› Forums › General Melanoma Community › removed from trial
- This topic has 22 replies, 7 voices, and was last updated 12 years, 9 months ago by
FormerCaregiver.
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- May 8, 2011 at 1:14 am
We are so scared, tired, and besdie ourselves. Derek was removed from his trial on Thursday after 5 weeks – P13K Mek inhibitor – Nras positive, BRAF negative). He has been feeling great, decreased his pain meds, lots of energy, etc. His blood tests this week showed his CV levels were at a critical level (breakdown of muscle enzyme). ABout 2700 and at 2400 you are off the trial. His has gone up before to somewhat high levels but had been decreasing and levels were stable.
We are so scared, tired, and besdie ourselves. Derek was removed from his trial on Thursday after 5 weeks – P13K Mek inhibitor – Nras positive, BRAF negative). He has been feeling great, decreased his pain meds, lots of energy, etc. His blood tests this week showed his CV levels were at a critical level (breakdown of muscle enzyme). ABout 2700 and at 2400 you are off the trial. His has gone up before to somewhat high levels but had been decreasing and levels were stable.
CV levels have gone up in other patients as well so we know it is a side effect of the drug but they also can rise due to extreme physical activity and Derek, in an effort to keep busy and get things done, layed flooring with my dad every day for 4 days prior to this appt and was exhausted at the end.
Our Drs are trying to plead our case to get us back on thinking that his levels shot up so high due to the physical labour – will find out Monday – is there anything we can do in the meantime. We did believe in this treatment very much.
What can I do? If he has a cat scan is it ethical to take him off if it is working? Can we do anything? We don't have the same options in canada and derek will not spend thousands of dollars travelling to the states and "take that away from his kids" – we can try ipi and IL-2 – but don't want to be taken off this trial…
I am due to have a baby in 3 weeks and cannot afford to be looking now for a new trial – we NEED to stay on this one.
Any suggestions please – Terra
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- May 8, 2011 at 3:00 am
Terra sorry to hear about that, maybe re do the bloods after he has a week of doing nothing but rest you never know it might be enough to show improvement. Hopefully he can restart but if not your other options sound reasonable. There is another a few on mpip have been taliking about Elsai E7080, maybe put that in your arsenal as another backup.
Best wishes
James
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- May 8, 2011 at 3:00 am
Terra sorry to hear about that, maybe re do the bloods after he has a week of doing nothing but rest you never know it might be enough to show improvement. Hopefully he can restart but if not your other options sound reasonable. There is another a few on mpip have been taliking about Elsai E7080, maybe put that in your arsenal as another backup.
Best wishes
James
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- May 8, 2011 at 5:20 am
Sorry that Derek has been removed from the trial. You mention extreme physical activity, and I
understand your husband's attitude in wanting to keep busy and to get things done. I used to be a
fitness fanatic and had the same attitude, but I eventually found out that we are only human and
are definitely not bulletproof. When one has any sort of illness, I learnt that one's energy
should be directed in a way as to maximise the chance that one's health will improve.Clinical trials often have strict conditions associated with them. Remember that many drugs used
in trials are unproven and experimental, and the doctors want to make sure that they don't do
more harm than good.I have just read your husband's profile, and it says that he is stage 3. Is that still the case?
I know that I haven't answered all your questions, but any new treatment options will depend
on what the doctors say on Monday. So, can you let us know?If you have any further concerns please don't hesitate to post.
Hope this helps.
Frank from Australia
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- May 8, 2011 at 11:35 am
I have not updated his profile in a long time. He progressed to satge 4 last spring and had lung surgery in June and then again in January. He has mes in his liver, bone, muscle, and 1 in kidney. He has previously done interferon, and chemo. I guess after this it is only ipi and IL-2 unless he changes his mind at some point and is willing to go down to states. We see the dr. again on monday and they will tell us if they got him back on – if not we will meet later in week with onc and decide what or where to go. Thank you foer the advice – both of you, and yes Derek must begin to understand to take care and do things at a normal pace. I know he is trying to get things accomplished for his family in case nothing works and before it is too late – but we would rather have him.
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- May 8, 2011 at 11:48 am
Hi Terra,
I too was ousted from a trial because of suspicious activity in my lungs. I'm waiting to find out if i've ventured into Stage 4 and if so, my oncologist has suggested IL-21. I'm in Toronto and both he and the Dr from the clinical trial in Montreal both suggested IL-21. I've only heard of IL-2, but apparently this is new and they didn't mention a clinical trial to me – just the drug. Perhaps this is something that you can mention to the oncologist.
I know how scared you are feeling right now, especially when you are due to give birth. I have an 18 month old daughter and we just bought a house a month ago, so this news has devastated me. Please don't ever give up hope. Your husband may be allowed to go back in the trial (after more blood work) or something else may be given to him which shows tremendous success.
