I am re-thinking the clinical trial in NYC and need advice

Hissy_Fitz
Hissy_Fitz Member Posts: 1,834
edited March 2014 in Ovarian Cancer #1
I have been searching for clinical trials closer to my home, because the mad dash to NYC this past week was horrendous and staying there from Feb 1st - 10th, as they would like is proving problematic. The hotel is $200 per night, which my husband insists is not an issue, but when you add in meals for 10 days, it's quite a chunk of change. The in-laws we were planning to stay with already have committed to international house guests the first week of Feb. I could push the start of my treatments back, but that would require a new CT scan, and I'm not sure my insurance would pay for it.

None of those are really deal-breakers, however. My main concern is that the MIMOSA project is due to be de-blinded in the next couple of months, and if I do this trial, I would be ineligible for inclusion in MIMOSA. I just realized this yesterday and have been pondering and praying over it ever since. I really, really, really want to participate in MIMOSA because it is so much further along and shows such great promise, for women in their first remission. It's not a sure thing, but it's the next best thing.

The trial in NYC is Phase I - no therapeutic expectations at all, just health/safety issues. I desperately want to be part of the research that (might) discover a vaccine for ovarian cancer. I have a daughter and 4 granddaughters. It would make my life seem less trivial, and my eventual death, of OC or not, worthwhile.

I need some input from my most valued friends and sisters on this, so please give me your feedback/opinions - everyone. And don't hold back! I really want to hear your honest, gut feelings and most personal thoughts. What would you do, if you were in my place?

Carlene
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Comments

  • Tethys41
    Tethys41 Member Posts: 1,376 Member
    It will happen if it's meant to be
    Carlene,

    First, I appreciate your raising this topic. This is the first I've heard of this project, and it sounds intriguing.

    I have learned through this whole expereience that things happen for a reason, and trying to force it does not produce the desired results. If you are having second thoughts and it appears you will not be able to participate in the part of the trial you were hoping to, perhaps that is a sign that it's not meant to be.

    Your arguments for wanting to participate are heartfelt. But I hope you realize that you and your life are far from trivial, whether you participate in this trial or not. The trial will be conducted and completed whether or not you participate. Your children and grandchildren will reap its benefits, regardless.

    I understand the fear of a recurrance. I had a success on my first go around with this disease, but the fear remains that it could return. There are a lot of things you can do to prevent its return. I'm working with an amazing naturopath who has a diet and lifestyle plan for me to follow to reduce, and possibly eliminate the possibility of recurrance. i posted some of the plan on this post yesterday under a topic about strengthening the immune system. Personally, I have greater faith in what I'm doing than trying another drug.

    I hope my words have helped and you find peace in your decision.

    Kate
  • poopergirl14052
    poopergirl14052 Member Posts: 1,183 Member
    Follow your instincts
    Carlene if you are haiving second thoughts now os the time to try the other trial you wanted I nevernheard of this trial but it may be more benificial for you own personal needs. Which ever you decide it will not be in vain. You will be part of a very important challenge thath will someday find a cure for future generations. Good luck, I hope this helps.....val
  • srwruns
    srwruns Member Posts: 343
    Don't ever do that again!
    Hi Carlene,
    I am not good at giving advice about the situation you are facing...with your mindfulness and input from others, family and close friends you will make the decision that is right for you. However please, don't ever ever ever make this statement again:

    "It would make my life seem less trivial, and my eventual death, of OC or not, worthwhile."

    Your posts have meant so much to so many to us. I have learned so much from you, I just love your picture, not because you are lovely but because of the radiance that shines through. If anything like this ever pops up in one of your future posts I will glady round up the sistas on this board and we will converge on Texas and and and ... well I don't know what but we sure would have a lot of fun!

    My guess is it was just a poor choice of words to express your decisioin making confusion at the moment. And for that, ok. So consider this a huge fluffing of your aura if you are feeling down and not worthy. Those kinds of feelings are legimate and do happen, but they must be VERY transitory, carthartic and then move back onto equilibirum.


    There, for someone who doesn't like to give advice you got my $1.00 worth. Susan
  • kikz
    kikz Member Posts: 1,345 Member

    Follow your instincts
    Carlene if you are haiving second thoughts now os the time to try the other trial you wanted I nevernheard of this trial but it may be more benificial for you own personal needs. Which ever you decide it will not be in vain. You will be part of a very important challenge thath will someday find a cure for future generations. Good luck, I hope this helps.....val

    Decision
    I am terrible about making decisions. It is a joke with family and friends. What I usually do is use the bottom line approach. It has helped me make important decisions in the past. I guess it includes the pro and con thing too.

