› Forums › General Melanoma Community › Non US citizens participating in US clinical trials.
- This topic has 48 replies, 7 voices, and was last updated 12 years, 6 months ago by FormerCaregiver.
- Post
-
- August 3, 2011 at 1:46 am
Hi,
I was wondering if anyone knows if it is possible for foreigners (in my case, Australian), to take part in clinical trials held in the US? Has anybody here done this before?
Thanks,
Ben.
(Stage IV)
Hi,
I was wondering if anyone knows if it is possible for foreigners (in my case, Australian), to take part in clinical trials held in the US? Has anybody here done this before?
Thanks,
Ben.
(Stage IV)
- Replies
-
-
- August 3, 2011 at 3:24 am
My husband and I were just at NIH for screening for clinical trials. NIH does accept foreigners. We met another Canadian couple there, and also ValinMtl is down there. You can contact them to see if anything is available, or look up their trials at http://www.clinicaltrials.gov – use National Institute of Health AND melanoma in the search engine, and it will give you a list.
I am not sure of other sponsored trials in the US, but if you look them up on the website there is usually a contact number you could call to ask them.
Best wishes to you,
Maria
-
- August 3, 2011 at 3:38 am
Hi Maria,Thanks for your reply. There is actually a specific trial I was interested in. I did email NIH regarding this (twice), though received no response. Just thought I’d ask this forum if it was indeed possible so I know if it’s worth thinking about it.
Thanks,
Ben. -
- August 6, 2011 at 6:34 am
I wrote Dr Rosenberg and he had his nurse e mail be back just before I was evaluated there for a trial here is another e mail contact at the NIH try it!
June A. Kryk, RN, MS. OCN
Research Nurse Specialist
NCI Surgery Branch
Immunotherapy
10 Center Drive
CRC 2-1730
Bethesda, MD 20892
[email protected]
301-451-1929
301-451-1927 FAX
-
- August 6, 2011 at 6:34 am
I wrote Dr Rosenberg and he had his nurse e mail be back just before I was evaluated there for a trial here is another e mail contact at the NIH try it!
June A. Kryk, RN, MS. OCN
Research Nurse Specialist
NCI Surgery Branch
Immunotherapy
10 Center Drive
CRC 2-1730
Bethesda, MD 20892
[email protected]
301-451-1929
301-451-1927 FAX
-
- August 3, 2011 at 3:38 am
Hi Maria,Thanks for your reply. There is actually a specific trial I was interested in. I did email NIH regarding this (twice), though received no response. Just thought I’d ask this forum if it was indeed possible so I know if it’s worth thinking about it.
Thanks,
Ben.
-
- August 3, 2011 at 3:24 am
My husband and I were just at NIH for screening for clinical trials. NIH does accept foreigners. We met another Canadian couple there, and also ValinMtl is down there. You can contact them to see if anything is available, or look up their trials at http://www.clinicaltrials.gov – use National Institute of Health AND melanoma in the search engine, and it will give you a list.
I am not sure of other sponsored trials in the US, but if you look them up on the website there is usually a contact number you could call to ask them.
Best wishes to you,
Maria
-
- August 3, 2011 at 5:18 am
Ben, I am from Melbourne. It is certainly possible for non US citizens to receive treatment in the US. However, I imagine that there would be a great deal of red tape to get through.
When one is stage IV, time becomes an important factor as one often can't wait for a few months to organise treatment and overseas travel, accommodation, etc. Therefore, I think that it would be wise to explore what is available locally while keeping all your options open.
What trial(s) are you interested in getting into?
Best wishes
Frank from Australia
-
- August 3, 2011 at 6:12 am
Hi Frank,
Thanks a lot for your reply. That's pretty much exactly what I am trying to do. I am currently on a GSK braf brain met trial. I amgine there would be quite a lot of red tape to get through, so I am looking into this now so I can be as prepared as possible to move to another trial if/when my disease becomes resitant to the drugs. The specific trial I am lookiong into is the brain met TIL/ACT trial being conducted my Dr. Rosenberg. I am quite sure there is nothing similar currently being conducted in Australia, and it does seem more promising that starting on Yervoy.
Thanks,
Ben.
