Rant about Doctors and their "knowledge" of their own clinical trials

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9/24/2010 6:08pm
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Replies: 16

I am livid.

I was downgraded from stage IIIC to stage IV 2 weeks ago.  I previously tested positive for the BRAF mutation and the doctor wanted to enroll me in the trial.

I filled out the paperwork with tears flowing from my eyes from the news.  I was knowledgeable enough on the the trial protocol from my own research and reading other postings here to know that one of the qualifications was the failure of a previous treatment, or as the protocol states "failure of at least one prior standard of care regimen ".  The only treatment I had so far was 2 surgeries and radiation treatment, all of which were known to the "Melanoma" specialist.  i asked him if the Radiation qualified me and he said yes.  When I called today to check up on the paperwork to make sure things were flowing through the proper channels, I asked one of the assistants to confirm what treatments would qualify me for the study.

She got back to me and confirmed that radiation treatment did NOT qualify me for the treatment.  She also informed me that they had another person in the same situation as myself and that person was starting the DTIC/Dacarbazine injection today and just so he was on a biochem/immuno treatment.  After that fails, he can apply for the BRAF treatment after waiting the 30 day prior treatment window.  They must have known about this qualification a week ago to get that person scheduled for the shot.  Why they did not inform me at the same time, i do not know.  Why they did not inform me when I called on Monday, I do not know.  I guess I need to check out the side effects from that treatment, but I dont have too many choices.

That is what they want to do with me.  I will see the doctor next Thursday, 3 weeks after my last Pet Scan, start me on a single injection of Dacarbazine and after the 30 days I would be able to start the BRAF trial.  I could say I never heard of such a crazy thing, but I have seen other things like that on this board and other things that are even more crazy. 

I just wanted to let everyone know that their doctors don't know everything.  You would think they knew the protocols of the clinical trials that they were running, but I guess that is too much to ask.

I was planning on getting second opinions by Dr Kaufmann and Dr Gajewski, but I don't know if I can fit that into my  schedule without using up my remaining few vacation days.  I need to save 3 days for the day long blood tests every hour once I actually start the BRAF trial.

Enough for my rant for now.

Bill

Bill from Illinois Stage IV Spine Mets, brain mets ans subq mets. starting whole brain radiation on 11/8 and then compassionate use IPI ASAP.

This same things has happened to me more than once by different prominent  melanoma specialist docotrs. These doctors have so many clinical trials they treat people like rats without really knowing the criteria for the trial& the patients history.

 

We all should be outraged!!!

Bill

 

Now that you are stage 4 and will be failing the 1st line treatment, what are your thoughts about doing IPI compassionate use. It appears to have a longer term durable respone than BRAF.

 

Good Luck

That is an option.

I was hoping that the Braf would be a better option for me and that I would be one of the lucky ones who had complete remission.  The side effects with the Braf pills are less than Ippi.  If the Braf option does not work, Ipi is always a backup plan, then IL2, then???

Bill

Bill from Illinois
Stage IV Spine Mets, brain mets ans subq mets.
starting whole brain radiation on 11/8 and then compassionate use IPI ASAP.

Bill, that is exactly the trouble Will ran into.  Same doctor, same problem.  They were clueless as to what the protocols were and we wasted valuable time.

Praying that this turns out well for you.  This should not happen.

Lori,

Yes, I feel like I wasted a few weeks time already.  If they knew the protocols they could have started the Dacarbazine 2 weeks ago.  Now it will be another week then another 30 days to try the Braf option.  After that, Ipi and ???

If Dr. Kaufmann was participating in the BRAF trial, I would probably call him on Monday, but he does not participate in that one.  Dr. Gajewski does participate in the same BRAF trial, but U of Chicago is a lot further to drive when I need to go in 7 or 8 times in the first 15 days for blood tests.

I guess we always have to weigh the pros and cons of our current doctors and treatments against the other options out there.  I am learning more about this every day.  That is one of the reasons I kept calling the doctors office.

