Are you currently (or have you been) in a Clinical Trial?
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Good day everyone. Just started a clinical trial funded from NCI (ETCTN-10287), Phase II, using Fulvestrant, Abemaciclib, and Copanlisib. The Copanlisib is an infusion which stops a protein PI3K-phosphoinositide 3-kinase. This protein is often mutated in cancer cells and causes resistance to treatment--all info from the trial information. I had my first infusion yesterday and other than blowing up my blood glucose levels, I had no problems. Starting Verzenio today and back on Fulvestrant. Thanks to all the kind folk who have posted about their experiences with abemaciclib, I also started metamucil today! I will keep you posted, although the first scan will be 3 months from now. I am definitely cultivating a new level of patience.
Best wishes!
Moving
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SusaninSF- You mentioned OncLive. I have gotten emails from them for webinars, etc. Some have piqued my interest. But I have never watched them. They say they are for medical personnel. And you have to register. I have actually tried to register and they ask if I am a doctor, nurse, etc and what company I am with. How do you participate in their stuff? I would really like to be able to learn from them.
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Hi Moving- Sounds like a great combo you are on. I hope it goes well for you. Keep us in the loop with how you are doing.
My trial biopsy went ok. I am so done with biopsies(4th in 4 months) I talked to the IR and he said the reference tumor looked about the same as 6 weeks ago. 👍🏻 I hope that means at least stable disease. Scan and plan in 2 weeks.
I talked to Dr Hamilton and asked her what she would recommend next if it is enough growth to move onto a new plan. She said I should to talk with MDACC about the VLS-101 trial. Or possibly go onto chemo and we even talked a little about pursuing the Neuroendocrine.
Dee
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Dee - 4 biopsies in 4 months sounds exhausting. You've been through so much lately trying to find the best trial. Stable disease is great news tho. I am sure your perseverance will pay off.
I have my 4 month trial CT scan at the end of next week. I am more nervous than usual after getting Covid during the last week of December. I am still tired from covid. I worry how my lung scans will look, and how much covid tampered with my immune system. However, I always find something to worry about before a scan, so I need to turn the worrier part of me off.
Moving - Your trial could be a great one - a triple punch to your mets. If your glucose becomes a concern, you could ask your doctor about using Metformin or taking Berberine (supplement). I am on Everolimus with my trial drug and it causes high glucose and cholesterol levels.
Susan - You've had such great success with your trial. It's encouraging for all of us. Love the bike!!
~Kar
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Just published in Science- a poop transplant can make all the difference to responding to immunotherapy. Immune cells have to interact with bacteria in the gut to get "activated" and we know from preclinical studies published years ago now that mouse strains with bad bacteria did not respond to immunotherapy, but that they could be converted to responders when they were caged together with the mice that did respond. This is because mice eat poop in their cages and the nonresponders were eating the poop of the responder mice and that made all the difference. Subsequent work identified multiple strains of specific "good" gut bacteria that were essential for a good response.
Now a clinical trial has shown the same for humans. About 40% of melanoma patients will respond to immunotherapy, but in testing those that failed to respond the first time, they found that 6/15 patients who got a fecal transplant from prior responders were then able to benefit from immunotherapy, and responses lasted a year or more. Now they will be able to identify the specific gut bacteria strains that are needed and create probiotic pills to ensure a good response to checkpoint inhibitors.
Solid tumors will require more than this, including drugs to hit the immunosuppressive cells in the tumor microenvironment, and its also been seen that vitamin B3 and anti-inflammatory pills can boost response - So. its not over, but its real progress!!
https://www.eurekalert.org/pub_releases/2021-02/uo...
https://science.sciencemag.org/content/371/6529/60...
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Thanks for the tips Susan. I've learned a lot from everyone on this thread.
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I just went on to look at a trial that I had bookmarked at NIH that was from Dr. Steven Rosenberg's lab that was using TILs to treat metastatic cancer, including breast cancer, The study number is NCT01174121.
It was supposed to run through December 2023. But now it's reading as "suspended."
I was under the impression that clinical trials only stop when they either are proven not to work, or if they are so successful that they are suspended to give the treatment to all participants.
Does anyone know anything about this trial, or anything about why a trial at NIH would be suspended like this? If I'm not mistaken, some version of this trial has been going on for a long time.
Thanks much.
