My doctor is once again suggesting I do this. I just don't think I'm ready to take that step. Why not leave well enough alone? So I'm curious. Is there anyone on these boards who has participated in this clinical trial or one like it?
Has anyone participated in this clinical trial?
Posted 11 May 2012 - 07:27 AM
It's totally a personal choice -- not sure I'd be ready to take the step either, mainly because I achieved a quick CCyR on standard Gleevec dosage and feel like it'll keep me stable for many years ... and I have three young kids and would prefer to count my blessings with Imatinib and press ahead without risking loss of response or or worse. I'd start on Michael's Curcumin regimen first.
If I'm reading this correctly, many CML patients qualify for this trial if CCyR on Gleevec standard dose. Also, folks like Susan (and some others I've spoken to) who first started on Interferon and transitioned to Gleevec back in the trial days appear to have either (1) an incredibly deep response after many years of Gleevec, or (2) are likely cured of the disease and could discontinue treatment all-together without relapse [but with careful monitoring to make sure]. And I've always wondered if this is because of the combination therapy approach that they received.
Clearly I'm no expert (but I did stay at a Holiday Inn Express last night), but I personally believe there's merit and promise to augmentation of a TKI ... either through a magic supplement of some kind, enduring some level of Interferon treatment in combo w/ the TKI, or immunotherapy which is one arm of this trial. Out of all of this, immunotherapy appears to be the most promising. Remember the T-cell genetic engineering trial for CLL and how amazing it was (for a small number of patients, but still)?
Here's a study specific to the vaccine + Imatinib combo. It sounds promising!! This study was published in Jan 2010 and involved a small number of patients. This might help in your decision-making process:
Dan - Atlanta, GA
CML CP Diagnosed March 2011
Posted 11 May 2012 - 08:15 AM
I read with great interest the paper you cited as well as the one Rissa cited. I e-mailed the authors to inquire about trials they may be contemplating with other TKI's besides Gleevec (Sprycel in my case). I will let you know if I get a reply back from the lead author.
It seems very reasonable that an adjunct therapy that targets a T-cell immune response can help us achieve a durable therapy free remission. My concern is that the response in the 19 patients studied only a few proceeded to CMR although most achieved a much deeper response than they had earlier. As the authors point out it is not known if the level of response achieved can be maintained if Gleevec is removed. That is the next step.
Thanks for reporting this.
(p.s. I would still continue taking Curcumin.)
Diagnosed 11 May 2011 (100% FiSH, 155% PCR)
with b2a2 BCR-ABL fusion transcript coding for the 210kDa BCR-ABL protein
Sprycel: 20 mg per day - taken at lights out with Quercetin and/or Magnesium Taurate
6-8 grams Curcumin C3 complex.
2015 PCR: < 0.01% (M.D. Anderson scale)
2016 PCR: < 0.01% (M.D. Anderson scale)
March 2017 PCR: 0.01% (M.D. Anderson scale)
June 2017 PCR: "undetected"
September 2017 PCR: "undetected"
Posted 11 May 2012 - 08:38 AM
I would want to study the results of the phase I trial and understand exactly what I was getting into. I believe people need to participate in studies if we are ever going to find a cure, but you do have to be prudent when you are on a therapy that is working and can keep you alive for many years. Messing with the immune system has to be taken seriously. We like to think it is a one way proposal. "We'll stimulate the immune system and try to go after the leukemia cells. It will either work or it won't." I think there is a piece of that equation missing. What if you damage the immune system in some way and develop an autoimmune disease or somehow turn the immune system against the person? I don't know enough about it, but I would want to understand all the risks up front. If I got comfortable that the risks were minimal then I would consider doing it.
Posted 11 May 2012 - 09:57 AM
Personally, I would not agree to this one. The "Randomized" part of the clinical trial means that you do not get to chose which therapy you are given, so you have a 50-50 chance of ending up on only Interferon plus a WBC stimulator. Not for me.
Posted 11 May 2012 - 11:55 AM
Thanks everyone for the responses. I called the nurse researcher from Johns Hopkins who left me a message last night and all I got was her voice mail. So we'll see if she calls back. I'm interested in the vaccine, but not so much the interferon. If she tells me I won't be given a choice, then I'll have to pass on this particular study. I need to have some control. Otherwise I'll just feel like a guinea pig. The vaccine does sound promising though.
Posted 11 May 2012 - 02:02 PM
I agree 100% with @Trey. I would not be interested in the Interferon arm at all ... and you don't get to choose. Don't think you'd want to get stuck taking that stuff ... pretty hard on the liver from what I understand, and can have some nasty side effects (flu-like symptoms and such). No thanks.
Curcumin is next on MY list (seriously) ... I've followed enough of Michael's case to be convinced that it can/will help but can't/won't hurt.
Dan - Atlanta, GA
CML CP Diagnosed March 2011
Posted 11 May 2012 - 02:21 PM
Hi: Just my 2 cents here. Yes, I did do Interferon every day 5 days a week with my weekends free of no drugs, and 2 weeks out of the month I had to do a combination of Interferon with Cytarabine..Two weeks out of the month I was doing 2 shots a day. I felt like I had the flu. I could not function at all. Then it started to take its toll on my liver which is why Ihad to stop all treatment. I did Hydrea for 5 months before I could start the trial for the Gleevec. So naturally this would turn me off. I do agree that some of these trials are necessary for people to participate in or where would we all be now.
I also have to ask how are you doing with your present treatment. I am so bad at keeping up with everyone's TKI and Response. If you are doing good with your present treatment, then I would not do this.
Posted 11 May 2012 - 02:32 PM
I just got off the phone with the nurse from Hopkins. She said I do not get to choose. I told her I would want to do the vaccine. She said they've actually had better responses from the people who are on the other interferon arm. Plus I would end up spending more time at Hopkins if I were chosen for the vaccine. I already stay late at work regularly to make up time for my current doctor appointments. Susan - I believe I'm pcru. My hem/onc doesn't seem interested in the acronyms. He just said it's undetectable. And I think the Hopkins people are looking for patients who are pcru. They are hoping the interferon or vaccine will be just enough to get rid of the parent stem cells. I don't think I'll do it. I think driving to Baltimore and spending so much time there will stress me out.
Posted 11 May 2012 - 05:08 PM
You posted "She said they've actually had better responses from the people who are on the other interferon arm."
Not very impressive. Sounds like a failure so far.
I have noticed over the years that some Oncs push their own clinical trials a wee tad too hard for my own personal liking. There is a personal interest issue that can come into play sometimes. Just sayin'
Posted 11 May 2012 - 09:40 PM
I agree. I'm not going to participate in this clinical trial.
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