On another similar note.  I had the the BRAF testing scheduled by a regular oncologist back in late April/ Early May.

When I had the next 2 meetings with the oncologist, he did not have the results and when I went to the "Melanoma Specialist" a week later, the results were still not in.  When I saw the "Melanoma Specialist" a few weeks later after my second surgery to discuss the next options, he did not discuss BRAF and did not have the results from the first Oncologist.  So off to Radiation I went and all the swelling and leg pain that goes with that.  I just happened to run into the first oncologist at the Radiologist office and asked him if the BRAF test was back yet.  He said it should only take a few weeks and since this was several months later, it should be in.  Of course I called the office first thing the next day and the results were in and I tested Positive.  I had the results faxed to me, mailed to me and faxed to the "Melanoma Specialist".  If I did not pursue this option, who knows if the specialist would have ever known if I tested positive or not.  When I saw the specialist again, he said a little birdie told him I was BRAF positive.  I guess it was a big birdie who told him, or at least saw to it that the paperwork went through.

So the other postings are correct.  We have to be our own Advocate, look out for the options on our own, pursue them as hard as we can and call, call, call if we are not getting the results we expect and demand.

Enough for now, at least until the next screw up happens.  Now I have to find out about the side effects from the Decarbazine to see if I can work the next day and if I can drive home.  That should be a fun day at the doctor's office, considering it is also my birthday.  Happy Birthday.  Sit down, shut up and roll up your shirt so they can poke me a few times in the arm.

Whew, i really go rolling there, didn't I.  I will try to keep the future postings shorter and more positive.  Lets all hope that the rest of the medical community can help keep things in line.

Bill

Bill from Illinois
Stage IV Spine Mets, brain mets ans subq mets.
starting whole brain radiation on 11/8 and then compassionate use IPI ASAP.

So sorry Bill, it does show me more now than ever that we are our best advocates. We must know more than they do. I am still following you.

Best wishes...

Deb
lovingwife to Bob, stage 3

I think most can identify with you during some time in our journey with melanoma.  I had one doctor look me in the face and suggest interferon...same doctor who prescribed interferon a year before AND it did not work!!  Obviously, hadn't read the file before our meeting!! 

Bill, is there any chance you could take temodar for a week (that's the first round treatment), it is a stage IV oral chemo?  First, it just MIGHT work (although not for me, some it does), second much less harsh on your body than dicarbazine...just take the anti-nausea pill and the one for constipation...really not difficult and that is for most.  Take care and best wishes on your decision. Val

P.S. I did not test positive for B-RAF so have done ipi about 2 weeks ago..a very few mild headaches..that's it to date for side effects.

Live Laugh Love
Nothing is worth more than this day!

Interesting idea.

I was researching the side effects of Dacarbazine and for a single dose, it seems kind of excessive.  The oral Tremodar might be a better option.  Thanks for the info.  I will ask the nurse and doctor about this next week.  it will be interesting to find out their what therir response is to that option.

But what if I actually respond to one of these one time treatments?  I could be part of the 15% who responds.  I need to keep my hope up for something to work.

Bill

Bill from Illinois
Stage IV Spine Mets, brain mets ans subq mets.
starting whole brain radiation on 11/8 and then compassionate use IPI ASAP.

Ah Bill,

I'm sorry about the stage IV status.  I'd be livid too, he SHOULD have known when you asked him that the radiation wouldn't count.

On another note - even though I like my doctor, we had it out once when he said to me "who's the expert here", when I broached a treatment question.  I grabbed his arm and said - some experts you guys are.  You don't really know what causes melanoma and you sure as hell don't know how to make it go away - those of us who do well do so by BLIND LUCK only - so don't talk to me of "experts".  For all the blather, it's always down to dumb luck.  I wish you all the best and lots and lots of luck.

