TNBC Vaccine Trial?
I believe a larger trial with more locations is opening soon (Mayo clinic in Jacksonville said later this year, but I know it has been delayed many times already.)
Does anyone know anything about this smaller one? (NCT02593227) I called today to get more information but haven't heard back yet. It appears after treatment there is no minimum amount of cancer you need to have left to participate. It is a little confusing though- one section says you can be stage I-III and another area says it is for IIb-III.
This trial interests me because the only other trial in my state I might be eligible for is a immunotherapy trial including Keytruda, but you have to have at least 1 cm of residual disease or positive nodes.
My MO is pretty excited about the immunotherapy outcomes so far, and the vaccine is also immunotherapy.
Has anyone talked ro their MO about this trial? Has anyone been offered this after getting a PCR?
Thanks!
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Before you start this immunotherapy clinical trial, ask if you will ever be able to do any other immunotherapy drug in the future? My MO said don't do immunotherapy trial as I would not be allowed to do any new treatment when it comes out of immunotherapy. And they are doing a lot right now developing immunotherapy treatments.
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I also go to Mayo in Jacksonville. My MO mentioned a trial the last time I saw her and said we'd discuss it when I came back for testing after radiation was finished. That appt. with her is Mon., July 17. She went into little detail but did say I'd be a perfect candidate. She also said it was a vaccine with a low grade chemo pill (but not for how long) as I recall and the trial hadn't started yet. I would assume that this is one of the two you're talking about and hopefully I will know more Monday
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Thanks Connie. I'm interested to hear what you find out at your appointment.
I'm actually in Michigan now ( I used to live in Jacksonville) but called Mayo Clinic a few months ago because I believe the vaccine was developed there and my husband's family still lives there (so it would be a easy place for me to travel to for a trial). Unfortunatly, the study I called about in Michigan still hasn't returned my call. I see my MO for the last time next Friday before surgery, so I was hoping to have more information to discuss with her at that appointment!0 -
I'll post what I find out probably Tuesday. I have bloodwork, PET scan, CAT scan, and bone density all Monday prior to seeing the MO. So it will be a long day and hopefully a day that doesn't bring any nasty surprises which I am, of course, nervous about. It will be a 12 hr day due to travel time and that'swithout taking time to stop for dinner and I expect to be exhausted.
If you have any specific questions you'd like answered, please tell me so I can ask.
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I'm very interested in hearing about this trial. I live in Kentucky but have family in Florida unfortunately not the Jacksonville area. Still very interested so I can ask my Oncologist about it.
Thanks and I wish you all the best on your upcoming test!
Hugs and prayers,
N
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Wow, that sounds like a super long day! Does your MO routinely do all those tests? My MO won't do any scans unless I have symptoms, so to date I've only had imaging related to the breast.
The majority of my questions are regarding the study in Michigan. The Mayo Clinic trial is written much better than the one I found here in Michigan (This is the Mayo trial: NCT03012100). For the Mayo trial it looks like you have to either have had positive nodes, a tumor over 5cm or not a PCR to be eligible. It also defines the frequency of treatments- monthly, then once every six months ( the Michigan trial just says to reoccurance, so could I be on this stuff for 5 years? 10 years?)
They should be able to answer these-
Is the vaccine considered immunotherapy?
Does this treatment cause hair loss?
What are the side effects?
Thanks so much!
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I didn't find out much of anything. First of all, her physician's asst. was ill today and she had to see both her patients and Gina's patients. So instead of seeing her at 4:30, I didn't get to see her until 5:45. She said she just hadn't no idea whenever the Mayo trial would begin. Although it sounds really odd to me, the Dept. of Defense is paying for this trial and requires more hoops to jump through and it has just not moved along as she'd hoped. I would think that I had misunderstood about the Dept. of Defense except she said said that last time and my husband also heard it both times.
However, Moffitt at Tampa is currently doing a trial on this same medication. She is turning my name in to them and she said if I didn't hear from them by Wed., to call them.
The only thing that I found out was that there are 6 shots at the rate of 1 per month. I didn't press her for any more info since it was 6:15 by this time. I also figured I would be better off getting the info from Moffitt since they are doing the trial.
