Are you currently (or have you been) in a Clinical Trial?
Comments
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Kathy, thanks for chiming in! You never know how much your information can help someone else.
I hope and pray that your next injection won't be as painful.
PS I have trouble updating my treatments too, so don't feel bad.
Yr Pal,
Katty
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yEs- I was just naive. I thought trials covered everything and was surprised to find I still had to cover certain things. Just me not being in top of things. I have god insurance so it’s not a problem. My only issue is that my trial is out of state so my insurance bills are a little harder to navigate.
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Leftfoot, this is an interesting and important discussion. I haven't thought about it much yet, but I always have assumed I would be signing up for probably multiple trials. On average, most trials fizzle out, however nowadays there are a lot of potential gamechanger trials going on, if ever there was a promising time to be in a trial, surely now is it!--- and before one takes too many chemos, because that can exclude you. And obviously, for Lucky4Life, she first got Ibrance-Letrozole through a trial and went six years, so that was way worthwhile! But I'd be fussy too, only a trial where I knew I was getting the drug, and a drug I had some good reason to believe would really help..
Lucky, were there supplements you took over the past six years that you think might have helped you get such a long response? Was the cancer just limited to a few places? Do you think there are others on the trial getting as long as you had?!
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Thanks Katty, I do believe I'll be asking for extra pain meds next time.
Curious, your comment on too many Chemo's was partly the reason I chose trials when first dx with mets. I also did not want my body so beaten from chemo that I couldn't qualify for a trial later.
Kathy
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Kathy (weareonthecusp) thanks for providing the info regarding the trials you've been on. I looked up your current trial - I only read the summary since I don't understand most of the medical explanation but it looks pretty interesting. It appeared that early on it was tested on a variety of cancer types. And you mentioned that they saw good response in the BC patients - yay - so do you know if it's only being tested on triple negative at this time? I'm just curious. In any case, it seems like a modality that may eventually have broader application if it works. Please forgive my ignorance but am I understanding correctly that you get an injection into the actual tumor? In your breast tumor? or brain met? Yikes! It sounds really painful. But, worth it if it works! I'm not in a clinical trial but I'm also getting Keytruda along with Herceptin (I'm ER/PR neg and HER2 pos) I've been on it for about 8 months and my last two scans have been NEAD. I know it doesn't work for everyone and it can have some scary side effects but for some it seems to be quiteeffective.I hope your trial combo works well for you!
Margarita
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Margarita, I know in the earlier coherts that many cancer types were involved. From my research, it seems they have had the best response in triple negative breast cancer. I am not sure of what stages they were. I know they have asked for a fast track for triple negative and that they were opening up the cohert with keytruda to triple negative first. As I understand it they can inject deep tumours as well as surface. I dont believe they inject brain. I have the opportunity to inject upto 6 tumours, I think but have only injected one in my underarm. This will happen 5 times with 3 biopsys. I'm not sure if they will want to inject more as the trial continues. Hope this answers all your questions.
Very happy to read you are nead,
Kathy
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Kathy, Can you post a link to your new trial?! Its too bad you had to leave the last one, especially since the brain met could have been there before and you were responding!! but no matter it sounds like this one you are getting more stuff, still immunotherapy- plus you can always add Celebrex and get about the same effect as the ep4 drug you got in the last trial!
Also Shetland, are you taking Celebrex or some other NSAID? these are anti-PI3K drugs, give an overall survival advantage to all with PI3K mutant cancers (I know I'm a broken record about this, but don't want people to forget)
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Curious, I am not sure why I am getting a message saying I cant post a link at this time but here is the trial #NCT03058289
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Hi again, Kathy! Here is the link to your trial, its got an impressive number of organizations who have signed up to give it a try.
https://clinicaltrials.gov/ct2/show/NCT03058289
Per their description: INT230-6 is comprised of a 3 agents in a fixed ratio - a cell permeation enhancer and two, potent anti-cancer payloads (cisplatin and vinblastine sulfate). The penetration enhancer facilitates dispersion of the two drugs throughout injected tumors and enables increased diffusion into cancer cells.
