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Participaing in a clinical trial?

JoanneNH
Posts: 55
Joined: Sep 2013

For those who are participating in a clinical trial, does it cost you anything?  Do they provide the med(s) and follow-up for free?  

Darron's picture
Darron
Posts: 223
Joined: Jun 2013

I believe every trial is slightly different. 

I am on Nivolumab-Sutent and the trial covers anything above and beyond what is considered standard of care.

For example, I had scans every 6 weeks for the first 24 weeks of my treatment. The standard of care was a scan every 3 months and the trial picked up the cost of the additional scans. The nivolumab is free of charge, but I pay for the sutent As the standard of care. I also pay a co pay at every visit on my insurance. They are investigating if I should be doing that, or if the trial should be picking up all visits above standard if care. This adds up, as I was going weekly for blood work and exams every week in the first 24 weeks. I now only go every 3 weeks for infusions.

I believe it differs patient by patient as well. I know of another patient in my trial that is driving 7 hours for his infusions. The trial is helping with gas money and hotel when he has to travel. (But I don't know how much they help)

If you are being considered for a trial, Talk to the doctors and their staff. There are no bad questions, financial ones included. I imagine you will find them eager to help in any way possible.

hope that helps answer your question. Are you considering a trial?

 

JoanneNH
Posts: 55
Joined: Sep 2013

My surgeon very briefly talked to me about it in my office visit with him.  He said it was a clinical trial involving everolimus and it would be taken orally.  When I saw him just before discharge, I told him I had looked it up and didn't particularly like the side-effects.  He said if you google Tylenol I probably wouldn't take that either.  He encouraged me to at least meet with the oncologist about it, and I will be seeing him, too, today.

 

I did sign up for two studies:  one involved giving 8 vials of blood preoperatively and the other allowed researchers access to my tumor for study (there was plenty to go around for everyone).

 

 

 

 

 

Darron's picture
Darron
Posts: 223
Joined: Jun 2013

I am a big fan of trials. It isnt just about research, it is also about helping yourself. Do you have any evidence of cancer now? If so, the side effects of just About anything to treat our cancers will have a 30 page list of side effects....

Dont be shy, investigate and ask.

twinthings's picture
twinthings
Posts: 403
Joined: Jun 2013

Darron, I'm curious to know if trials are something patients have to ask to be involved with.  Or, do doctors recommend them based on tumor type, size, grade, geographical location of patient, etc?  In other words, if I were eligible for a trial, would I KNOW I were eligible?  Can I assume that because my doctor didn't mention a trial, that trials aren't an option for me?

 

I'd appreciate your thoughts.

 

Sindy

JoanneNH
Posts: 55
Joined: Sep 2013

Darron:  I am a stage II due to the size (7.5 cm).  No visible sign on preoperative scans of spread, and the margins were clear.  I will have a  CT of the chest, abdomen, and pelvis in about a month as a baseline postsurgery (9/17).   Oncologist said that I have a 20% chance of future cancer.  

 

This is the trial that was offered to me:      http://www.cancer.gov/clinicaltrials/search/view?cdrid=668388&version=HealthProfessional

 

I don't know how you can find out if you are eligible for a trial.  My doctor spoke to me about studies preop.  I have done two already:  one involved donating 8 vials of blood and the other was to allow researchers access to my tumor.  

 

 

Darron's picture
Darron
Posts: 223
Joined: Jun 2013

 from what I understand, clinicaltrials.Gov is a good starting place. When I went to see my oncologist I thought I was stage II or III and was going to investigate the"Everest" trial. Much to my surprise, my surgeon was so impressed with my 17cm tumor that he missed the 3.4cm one on my other adrenal glad....welcome to stage IV, bye to the Everst trial.

the trials tend to be close to major medical areas, I live in the suburbs of Charlotte, only 20 minutes from the Levine Cancer Institute. My introduction to trials was by word if mouth from one if my son's friends mom. It was not from me searching, it just fell in my lap.

