› Forums › General Melanoma Community › Clinical Trial Acceptance Criteria–Advice/Comments
- This topic has 33 replies, 5 voices, and was last updated 11 years, 4 months ago by
Charlie S.
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- November 28, 2012 at 8:23 pm
Hello Everyone. Just wanted to ask for comments/experiences from my friends on Clinical trials..any trial for Stage IV. Trying to get my brother on a trial but I am afraid his weak state will be a factor that they will exclude him. Have any of you or know of anyone that particicpated despite the ECOG/Perfomance status….He is able to do daily activities of daily living…shower, eat, hygiene, dressing himself….BUT…not able to walk fo long period of time. Just going for his appts.
Hello Everyone. Just wanted to ask for comments/experiences from my friends on Clinical trials..any trial for Stage IV. Trying to get my brother on a trial but I am afraid his weak state will be a factor that they will exclude him. Have any of you or know of anyone that particicpated despite the ECOG/Perfomance status….He is able to do daily activities of daily living…shower, eat, hygiene, dressing himself….BUT…not able to walk fo long period of time. Just going for his appts. is tuff and exhausts him. Also, most tell me the trials are easier to handle than doing chemo. They experienced less side effects—lethargy, fatigue..etc. Were you at the worst stage of this" beast of a disease " and still got accepted into a trial.
Thanks for your time and comments. You all make this nightmare that I am living easier by your help.
THANK YOU !!!!!!!!!!
Susan
- Replies
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- November 28, 2012 at 10:51 pm
Susan:
Trials are set up with strict criteria, but often with some wiggle room. This will very much depend on the trial, the center where the trial is being conducted, and the investigator on the trial. I would certainly push for it.
Regarding trials being easier to handle, unfortunately there are no clear guidelines. Sometimes they are, and sometimes they aren't. I will say that a lot of exciting progress is being made in the context of trials. You may know that two new drugs were approved last year. Since then, trials of other drugs or of combinations of drugs have, in early studies, shown improvement over the drugs that are already approved. Certainly it is worth discussing with your brother's treatment team.
Tim–MRF
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- November 28, 2012 at 10:51 pm
Susan:
Trials are set up with strict criteria, but often with some wiggle room. This will very much depend on the trial, the center where the trial is being conducted, and the investigator on the trial. I would certainly push for it.
Regarding trials being easier to handle, unfortunately there are no clear guidelines. Sometimes they are, and sometimes they aren't. I will say that a lot of exciting progress is being made in the context of trials. You may know that two new drugs were approved last year. Since then, trials of other drugs or of combinations of drugs have, in early studies, shown improvement over the drugs that are already approved. Certainly it is worth discussing with your brother's treatment team.
Tim–MRF
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- November 28, 2012 at 10:51 pm
Susan:
Trials are set up with strict criteria, but often with some wiggle room. This will very much depend on the trial, the center where the trial is being conducted, and the investigator on the trial. I would certainly push for it.
Regarding trials being easier to handle, unfortunately there are no clear guidelines. Sometimes they are, and sometimes they aren't. I will say that a lot of exciting progress is being made in the context of trials. You may know that two new drugs were approved last year. Since then, trials of other drugs or of combinations of drugs have, in early studies, shown improvement over the drugs that are already approved. Certainly it is worth discussing with your brother's treatment team.
Tim–MRF
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- November 29, 2012 at 2:48 am
Raz ma-tazz aside, here is the deal with clinical trials: They all have excluisions, but there is no one universal exclusion that extends to every trial.
Some trials exclude those with a history of brain mets; some trials want those that have not responded to a prior specific approved therapy; or a prior clinical trial.; some want a timeline from one trial or treatment to another. some want a specific cell type, some want a specific genotype, some want a certain melanoma mutation(or not), some want the presentation of or the abense of a particular scientific marker….the point is all trials have specific parameters for admission /exclusion and no one factor alone says one is in or out.
Reading closely, all trials in their abstract have exclusions. Read them.
All that aside, if you could post the particulars of your brothers present status, that would be helpfull for any of us to provide guidance, because patient status is everything when it comes to trials.
And to answer one of your questions' just being in poor health due to complications of melanoma……………….to an extent; is not by itself an automatic exclusion for clinical trials.