-
- September 22, 2011 at 7:15 am
Ben, I wonder if you have considered IL-2 and/or Yervoy as additional options? The way
that melanoma research is going is that there is a trend to follow one treatment with
another. This is because melanoma has the unfortunate tendency to overcome most
treatments, with the duration of response to treatment being quite short in many cases.I don't know if IL-2 treatment is available here, but it has the ability to give a small
percentage of patients the chance of achieving long-term remission.Best wishes
Frank from Australia
-
- September 23, 2011 at 10:17 am
Hi Frank,
I have had a look at those options. Side note: Do you know if IL-2 AND Yervoy is available here (Australia)? One paper indicated that this give the highest rate of complete response, although the sample size was small.
In any case, just from what I can see, the most promosing hope for a long term response seems to be TIL/ACT therapy combined with TBI, so, if possible, I would like to get on that, wherever that might be.
Thanks for your help!
Ben.
-
- September 23, 2011 at 1:41 pm
Ben, IL-2 and Yervoy certainly appear to be a good combination. The idea at the moment is to follow one with the other. However, I doubt if IL-2 has been approved in Australia for melanoma treatment outside of clinical trials.
Of course, TIL/ACT therapy is very promising but I am concerned by how long it will take to commence treatment. I feel that time could be of the essence and therefore it is probably best to have alternative options lined up.
Hope this helps.
Frank from Australia
-
- September 23, 2011 at 1:41 pm
Ben, IL-2 and Yervoy certainly appear to be a good combination. The idea at the moment is to follow one with the other. However, I doubt if IL-2 has been approved in Australia for melanoma treatment outside of clinical trials.
Of course, TIL/ACT therapy is very promising but I am concerned by how long it will take to commence treatment. I feel that time could be of the essence and therefore it is probably best to have alternative options lined up.
Hope this helps.
Frank from Australia
-
- September 23, 2011 at 10:17 am
Hi Frank,
I have had a look at those options. Side note: Do you know if IL-2 AND Yervoy is available here (Australia)? One paper indicated that this give the highest rate of complete response, although the sample size was small.
In any case, just from what I can see, the most promosing hope for a long term response seems to be TIL/ACT therapy combined with TBI, so, if possible, I would like to get on that, wherever that might be.
Thanks for your help!
Ben.
-
- September 22, 2011 at 7:15 am
Ben, I wonder if you have considered IL-2 and/or Yervoy as additional options? The way
that melanoma research is going is that there is a trend to follow one treatment with
another. This is because melanoma has the unfortunate tendency to overcome most
treatments, with the duration of response to treatment being quite short in many cases.I don't know if IL-2 treatment is available here, but it has the ability to give a small
percentage of patients the chance of achieving long-term remission.Best wishes
Frank from Australia
-
- August 3, 2011 at 6:12 am
Hi Frank,
Thanks a lot for your reply. That's pretty much exactly what I am trying to do. I am currently on a GSK braf brain met trial. I amgine there would be quite a lot of red tape to get through, so I am looking into this now so I can be as prepared as possible to move to another trial if/when my disease becomes resitant to the drugs. The specific trial I am lookiong into is the brain met TIL/ACT trial being conducted my Dr. Rosenberg. I am quite sure there is nothing similar currently being conducted in Australia, and it does seem more promising that starting on Yervoy.
Thanks,
Ben.
-
- August 3, 2011 at 5:18 am
Ben, I am from Melbourne. It is certainly possible for non US citizens to receive treatment in the US. However, I imagine that there would be a great deal of red tape to get through.
When one is stage IV, time becomes an important factor as one often can't wait for a few months to organise treatment and overseas travel, accommodation, etc. Therefore, I think that it would be wise to explore what is available locally while keeping all your options open.
What trial(s) are you interested in getting into?
Best wishes
Frank from Australia
-
- August 3, 2011 at 5:25 am
I'm not even sure why you would need to come to the U.S. If you check out the locations Australia seems to have most of the same trials and the are open for enrollment, where many of the U.S. are closed. One I looked at was:
http://www.clinicaltrials.gov/ct2/show/study/NCT01266967?term=GSK+BRAF&rank=2&show_locs=Y#locn
Unless you have relatives here, and could get a Visa to stay for a while, it's just not the best option.
Good Luck,
Mary
Stage 3
-
- August 4, 2011 at 3:02 am
Ben,
If you talk to Linda Williams @ NIH/NCI, she told me that if I had > 3 brain mets (I've had 5) NIH wouldn't take me for any trials. Your profile says you've had 3 so you should just get in under the wire on that criteria.
