Do I have to live where the clinical trial facility is?

Carolina59

I want to talk to my onc about the clinical trials for HER2+ vaccines, but I'm wondering if I have to be in the same city as the trial or can I receive the meds from my onc.

I think I am eligible for at least one of them.

Thanks for any info.

Carolina

olduser

It depends on the trial. My partner is starting a trial next week that is out of the Mayo Clinic, but we live in Toledo. I guess the oncologist / cancer center where she is treated is one of the approved sites for the trial. Definitely ask your onc!

 Mary 

rsben70

a lot of trials are nationwide, just ask your onc, they will know...

Carolina59

Thanks for your responses. I see onc on 1/20 so I hope to find out more then.

orange1

Can you provide a little information about the vaccine trial.  I am interested.

Thanks, 

Sassa

To have a local doctor provide the research article, there are several hoops that the docs have to go through.

The local doctor will have to be approved by the FDA as a clinical investigator (paperwork involve; he will be included under the principle investigator's approval).  His site will have to be approved by an Institutional Review Board.  Depending on his hospital affiliation, the local IRB may insist on having the oversight; may defer to the principle investigator's IRB, or may decide that the clinical trial is not something they could support (due to staffing, demands on labs and diagnostic equipment or not feeling adequate care could be given in case of an adverse event).

In addition, all clinical investigators get big bucks from the sponsor to perform the study.  The principle investigator would need to adequately compensate the local doctor for the time spend on the trial (there is more involved than just giving an injection).

So unless your local facility is an already approved clinical trial site, it may not be possible to obtain investigational items locally.

JoniB

I was very interested in taking part in this trial.  I knew that the two facilities closest to me were in Pennsylvania and in North Carolina.  I found out that the Pennsylvania hospital was very far west and by the time I called they were no longer doing the trial.  I called Wake Forest in NC and was told that I would have to spend three days a month there for six months.  North Carolina is a one hour flight for me - but a 10 hour drive.  I could not afford to fly there every month, stay in a hotel and rent a car.  I would also have to take this time off from work.  If this facility was closer, I would have been very, very interested.  

Carolina59

Sassa, thanks for the info. I am treated at a top-level NYC cancer center, and I know they do clinical trials (but they are not a site facility for these particular trials). So I will find out more from my onc. when I see him.

Joni0702, thanks for letting me know your info about having to stay there. I was thinking about Wake Forest, but that would be expensive for me, too, although I do have a cousin in Winston-Salem whom I could stay with. But I have a 4 y.o. dd, and that would make it a real hassle. I'll let you know what I find out from onc., but it doesn't sound very promising. 

orange1, here is a link to one trial:

http://clinicaltrials.gov/ct2/show?spons="Walter+Reed+Army+Medical+Center"&spons_ex=Y&rank=29

There is also a vaccine called E75 which is in Phase III trials.

JoniB

One more comment about the vaccine trial at Wake Forest - you must have finished whatever treatment within the last 6 months. 

Carolina59

Hi Joni,

Yes, I noted that. My tx was finished on 8/15/08, so it's really cutting it close.

snowyday

I'm not sure if I already asked this question are any of you on herceptin right now? I asked my Onc about the vaccine and he (rudely) said, why would you get the your on herceptin now.  So I'm confused I want this vaccine.  Any info out there, by the way I'm in Canada. 

Carolina59

Snowyday, you're not eligible for this trial until you've finished all primary tx, including Herceptin. Then you are eligible (at least time-wise) during the 1 to 6 mos. after you finish Herceptin.  

I noticed in your signature though that you are Stage IV even though you are node-neg. Do you have mets? You have to be NED to be eligible. And you would have to ask about whether you have to be a USA resident to participate.

My onc. also dismissed it, even though he said I would be eligible. I'm going for a 2nd opinion onc. appt. tomorrow.

By the way, we were diagnosed on almost the same day. I went to the breast surgeon on 5/24/07, and she and the radiologist were 99% sure I had cancer, but I didn't get the official pathology results until 5/31.