There are good odds you will never see cancer again, But I know that when I was post op and thought I was cancer free, I didn't want to sit and wait to see if it came back. I wanted to fight!

Where are you located? I will be happy to e-mail my trial nurse and see if she is aware of any preventative trials.

Some if thpulling time survivors here may have more info than me, but I will help how I can.

 

twinthings's picture
twinthings
Posts: 403
Joined: Jun 2013

Thank you for your thoughts, Darron! 

I live in Oklahoma City, Oklahoma, but work in Ohio.  It sounds to me like the trials require lots of doctor's visits for lab work and scans, which obviously don't jive with my work schedule.   When talking to the surgeon, prior to my surgery, my husband and I thought he dwelled an awful lot on my work schedule and the fact that I am only home once every 8-10 weeks.  Perhaps that's why a trial wasn't offered. 

It seems to me, compared to most posts I've read, my tumor was small by comparison, at just 4.7 cm.  And my cancer was Clear Cell type, which from what I understand, is the most common.  My cancer was contained to the kidney and had clear margins.  My adrenal gland was not removed nor were lymph nodes biopsied.  I 'm sure all of these things factor into eligibility, along with geographical location.

I truly am one of the lucky ones!

 

 

Darron's picture
Darron
Posts: 223
Joined: Jun 2013

Ask questions and get answers from your doc. Here is a good list to start with. Note that the trial has to start within 84 days if surgery, so your clock is ticking if you want to try it. Also, it is a placebo trial, which means there is a 50% chance you will take a sugar pill And they will simply take blood and monitor you.

Good ? For the doc:

how often are visits? For how many weeks?

do I have a co pay every visit?

what will be monitored while I am on trial( blood, kidney, liver?)

does the trial cover scans? how many?

what are risks and side effects?

 

hope that helps!

 

Darron's picture
Darron
Posts: 223
Joined: Jun 2013

Ask questions and get answers from your doc. Here is a good list to start with. Note that the trial has to start within 84 days if surgery, so your clock is ticking if you want to try it. Also, it is a placebo trial, which means there is a 50% chance you will take a sugar pill And they will simply take blood and monitor you.

Good ? For the doc:

how often are visits? For how many weeks?

do I have a co pay every visit?

what will be monitored while I am on trial( blood, kidney, liver?)

does the trial cover scans? how many?

what are risks and side effects?

 

hope that helps!

 

JoanneNH
Posts: 55
Joined: Sep 2013

Good questions.  They might be answered in the 17-page consent form which I have yet to read.  I see a list of the side-effects in them and I also looked up the drug on the Mayo Clinic web site.  I never thought to ask about co-pays which turns out to be about $300 with my insurance plan since an oncologist is considered a specialist.   

 

I am going to give myself a couple of days off before tackling all those pages.  Oncologist did say that the scans and blood work would be covered by my insurance as they are considered the standard of care.  

 

I have an oncologist at the Dartmouth-Hitchcock Medical Center in Lebanon, NH, and then (yet to be arranged) follow-up during the winter in either Lakeland, FL, or the MD Anderson Cancer Center branch in Orlando (if I have the courage to drive there--massive traffic there).  

 

Oncologist said that if there are any side-effects, they are treated, and I can stop at any time for any reason.   Pretty much would know that I am getting the drug if some of those come up, I guess.