I've talked to MDAnderson in Houston who also do TIL/ACT. Unlike NCI, MDAnderson will harvest TIL from brain mets — so I was told at least. So for TIL/ACT in my circumstances I've put NCI/NIH off my list but MDAnderson on.
– Kyle
-
- August 4, 2011 at 3:02 am
Ben,
If you talk to Linda Williams @ NIH/NCI, she told me that if I had > 3 brain mets (I've had 5) NIH wouldn't take me for any trials. Your profile says you've had 3 so you should just get in under the wire on that criteria.
I've talked to MDAnderson in Houston who also do TIL/ACT. Unlike NCI, MDAnderson will harvest TIL from brain mets — so I was told at least. So for TIL/ACT in my circumstances I've put NCI/NIH off my list but MDAnderson on.
– Kyle
-
- August 4, 2011 at 9:26 am
Hi Kyle,
Thanks for that. I did have 6 brain mets, though 3 were surgically removed. Thanks for the info re MDAnderson, I was not aware of that, or that in even mattered where the TIL were harvested from. What phase is that trial? More research for me to do I guess. It does seem a pretty rich area at the moment.
Good luck with the treatment, I would be especially interested to hear how you go with it.
Thanks!
Ben.
-
- August 4, 2011 at 1:40 pm
Ben,
I may have misunderstood Linda — it may be no more than 3 *active* brain mets, not 3 brain mets ever, that are a problem for NIH/NCI.
In the U.S., there are ACT/TIL trials at Moffitt and MDAnderson as well (linked).
-
- August 5, 2011 at 6:11 am
Hi Kyle,Thank you very much for those links! I have read some preliminary results from the technique as used by NIH, though haven’t ben able to find anything about these trials. Are you signed up to one of these two?
I did receive an email from NIH regarding the brain met ACT/TIL. was told that I would not qualify as my brain mets have not received dedicated treatment.
Thank you very much for your help Kyle,
Ben. -
- August 5, 2011 at 4:56 pm
Ben, I'm not a participant in the Moffitt or MDAnderson ACT/TIL trials. I'm continuing to look into them as a Plan B or Plan C. However, brain mets complicate everything when it comes to entrance criteria. Also those trials are hypothetical for me for the time being, among other things I would need to be off IPI for 30 days.
The MDAnderson trial appears to have the most permissive entrance criteria with regards to brain mets (still restrictive though).
-
- August 5, 2011 at 4:56 pm
Ben, I'm not a participant in the Moffitt or MDAnderson ACT/TIL trials. I'm continuing to look into them as a Plan B or Plan C. However, brain mets complicate everything when it comes to entrance criteria. Also those trials are hypothetical for me for the time being, among other things I would need to be off IPI for 30 days.
The MDAnderson trial appears to have the most permissive entrance criteria with regards to brain mets (still restrictive though).
-
- August 5, 2011 at 6:11 am
Hi Kyle,Thank you very much for those links! I have read some preliminary results from the technique as used by NIH, though haven’t ben able to find anything about these trials. Are you signed up to one of these two?
I did receive an email from NIH regarding the brain met ACT/TIL. was told that I would not qualify as my brain mets have not received dedicated treatment.
Thank you very much for your help Kyle,
Ben. -
- August 4, 2011 at 1:40 pm
Ben,
I may have misunderstood Linda — it may be no more than 3 *active* brain mets, not 3 brain mets ever, that are a problem for NIH/NCI.
In the U.S., there are ACT/TIL trials at Moffitt and MDAnderson as well (linked).
-
- August 4, 2011 at 9:26 am
Hi Kyle,
Thanks for that. I did have 6 brain mets, though 3 were surgically removed. Thanks for the info re MDAnderson, I was not aware of that, or that in even mattered where the TIL were harvested from. What phase is that trial? More research for me to do I guess. It does seem a pretty rich area at the moment.
Good luck with the treatment, I would be especially interested to hear how you go with it.
Thanks!
Ben.
-
- August 3, 2011 at 5:25 am
I'm not even sure why you would need to come to the U.S. If you check out the locations Australia seems to have most of the same trials and the are open for enrollment, where many of the U.S. are closed. One I looked at was:
http://www.clinicaltrials.gov/ct2/show/study/NCT01266967?term=GSK+BRAF&rank=2&show_locs=Y#locn
Unless you have relatives here, and could get a Visa to stay for a while, it's just not the best option.
