seizures and bleeding
- This topic has 12 replies, 5 voices, and was last updated 14 years, 7 months ago by
nickmac56.
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- June 29, 2011 at 12:28 am
The National Cancer Institute at the NIH just told me my wife is ineligible for any trial there. Ever. Their reason was not that there was evidence of active brain mets, or that we had to wait three months from the last brain met treatment. It was that my wife's brain tumors bled (requiring the craniotomy and Cyberknife) and she suffered a seizure as a result of the brain irritation from the Cyberknife. "The seizures make her ineligible".
I think we all know how terrible it is to have this disease and it's metastatic. It's worse if you have brain mets because you are excluded from any clinical trials that I can find, unless you are BRAF positive (which my wife is not). So the hope is that your brain is at least free of disease for long enough after a particular brain met treatment that you can slide into a clinical trial – like the adaptive cell therapy and andeslukin combo.
If anyone knows of any clinical trial that does not have brain met exclusions or this new "no seizure clause" I'd love to know about it.
And for anyone getting Cyberknife or any other form of brain radiation, be sure to get on sufficient anti-seizure meds (not just steroids) prior to and well after the treatment. Because then at least if you are clear for a period of time you at least have a shot at an NCI clinical trial.
We are of course devastated by this news.
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- June 29, 2011 at 1:24 am
Sorry to hear there is nothing available at the moment re:trials for Meagan, Nick. I find it very strange that they have said "ever"?!! Trial inclusion and exclusion criteria are specific to each trial protocol. How can they possibly know that a particular trial exclusion is going to included in the future? I understand that the currently running trials, or those about to recruit, may have those exclusion criteria, but over the course of a few years I have seen some exclusion criteria which were pretty much across the board for all trials, expand to allow certain conditions & drugs etc. to participants.
I sense your frustration. I am able to very much empathise with it. I used to get so disheartened when I'd be reading a trial that looked promising for me, and always find there was at least once exclusion criteria that I met. (Usually they were CNS involvement, stable brain mets for x months, or measurable extracranial disease- every. single. time.)
I think it's time that trials included more cohorts, frankly. That way the outcomes wouldn't affect the outcomes of their more 'preferred patient population', but could still be collecting valuable data, and perhaps allow for sooner discovery of drugs that may indeed provide some positive outcomes for the patients which they don't expect to have a benefit. Adding a couple of cohorts to a study would be far less expensive than designing and running a trial later down the track, surely? But meh- what do I know? I have a head like swiss cheese these days 😛
Wishing you both the best, and hoping you catch a break soon!
Nic
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- June 29, 2011 at 1:24 am
Sorry to hear there is nothing available at the moment re:trials for Meagan, Nick. I find it very strange that they have said "ever"?!! Trial inclusion and exclusion criteria are specific to each trial protocol. How can they possibly know that a particular trial exclusion is going to included in the future? I understand that the currently running trials, or those about to recruit, may have those exclusion criteria, but over the course of a few years I have seen some exclusion criteria which were pretty much across the board for all trials, expand to allow certain conditions & drugs etc. to participants.
I sense your frustration. I am able to very much empathise with it. I used to get so disheartened when I'd be reading a trial that looked promising for me, and always find there was at least once exclusion criteria that I met. (Usually they were CNS involvement, stable brain mets for x months, or measurable extracranial disease- every. single. time.)
I think it's time that trials included more cohorts, frankly. That way the outcomes wouldn't affect the outcomes of their more 'preferred patient population', but could still be collecting valuable data, and perhaps allow for sooner discovery of drugs that may indeed provide some positive outcomes for the patients which they don't expect to have a benefit. Adding a couple of cohorts to a study would be far less expensive than designing and running a trial later down the track, surely? But meh- what do I know? I have a head like swiss cheese these days 😛
Wishing you both the best, and hoping you catch a break soon!