 

LynninNC
Posts: 12
Joined: Jul 2013

I am in a study at Duke University. It is a double blind placebo study to see if votrient can inhibit the start of mets. My surgeon suggested I would be a good candidate because of my stage (lll) and the presence of sarcamatoid features (only 5%). He also referenced my age (50) and good health. The Cancer Center in the local regional hospital had a clinical study nurse that help me connect with Duke but I found the study on the NIS website.  It is a Phase 3 trial, meaning that it has already gone thru 2 phases looking at side effects etc and shows good potential for efficacy. There was an 80 day time line from surgery I think.   I pay for the standard care stuff (scans every 6 months) buts the Trial pays for the rest. It involves more frequent scans and bloodworK and votrient pills every day.    I like the fact I am being proactive and taking some semblance of control. And it was people willing to do clinical trials that has advanced treatment so well in the last 10 years. I like doing my part.    Another advantage is that should the cancer return I have an in at Duke.    There are a good number of trials out there and the list of questions that Darren created for you should help in your search.  I saw a good number in Boston when doing my search....so if you are in NH that might we a good place to start. Each hospital lists the clinical studies it is participating in on their website.    All my best. Lynn

Texas_wedge's picture
Texas_wedge
Posts: 2807
Joined: Nov 2011

By now, the best of all places to seek suitable trials is on the Smart Patients site where there is a highly sophisticated trial search facility.

dhs1963's picture
dhs1963
Posts: 373
Joined: May 2012

I am not in any adjuvant theopy trials.  I have mSRCC, (solitary lung met).  Currently NED (but scan next week). 

The problem is the tumors can adapt to the medicine from the trial; a specific medicine might only work for 12 moths or so, then the tumor evolves and the drug is no longer effective. 

The way my Dr. explained it (at NIH) is you do not want to give up the 12-18 months of a drug while the cancer is not a threat.  If present, it will find a way around the the blocked growth mechanism.  Save it for when you need it.

Consider that before agreeing to a trial.  (FWIW, I am in a "clinical research setting" for familial kidney cancer).  At NIH, everything is covered.

NanoSecond's picture
NanoSecond
Posts: 532
Joined: Oct 2012

I am so pleased you have pointed this out.  This factor should be seriously considered before entering into any clinical trial of adjuvant therapies based on the current crop of TKI's.  Not one has been shown to be effective.  And you risk losing the use of whatever drug is being tested if you later do develop mets.

I was given the opportunity to consider such a trial after my initial surgery back in May 2010.  I was NvED after my surgery but declined to participate (it was a clinical trial of Sutent as adjuvant therapy).  Even though I did develop mets 2+ years later, I am pleased I did not choose to enter this trial.  At this point in time I have gotten over one year on Sutent and it still seems to be going strong for me.

I am all for clinical trials that make some sense.  But the adjuvant trials just do not.

Phoenix Rising's picture
Phoenix Rising
Posts: 154
Joined: Jul 2012

Hi Joanne!  I am currently in the LY2875358 trial.  So far, it has not cost me anything except my valuable sick and vacation time from work.  My insurance co. covers the scans and the trial covers everything else ( I think), including my parking when I come in for infusions, blood tests, and scans.  So basically, there has been no out of pocket cost associated with the trial.  I haven't seen where they are billing insurance for anything other than the scans.

gatorbob
Posts: 20
Joined: Oct 2013

I am on the same trial. Beginning the 13th month! Are you at Emory?? Phase one ?

 

todd121
Posts: 593
Joined: Dec 2012

I'm in the Everest trial (everolimus). It's a good question. I asked, but didn't really get a good answer. I decided to do the study independent of that question.

The meds are provided free. The insurance company agreed to pay their part of the followups, blood work, and scans. It was not free. I have a 10% copay, and I had to pay it. It may not sound like much, but it did add up. The blood work every 6 weeks is mainly to monitor how I'm doing on the drug. The scans are just slightly more than would be normal in terms of what would have been done. I'm getting CT scans of my chest, abdomen and pelvis every 18 weeks. I pay my share of those.

So far I don't regret doing the study. I know many people on this site are against these adjuvant studies. I know this is not likely to work, but I felt at a 50% risk of recurrence, the risk was too high not to do something. I put some of my trust in the doctors participating in the studies. Perhaps I'm naive, but I assumed that they wouldn't be doing the study if they didn't have some hope that it might work.