With caution………….if one wants a quick read……….again, with caution……….give the clinical trial nurse line a call at NIH for a quick sort of what he does and does not qualify for.
Hope this helps
Cheers,
Charlie S
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- November 29, 2012 at 7:03 pm
Charlie, I was so happy that you responded to my post. I have read your posts and see everyone appreciates your guidence, advice, and motivating us all to fight. These trials are soooo confusing. I printed out someones posts how these trials are broken down. I have read many of them and do see how some want HLA antigen for the combo PD1 and vaccine trial like at Moffett.
I know these trials are not a walk in the park but chemo is not either and his Onc. is not recommending it anymore. She want s him to build up his strength but I feel time is of the essence with this beast mel.
Sorry I did not make up a profile..keep on meaning to do it and when I think about it as I am going to type it….I get a reality check on how bad it is…then I stop and block it out. I see yours and say…wow and feel like a dope thinking like this.
I will try to put all history…sorry if too much. He is 46 now. Braf-neg and ckit pos.
Dx. 2/2010. Primary Acral Lent. Primary site Lft. Heel. Stage 3 at diagnosis. ulcerated. size 1.5mm. Had sent. node bx. next and one node for micro. mets 1% of the node. then had groin dissection.–clear. few months later pet shows new massin left pelvis, surgery performed and more nodes taken..mass obviously was mel. but nodes neg. Had a few more sateliites pop up on left lower extremity…radiation took care of that. now 12/2011…had yervoy but failed. 2/2012 pet shows mets lungs, abdominal nodes, another mass near area which was excised which had rad. tx but did nothing. Started temodor2012, that also did nothing then they added abraxane, did nothing further growth in mets. Then in about july doc. changed to carbo and nexavar….all decreased but the monster mass in the abdomen stayed the same. Now in 11/2012. had appt. and doc felt mass got bigger on exam. chemo on hold. last appt was few days ago..no more chemo. Doc really not pushing for a trial and did not in the past. Probably thought chemo would work. So here I am trying to see if a trial will help so we know if everything has been done. His physical state…He lost a lot of wt. 50 lbs since stage 4 in 2/2012. can't run marathons or chase after his 4 young kids because of the left leg having radiation/etc. He is weak but has good appetite, can do ADL's, works on the computer, reads and gets PT at home. I will say walking around house or just going to the car for his appt in NYC is tuff and exhausts him. He is not wheelchair or bed bound. No scans have been done since 6/2012. I am hoping the brain is still clear. He is not ready to give up but I think he feels the docs are and suggested hospice. If we don't make a trial and nature takes its course then at least we know all was done that could be done.
I hope this was not too much to read.
I have been told mixed comments about NIH….and don't know what to make of them. I don't know where I will start first…probably sloan since we are in NYC but will travel outside our state if need be. I was going to call NIH but thought would wait.
You are a help and thanks for your time and reading my long post…
Regards
Susan
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- November 29, 2012 at 7:03 pm
Charlie, I was so happy that you responded to my post. I have read your posts and see everyone appreciates your guidence, advice, and motivating us all to fight. These trials are soooo confusing. I printed out someones posts how these trials are broken down. I have read many of them and do see how some want HLA antigen for the combo PD1 and vaccine trial like at Moffett.
I know these trials are not a walk in the park but chemo is not either and his Onc. is not recommending it anymore. She want s him to build up his strength but I feel time is of the essence with this beast mel.
Sorry I did not make up a profile..keep on meaning to do it and when I think about it as I am going to type it….I get a reality check on how bad it is…then I stop and block it out. I see yours and say…wow and feel like a dope thinking like this.
I will try to put all history…sorry if too much. He is 46 now. Braf-neg and ckit pos.
