Your precious advice on clinical trial – Stage 3 low dose ipi + nivo

I was in a clinical trial at Johns Hopkins and did not pay for the trial drug — the drug company took care of that. However, I was responsible for the followup visits and scans.

While I was on that trial, I was followed very closely by my doctor. So, if you're accepted in to that trial, expect to make frequent visits to Providence initially. Doctors will want to keep a close watch on you. These visits should decrease over time. It's very important that you keep to whatever schedule they have outlined for you.

When you get accepted into the trial you will get detailed paperwork explaining the entire process to you.

Have you tried contacting the facility to see what options they have for non-US patients? Often, they can help with transportation and hotel stays. 

I was in a clinical trial at Johns Hopkins and did not pay for the trial drug — the drug company took care of that. However, I was responsible for the followup visits and scans.

While I was on that trial, I was followed very closely by my doctor. So, if you're accepted in to that trial, expect to make frequent visits to Providence initially. Doctors will want to keep a close watch on you. These visits should decrease over time. It's very important that you keep to whatever schedule they have outlined for you.

When you get accepted into the trial you will get detailed paperwork explaining the entire process to you.

Have you tried contacting the facility to see what options they have for non-US patients? Often, they can help with transportation and hotel stays. 

I was in a clinical trial at Johns Hopkins and did not pay for the trial drug — the drug company took care of that. However, I was responsible for the followup visits and scans.

While I was on that trial, I was followed very closely by my doctor. So, if you're accepted in to that trial, expect to make frequent visits to Providence initially. Doctors will want to keep a close watch on you. These visits should decrease over time. It's very important that you keep to whatever schedule they have outlined for you.

When you get accepted into the trial you will get detailed paperwork explaining the entire process to you.

Have you tried contacting the facility to see what options they have for non-US patients? Often, they can help with transportation and hotel stays. 

First impression- looks like a good option.  No placebo !

Yes,I think it is feasible to be away from the hospital BUT you need to keep in close touch re side effects and talk to them about how they manage distant patients. Get your local docs on side too and talking to your experts. BTW I was offered a trial at main centre – but infusions at more local hospital if that suited me- refused as wanted to be in the specialist centre if further treatment needed- which is how it turned out- but this might be possible.

Think there is already a fair bit of info on the board re trials and who bears the costs in the USA.

Scans- best guess three monthly. Details will be in trial invitation.

Drugs co usually state will pay reasonable cost of travel- whatever that means.

probably two parts to trial- one screen for suitability- part two consent to taking part. Have to have trial explained by physician – then 24 hr cooling off period – then sign consent in front of witnesses.

My reading is that you would prefer to be proactive- and are willing to risk side effects to get systemic immunotherapy treatment at earliest opportunity…If thats right- go for it- but you might be barred from some trials later if you have already used PD1 ..all be it for 6 months only….

Good luck

Deb

First impression- looks like a good option.  No placebo !

Yes,I think it is feasible to be away from the hospital BUT you need to keep in close touch re side effects and talk to them about how they manage distant patients. Get your local docs on side too and talking to your experts. BTW I was offered a trial at main centre – but infusions at more local hospital if that suited me- refused as wanted to be in the specialist centre if further treatment needed- which is how it turned out- but this might be possible.

Think there is already a fair bit of info on the board re trials and who bears the costs in the USA.

Scans- best guess three monthly. Details will be in trial invitation.

Drugs co usually state will pay reasonable cost of travel- whatever that means.

probably two parts to trial- one screen for suitability- part two consent to taking part. Have to have trial explained by physician – then 24 hr cooling off period – then sign consent in front of witnesses.

My reading is that you would prefer to be proactive- and are willing to risk side effects to get systemic immunotherapy treatment at earliest opportunity…If thats right- go for it- but you might be barred from some trials later if you have already used PD1 ..all be it for 6 months only….

Good luck

Deb

First impression- looks like a good option.  No placebo !

Yes,I think it is feasible to be away from the hospital BUT you need to keep in close touch re side effects and talk to them about how they manage distant patients. Get your local docs on side too and talking to your experts. BTW I was offered a trial at main centre – but infusions at more local hospital if that suited me- refused as wanted to be in the specialist centre if further treatment needed- which is how it turned out- but this might be possible.

Think there is already a fair bit of info on the board re trials and who bears the costs in the USA.

Scans- best guess three monthly. Details will be in trial invitation.

Drugs co usually state will pay reasonable cost of travel- whatever that means.

probably two parts to trial- one screen for suitability- part two consent to taking part. Have to have trial explained by physician – then 24 hr cooling off period – then sign consent in front of witnesses.

My reading is that you would prefer to be proactive- and are willing to risk side effects to get systemic immunotherapy treatment at earliest opportunity…If thats right- go for it- but you might be barred from some trials later if you have already used PD1 ..all be it for 6 months only….

Good luck

Deb

My husband was on a IPI/GMCSF clinical trial starting in Mar. 2011.  The drugs were paid for by the drug company and everything else that is normally done he or our insurance paid for.  He had blood tests before each infusion to make sure his counts were good enough to get the drug.  He did the every 3 weeks for the 12 weeks and then went on maintenance doses of every 12 weeks.  All the drugs were paid for the entire time he was on the trial which he stayed until Dec. 2013 even though he became NED in July 2012.  So other than drugs his insurance paid their part for the scans, blood tests, doctor visits.

We were advised to keep in close contact with the Oncologist as well and not go to a hospital until after contacting him (which we had a facility that had someone on duty for many hours a day and we had the doctors cell phone number if needed.)

Hope this helps some with your question on what we in the US pay for.

Judy (loving wife of Gene Stage IV and now NED for almost 4.5 years)

My husband was on a IPI/GMCSF clinical trial starting in Mar. 2011.  The drugs were paid for by the drug company and everything else that is normally done he or our insurance paid for.  He had blood tests before each infusion to make sure his counts were good enough to get the drug.  He did the every 3 weeks for the 12 weeks and then went on maintenance doses of every 12 weeks.  All the drugs were paid for the entire time he was on the trial which he stayed until Dec. 2013 even though he became NED in July 2012.  So other than drugs his insurance paid their part for the scans, blood tests, doctor visits.

We were advised to keep in close contact with the Oncologist as well and not go to a hospital until after contacting him (which we had a facility that had someone on duty for many hours a day and we had the doctors cell phone number if needed.)

Hope this helps some with your question on what we in the US pay for.

Judy (loving wife of Gene Stage IV and now NED for almost 4.5 years)

My husband was on a IPI/GMCSF clinical trial starting in Mar. 2011.  The drugs were paid for by the drug company and everything else that is normally done he or our insurance paid for.  He had blood tests before each infusion to make sure his counts were good enough to get the drug.  He did the every 3 weeks for the 12 weeks and then went on maintenance doses of every 12 weeks.  All the drugs were paid for the entire time he was on the trial which he stayed until Dec. 2013 even though he became NED in July 2012.  So other than drugs his insurance paid their part for the scans, blood tests, doctor visits.

We were advised to keep in close contact with the Oncologist as well and not go to a hospital until after contacting him (which we had a facility that had someone on duty for many hours a day and we had the doctors cell phone number if needed.)

Hope this helps some with your question on what we in the US pay for.

Judy (loving wife of Gene Stage IV and now NED for almost 4.5 years)