Nic
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- June 29, 2011 at 1:44 pm
Nick,
I'm sorry. Praying someone somewhere will be compassionate and offer your wife treatment that will help.
I wish someone would explain to me, to my satisfaction, why, instead of doing like they've done to your wife and essentially said "sorry.", why they can't instead say, "We normally wouldn't do this, but since there isn't anything currently available that will help, we'll try this..it just might work, even though we think the odds are stacked against it"
You ought to be given the option of saying, "We know the risks and we know it might not help but we're willing to take that chance."
They're making advances all the time, hold on to hope.
Lord, in Your mercy. In Your mercy, Lord. Amen.
Grace and peace,
Carol
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- June 29, 2011 at 1:44 pm
Nick,
I'm sorry. Praying someone somewhere will be compassionate and offer your wife treatment that will help.
I wish someone would explain to me, to my satisfaction, why, instead of doing like they've done to your wife and essentially said "sorry.", why they can't instead say, "We normally wouldn't do this, but since there isn't anything currently available that will help, we'll try this..it just might work, even though we think the odds are stacked against it"
You ought to be given the option of saying, "We know the risks and we know it might not help but we're willing to take that chance."
They're making advances all the time, hold on to hope.
Lord, in Your mercy. In Your mercy, Lord. Amen.
Grace and peace,
Carol
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- June 29, 2011 at 5:07 pm
Have you looked into ACT/TIL trials at MDA and Moffitt to see if they exclude or not based on prior seizures?-
- June 29, 2011 at 9:09 pm
Yes, had an email exchange with Jeff Weber and he explained it's an FDA issue. She's not eligible for anything Moffitt is doing. Have an email into Hsu and have talked to Cancer Care Alliance clinical trial rep who works with Dr. Lee and she is pretty sure they can't take her either, although she is checking. I think Dr. Weber's statement is pretty accurate, "This is certainly a difficut situation".
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- June 30, 2011 at 12:38 am
Are you going to check out the suggestion he gave? "the possibility of biochemotherapy off protocol, using temodar, CDDP, IL-2, IFN and velban, and Kim Margolin or John Thompson at U Washington have lots of experience with this regimen." I never heard of velban…( I did do temodar with radiation and it stopped working after5 or 6 months…)
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- June 30, 2011 at 12:38 am
Are you going to check out the suggestion he gave? "the possibility of biochemotherapy off protocol, using temodar, CDDP, IL-2, IFN and velban, and Kim Margolin or John Thompson at U Washington have lots of experience with this regimen." I never heard of velban…( I did do temodar with radiation and it stopped working after5 or 6 months…)
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- June 30, 2011 at 1:36 am
indeed I am – we will review with our oncologist who knows her – and schedule a consult with her. Dr. Weber's following lines are worrisome though:Protocols are going to be tough given the history of a brain met, the likely post SRS edema causing the need for multiple anti-seizure meds, and the fact that most trials will exclude someone taking so many seizure meds (because the protocol meds may exacerbate the seizures). I would probably call Kim and ask for a consult to discuss this after the next MRI, assuming that there is no or less edema.
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- June 30, 2011 at 1:36 am
indeed I am – we will review with our oncologist who knows her – and schedule a consult with her. Dr. Weber's following lines are worrisome though:Protocols are going to be tough given the history of a brain met, the likely post SRS edema causing the need for multiple anti-seizure meds, and the fact that most trials will exclude someone taking so many seizure meds (because the protocol meds may exacerbate the seizures). I would probably call Kim and ask for a consult to discuss this after the next MRI, assuming that there is no or less edema.
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- June 29, 2011 at 9:09 pm
Yes, had an email exchange with Jeff Weber and he explained it's an FDA issue. She's not eligible for anything Moffitt is doing. Have an email into Hsu and have talked to Cancer Care Alliance clinical trial rep who works with Dr. Lee and she is pretty sure they can't take her either, although she is checking. I think Dr. Weber's statement is pretty accurate, "This is certainly a difficut situation".
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