The Sponsor's in vivo, non-clinical data shows that INT230-6 thoroughly saturates and kills injected tumors. In addition, the drug induces an adaptive (T-cell mediated) immune response that attacks not only the injected tumor, but non-injected tumors and unseen micro-metastases. Cured animals become permanently immunized against the type of cancer that INT230-6 eliminates.
So, it sounds like they use this new drug to get the anti-cancer drugs into the tumor cells, and then the killed cells attract the immune system which can then go off and fight the cancer in all other parts of the body. Most of the arms are testing the drug alone, but one arm is also adding Keytruda, and it sounds like they may add another arm to include Keytruda plus CTLA-4 antibody.
So definitely they are aiming for the big immunotherapy response- Good Luck!!!!
PS Forgot to point out that, given that you responded well to your last trial which was immunotherapy only (plus ep4 NSAID), it seems that your cancer is sensitive to immunotherapy. So adding this extra injectable component to give the immune system some dead cancer markers to go sniff out, will hopefully boost that up further. Interesting approach..
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also, for immunotherapy, the immune cells have to get activated by passing thru the gut where they get stimuated by bacteria and certain "good" bacteria strains are important for this. They are testing specific formulations of probiotics (like Bifidobacterium infantis) to boost this response https://immuno-oncologynews.com/2019/12/12/clinica...
So eat up some good salads and yogurts that will expose you to a variety of the good bacteria! Also a recent paper came out showing that there was a boost for immunotherapy just from taking standard pre-biotics (which have fiber that acts as a 'fertilizer' that boosts all gut bacteria)..
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Lactoferrin also works in the gut to boost immune response, but I would use caution with combining anything immune modulating with an actual cancer immunotherapy.
https://www.jpeds.com/article/S0022-3476(16)00294-8/fulltext
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC48140...
I read that probiotics are linked to a reduced response rate for cancer immune therapies. In particular, a 70% reduced response rate for melanoma immunotherapy has been reported.
https://www.statnews.com/2019/04/02/probiotics-are...
https://www.parkerici.org/the-latest/probiotics-li...
KEY FINDINGS
Overall, Parker Institute and MD Anderson researchers found that diet and supplements appear to have an effect on a patient's ability to respond to cancer immunotherapy, most likely due to changes in the patient's gut microbiome.
Among the findings:
- Over-the-counter probiotic supplement use was linked to a 70% lower chance of response to immunotherapy with anti-PD-1 checkpoint inhibitors in a subset of 46 melanoma patients
- 42% of all patients reported taking over-the-counter probiotics among those who took the lifestyle survey
- Probiotics were linked to lower gut microbiome diversity, previously shown to be associated with poorer response to anti-PD-1 checkpoint inhibitors
- Patients eating high-fiber diets were about 5 times as likely to respond to immunotherapy treatment with anti-PD-1 checkpoint inhibitors
- Patients eating diets rich in whole grains had more bacteria associated with positive response to checkpoint immunotherapy
- Diets high in processed meat and added sugar had fewer bacteria associated with a positive response to checkpoint immunotherapy
"Eating a high-fiber diet has long been shown to have health benefits. In this case, we see signs that it is also linked to a better response to cancer immunotherapy," Spencer said. "Definitely another good reason to load up on whole grains, vegetables and fruits."
ADDITIONAL MICROBIOME-CANCER IMMUNOTHERAPY TRIALS UNDERWAY
While this study focused on correlations rather than root cause, other randomized, controlled clinical trials are underway that are designed to directly answer the question of whether one can manipulate the microbiome – through food, fecal transplant or other means – to improve cancer immunotherapy response.