Dx. 2/2010. Primary Acral Lent. Primary site Lft. Heel. Stage 3 at diagnosis. ulcerated. size 1.5mm. Had sent. node bx. next and one node for micro. mets 1% of the node. then had groin dissection.–clear. few months later pet shows new massin left pelvis, surgery performed and more nodes taken..mass obviously was mel. but nodes neg. Had a few more sateliites pop up on left lower extremity…radiation took care of that. now 12/2011…had yervoy but failed. 2/2012 pet shows mets lungs, abdominal nodes, another mass near area which was excised which had rad. tx but did nothing. Started temodor2012, that also did nothing then they added abraxane, did nothing further growth in mets. Then in about july doc. changed to carbo and nexavar….all decreased but the monster mass in the abdomen stayed the same. Now in 11/2012. had appt. and doc felt mass got bigger on exam. chemo on hold. last appt was few days ago..no more chemo. Doc really not pushing for a trial and did not in the past. Probably thought chemo would work. So here I am trying to see if a trial will help so we know if everything has been done. His physical state…He lost a lot of wt. 50 lbs since stage 4 in 2/2012. can't run marathons or chase after his 4 young kids because of the left leg having radiation/etc. He is weak but has good appetite, can do ADL's, works on the computer, reads and gets PT at home. I will say walking around house or just going to the car for his appt in NYC is tuff and exhausts him. He is not wheelchair or bed bound. No scans have been done since 6/2012. I am hoping the brain is still clear. He is not ready to give up but I think he feels the docs are and suggested hospice. If we don't make a trial and nature takes its course then at least we know all was done that could be done.
I hope this was not too much to read.
I have been told mixed comments about NIH….and don't know what to make of them. I don't know where I will start first…probably sloan since we are in NYC but will travel outside our state if need be. I was going to call NIH but thought would wait.
You are a help and thanks for your time and reading my long post…
Regards
Susan
-
- November 29, 2012 at 7:03 pm
Charlie, I was so happy that you responded to my post. I have read your posts and see everyone appreciates your guidence, advice, and motivating us all to fight. These trials are soooo confusing. I printed out someones posts how these trials are broken down. I have read many of them and do see how some want HLA antigen for the combo PD1 and vaccine trial like at Moffett.
I know these trials are not a walk in the park but chemo is not either and his Onc. is not recommending it anymore. She want s him to build up his strength but I feel time is of the essence with this beast mel.
Sorry I did not make up a profile..keep on meaning to do it and when I think about it as I am going to type it….I get a reality check on how bad it is…then I stop and block it out. I see yours and say…wow and feel like a dope thinking like this.
I will try to put all history…sorry if too much. He is 46 now. Braf-neg and ckit pos.
Dx. 2/2010. Primary Acral Lent. Primary site Lft. Heel. Stage 3 at diagnosis. ulcerated. size 1.5mm. Had sent. node bx. next and one node for micro. mets 1% of the node. then had groin dissection.–clear. few months later pet shows new massin left pelvis, surgery performed and more nodes taken..mass obviously was mel. but nodes neg. Had a few more sateliites pop up on left lower extremity…radiation took care of that. now 12/2011…had yervoy but failed. 2/2012 pet shows mets lungs, abdominal nodes, another mass near area which was excised which had rad. tx but did nothing. Started temodor2012, that also did nothing then they added abraxane, did nothing further growth in mets. Then in about july doc. changed to carbo and nexavar….all decreased but the monster mass in the abdomen stayed the same. Now in 11/2012. had appt. and doc felt mass got bigger on exam. chemo on hold. last appt was few days ago..no more chemo. Doc really not pushing for a trial and did not in the past. Probably thought chemo would work. So here I am trying to see if a trial will help so we know if everything has been done. His physical state…He lost a lot of wt. 50 lbs since stage 4 in 2/2012. can't run marathons or chase after his 4 young kids because of the left leg having radiation/etc. He is weak but has good appetite, can do ADL's, works on the computer, reads and gets PT at home. I will say walking around house or just going to the car for his appt in NYC is tuff and exhausts him. He is not wheelchair or bed bound. No scans have been done since 6/2012. I am hoping the brain is still clear. He is not ready to give up but I think he feels the docs are and suggested hospice. If we don't make a trial and nature takes its course then at least we know all was done that could be done.
I hope this was not too much to read.
I have been told mixed comments about NIH….and don't know what to make of them. I don't know where I will start first…probably sloan since we are in NYC but will travel outside our state if need be. I was going to call NIH but thought would wait.
You are a help and thanks for your time and reading my long post…
Regards
Susan
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- November 29, 2012 at 11:38 pm
It sounds like your brother has a very aggressive tumor and has been through a lot in the last 3 years. He sounds like a great guy! Given all that he has been through, does he really want to try another treatment? More than one poster here has said that the stress of all the doctors and hospitals and anxiety and side effects does more harm than good. I hope that you are able to have a quiet and compassionate conversation with him before you go much farther in your quest to find clinical trials.