DebbieH

Debbie,

Thanks for the post.  I like the part about grabbing his arm.  I will have to remember that one.  It may prove to be usefule sometime in the near future.

Bill

Bill from Illinois
Stage IV Spine Mets, brain mets ans subq mets.
starting whole brain radiation on 11/8 and then compassionate use IPI ASAP.

Much the same thing happened to my husband. He had ONE dose of a mild chemo to "enable" a vaccine. The dose was prescribed by an onc. When the possibilty of a clinical trial came available he was disqualified as he had chemo, even tho it was one very mild dose...criminal. I sent in a letter of complaint, but it was not addressed. I live in Victoria Canada. That was 10 years ago and nothing has improved....My thought go out to you, you have enough on your plate dealing with this miserable diseae without having to rely on incompetent doctors.

Bill, 

I am so sorry to hear your latest news....I agree with Joan..it is just criminal. Some of the docs are insulted when questioned.....I would think the really good ones wouldn't be, especially when we know they have a ton of patients and may not remember EVERYTHING but give me a break...protocols and radiation. You would think they would be on top of that. As had been said here many times you are your own best advocate...another mpip truth. I hope and pray that maybe the darcarbzine WILL work for you.

molly

Thanks all.

I will call the doctors office on Monday to make sure that Dacarbazine or Temodar are acceptable treatments.  If I take one of them and find out in 30 days that I do not qualify, I will be quite upset.  If they feel insulted that I would question them, I will remind them that they thought radiation treatment would qualify me and that they were wrong on that.  if I was there in person, I would tug on their sleve (per the other poster). LOL.   hey I need to have some humor during this ordeal.

As far as I know, none of these treatments will disqualify me from compassionate use Ipi if the Braf treatment fails.

If someone knows more about the qualifications for compassionate use IPI, please let us all know.

Bill

Bill from Illinois
Stage IV Spine Mets, brain mets ans subq mets.
starting whole brain radiation on 11/8 and then compassionate use IPI ASAP.

Bill:

Look at clinicaltrials.gov, where you can get your own information about criteria for inclusion and exclusion.  You need to know what they are to get into any trial, and do not rely on nurses, study coordinators, or even doctors without doing your own research and asking lots of questions (repeatedly id necessary)  You can also contact the company who sponsors a tril directly to clarify inclusion/exclusion criteris.

Here is a quote from http://clinicaltrials.gov/ct2/show/NCT00495066

  1. Must have failed at least one systemic therapy for malignant melanoma or be intolerant to at least one prior systemic treatment. Note: Enrollees must not be eligible for a clinical study with ipilimumab

I think you are getting good advice from others here, especially about trying Temodar instead of dacarbazine. Thats all I have to say except that I wish you the best.

Jim in Denver

Thanks Jim,

I was looking at that very information on Clinical trials.gov and did not think Radiation was sufficient, but Hey, I am not the specialist.  That is why I kept asking them to confirm what qualifies as treatment.

I sure hope the dacarbazine or temodar do not disqualify me from any future treatment.

Plan A - BRAF.

Plan B - Compassionate use Ipi.

Plan C - ? dont know yet.

Bill

Bill from Illinois
Stage IV Spine Mets, brain mets ans subq mets.
starting whole brain radiation on 11/8 and then compassionate use IPI ASAP.

Bill, I'd call whomever runs the actual trial.  The Melanoma Specialist you are seeing screwed up at least three times re: qualification/disqualification issues for Will.  He and his partner also failed to have Will B-raf tested, HLA- A2 tested, and when I did it myself (at another place),, kept forgetting the status on these tests.  I don't know if they simply see too many patients or fail to write things down or what, but the final straw was the ALT801 trial that he was insistent was best for Will.  I contacted the company running it, got them to hurry up the set up in Chicago and then found out that the chemo that this same doctor prescribed for Will - dacarbazine - disqualified him. 

I know I am biased on this doc but I'd definitely do an end run around them regarding vital issues at this point.