Part of the reason I picked everolimus, was that my doctor told me in his experience the side effects were much more tolerable than votrient. And I considered that I didn't want to take votrient being NED, saving it in case I need it someday. And it seemed everolimus might have a better chance at being effective as an adjuvant therapy than votrient did because of the way it works on the cells at a cellular level instead of a systemic level like votrient attacking a tumor's ability to create a blood supply for itself.

Most of these post-nephrectomy adjuvant therapy studies require you to enter the study within a certain number of weeks of having your kidney removed. If anyone is interested in them, you have to investigate them immediately upon having your surgery.

Todd

foxhd's picture
foxhd
Posts: 1928
Joined: Oct 2011

I was so fortunate to be on the anti-pd1 trial for about 18 months. It cleared about 90% of my tumors. However, to this day there is disagreement as to what costs I have been responsible for. More specifically the costs for 2 biopsies and multiple scans which I have had to pay for. This has been an ongoing battle. I believe I have the upper hand and expect reimbursement soon. The protocol for my trial requires updated signed consents as the researchers learn of things like side effects. I have been asked to sign another update but have refused to do so since I have been removed from the study. This has caused an issue where now they won't be able to use my data. This is not going over well. A thorough  look is being made regarding billing, patient satisfaction, and research practice. My contention is that the billing department has been lazy and uninterested in correct procedures. I think some heads will roll. In the overall scope and cost of drug trials, and future profits, it is petty cash to them. The data is invaluable. It has not been an issue of me being cheap. I have paid all bills as I don't need my credit rating damaged. I am also happy to pay my share for care. My contract states, "AT NO CHARGE TO PATIENT OR INSURANCE." So the fight goes on. Be careful.

GSRon's picture
GSRon
Posts: 1270
Joined: Jan 2013

Todd, I keep reading your posts on adjuvant therapy.. and it appears to me you are reacting emotionally and not logically..  So far none of those kinds of studies showed any success.  Why those types of trials keep showing up is a wonder to me..?  Follow the money.. is what I think.  I am all for a trial that may lead to something positive, but this type just does not "pencil" to me.  Someone will quickly let me know if I am off base...

You keep saying your odds are 50%.. that may or may not be true.. does not really matter.  If you are stage 3 then anything can happen.

But what you fail to see is the negative of this type of trial..  First, since your insurance would cover the follow ups, then no gain there...  But there are only so many drugs we have.. and it is not a lot of them.  Not all drugs work for everyone.. that further can reduce the number of treatments you can get, if needed.  Sadly if you use up a good drug now, you won't have it later, so may lose time on your life clock..  There really is nothing to gain..  The only gain I can see is if you can not tolerate that drug for some reason.

I know you and many "think" you need to be pro active... Nothing is stopping you from being pro active..  Two of the best things you can do, is improve your diet and increase exercize..  I suspect Neil will chime in on the diet front..

I wish you luck...

Ron

dhs1963's picture
dhs1963
Posts: 373
Joined: May 2012

Adjuvant theropies may eventually find something, but it will probably be different than what we currently use.

NO TRIAL HAS SHOWED EXTENDING LIFE.  They have shown longer disease free intervals, but when the disease comes back, the disease has evolved away from that target.  So, do you want to use the time with the target now, or later when there is disease?

Being proactive means being religious about the scans.  Get them as needed.  Do not skip them.  The tumor will not (usuallY) grow for NED to dangerous that quickly with RCC

todd121
Posts: 593
Joined: Dec 2012

I appreciate your feedback. Not sure that your analysis of me being emotional while you're being rational is really a fair one, but I hear your argument. Perhaps we can disagree and both be rational? Or both be a little emotional, and mostly rational and still disagree? You may not know everything that went into my decision. I'll try and present a little more information, but not to change your mind, but perhaps to ease your concern that I'm a little hysterical (not in the funny sense! Lol).

I've been on this study for 9 months. I'm almost done. The discussion and decision was made back in January.