However, if he does want to keep trying, I would suggest you look into the Phase 1 clinical trial called "Study to Assess the Safety, Tolerability, and Pharmacokinetics of AMP-224 in Patients With Advanced Cancer:" You can see the study details at: http://www.melanoma.org/community/mpip-melanoma-patients-information-page/gskamplimmune-pd1-trial
You're a good sister, and I wish you both the best.
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- November 29, 2012 at 11:38 pm
It sounds like your brother has a very aggressive tumor and has been through a lot in the last 3 years. He sounds like a great guy! Given all that he has been through, does he really want to try another treatment? More than one poster here has said that the stress of all the doctors and hospitals and anxiety and side effects does more harm than good. I hope that you are able to have a quiet and compassionate conversation with him before you go much farther in your quest to find clinical trials.
However, if he does want to keep trying, I would suggest you look into the Phase 1 clinical trial called "Study to Assess the Safety, Tolerability, and Pharmacokinetics of AMP-224 in Patients With Advanced Cancer:" You can see the study details at: http://www.melanoma.org/community/mpip-melanoma-patients-information-page/gskamplimmune-pd1-trial
You're a good sister, and I wish you both the best.
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- November 29, 2012 at 11:38 pm
It sounds like your brother has a very aggressive tumor and has been through a lot in the last 3 years. He sounds like a great guy! Given all that he has been through, does he really want to try another treatment? More than one poster here has said that the stress of all the doctors and hospitals and anxiety and side effects does more harm than good. I hope that you are able to have a quiet and compassionate conversation with him before you go much farther in your quest to find clinical trials.
However, if he does want to keep trying, I would suggest you look into the Phase 1 clinical trial called "Study to Assess the Safety, Tolerability, and Pharmacokinetics of AMP-224 in Patients With Advanced Cancer:" You can see the study details at: http://www.melanoma.org/community/mpip-melanoma-patients-information-page/gskamplimmune-pd1-trial
You're a good sister, and I wish you both the best.
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- December 1, 2012 at 1:43 am
Please don't beat yourself up or apologize. That is not necessary.
Even iwithout knowing, you fleshed out four things that are important, specific and require consideration: Acral Melanoma, C-Kit Positive , Chemotherapy.and Gleevec
Now bear in mind that what follows is only an opinion, and just like rectums…….everybody has one.
One: Acral melanoma is a subtype of Melanoma, and as a result of its' unique molecular makeup, has a fewer percentage of presentations than other subtypes and does not respond well to treatment as the more other "mainstream" subtypes of Melanoma.
Two: Acral Melanoma often ,(but not always) it has been discovered harbors , the C-Kit Mutation.
Three: In general, with exceptions, Melanoma of any stripe respond poorly to most Chemotherapy approaches.
Four: It has been shown in clinical settings and patient outcomes, that the C-Kit mutation/pathway DOES in many instances (but not all) respond to Gleevec.
So, rather than chase clinical trials, how about looking at Gleevec?
At this point, I will defer to my pal Jerry Ellis. (Jerryfromfuquay?)
Jerry, whom I first "met" here online some years ago and later met in person, has the C-Kit Mutation and has been on Gleevec for sometime. Prior to Gleevec, he had considerable disease involvement, and through giant hoops jumped, finally was able to find his C-Kit mutation and a guided solution; although not disease free, he IS managing his diesease and living his life.
Without speaking for him, I can tell you it was a long and hard road for him to find a solution; but he DID find it in partnership with his selected team at the University of Virginia.
So, in closing, look hard, exploit and exhaust all of the at the C-Kit mutation and Gleevec options now working and available first before chasing down trials; and certainly before even placing chemotherapy in the decision tree.
With that, HELLOOOOOOOOOOOOOOOOOO Jerry; time for you to enter stage right !
Hope this helps.
Charlie S
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- December 1, 2012 at 1:43 am
Please don't beat yourself up or apologize. That is not necessary.