Good Luck,
Mary
Stage 3
-
- August 5, 2011 at 1:36 am
Ben, good luck. I hope you don't need plan 'B' ..C …whatever. I so admire you and all the other active Stage 4 warriors. I had never in my life imagined this kind of fight went on.
Mary
Stage 3
-
- September 20, 2011 at 2:31 pm
Hi Ben
I haven't been on the board for years (with the upgrade I thought it was time . . .) but often "lurk" to see how everyone is going. I've had a few tears tonight reading about NicOz and looking back on a few of her posts saw this one from you. I understand that you wrote this a while back but I thought I may be able to help.
My Dad participated in a trial run by Pfizer at UCLA in 2005 (we are in Perth). To be honest it wasn't all that difficult and the trial staff were very helpful. He could do all of the preliminary testing here – his onc was wonderful and was happy to help in any way he could. As you are aware, trials are free and there was a hostel near to the hospital for patients which is reasonably priced (actually very nice).
What was a barrier was the other expenses. I contacted many government agencies to see if they could help but they wouldn't provide any financial assistance to "experimental treatments". As part of the trial Dad had to travel to the US every month (we stayed there for about a month at the beginning to do specialised testing that couldn't be done here). As Dad was so unwell at the time we had to fly business class which obviously wasn't cheap. For the latter trips Mum and him would fly in, go straight to the hospital to have the treatment, stay overnight and then fly home (as you know, over 24 hours travelling time one way).
The reasoning behind staying only overnight as we couldn't afford for him to require any medical treatment not covered by the trial (as no medical insurance would cover it being in a foreign country). We once had to get him a blood transfusion and it was a couple of thousand dollars which had to be paid before they even let him through the door.
I won't ramble on, be do let me know if you would like any further information. I found the US institutions (I rang a few) to be nothing but helpful ~ and we made the decision to travel as Dad didn't have the time to wait for the trial to come here (which it eventually did).
All the best
Kristy
-
- September 22, 2011 at 6:13 am
Hi Kristy,
NicOz's passing is very sad news. Particularly being on the same trial and with similar met locations etc as her, really magnifies my situation and illustrates how strongly I need to fight myself for this. Very sobering.
Thank you very much for taking the time to write to me on this, it is very helpful.
At the moment, expense is a secondary issue. Did you set up the meetings with the UCLA team yourself from Perth, or did your local Oncs do this for you? I have written to a couple of the locations, and received very terse replies, or none at all. I got the impression that they seemed to be willing to only deal with those in the medical profession rather than the patient directly.
Maybe I should give them a call instead!
Thanks again!
Ben.
-
- September 23, 2011 at 1:15 pm
Hi Ben
You definitely need to call. You can imagine how many e-mails they would receive.
I did a few "general" calls to such places as MD Anderson where they would give me only non-specifics (which is understandable as they didn't have any of my Dad's records, only what I was telling them). Also did the rounds of all Australian hospitals.
Another US oncologist rang me back and did talk directly about my Dad's case which I thought was amazing. He wasn't a patient and wasn't likely to be, and this guy had me on the phone for about 20 minutes, which I appreciated beyond words.
With the study (CP675,206, which became known as tremelimumab, another CTLA antibody, very similar to ipilimumab – which is now Yervoy but at the time was also a trial not yet available here and called MDX-010), I initally found out about it on this site. I then looked at the Clinical Trials websites (eg. http://www.clinicaltrials.gov) to see where these trials were being held (checked with our oncologist first to see the time frames for Australia – too long for us to wait). At the bottom of the trial notes (from the internet), there are contact details. I just phoned those numbers (lots of getting up in the middle of the night and leaving messages etc). We also had the support of an excellent oncologist who followed the trial protocols. To be honest I don't know how much communication he had to do but I got the impression it really wasn't a lot. More on the side of making sure Dad met the protocols and had the appropriate testing done.
The trial team headed by Dr Antoni Ribas were very helpful and it really couldn't have gone smoother. UCLA is such an enormous hospital, it was great that they had the facilities for patients so we could stay close by at low cost. My Dad couldn't have done any of this without the support from my Mum – you will have to have someone to go with you – not only due to the effects of any medication but also to be another set of ears (they tell you so much that you can't remember everything, particularly when it can be so overwhelming).