    I just want to say that you are an inspiration to so many of us on this board. You research and investigate and learn so much about this dreaded disease. I tend to go the other way. I don't even want to say the word cancer or especially ovarian cancer. It's hard to read about ovarian cancer when so much is negative. So people like yourself will be the pioneers who lead the way for a cure. We may not be doctors, we are guinea pigs (no offense) but both are essential to vital research.

    Whatever you choose, there is no wrong decision. You have the courage to try. Good luck and know my prayers are with you and your family.

    Karen
  • Hissy_Fitz
    Hissy_Fitz Member Posts: 1,834

    Follow your instincts
    Carlene if you are haiving second thoughts now os the time to try the other trial you wanted I nevernheard of this trial but it may be more benificial for you own personal needs. Which ever you decide it will not be in vain. You will be part of a very important challenge thath will someday find a cure for future generations. Good luck, I hope this helps.....val

    The MIMOSA trial is
    The MIMOSA trial is officially called "Efficacy Multicentre Trial of ImmunoTherapy Vaccination With Abagovomab to Treat Ovarian Cancer Patients (MIMOSA)". There have been several posts about it here. It started in 2006 or 07 and is closed now, as far as recruiting. It is a large, international study with (I think) over 900 women participating in the latest phase. The results of the study are due out very soon - sometime in the first half of 2011. If they are overwhelmingly positive the vaccine is apt to be fast-tracked thru the FDA process and approved before the end of the year.

    I only realized yesterday that if I go forward with the Phase I vaccine trial in NYC, I will not be able to get the MIMOSA vaccine, if it should go into another round of tests. I would have to wait until it went "public", and I would have to drop out of the trial at Sloan-Kettering. Which I absolutely know already that I would do. The MIMOSA vaccine shows more promise than anything to come along in years - at least as as much as Avastin.

    Of course, I risk almost certain recurrence, eventually, if I wait. Which is not to say I could not recur while on the MSK trial. I very well could. The whole thing is a crap shoot. I figure I have six months to get on something. That seems to be about the average length of time it takes the beast to show up again.

    I am truly torn by this decision. I am totally discounting my family's input. They mean well, but their responses come from emotion, not hard evidence or cold logic.

    Carlene
  • This comment has been removed by the Moderator
  • poopergirl14052
    poopergirl14052 Member Posts: 1,183 Member
    No life is trvial
    I agree with shrns all the way!!!.You give us all hope, you are very smart and passionate lady. We are all on this earth for a reason. We will com e down to Texas and shake you silly if you say that again...lol....val
  • kikz
    kikz Member Posts: 1,345 Member
    srwruns said:

    Don't ever do that again!
    Hi Carlene,
    I am not good at giving advice about the situation you are facing...with your mindfulness and input from others, family and close friends you will make the decision that is right for you. However please, don't ever ever ever make this statement again:

    "It would make my life seem less trivial, and my eventual death, of OC or not, worthwhile."

    Your posts have meant so much to so many to us. I have learned so much from you, I just love your picture, not because you are lovely but because of the radiance that shines through. If anything like this ever pops up in one of your future posts I will glady round up the sistas on this board and we will converge on Texas and and and ... well I don't know what but we sure would have a lot of fun!

    My guess is it was just a poor choice of words to express your decisioin making confusion at the moment. And for that, ok. So consider this a huge fluffing of your aura if you are feeling down and not worthy. Those kinds of feelings are legimate and do happen, but they must be VERY transitory, carthartic and then move back onto equilibirum.


    There, for someone who doesn't like to give advice you got my $1.00 worth. Susan

    Carlene are you saying
    that if that MIMOSA vaccine proves effective and it's approved we may all have a chance to use it by the end of the year. Or is it only for people without recurrance?

    Karen
  • srwruns
    srwruns Member Posts: 343
    srwruns said:

    Don't ever do that again!
    Hi Carlene,
    I am not good at giving advice about the situation you are facing...with your mindfulness and input from others, family and close friends you will make the decision that is right for you. However please, don't ever ever ever make this statement again:

    "It would make my life seem less trivial, and my eventual death, of OC or not, worthwhile."

    Your posts have meant so much to so many to us. I have learned so much from you, I just love your picture, not because you are lovely but because of the radiance that shines through. If anything like this ever pops up in one of your future posts I will glady round up the sistas on this board and we will converge on Texas and and and ... well I don't know what but we sure would have a lot of fun!