Lisa
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- May 8, 2011 at 11:48 am
Hi Terra,
I too was ousted from a trial because of suspicious activity in my lungs. I'm waiting to find out if i've ventured into Stage 4 and if so, my oncologist has suggested IL-21. I'm in Toronto and both he and the Dr from the clinical trial in Montreal both suggested IL-21. I've only heard of IL-2, but apparently this is new and they didn't mention a clinical trial to me – just the drug. Perhaps this is something that you can mention to the oncologist.
I know how scared you are feeling right now, especially when you are due to give birth. I have an 18 month old daughter and we just bought a house a month ago, so this news has devastated me. Please don't ever give up hope. Your husband may be allowed to go back in the trial (after more blood work) or something else may be given to him which shows tremendous success.
Lisa
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- May 8, 2011 at 11:35 am
I have not updated his profile in a long time. He progressed to satge 4 last spring and had lung surgery in June and then again in January. He has mes in his liver, bone, muscle, and 1 in kidney. He has previously done interferon, and chemo. I guess after this it is only ipi and IL-2 unless he changes his mind at some point and is willing to go down to states. We see the dr. again on monday and they will tell us if they got him back on – if not we will meet later in week with onc and decide what or where to go. Thank you foer the advice – both of you, and yes Derek must begin to understand to take care and do things at a normal pace. I know he is trying to get things accomplished for his family in case nothing works and before it is too late – but we would rather have him.
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- May 8, 2011 at 5:20 am
Sorry that Derek has been removed from the trial. You mention extreme physical activity, and I
understand your husband's attitude in wanting to keep busy and to get things done. I used to be a
fitness fanatic and had the same attitude, but I eventually found out that we are only human and
are definitely not bulletproof. When one has any sort of illness, I learnt that one's energy
should be directed in a way as to maximise the chance that one's health will improve.Clinical trials often have strict conditions associated with them. Remember that many drugs used
in trials are unproven and experimental, and the doctors want to make sure that they don't do
more harm than good.I have just read your husband's profile, and it says that he is stage 3. Is that still the case?
I know that I haven't answered all your questions, but any new treatment options will depend
on what the doctors say on Monday. So, can you let us know?If you have any further concerns please don't hesitate to post.
Hope this helps.
Frank from Australia
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- May 8, 2011 at 6:02 pm
Hey Terra,
Just wanted to let you know that they kicked Jason off the trial for 3 weeks and after Dr. Bedard and Karen talked with the medical monitor for the study they did let him back on, even though it was against the trail protocol.
We found it incredibly frustrating that the Dr. wasn't more positive about getting him back on the trial but in the end they did, hold tight and hopefully Derek's bloodwork will be good on Monday.
Good luck, my thoughts are with you guys…
Tell Derek to take it easy and not push himself!
Emily
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- May 8, 2011 at 6:02 pm
Hey Terra,
Just wanted to let you know that they kicked Jason off the trial for 3 weeks and after Dr. Bedard and Karen talked with the medical monitor for the study they did let him back on, even though it was against the trail protocol.
We found it incredibly frustrating that the Dr. wasn't more positive about getting him back on the trial but in the end they did, hold tight and hopefully Derek's bloodwork will be good on Monday.
Good luck, my thoughts are with you guys…
Tell Derek to take it easy and not push himself!
Emily
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- May 10, 2011 at 3:18 am
Unfortuantely, we did not get an answer today, we did blood work, and the cv levels are going down, but the company is likely going to only look at the fact that they went over the max. Dr. Bedard does not think we are going to get back in. Hoping to hear for sure on thursday and then meet with our onc and see about another option, most likely ipi, as he is braf negative.
Thanks for your suggestions and hopefully he will be on something else before this baby comes. I really hoped that we would not ever have to be,.
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- May 10, 2011 at 9:15 am
Thanks for the update. It really sounds like you are caught up in red tape at the moment. Ipi
would be a great alternative option, and could probably be more effective.I hope that you hear some better news on Thursday.
Frank from Australia
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- July 18, 2011 at 1:31 am
Hi Frank from Australia
We are on the Sunshine Coast. My husband has stage IV metastatic melanoma. Surgery is not an option. We are looking for medical oncologists in Brisbane or Queensland with experience in administering ipi. Trials of drugs such as E7080 seem non existent in our state. Yervoy has only just been approved.
Any suggestions?
Thanks
Frances from Queensland
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- July 18, 2011 at 1:31 am
Hi Frank from Australia
We are on the Sunshine Coast. My husband has stage IV metastatic melanoma. Surgery is not an option. We are looking for medical oncologists in Brisbane or Queensland with experience in administering ipi. Trials of drugs such as E7080 seem non existent in our state. Yervoy has only just been approved.
Any suggestions?
Thanks
Frances from Queensland
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- July 18, 2011 at 1:32 am
Hi Frank from Australia
We are on the Sunshine Coast. My husband has stage IV metastatic melanoma. Surgery is not an option. We are looking for medical oncologists in Brisbane or Queensland with experience in administering ipi. Trials of drugs such as E7080 seem non existent in our state. Yervoy has only just been approved.