My only other suggestion is to work closely with your oncologist (our first two were useless so it took a while for us to find one who would go out to bat for us), there may well be suitable trials here in Australia.
Let us know how you get on.
All the very best
Kristy
-
- September 23, 2011 at 1:15 pm
Hi Ben
You definitely need to call. You can imagine how many e-mails they would receive.
I did a few "general" calls to such places as MD Anderson where they would give me only non-specifics (which is understandable as they didn't have any of my Dad's records, only what I was telling them). Also did the rounds of all Australian hospitals.
Another US oncologist rang me back and did talk directly about my Dad's case which I thought was amazing. He wasn't a patient and wasn't likely to be, and this guy had me on the phone for about 20 minutes, which I appreciated beyond words.
With the study (CP675,206, which became known as tremelimumab, another CTLA antibody, very similar to ipilimumab – which is now Yervoy but at the time was also a trial not yet available here and called MDX-010), I initally found out about it on this site. I then looked at the Clinical Trials websites (eg. http://www.clinicaltrials.gov) to see where these trials were being held (checked with our oncologist first to see the time frames for Australia – too long for us to wait). At the bottom of the trial notes (from the internet), there are contact details. I just phoned those numbers (lots of getting up in the middle of the night and leaving messages etc). We also had the support of an excellent oncologist who followed the trial protocols. To be honest I don't know how much communication he had to do but I got the impression it really wasn't a lot. More on the side of making sure Dad met the protocols and had the appropriate testing done.
The trial team headed by Dr Antoni Ribas were very helpful and it really couldn't have gone smoother. UCLA is such an enormous hospital, it was great that they had the facilities for patients so we could stay close by at low cost. My Dad couldn't have done any of this without the support from my Mum – you will have to have someone to go with you – not only due to the effects of any medication but also to be another set of ears (they tell you so much that you can't remember everything, particularly when it can be so overwhelming).
My only other suggestion is to work closely with your oncologist (our first two were useless so it took a while for us to find one who would go out to bat for us), there may well be suitable trials here in Australia.
Let us know how you get on.
All the very best
Kristy
-
- September 22, 2011 at 6:13 am
Hi Kristy,
NicOz's passing is very sad news. Particularly being on the same trial and with similar met locations etc as her, really magnifies my situation and illustrates how strongly I need to fight myself for this. Very sobering.
Thank you very much for taking the time to write to me on this, it is very helpful.
At the moment, expense is a secondary issue. Did you set up the meetings with the UCLA team yourself from Perth, or did your local Oncs do this for you? I have written to a couple of the locations, and received very terse replies, or none at all. I got the impression that they seemed to be willing to only deal with those in the medical profession rather than the patient directly.
Maybe I should give them a call instead!
Thanks again!
Ben.
-
- September 20, 2011 at 2:31 pm
Hi Ben
I haven't been on the board for years (with the upgrade I thought it was time . . .) but often "lurk" to see how everyone is going. I've had a few tears tonight reading about NicOz and looking back on a few of her posts saw this one from you. I understand that you wrote this a while back but I thought I may be able to help.
My Dad participated in a trial run by Pfizer at UCLA in 2005 (we are in Perth). To be honest it wasn't all that difficult and the trial staff were very helpful. He could do all of the preliminary testing here – his onc was wonderful and was happy to help in any way he could. As you are aware, trials are free and there was a hostel near to the hospital for patients which is reasonably priced (actually very nice).
What was a barrier was the other expenses. I contacted many government agencies to see if they could help but they wouldn't provide any financial assistance to "experimental treatments". As part of the trial Dad had to travel to the US every month (we stayed there for about a month at the beginning to do specialised testing that couldn't be done here). As Dad was so unwell at the time we had to fly business class which obviously wasn't cheap. For the latter trips Mum and him would fly in, go straight to the hospital to have the treatment, stay overnight and then fly home (as you know, over 24 hours travelling time one way).
The reasoning behind staying only overnight as we couldn't afford for him to require any medical treatment not covered by the trial (as no medical insurance would cover it being in a foreign country). We once had to get him a blood transfusion and it was a couple of thousand dollars which had to be paid before they even let him through the door.
I won't ramble on, be do let me know if you would like any further information. I found the US institutions (I rang a few) to be nothing but helpful ~ and we made the decision to travel as Dad didn't have the time to wait for the trial to come here (which it eventually did).
All the best
Kristy
-
- You must be logged in to reply to this topic.