    My guess is it was just a poor choice of words to express your decisioin making confusion at the moment. And for that, ok. So consider this a huge fluffing of your aura if you are feeling down and not worthy. Those kinds of feelings are legimate and do happen, but they must be VERY transitory, carthartic and then move back onto equilibirum.


    There, for someone who doesn't like to give advice you got my $1.00 worth. Susan

    my edit to my comment
    I said "Those kinds of feelings are legitimate..." I would edit that to be they are NOT legitimate feelings in that they are not based in fact, but we all know that those feelings do happen so my intent was to say: acknowledge them for what they are, a mood slump, a bad day, or whatever, then move back to a better space. Or you're gonna get your butt kicked!
  • Hissy_Fitz
    Hissy_Fitz Member Posts: 1,834
    kikz said:

    Carlene are you saying
    that if that MIMOSA vaccine proves effective and it's approved we may all have a chance to use it by the end of the year. Or is it only for people without recurrance?

    Karen

    The MIMOSA vaccine is being
    The MIMOSA vaccine is being tested on women who were NED following first line treatment with platinum based drugs. These women were selected back in 2006 or 2007. The ones who are still in the trial are still NED, because a recurrence means you failed the trial and you get kicked out. They are no longer receiving the injections, but they are being followed (exams, blood work, CT scans, etc).

    Once the vaccine is approved by the FDA, physicians can prescribe it for anyone they think may benefit from it. Whether all insurance carriers will pay for it (off label) is another issue. But the short answer is "yes"....if you can talk your doctor into giving it to you, once the FDA releases it for production, you can get it.

    What is more likely in the next few months is that the study will be released and the drug will go into further testing. Until it is approved by the FDA, only women who fit the criteria will be able to get the vaccine. If there are more studies done, it will likely be women in first remission, and who have NOT done other vaccine or treatment trials, who will be eligible. But it would not be a blind study. Everyone would get the vaccine. Of the women still in the trial, some probably got a placebo and, thus, would have been NED all this time on their own (or by the grace of God), but definitely not because of the vaccine. But statistically, there are more women still NED than should/would have been, if they had not received the drug.

    Carlene
  • Tethys41
    Tethys41 Member Posts: 1,376 Member
    unknown said:

    This comment has been removed by the Moderator

    Thanks
    Nancy,

    Thanks so much for acknowledging my posts. I am so excited about how I am approaching this disease with my naturopath that I want to shout it from the hilltops. Often, however, I feel like I'm talking to a brick wall when I try to share what I have learned about keeping this thing at bay. I love that you are doing similar things and that they are working for you too. Maybe if we keep sending the message, eventually someone will listen.

    Kate
  • kayandok
    kayandok Member Posts: 1,202 Member
    Oh My,
    just running out the door to my daughters special olympic track, and will write more later, Carlene. Prayers that you can make a decision (I suspect it is a skill you have actually great success with over the years!) and then have conplete peace about the choice. I can just see you making a list and checking off the pros and cons as I write. Then there is your gut feeling. Go with that!
    Hugs,
    kathleen
  • lindaprocopio
    lindaprocopio Member Posts: 1,980
    kayandok said:

    Oh My,
    just running out the door to my daughters special olympic track, and will write more later, Carlene. Prayers that you can make a decision (I suspect it is a skill you have actually great success with over the years!) and then have conplete peace about the choice. I can just see you making a list and checking off the pros and cons as I write. Then there is your gut feeling. Go with that!
    Hugs,
    kathleen

    I'm a big believer in Pros and Cons lists for decision-making.
    I find I always cheat for the side I truly want in my heart to 'win' when I list Pros and Cons. & then I know what to do.

    It is all a crap shoot, but that kind of stressful crazy winter travel to NYC CAN'T be good for you. (((Charlene))).
  • nancy591
    nancy591 Member Posts: 1,027 Member
    MIMOSA
    I googled MIMOSA and I see that Dr. S from MSK was actively involved in this study and he discussed it at the annual ACSO meeting last year.
    Link:

    http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=74&abstractID=48763

    Author(s):
    P. Sabbatini, J. S. Berek, A. Casado, K. Cwiertka, T. Pinter, A. Pluzanska, G. Scambia, E. Pujade-Lauraine, J. B. Vermorken, J. Pfisterer; Memorial Sloan-Kettering Cancer Center, New York, NY; (...et al)

    I would call Dr. S and discuss your concerns with him. See what his take is. He obviously is informed!!!