The Parker Institute is now conducting such a trial in collaboration with MD Anderson and Seres Therapeutics. This randomized, placebo-controlled clinical study is evaluating whether a specially designed oral microbiome pill with specific types of bacteria could positively impact a patient's response to checkpoint inhibitors.
The study is open at MD Anderson and the Angeles clinic. For additional information on this trial (NCT03817125) please visit www.clinicaltrials.gov.
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Sorry to interrupt this important discussion about gut health and the immune system. I have something to say about my experience a week into my trial. I have been so miserable with diarrhea, nausea, and inability to eat. I am weak and my heart pounds. I told them on Saturday I needed a dose reduction but all they did was add more anti D and anti nausea drugs. Yesterday I told the nurse I would not take the neratinib that day. She said she would look up the dose reduction guidelines. What?! You should have checked that already, Lady. So I looked up the guidelines on the Nerlynx web site. My diarrhea is at least grade 2, maybe grade 3. At 5 or more days of grade two the neratinib is supposed to be interrupted, and not resumed until it goes to grade 0-1. If that takes less than a week, resume at same dose. If that takes more than a week, reduce the dose. So I should already have been taken off it. I think they should have been checking on me every day, even if the study protocol only said the first three days. I am telling you, I will not resume at the same dose. How many days can a person go without eating? Yesterday I managed half a cracker, half a banana, and some electrolyte drink. And I threw up. I feel like I will starve to death. The protocol says everyone starts at the maximum dose, even though the nerlynx web site describes a gradual dose increase as a way to manage diarrhea. I feel like the pharmaceutical company that designed the trial and even the nurse and doctor care more about their protocol and selling as many pills as possible than they do about me. Very disappointed in them. Now I am looking out for myself because it appears nobody else is.
SUMMIT phase II neratinib herceptin faslodex
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Shetlandpony, I am sorry you are experiencing such harsh side effects. I have not as of yet had this kind of reaction on any trial so far. I would refuse the treatment as well if I had. I hope the trial Drs come up with some kind of solution. I know that during a trial the Drs sometimes have their hands tied as far as dosages go, and what types of meds they can prescribe or allow you to be on, but getting your side effects under control and your well being should be the number one thing they are interested in. If you feel as though it's not, you always have option to leave but I read you really want this drug. Maybe call your own Dr, not trial Dr and ask his opinion?
I sure hope you get some relief soon,
Kathy
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((((((((( ShetlandPony))))))) We're thinking of you!!
They should certainly be keeping a closer check on you. 0 -
The thing is my insurance company actually approved the neratinib so if I can get faslodex from them too that would be a real option. It was my own onc I talked to on Saturday. But the rest of the time it is our cancer center's trial nurse and she relays what I say to my onc. How stupid is that? I am goi g to start communicating w my onc directly after I talk to the nurse.
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Thank you, Mods. What would I do without the support here?
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ShetlandPony, do you/they use their health portal for communication?
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I don’t do portals. I just email my onc. So I just sent her one that said we need to talk. There is the question of the trial but we also need to talk about the damaged trust.
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So sorry this happened, Shetland.
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Wow. Shetland. This has to shake your trust with how you are being monitored. I hope you are not dehydrated. Your pounding heart scared me. I am sorry you had to be your own advocate, but glad you are now communicating directly to Onc.
Makes me wonder about the other trial patients..
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Right? What happens to those who don’t look things up and advocate for themselves?
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Sandi, the pounding heart scared the triage nurse on the phone, too. She asked DH to tell her my pulse lying down, sitting, and standing. Then she said I must go to the ER for fluids and electrolytes. So that’s where I am.
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thinking of you Shetland.. so sorry and I really hope you get some relief soon.