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Thanks Connie! I'm not surprised the Mayo clinic trial hasn't started, it's been delayed many times. The trial at Moffitt is the same as the trial here in Michigan I initially asked about. I still haven't heard from the study in Michigan, so I left a message at Moffitt yesterday. I see you had surgery before chemo, I will be having surgery afterwards so the eligibility for each of us will be differnet. Hopefully one of us will hear something soon! I see my MO for the last time before surgery this Friday and I wanted to talk to her about this as an adjuvant option based on my final pathology.
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I finally heard back from someone about this trial. It is open to stages I-III, and if you've had neoadjuvant chemotherapy there is no minimum amount of cancer that has to be leftover (so you can participate even with a PCR). You have to be finished with active treatment within a year (I think she said 360 days) and can participate if you've also had additional adjuvant chemotherapy. There are 2 phases of the trial- the initial phase you get the vaccine 6 times every 4 weeks, then you move on to phase 2 getting the vaccine every 6 months for up to 3 years. There is no placebo, everyone will get the vaccine but there are 4 arms- They are testing a high and low dose of the vaccine, and they are testing it with and without a small dose of chemo to start with. Overall I thought this sounded very promising, especially for those who did have a PCR or had a small amount of cancer left after neoadjuvant chemotherapy, as most trials exclude them. I am waiting to find out if it would be best to see the Dr now or after my surgery- I will let you all know more as I find out!
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Hope you don't mind if I chime in on this topic. If it is the same as what my Dr has been talking about then it's called TAP Immune. It targets the folate receptor believed to be attributed to TNBC. It has already been confirmed in ovarian cancers, so the link was worth investigating. My dr wants me to begin this immediately following the end of my six months of xeloda coming up in 2 months. I did not have a complete response to chemo at surgery. I am eager to do what I can to reduce any risk of recurrence. I'll be 36 this week and have an 18 month old. I am coming up on my one year survivor date (diagnosis). I am a little apprehensive of the study because it is 3.5 years, and we had hoped to have another baby. But I want to be here for my son, so I'm leaning toward participating
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Hi abwatford, Yes the trial is being sponsored by TapImmune. The vaccine is the Folate Receptor Alpha Peptide vaccine, and it does appear to be a long term commitment (at least 3 years). I am hoping to participate in this trial if I find out I had a PCR, or if I have some residual cancer, but not enough for the immunotherapy trial (1 cm). Do you mind if I ask where you would be doing the trial? When I spoke to the Dr leading the trial here in Michigan she asked if I was close to be finished with chemotherapy, kind of hinting that timing might be an issue (which made we wonder if the trial is going to be full soon?). If I have some residual cancer I would also like to do Xeloda, so that adds another 6 months before I could get into this. I like you am pretty young (just turned 32) and have 2 small children (4 and 18 months) and am willing to do whatever it takes to beat this and be around for them. My husband and I weren't sure if we wanted to have a 3rd child or not, but it seems as though this has made that decision for us (which I absolutely hate).
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hi Sam,
I am doing treatment in Dallas, Texas. My nurse leading the clinical trials hinted around that they were having trouble filling spots so they talked about opening up the applicant pool (i.e.-different stages/Responses). That might be why your Dr was asking questions. Although from one of your previous posts the potential candidates they talked about with you were different than when I spoke to someone at first. The nurse has been super open and honest with me, which I love. Since I'm on the fence she comes to check on me when I go for my xeloda checks. One thing she did mention which made me feel a bit better was that the trials account for drop outs (not that any of us go into things saying we aren't going to finish), but three years is a long time for a trial. She said that at some point people just get ready to live their lives and that's okay too. I appreciate someone who gets it!
I actually was under the impression that TAPImmune was an immunotherapy trial, what is the one you mentioned in your previous post?
How are you and your family holding up during your treatment?
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Hi Abwatford,
Yes, this vaccine trial is a immunotherapy trial- but it's different than another immunotherapy trial my MO mentioned to me. The other trial is for people who have over 1 cm of residual cancer (or positive nodes) after neoadjuvant chemotherapy, and it uses Keytruda, which is approved for treatment of lung cancer. To my knowledge this vaccine isn't approved to treat anything else, it is a completely new drug. So either the vaccine or Keytruda are the only trials I would be eligible for in my state. Obviously, I hope I'm not eligible for the Keytruda trial ( if they find any residual cancer I hope it is a lot less than 1 cm).