    For all who don't know, a Phase I clinical trial IS a dose escalation trial to evaluate safety. Yes, it IS a risk but you are closely monitored. Personally, I don't think I would do a phase I trial as an active treatment unless it was in conjunction with a standard chemo. This trial though is to prevent recurrence. So, in this case I think I would try it. Whats to lose? But, as Carlene mentioned, she would be ineligible for the other trial.

    It is a tough call Carlene. I would talk to Dr. S and see if it is worth waiting for and how long the wait might be.

    GOOD LUCK!!!!
  • anicca
    anicca Member Posts: 334 Member
    You can stay with me.
    Carlene, I realize you do not know me because I just joined and began posting recently, but I live in Brooklyn, 20 minutes from JFK and an easy trip via express bus or subway to MSK. I have a large (but messy) house, and you and your husband are more than welcome to stay with us (just me and my husband these days.) I may even be able to drive you to and from your appointments, depending on the days/times. One of my friends drove me to 5 of my 6 chemos, and I would love to be able to pay it forward.

    I hope this can take logistics and cost somewhat out of the equation for you and help you to make a choice based purely on the merits of the two options.

    Dinah
  • jloe
    jloe Member Posts: 174
    That's tough one!
    Carlene,
    I don't think that you life is trivial and expecially to your family. Based on your exceptional communication skills and your intelligent aggressive approach to your situation has already made you a tremendous asset to your family. I think that it would be a good idea to contact Dr. S and discuss your concerns. I think that there is a wealth of information at your fingertips through him. I myself do not understand a lot about clinical trials and relied on my doctor to guid me in the right direction throughout my entire ordeal and I have been very lucky with the guidence so far. I am amazed at the amount of research that you and others do on your own and am totally impressed. I'm sure that they were as impressed at MSKCC with your ability to obtain as much information as you do. I hope they are able to help you with your decision. Prayers to you!
  • Mwee
    Mwee Member Posts: 1,338
    OK, this is what I would do
    First let me say how much I respect you, Carlene. You definitely wear the "big girl panties" well. I'm hearing how difficult it is going to be for you to wait and watch to see if recurrance is in your future. With that in mind, I think you'd be more comfortable joining the MIMOSA trial. You would know that the study is deblinded and you are a person that needs to see the facts.

    I have three granddaughters 4, 6, and 9 and I hope everyday that new treatments will be in place for them.
    ((((HUGS)))) Maria
  • Mwee said:

    OK, this is what I would do
    First let me say how much I respect you, Carlene. You definitely wear the "big girl panties" well. I'm hearing how difficult it is going to be for you to wait and watch to see if recurrance is in your future. With that in mind, I think you'd be more comfortable joining the MIMOSA trial. You would know that the study is deblinded and you are a person that needs to see the facts.

    I have three granddaughters 4, 6, and 9 and I hope everyday that new treatments will be in place for them.
    ((((HUGS)))) Maria

    Gut feelin!
    Mimosa!
  • pattysoo
    pattysoo Member Posts: 170
    Decisions, decisions
    I really liked Nancy's suggestion to call MSK and express your concerns. This is one tough decision, as are many others we have to make. My concern with the MSK trial was the large number of CT scans they required. The cost was prohibitive for me, but also the amount of radiation was a real concern. Can you find out any other information on the scheduling of the MIMOSA project?

    You inspire me in many ways. I'm sorry to say I'd never heard of the MIMOSA project. Now I'll go look at it closer. As for hotels in NYC, my neighbor (single woman) who travels frequently) recommends a Red Roof Inn that's in the middle of the city. It's clean, nice, cheaper(er) and safe. Altogether better than you'd expect from a RRI. If you want more precise info I can get it from her.

    Good luck with your decision. The odds are pretty hard to define here.
  • nancy591
    nancy591 Member Posts: 1,027 Member
    pattysoo said:

    Decisions, decisions
    I really liked Nancy's suggestion to call MSK and express your concerns. This is one tough decision, as are many others we have to make. My concern with the MSK trial was the large number of CT scans they required. The cost was prohibitive for me, but also the amount of radiation was a real concern. Can you find out any other information on the scheduling of the MIMOSA project?

    You inspire me in many ways. I'm sorry to say I'd never heard of the MIMOSA project. Now I'll go look at it closer. As for hotels in NYC, my neighbor (single woman) who travels frequently) recommends a Red Roof Inn that's in the middle of the city. It's clean, nice, cheaper(er) and safe. Altogether better than you'd expect from a RRI. If you want more precise info I can get it from her.

    Good luck with your decision. The odds are pretty hard to define here.

    scans
    Does this trial have a large number of scans? I participated in a trial at MSKCC and the number of scans was as you expect. One prior to starting and one at the conclusion of the trial.