Bev
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Dear Bev, uh, thanks for finding out - this trial was on my list (it is not that we'd be able to get into it as we are not in US but still). I googled a bit and found something - seems it was suspended because of COVID (Suspended: Action taken by IRBO)! What does IRBO men? Please check this out: https://covid19.bgcarlisle.com/ Whatever that means, it is still very sad clinical trials stop because of this virus:/ Hope they will be able to resume and continue?
Saulius0 -
Saulius,
That was fascinating info about all of the studies affected by Covid.
IRB in the US means Institutional Review Board. So before any studies involving humans start out, they must have IRB approval. A similar thing happens in academia. So my guess is that because that trial involved treatment of people within NIH, and a lot of visits, they just determined that it was too risky to bring people in as often as it was necessary with this trial. At least it's not terminated, so there's hope that it will be picked back up at some point in the future.
Of course, this morning I got in my inbox the National Cancer Institute's newsletter, with the first story being about the National Cancer Act being FIFTY (50) years old. So my next question is: WHERE IS THE CURE????
And we trudge on...
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Oh my, 50 years... I think I know the real reason. I'll try to give an example (sorry, it is not the topic of this thread): SpaceX Moon program vs Apollo program. In 1960 there was nothing... no semiconductor technologies, no powerful computers, actually... there was really nothing. And yet, after potus Kennedy's spoke in Spetember 1961, in 8 years the man was on the moon. Yes, it was costly, yes, people sacrificed lives but... now take SpaceX (with all the respect to Mr. Musk)... founded in 2002, with the goal to put man on the Moon and beyond, with all the computing power and novel technologies, in 2021 they have not left the lower Earth orbit. Now what is the difference you may ask? And there's big difference. Apollo recruited ~400.000 people, ~20.000 companies that worked under one body's strict supervision (NASA) and functioned as one effective organization - yes, humanity can build such big effective organizations when they want. Now Mr. Musk must work with 8.000 people (okay okay, we may argue 400.000 is exchanged by 8.000 because we have all these new technologies but...), must pay them wages, and believe me, if they would not be paid, they'd walk right away to Boeing or somewhere else. Now because they must be paid, SpaceX has to release some "interim-product" to get returns, then another one, and then... yes, in 50 years they will be on the "Moon and beyond". When SpaceX capsule touched ISS, Mr. Musk commented how proud he was but the old lad Buzz Aldrin just commented "been there (60 years ago), done that, you have to try harder" (I don't remember exact text). Same analogy can be applied to Big Pharma. Let's say Novartis has 5 breast cancer principal scientists and 200 assistants who know not much, just do the daily job. Now 5 people is really nothing and their brain cannot be enough to find solution to such complex problem as cancer. And yet these all people must be paid. So they work hard for 5 years and the management says "hey guys, we have to release and sell something", and they release some "interim product", get their returns, and work forward, then release another drug in another five years that is a bit better (yes, 5 brains can do only this), and so on... and yet they have to be competitive against other companies, so they have to release something "faster" than others, so the product is even more "interim" than it could be... No conspiracy, just real life. I always say that most complex problems must be solved on national levels, not in private entities... Just give me 500 bestest:) breast cancer scientists, 100 laboratories, all tools and money and... there would be a cure in 3-5 years, I am sure. This is the biggest problem in cancer research - it is scattered all over the place, puzzle parts are not in one place but rather... all around the world. Now you guys tell me, how do we assemble such a puzzle?
Saulius
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Saulius,
Good explanation. Big problem. At least there is some slight integration now on clinical trials. ASCO and ESMO try to pull together disparate ideas. But our scientists still seem to be separated so much of the time in their trials, and I do wonder how much info is actually cross-exchanged between institutions, countries, and cancer agencies.
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Saulius,
Love the space program analogy. Thanks for sharing. I feel stuck in the interim!
Dee
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candy, I believe there is a category "Other". I don't remember having to lie to get on but maybe I did. ;-)
Moving, Copanlisib sounds similar to Piqray (Alpelisib). Piqray also makes your blood sugar level rise. I was able to get my blood sugar levels back to normal by going on a Keto diet. I would recommend that you try this before getting on Metformin. I'm not a dieting person but the Keto diet really worked. I lost weight, my blood sugar levels went down to normal AND my cholesterol, which is borderline too high, went way down as well. Surprising given all of the fat I was ingesting. Once I was off of Piqray, I stopped the Keto diet as well. Another surprise benefit of being on Piqray was that my skin never looked better. My friends literally made me teach them my skincare regimen but I soon after figured out that it was the Piqray! On the down side, a month after getting off of the medication I developed a terrible, itchy rash. That went away when I started taking Zyrtec and using Triamcinolone cream as prescribed by my Dermato Oncologist. Hope all goes well for you on this trial!