I spoke with the coordinator at the vaccine study again and he did mention they have been opening up the eligibility to get more people in. He also said they hoped to have all the participants in by the end of the year. He said I wouldn't loose my hair (even if I got placed in the arm with the chemo) because it is so low dose, and the only side effect they have had is 1 person complaining of redness around the injection site. Considering all the side effects I've had from chemo, I'll take that!
As far as my family- I have felt mostly good through chemo, and I cold capped to keep my hair so my oldest son doesn't have any idea that something is going on. I have times where I feel more anxious than others, but since starting treatment and being able to tell I was responding I've felt a lot better. I have my last chemo tomorrow, and as excited as I am for it to be over I'm a little scared as well. I'm just really looking forward to having the surgery and knowing what is next. My husband also just wants the surgery to be over to know this thing is out of my body.
How are you holding up? You are about 6 months ahead of me- Do you still think about cancer everyday, or has it gotten better?
I can't wait for this to not be the center of our lives anymore, but I worry that is going to take years.
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Is anyone doing the I-Spy trial? My dr is trying to get me into it. Would love to connect with someone to hear about their experience. I read a little about it, but sometimes reading the medical jargon is not the same as hearing about it firsthand.
Thanks!
Rebekah
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Hi Rebekah,
I did not participate in that trial (none of my Dr's even mentioned it as an option so they must not being doing it anywhere around here). But it looks very promising in regards to increasing your chances of getting a PCR. I had my Dr give me carboplatin off trial to hopefully increase my chance of a PCR. We will find out if that helped in about a month!
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Sam0623,
I have heard good things about Carboplatin and asked my doctor about that too, so I think it's great that you are getting it. I hope it works great for you. Can you post back here and let us know? My doctor said she wouldn't give it to me unless AC and Taxol don't work. I'd rather have it the way you are having it with Carboplatin + Taxol.
Rebekah
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I had Carboplatin w/ taxol and had problems with platelet counts and it had to be discontinued after 9 treatments. I also lost 4 weeks with 2 two week delays. After the first two week delay, they reduced the amount of Carboplatin. After the 2nd delay, they had to discontinue it.
I am anxious for Aug 30 to arrive and for me to get to Moffitt and find out all about their trial and if I qualify. I met with both my surgeon and RO this week on follow ups ad they both really want me to get into this trial.
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I also got cut off from the Carbo early. I was supposed to get it every 3 weeks, 4 times total, however my wbc could not keep up so they stopped it after 2 doses.The NP mentioned I was getting a pretty high dose because of my age (I guess the dosage is based in your weight and liver function). I sure hope it was enough! Apparently I am one of the rare people who get neutropenic just from Taxol, so the Taxol/Carbo was just too much. My platelets have been fine the entire time though. Go figure!
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Sam0623, I asked my ONC for Carbo because of the increased chance of getting a PCR and at first he said no and sent me to start on my weekly Taxol. He came running out to the waiting room and after talking it over with his colleagues he did start me and I had 12 weeks of Taxol with Carbo added every 3 weeks. I did get a PCR! I did ask about the trials but wonder if Inshould inquire again. My mom had uterine cancer 10 years ago and they said it was confined so she had surgery to remove and radiation. She was just diagnosed with Stage 4 so the worry about recurrence has been bothering me
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Hi redporchlady,
I totally get the fear of reoccurance, especially when you've seen it happen with a family member. My dad was diagnosed with colon cancer, which was surgically removed and he had no other treatment. 2 years later it came back in his liver, which they managed for awhile with chemo but eventually he passed away a few years later. I never really second guessed his treatment, but now going through this experience myself I wonder if he would have had the reoccurance if he had chemo in the first place.. It made the decision to have chemo a very easy one for me.
I see you are almost 3 years out- with the PCR and already being that far out I would feel very optimistic if I were you, but I totally get it's hard sometimes. Unfortunately, I know for this trial you have to have finished treatments within the last 360 days, so I don't think this one would be a good option. I've looked into a few trials, and this has been the only one I have found so far that accepts patients with a PCR- One study coordinator told me (regarding another study) that there isn't much available in clinical trials for those with a PCR because they consider 90% of them are cured.
I, like all of us here hope so much to find out I had a PCR, but I'm trying to prepare myself for the fact that may not be the final result.. All the signs are pointing to the fact that I had a good response to chemo (tumor has not been felt since 3rd AC and no longer shows up on US) but I feel like I have heard of so many women with similar clinical results and still don't get a PCR.