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Hi. Wondering if anyone here is on or familiar with IMMU-132 (Sacituzumab Govitecan)? (Gumdoctor - I'm so sorry to hear the drug didn't work out for you. You are in my thoughts)
In particular I want to know if anyone has kept their hair or had success with cold capping? Gearing up for the ER+ trial of this drug and really wanting to not lose my hair again
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Here is a recent story about some of the SERDs that are coming along- I am not very familiar with how these drugs get to market, and the story is not very clear about this, but it seems to say they may be ready to file for FDA approval next year? But if so, that would be at the end of phase 2 study, so don't they need to go through a phase 3 trial?
https://www.evaluate.com/vantage/articles/news/cor...
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(Sorry for partial cut-and-paste from my post on the Nerlynx thread.)
The fluids worked wonders, and I am have spent the today eating.
I am still waiting to hear from my onc; not sure what is going on there. Feeling like nobody has been properly looking out for me on this trial. Earlier in the day that I went to the ER, I talked to the trial nurse. She asked if I would resume Nerlynx that day. I told her no, not without talking to my onc. Can you believe she even asked that? And she still did not figure out how bad off I was. It was the urgent care nurse on the phone who did that.
I want to walk away but I ought to give this drug combo another chance. I would like to go back on with gradual dose escalation but do not know if that is allowed. I have asked for a copy of the protocol, rules, etc. Because obviously this is a do-it-yourself project.
SUMMIT basket trial.
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Hi Shetland, I can't believe this is typical Clinical Trial behavior. Is there a liaison with this Clinical Trial dept that can address neglect of a trial participant? I mean, they are putting your life in jeopardy and you have enough to deal with..like that stupid stent you have to replace every few months...ugh.
Thinking you you.
S
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Shetland, I am also on that combo, but not in a trial. My onc. at Mayo started me with Nerlynx, faslodex in October. Just added herceptin this month. I started Nerlynx 3 pills a day for week, then titrated up to 6. Finally got the D under control, Herceptin seems to have kicked it up again, but manageable. I have an Her2 mutation, failed on Ibrance after initial recurrence. Zofran also helps with the appetite and diarrhea. If it helps, everything calmed down with the Nerlynx after a few weeks( after I got to 6). I know from following on these boards that you really keep up and understand all that is going on with research. Do you think this protocol is going to be worth it for us?
Claire
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I have an update, my friends. My onc called. She has been sick. She is moving me to a different trial nurse. And she says yes, I can go back on using a gradual dose escalation. She gave me to understand that the rules are not set in stone because the main thing is to show efficacy. So I guess they would rather adapt than have people quit, right? It seems my situation was not typical. But you know, I always tell them, I am a lightweight and if you give me a standard adult dose of anything there is good chance you will be overdosing me.
Marley, how interesting that your onc put you on this protocol not on the trial. Did you have trouble getting insurance approval? Did you two consider the trial? I wish I could live up to your faith in my keeping up with the research! Sometimes I get tired and coast. But I had read up on Her2 mutations and some success stories. My hope is that neratinib will be long-term successful the way herceptin often is for Her2+. My onc has another stage iv ILC patient who got 18 months of NED on single-agent neratinib! My sense is that my onc has an idea that this drug may be particularly good for ILC and/or these Her2 mutations. (These mutations are more common in ILC.) She says it is the logical next thing to try and I agree. Even though a few days ago I felt like walking away, I realized I needed to give it another chance.
Sandi, when I asked my onc why do the trial instead of get the drugs on my own through insurance, she said when you are on a trial we keep a really close eye on you. When I talked to her, of course, she acknowledged the recent failure! Of course another way they keep a close eye is they scan very often. Going forward, I will talk to the new trial nurse when she calls, but I will also email my onc and onc nurse my own updates. If my onc nurse had been in charge of me things would not have gone on so badly for so long.
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Shetland- I was unable to get access to the drug without being on Trisl. Insurance would not pay for it in a metastatic setting as it hasn’t been approved for that yet the and we make too much as a family to qualify for help to pay for it on our own. The drug company, hospital foundations, and all other people who shell with expensive drugs all said the sdd as me thing. I was lucky to have gotten into a drug trial and get access to the drug.
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