Hugs, Susan
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Hi. I had my 4 month scan today. I am on the AZD9833 (oral SERD) trial with Everolimus. My liver remains clear. All my existing long nodules remain the same size, except my largest nodule grew from 13mm to 15mm. Sadly, I have a whole bunch of new nodules. The largest is 3mm. They think the new nodules are from the Covid I had starting on December 27th. But they have no way of knowing if they are cancer or covid related. I have no idea what to think. I may even be kicked off the trial. If the new nodules are from covid, I think I may want to stay on the trial if I had a choice. What a mess! ~Kar
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KarPC
I care about your mixed report. I hope the new nodules are just covid. Maybe they will let you stay on the trial to be sure. Stupid cancer. Keep us updated.
Dee.
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Karpc, If they are Covid-related, they shouln't change again, i that right? If so, can't they keep you in the trial and scan again after a few weeks?
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Dee- What trial are you on now? Hope things are stable now..
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Curious - I am onARV-471 single agent
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Cure-ious. I think you are right. The covid aspect should either not change or hopefully start to resolve. I agree that they should be able to keep me in the trial and scan again soon. I hope so. I would like to assume anything new was 100% due to covid. These trials have so many rigid rules though. ~kar
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KarPC It must be stressful. I care that you are in this limbo. When will your trial give you an answer about participation? 🙏🏻
It would be nice to know if the new nodules are covid.I was thinking about the new estradiol PET and how that may be an option someday in the future for these kind of issues. Covid nodules should not uptake estradiol and you could know the difference. Wish you could get that to have peace of mind now!
Dee
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Dee, Yes, the new estradiol PET would be fantastic! I had the CT scan early. My scheduled day to meet with the trial people and my regular onc (at same cancer center) is Thursday. Being that the results came in on a Friday evening before a 3 day weekend, I don't think anyone will look at my scans until Tuesday. I sent a mychart message today asking if I could come in early to get my blood work done - Tuesday or Wednesday. If my tumor markers are good, maybe they will take that into consideration. My tumor markers last month were good and that was 4 weeks after having covid. ~Kar
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well nasty Nashville weather has postponed my scan & plan appointment to next week. It’s hard to be upset about that, but scanxiety is real and to top that off my BP is not cooperating since covid/antibody infusion. I am averaging 160’s over mid 90’s. It was higher but I went back on HCTZ (hope my magnesium doesn’t drop). Stupid cancer- scans always hit you in the face with it.
Dee
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Oh, Dee, I'm so sorry that your scans and meeting have been put off. I mean, we can't control the weather, but as you said, scanxiety is so real. I hope the week passes quickly, and that you can keep your anxiety and your BP low. Thinking about you.
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Two immunotherapy papers in the latest Nature; these concern two different types of immune cells in the microenvironment: 1) Killer T cells (self-explanatory, eat tumors and invaders) and 2) Regulatory T cells (T-regs for short), which are there to protect our own cells from the immune system.
First paper shows that tumors keep Killer T cells at bay by eating up all available nutrients, whereas they attract T-regs by secreting lactic acid, which those cells. eat. To eat lactic acid, the T-regs need an enzyme MCT-1, and inhibiting that enzyme gets them out of the tumor environment and lets the killer T cells get in to attack the tumor. An inhibitor of MCT-1 AZD3965 is already in clinical trials and apparently is well-tolerated, and now will need to be tested in combination with immunotherapy.
https://www.nature.com/articles/s41586-020-03045-2
https://www.pittwire.pitt.edu/news/cancer-tricks-i...
Second paper reports that cancers dependent on glucose (high-glycolysis) generally do not respond well to immunotherapy, and that inhibiting glucose to these tumors makes a big difference. By contrast, they find glucose is helpful to killer T cells work and is not good for T-regs. So the ideal treatment would be to starve the tumor of glucose without inhibiting glucose to the immune cells, and they show that in glucose-starved tumors, immunotherapy gets rid of the T-reg problem and increases infiltration of killer T cells.