Any suggestions?
Thanks
Frances from Queensland
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- July 18, 2011 at 7:00 am
Hi Frances, I am from Melbourne. If you are certain that surgery is not possible, then
systemic treatments certainly need to be looked at.As Yervoy (ipi) has only very recently been approved by the TGA here, there won't be many
medical oncologists who have experience with it. Therefore, you will need to ask your
current oncologist if they know anyone who can help you. Perhaps they might be able to
arrange something regarding Yervoy treatment? See:
http://www.melanomapatients.org/content/view/188743/217/Here is a list of the relevant clinical trials that could be considered:
http://www.clinicaltrials.gov/ct2/results?term=melanoma&recr=Open&rslt=&type=&cond=&intr=&outc=&lead=&spons=&id=&state1=&cntry1=PA%3AAU&state2=&cntry2=&state3=&cntry3=&locn=&gndr=&rcv_s=&rcv_e=&lup_s=&lup_e=Here are the details of an E7080 trial:
http://www.clinicaltrials.gov/ct2/show/NCT01136967?term=melanoma&recr=Open&cntry1=PA%3AAU&rank=10
(It looks like some travel will be needed if you are interested in this trial).I encourage you to complete the profile page for your husband, as this will help us to
help you better.Best wishes
Frank from Australia
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- July 18, 2011 at 7:00 am
Hi Frances, I am from Melbourne. If you are certain that surgery is not possible, then
systemic treatments certainly need to be looked at.As Yervoy (ipi) has only very recently been approved by the TGA here, there won't be many
medical oncologists who have experience with it. Therefore, you will need to ask your
current oncologist if they know anyone who can help you. Perhaps they might be able to
arrange something regarding Yervoy treatment? See:
http://www.melanomapatients.org/content/view/188743/217/Here is a list of the relevant clinical trials that could be considered:
http://www.clinicaltrials.gov/ct2/results?term=melanoma&recr=Open&rslt=&type=&cond=&intr=&outc=&lead=&spons=&id=&state1=&cntry1=PA%3AAU&state2=&cntry2=&state3=&cntry3=&locn=&gndr=&rcv_s=&rcv_e=&lup_s=&lup_e=Here are the details of an E7080 trial:
http://www.clinicaltrials.gov/ct2/show/NCT01136967?term=melanoma&recr=Open&cntry1=PA%3AAU&rank=10
(It looks like some travel will be needed if you are interested in this trial).I encourage you to complete the profile page for your husband, as this will help us to
help you better.Best wishes
Frank from Australia
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- July 18, 2011 at 1:32 am
Hi Frank from Australia
We are on the Sunshine Coast. My husband has stage IV metastatic melanoma. Surgery is not an option. We are looking for medical oncologists in Brisbane or Queensland with experience in administering ipi. Trials of drugs such as E7080 seem non existent in our state. Yervoy has only just been approved.
Any suggestions?
Thanks
Frances from Queensland
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- May 10, 2011 at 9:15 am
Thanks for the update. It really sounds like you are caught up in red tape at the moment. Ipi
would be a great alternative option, and could probably be more effective.I hope that you hear some better news on Thursday.
Frank from Australia
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- May 10, 2011 at 3:18 am
Unfortuantely, we did not get an answer today, we did blood work, and the cv levels are going down, but the company is likely going to only look at the fact that they went over the max. Dr. Bedard does not think we are going to get back in. Hoping to hear for sure on thursday and then meet with our onc and see about another option, most likely ipi, as he is braf negative.
Thanks for your suggestions and hopefully he will be on something else before this baby comes. I really hoped that we would not ever have to be,.
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- July 18, 2011 at 2:36 am
I was wondering when IL-2 became available in Canada? IThe administration requires hospitalization for a week in a specialed trained ward or in ICU for each of the seperated six weeks of administration. (3 rounds of 2 seperated weeks each.)
IL_2 has been an approved drug in the US since the mid 1990's. and has the best long term response of approved melanoma treatments. It provides long term results (essential considered a cure) for 5% of melanoma patients and a partial response in an additional 15% of melanoma patients. They still don't know why it works on some and not others.
Trial rules are often not ethical, they seldem look at what will keep the patient alive, but more at what will look best in their results. Please urge your doctors to PUSH!
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- July 18, 2011 at 2:36 am
I was wondering when IL-2 became available in Canada? IThe administration requires hospitalization for a week in a specialed trained ward or in ICU for each of the seperated six weeks of administration. (3 rounds of 2 seperated weeks each.)
IL_2 has been an approved drug in the US since the mid 1990's. and has the best long term response of approved melanoma treatments. It provides long term results (essential considered a cure) for 5% of melanoma patients and a partial response in an additional 15% of melanoma patients. They still don't know why it works on some and not others.
Trial rules are often not ethical, they seldem look at what will keep the patient alive, but more at what will look best in their results. Please urge your doctors to PUSH!
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