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Sam0623,
Thanks for sharing about your dad and I am sorry that you lost him and going thru your own battle. My lump in my breast and my armpits almost disappeared during chemo so they told me I may not get a PCR but after the surgery the tissue they removed was completely treatment affected and the chemo did its job. I see your surgery is coming up and please come back and let me know how it goes. I hope that you get a PCR and interested in how the trials go.
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I haven't read all these answers but if vaccine is the same as clinical trial for immunotherapy, then I want to write what my doctor said. I visited Johns Hopkins U, to see if I qualify for another clinical trial. I didn't qualify for the trial I was going to see about, but he doctor was trying to encourage me to come back for an immunotherapy trial. I told my regular MO and he said I should never sign up for an immunotherapy trial because after you get the trial, you can NEVER get immunotherapy again in your life After they develop something that really works. There are lots of things on the horizon. Don't put yourself in a place where you can't get more proven treatment.
So I would discuss this point with your doctor if you are considering immunotherapy clinical trial.
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I started this vaccine clinical trial today. I had met with them a few weeks ago, qualified and here I am. Fingrts crossed that this works
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Awesome Connie! I have my appointment next week, although I'm not sure if I will be a great candidate for the trial anymore. I had my surgery 9/1 and basically found out that chemo was completely ineffective on my tumor and I have 8 nodes involved. I am devastated, but moving on looking for other possible treatments (which this could still be one). I'm going to MD Anderson in 2 weeks and I hope and pray they know what to do with a chemoresistant tnbc. I kept this appointment since I had it anyway and figured several different opinions couldn't hurt.
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I hope that MD Anderson has some good answers for you. They're supposed to be the best place to go. I know that the timeline for the clinical trial is that you have to have finished treatment more than 2 mos but less than 1 yr.
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Hi, ladies! Im in the didn't get PCR group (missed it by much as per Agent Get Smart). I just finished 6 cycles of Xeloda and am in the 60 day clean up period. I signed up for the folate receptor alpha vaccine immunotherapy phase two clinical trial at the KU Cancer Center in KC, KS. I hope I qualify. The trial nurse said its filling up and will likely closely year end. My screening apt is Oct 20th,and she said you find out what group you get randomized in two-three days later. I would then start in early Nov. Who else besides Connie1230 is currently in this trial? I'd love to hear how it's going for you
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Thanks to this wonderful board and the awesome women and men who post here, I am trying to enter this trial as well. I will be traveling across two states to do so, but for the sake of extending my life I'll do it. The Texas Presbytarian Oncology Center is where I'll be traveling to, if I make it in. Sure do hope I qualify.
I'm so very grateful for this website, and you ladies, and this resource. It may be a life saver.
Love to all on this Saturday.
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Hi, JoJoBird! I hear ya, I'm driving 3 hrs each way to get to my hospital, if I'm accepted. Sounds like you may win the distance race tho
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Hi ladies! I had my appointment with the center in my state conducting this trial and I'm in. The criteria to qualify is pretty simple- they let me go ahead and sign the consent right then (even though we were waiting on the results of my PET scan- which were good thank God!). I just have to complete radiation and then wait the 60 days. The Dr leading this trial also mentioned to me they plan on having it filled up by the end of the year- when I signed up last week there were 12 spots left, but I'm not sure if that's nationally or just at my center. It is a 2.5 hour drive for me- but it doesn't seem to be a huge commitment regarding number of visits- according to the consent form you go every 4 weeks for 6 months, and then every 6 months for 3 years. If you get put into one of the arms where you get chemo first you get that 3-4 days before your first injection (it's really low dose- you don't lose your hair or anything). It seems to be very well tolerated- the only side effects my doctor said patients complained about were normal vaccine side effects (soreness/redness near the injection site). I just wish I had time to do 6 cycles of Xeloda first- but the Dr seemed pretty convinced this would be closed by then. I am still going to M.D. Anderson this week for a 2nd opinion on basically everything, but they don't have any trials other than the Keytruda study that I would qualify for so I still think this is my best bet.
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Sam0630 - that's great that they could sign you up already! I hope this study can not only give us all a sense of peace but a sense of purpose, knowing we will be helping others in the future!
I'm curious - did you all get PCR after neoadjuvant chemo or not? I'm in the not category.
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