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PS Also, a paper in Cell confirming tumor mutation burden as the biggest single predictor of response to immunotherapy but reporting a new system that give a much stronger prediction when considering TMB plus expression of a raft of other genes. Interestingly, Cyclin D amplification is associated with resistance to immunotherapy, whereas it is a strong indicator of response to Ibrance- this finding is consistent with reports that folks who respond well to Ibrance usually don't do well with immunotherapy, and also that Ibrance can make immunotherapy work better..
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Cure-ious,
Is Cyclin D amplification something that shows up in an F1 or similar genomic report?
Just asking bc, as you know, I've recently moved onto immunotherapy with high tumor mutation burden.
Also, what did you mean that Ibrance an make immunotherapy better? Do you mean Ibrance combined with immunotherapy or before immunotherapy or what? Tried to get into that Cell article but it's behind a paywall.
Thanks.
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Hi Bev,
I couldn't get it on Sci-Hub, the article says the group have some leads on how to block glucose uptake only in the tumor cells, but I don't know how they want to try to do that.
I do think CycD amplified would be indicated on Foundation One report- CycD is the partner of CDK4 and is needed for the kinase to be active, so high levels of CycD would mean very active CDK4 and hence tumor cell sensitivity to Ibrance. But you can be sensitive to Ibrance for all sorts of other reasons. UCLA reports that in the Ibrance trials, those with low PDL1 did well on Ibrance, and as Moth said, that can be a marker of low inflammatory tumor microenvironment.
as for the other, there were multiple reports that Ibrance made immunotherapy work better in mice and in cells grown in vitro- however we have not seen clinical trials report that tho I guess a few are still limping along and have not reported. Most likely, there are bigger problems that the tumor microenvironments are too protective of the tumor- with high tumor mutation then the killer T cells can infiltrate and respond to immunotherapy.
When will you know if its working?!!!
Now that I finally got a Covid shot I really want immunotherapy- for sure it would not work on me as monotherapy, but there are so many ways reported to improve it, we need some good clinical trial to get going. It would be wonderful if we could just go from one immunotherapy trial to another...
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Cure-ious,
Thanks for the info.
I guess for me, it's decent news, even though I know zippo about my Cyclin D amplification -- I don't think it showed up on any of my reports. In fact, my very first genomic report didn't even indicate that Ibrance was a drug that should be tried with me -- my MO just put me on it as standard of care, I guess. Ibrance was not my wonder drug -- it did hold me stable for a bit, but my TMs were consistently moving upward, even though I stayed on it for 18 months.
I had my second keytruda infusion this past Tuesday. In three weeks I have my third, and I'll get the double dose and switch to every six weeks for infusions. That will put me at April 6 for my fourth infusion. On that day, I will see my MO -- this past week, I saw the NP, and for my next infusion, if the blood work is okay, I don't think I'm seeing either the NP or the MO. The MO is usually the one who calls the shots on scans, so I assume some time after April 6 I'll at least have a CT. At the end of April, I'll be at 4 months since my last CT in late December. So guess that's when we'll know if it's working or not -- unless my MO decides to put off the scans a bit longer. From what I understand, it takes immunotherapy some time to work. I haven't had tumor marker tests since the very beginning of January (after having them pulled every 4 weeks for a year and a half) but those will be starting up again before my next infusion, so those may tell us something at some point. Again, I've been told by people on keytruda that their TMs went up a bit at the beginning, so that may provide no information without a definitive answer.
This is the downside of immunotherapy, I guess.
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Well, in the absence of data of any kind, how do you feel? Being off all other meds, must be kinda nice?! A bit of a drug holiday...
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hello all
I am pushing through chemo (Gem/carbo) for my TNBC mets but already thinking about what trial I want to go on when next line of treatment is needed. I have my heart set on immunotherapy not least because I know the earlier in treatment lines it is trialed the better, and there are a few options here in the UK. But there is also a CDK7 trial (https://clinicaltrials.gov/ct2/show/NCT03363893?term=carrick+module&rank=1) that I am interested in. I know Cure-ious has spoken about the promise of CKD7 inhibitors but also that someone (NewGardener) was on one and it was short lived. Just wondering if people gave strong thoughts on trying a CDK7 inhibitor monotherapy trial. As a reminder, I was diagnosed tnbc mets in lungs and mediastina in November, but was strongly ER+/PR+ at primary. My foundation one showed an odd mix of hormone positive genes (like an ESR1 amplification) and classic TNBC genes (EGFR amplification, Rb1 mutation). In my mind, something that can work on both hormone and non-hormone driven cancers may be needed but I have no science background - anyway that's why I'm attracted to the CDK7 trial0