I had advice from 3 oncologists, 2 of them RCC experts. 2 of the 3 of them agreed with me, one had an attitiude of it being totally up to me to do it or not, but if I did it wanted me to use a different drug which he thought had a better chance of being effective, but he wouldn't explain to me why he thought it had a better chance. Because of his refusal to explain his reasoning, I decided to discount his advice.

None of the doctors brought up your argument or discouraged me from doing it. In fact, I don't think I heard this argument on the board until a few months later. I think it makes a fairly good case for waiting. The 50% odds are supported by several studies which I've read and 2 RCC experts independently quoted me that number. If I had been Stage 1, I very probably would have not done the study. It does ignore the main premise of what adjuvant therapy is all about as explained to me by one of the doctors: that is that a less effective drug, when presented with a very small number of cells, may be effective in eliminating or drastically cutting back those small number of cells to the point of if there are very, very small numbers left your immune system may handle those. The hope is this less effective drug might cure the cancer or give a much longer time to recurrence when presented early before any tumors show up.

I also had talked to and seen the posts of another member here who was on the same study and was having minimal/no side effects. My doctor told me his experience was that most patients tolerate this drug really well. The drug I'm taking has been used by organ donor recepients for years, so there's a lot of history with it.

Yes. It's a chance I took, but I'm ok with it. I agree with you and others that it's not very likely to work. However, we're not going to know that for a few years until they collect the data and see.

And I wish you luck too.

Todd

cww71964's picture
cww71964
Posts: 95
Joined: Dec 2011

Hi,

Just happened to check in today and thought I would add my 2 cents. I finished up the Everolimus trial back in March. No real side effects at all except my triglycerides were up by 200 points. Two months after the trial, I dropped 180 points so I know I was getting the drug and not the placebo. I had my 18 month scan a few days ago and go to the oncologist tomorrow to get results. My cost of the trial was co-pay for scans every 18 weeks and co-pays for oncologist every 6. Now that I am off the trial the insurance has preapproved me for scans every 6 months for the next 2 years. I am happy that I went on the trial as I felt like I was able to take my health into my own hands and try and do something about my situation.

 

Thanks,

Wayne

cww71964's picture
cww71964
Posts: 95
Joined: Dec 2011

Hi,

Just happened to check in today and thought I would add my 2 cents. I finished up the Everolimus trial back in March. No real side effects at all except my triglycerides were up by 200 points. Two months after the trial, I dropped 180 points so I know I was getting the drug and not the placebo. I had my 18 month scan a few days ago and go to the oncologist tomorrow to get results. My cost of the trial was co-pay for scans every 18 weeks and co-pays for oncologist every 6. Now that I am off the trial the insurance has preapproved me for scans every 6 months for the next 2 years. I am happy that I went on the trial as I felt like I was able to take my health into my own hands and try and do something about my situation.

 

Thanks,

Wayne

todd121
Posts: 593
Joined: Dec 2012

Nice to see you here. I've been on 9 months. Getting my next 18 week scans next week and very anxious about them.

My side effects are also minimal. My creatinine was up just a little last time, and that made me nervous. I'm hoping this time it will be back down. I'm pretty sure I'm one the drug. I've had fatigue and nausea mainly, but it has come and gone and been mostly mild. There were some other changes that I won't go into that makes me pretty sure I'm on the drug.

I'll be glad to finish. I'm getting antsy to get off it and see what it feels like to be off it. I've even thought of quitting (the 1 year is a fairly arbitrary time to have selected). Anyway, I think I can handle 3 more months, so I'll just stay.

Hoping my 18 week scans turn out NED. So far so good.

Todd

cww71964's picture
cww71964
Posts: 95
Joined: Dec 2011

My scans were negative and I am positive yours will be too. Other than my cholesterol dropping, I did notice I was less fatigued during the day. You have come this far so you may as well finish.

Wishing you the best,

Wayne

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