• JMS's Avatar

    Clinical trials

    Asked by JMS on Tuesday, November 12, 2013

    Clinical trials

    Yesterday, my Johns Hopkins doctor suggested I consider joining a clinical trial of T-cell and vaccination treatments. I qualify for the study as I've been on Folfirinox chemo for about 7 months. It also doesn't require a measurable tumor (that most studies do). My concern is the risk/benefit. I know that I won't be able to tolerate the current chemo side effects too much longer and that this regimen tends to stop working after a few months - so it may not be an option for too much longer. But, there are significant risks fro the trial, mostly because it could compromise the immune system and lead to organ failures. So, have any of you had experience with clinical trials? Do you have advice for me? Thanks for any light you can shed on my decision. JMS

    12 Answers from the Community

    12 answers
    • Dick_K's Avatar
      Dick_K

      JMS, I started in a phase 2 clinical trial for metastatic melanoma in March 2010 and although the drug got accelerated FDA approval in August 2011, I continue in the trial.

      From my personal experience I can tell you that the medical staff I have is very good and through about follow-up and the pharma protocols are also very stringent. I started out with weekly check-ups, then every three weeks, and today my check-ups are every six weeks. News about side effects and results are quickly recorded and shared throughout the various centers administering the trial – one learns from another and one teaches another.

      For me, I have been very fortunate with my treatment and I am on the very far right of the bell curve. It was a decision I made with full knowledge that it might not work but if it did, it could buy time until something else came along. There is also that feeling that is hard to describe that by participating I am going to be able to help other people who could benefit from the knowledge gained by trial participation.

      I hope you can come to grips with your decision; regardless of your decision to participate or not, best of luck to you.

      over 7 years ago
    • PerryLowell's Avatar
      PerryLowell

      What phase trial is it?

      over 7 years ago
    • JMS's Avatar
      JMS

      Dear PerryLowell - apparently the T-cell trials fall into a non-phase category. This one is designed for 92 patients, 1/2 of whom will be selected out into a control group that will not receive the treatments (we will be notified of this right away). Those remaining in the trial will receive vaccinations and T-cell treatments every 3 weeks for a period that is determined on a case-by-case basis (according to patient response, apparently). The troublesome side-effects center around problems with possibilities that the body's immune system might go after vital organs (kidney, liver, lungs, etc.), but we would be monitored closely. The benefit of the trial is that it would - if successful - buy me time until something better and more effective comes along.

      For Dick_K - thank you for your response. It is very helpful. Regards, JMS

      over 7 years ago
    • geekling's Avatar
      geekling

      You are either very brave or very desperate or both.

      Phase 1 = less than one hundred people, a portion of whom are controls (no drug given). This group usually requires both bravery and desperation as they are agreeing to try something new and are, in fact, the first actual humans to use a particular protocol.

      Phase 2 = can be more or less than 100 people (usually more) but either nobody died in the first phase or no more than one out of fifty and some of those 49 folks are cured or have their lives extended.

      Phase 3 = usually a lot more people. It is still an experiment but the drugs have proved somewhat safe with relatively tolerable side effects and seem to cure the condition.

      Phase 4= The FDA says to the company to go ahead and sell whatever it is to people.

      http://www.nlm.nih.gov/services/ctphases.html

      At this point the stuff is either Vioxx sneaky or Heaven sent like penicillin.

      The chemotherapy which brought me back to Western medicine had finished phase 2. I wasn't in phase 3 but I took the drugs along with trial members who still had their tumors. Mine had been (mostly) resected and I thought the drugs would get rid of the roots which had been left inside of me. Without meaning to be punny, that cancer is behind me as I was declared free of cancer in 2003. I remain in that condition. There are complications. I am cancer free.

      I hope you, sometime soon, get to hear those words directed at you.

      over 7 years ago
    • FreeBird's Avatar
      FreeBird

      JMS I am sorry you are faced with these difficult choices, and that you're hurting from the FOLFIRINOX. I don't know enough about the clinical trial you're considering. Do you have a clinical trial number or link to the information for that? If we can find a page for it, and it's a later phase study, we might be able to read some of the results they got from earlier studies. That kind of information could be helpful.

      In general, if Gemzar has failed, and you can't do Folfirinox, and they've ruled out other combinations of 5-FU, I think you're running out of mainstream chemo options without a clinical trial if you're at stage 4, from what I've read and heard from the doctors. Where did your cancer spread again?

      over 7 years ago
    • country's Avatar
      country

      Good luck to you jms in your decision, I know it is hard, we are praying for you and I believe the doctors do watch you so closely,
      Country

      over 7 years ago
    • JMS's Avatar
      JMS

      Hi to those who have kindly responded to my question. Let me try to respond to the couple of additional questions posed. First, I now know that this would be a Phase 2 trial. Second, to answer Country's question about metastasis, when I completed my rounds of Gemzar last February (and doctors thought I had been cured), my first scan showed a metastasis to my sacrum bone. Following cyberknife treatments to that tumor last April, it is now gone, but I had to resume chemo treatments due to rising tumor marker numbers.
      I haven't yet decided whether or not to join the trial, but am tending towards doing so. Thanks so much for your input. JMS

      over 7 years ago
    • FreeBird's Avatar
      FreeBird

      First I would get clear on what you want, and what you do not want. I would ask the question, "Is this going to do more harm than good?" and "Based on the evidence so far, what are the realistic expectations or hopes for this treatment?"

      If it is reasonable that based on the evidence from the earlier studies, based on the science, that this might help you to reach your goals, then you can decide whether it's worth the risks of creating new problems. If you can find the previous study, you might get hints that will help you answer those questions. Ask the Pancreatic Cancer Action Network if they can find information on that clinical trial. They're very good about sending information by email. http://www.pancan.org/section_facing_pancreatic_cancer/oneonone_support/ That will at least give you peace of mind that you did everything you could to make an informed judgment and decision, and that you couldn't do anything differently. You already know what's going to happen without treatment, unless there's a miracle. If you decide for no more treatment, hospice care can make a difference in quality of life and from what I heard from the nurses, can even help to extend life. If you decide that you're willing to accept the risks of a clinical trial, and the information shows that the benefits could outweigh the risks, and your goal is to try anything, then I would lean towards trying it.

      You have a terrible set of choices, and my heart goes out to you.

      over 7 years ago
    • greatlife's Avatar
      greatlife

      Who is the trial oncologist at Johns Hopkins? I am in a pancreatic cancer vaccine trial there with Dr. Lei Zheng. I started the trial 10/2011. It is a trial for cancer-free survivors, but I know that he and other researchers there has other immunology trials available for metastasized patients. Perhaps this will help you to get more information. You are very wise to seek treatment at Johns Hopkins.

      about 7 years ago
    • deSmile's Avatar
      deSmile

      Hi!

      I believe we are in that study with Dr Dung Le. Made through 3 out of 4 treatments. Side effects different than Folfironox and progressively worsening but hey tolerating and here to talk about it!

      over 5 years ago
    • deSmile's Avatar
      deSmile

      Let us know if you want further details... But did 2 treatments no then spent 10 days on vacation in Aruba.. 3rd wrecked havoc on GI system but working my way back... 4th will be discussed in a few weeks.

      over 5 years ago
    • deSmile's Avatar
      deSmile

      Let us know if you want further details... But did 2 treatments no then spent 10 days on vacation in Aruba.. 3rd wrecked havoc on GI system but working my way back... 4th will be discussed in a few weeks.

      over 5 years ago

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