Even iwithout knowing, you fleshed out four things that are important, specific and require consideration: Acral Melanoma, C-Kit Positive , Chemotherapy.and Gleevec
Now bear in mind that what follows is only an opinion, and just like rectums…….everybody has one.
One: Acral melanoma is a subtype of Melanoma, and as a result of its' unique molecular makeup, has a fewer percentage of presentations than other subtypes and does not respond well to treatment as the more other "mainstream" subtypes of Melanoma.
Two: Acral Melanoma often ,(but not always) it has been discovered harbors , the C-Kit Mutation.
Three: In general, with exceptions, Melanoma of any stripe respond poorly to most Chemotherapy approaches.
Four: It has been shown in clinical settings and patient outcomes, that the C-Kit mutation/pathway DOES in many instances (but not all) respond to Gleevec.
So, rather than chase clinical trials, how about looking at Gleevec?
At this point, I will defer to my pal Jerry Ellis. (Jerryfromfuquay?)
Jerry, whom I first "met" here online some years ago and later met in person, has the C-Kit Mutation and has been on Gleevec for sometime. Prior to Gleevec, he had considerable disease involvement, and through giant hoops jumped, finally was able to find his C-Kit mutation and a guided solution; although not disease free, he IS managing his diesease and living his life.
Without speaking for him, I can tell you it was a long and hard road for him to find a solution; but he DID find it in partnership with his selected team at the University of Virginia.
So, in closing, look hard, exploit and exhaust all of the at the C-Kit mutation and Gleevec options now working and available first before chasing down trials; and certainly before even placing chemotherapy in the decision tree.
With that, HELLOOOOOOOOOOOOOOOOOO Jerry; time for you to enter stage right !
Hope this helps.
Charlie S
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- December 3, 2012 at 3:35 pm
Thank you again Charlie. I have read many of Jerry's posts and he too has been helpful. I knew he was on Gleevac.
My only concern is that my brother was on nexavar with carbo for about 3 mths and now stopped. I am no expert on these drugs but they are in the same class??? Don't know if one is preferred over the other or have additional compunds and they differ that way.
Also, over the past few days he has been very weak. His nutrition is a big factor and its the cause of his fatigue and weakness big time on top of the cancer. He needs to get pumped up.
I appreciate your return comment and Jerry's. May pick your brain again after the posts…
Thank you !!!!!!!!
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- December 3, 2012 at 3:35 pm
Thank you again Charlie. I have read many of Jerry's posts and he too has been helpful. I knew he was on Gleevac.
My only concern is that my brother was on nexavar with carbo for about 3 mths and now stopped. I am no expert on these drugs but they are in the same class??? Don't know if one is preferred over the other or have additional compunds and they differ that way.
Also, over the past few days he has been very weak. His nutrition is a big factor and its the cause of his fatigue and weakness big time on top of the cancer. He needs to get pumped up.
I appreciate your return comment and Jerry's. May pick your brain again after the posts…
Thank you !!!!!!!!
-
- December 3, 2012 at 3:35 pm
Thank you again Charlie. I have read many of Jerry's posts and he too has been helpful. I knew he was on Gleevac.
My only concern is that my brother was on nexavar with carbo for about 3 mths and now stopped. I am no expert on these drugs but they are in the same class??? Don't know if one is preferred over the other or have additional compunds and they differ that way.
Also, over the past few days he has been very weak. His nutrition is a big factor and its the cause of his fatigue and weakness big time on top of the cancer. He needs to get pumped up.
I appreciate your return comment and Jerry's. May pick your brain again after the posts…
Thank you !!!!!!!!
-
- December 1, 2012 at 1:43 am
Please don't beat yourself up or apologize. That is not necessary.
Even iwithout knowing, you fleshed out four things that are important, specific and require consideration: Acral Melanoma, C-Kit Positive , Chemotherapy.and Gleevec
Now bear in mind that what follows is only an opinion, and just like rectums…….everybody has one.
One: Acral melanoma is a subtype of Melanoma, and as a result of its' unique molecular makeup, has a fewer percentage of presentations than other subtypes and does not respond well to treatment as the more other "mainstream" subtypes of Melanoma.
Two: Acral Melanoma often ,(but not always) it has been discovered harbors , the C-Kit Mutation.
Three: In general, with exceptions, Melanoma of any stripe respond poorly to most Chemotherapy approaches.
Four: It has been shown in clinical settings and patient outcomes, that the C-Kit mutation/pathway DOES in many instances (but not all) respond to Gleevec.
So, rather than chase clinical trials, how about looking at Gleevec?
At this point, I will defer to my pal Jerry Ellis. (Jerryfromfuquay?)
Jerry, whom I first "met" here online some years ago and later met in person, has the C-Kit Mutation and has been on Gleevec for sometime. Prior to Gleevec, he had considerable disease involvement, and through giant hoops jumped, finally was able to find his C-Kit mutation and a guided solution; although not disease free, he IS managing his diesease and living his life.
Without speaking for him, I can tell you it was a long and hard road for him to find a solution; but he DID find it in partnership with his selected team at the University of Virginia.
So, in closing, look hard, exploit and exhaust all of the at the C-Kit mutation and Gleevec options now working and available first before chasing down trials; and certainly before even placing chemotherapy in the decision tree.
With that, HELLOOOOOOOOOOOOOOOOOO Jerry; time for you to enter stage right !
Hope this helps.
Charlie S
-
- November 29, 2012 at 2:48 am
Raz ma-tazz aside, here is the deal with clinical trials: They all have excluisions, but there is no one universal exclusion that extends to every trial.
Some trials exclude those with a history of brain mets; some trials want those that have not responded to a prior specific approved therapy; or a prior clinical trial.; some want a timeline from one trial or treatment to another. some want a specific cell type, some want a specific genotype, some want a certain melanoma mutation(or not), some want the presentation of or the abense of a particular scientific marker….the point is all trials have specific parameters for admission /exclusion and no one factor alone says one is in or out.
Reading closely, all trials in their abstract have exclusions. Read them.
All that aside, if you could post the particulars of your brothers present status, that would be helpfull for any of us to provide guidance, because patient status is everything when it comes to trials.
And to answer one of your questions' just being in poor health due to complications of melanoma……………….to an extent; is not by itself an automatic exclusion for clinical trials.
With caution………….if one wants a quick read……….again, with caution……….give the clinical trial nurse line a call at NIH for a quick sort of what he does and does not qualify for.
Hope this helps
Cheers,
Charlie S
-
- November 29, 2012 at 2:48 am
Raz ma-tazz aside, here is the deal with clinical trials: They all have excluisions, but there is no one universal exclusion that extends to every trial.
Some trials exclude those with a history of brain mets; some trials want those that have not responded to a prior specific approved therapy; or a prior clinical trial.; some want a timeline from one trial or treatment to another. some want a specific cell type, some want a specific genotype, some want a certain melanoma mutation(or not), some want the presentation of or the abense of a particular scientific marker….the point is all trials have specific parameters for admission /exclusion and no one factor alone says one is in or out.
Reading closely, all trials in their abstract have exclusions. Read them.
All that aside, if you could post the particulars of your brothers present status, that would be helpfull for any of us to provide guidance, because patient status is everything when it comes to trials.
And to answer one of your questions' just being in poor health due to complications of melanoma……………….to an extent; is not by itself an automatic exclusion for clinical trials.
With caution………….if one wants a quick read……….again, with caution……….give the clinical trial nurse line a call at NIH for a quick sort of what he does and does not qualify for.
Hope this helps
Cheers,
Charlie S
-
- November 29, 2012 at 8:33 am
I know of a person excluded from a anti pd 1 trial because they were in so much pain they arrived in a wheel chair.
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- November 29, 2012 at 6:15 pm
Thank you Lynn. He is not even close to that…Thank God. I appreciate your post to me and all the others re: Moffett. I am actually going to email Dr. Weber. I know you have posted many times that he accepts emails and returns them. Thank you again.
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- November 29, 2012 at 6:15 pm
Thank you Lynn. He is not even close to that…Thank God. I appreciate your post to me and all the others re: Moffett. I am actually going to email Dr. Weber. I know you have posted many times that he accepts emails and returns them. Thank you again.
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- November 29, 2012 at 6:15 pm
Thank you Lynn. He is not even close to that…Thank God. I appreciate your post to me and all the others re: Moffett. I am actually going to email Dr. Weber. I know you have posted many times that he accepts emails and returns them. Thank you again.
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