Are you currently (or have you been) in a Clinical Trial?
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Happy Anniversary!!!
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Novagirl, thanks for your well wishes on erdafinitinib. Perhaps you will be in the same trial sometime soon with your FGFR amplification. Not sure you need the full F1 report before your March doctor’s appointment but if so, you can call F1 and they will email it within minutes.
Katty, congrats on reaching your milestone and 20-year anniversary!!! I hope your will do something special to celebrate!
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JFL,
Thank you for suggesting calling F1, I don’t know why I didn’t think of that.
Ditto on everyone’s sentiments Katty...Hally Anniversary
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JFL - was doing some research on BCO and ran into the posting from you about the basket trial. I am currently looking into something similar, I believe. I also have the FGF3, FGF4, and FGF19, as well as FRS2 (and others of course). I had a consult yesterday and they recommended lenvatinib as one of my match drugs. Anyway, it might be interesting for us to connect more. Wanted to post this here before I forgot
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Thrivingmama, keep me posted on what treatment you end up taking and whether it is part of the NCI MATCH basket trial or another trial! Would love to track your status given I have those same FGF amplifications.
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Hope there will be clinical trial for this soon.
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hi
About four years ago I did a vaccine trial at Johns Hopkins-it was an immunotherapy trial that used your t-cells to identify cancer cells and attack them.
I have Erpr+ bone mets diagnosed denova 51/2 years ago I was stable when I entered the trial and have been stable since at my last Pet I had no active tumors.
I’ve only taken tamoxifen and xgeva since diagnosis-I know people say that immunotherapy doesn’t work on hormone positive cancer or bone mets but I think it did something and would do it again in a heartbeat.
Kristin
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hi Kristin,
Thanks for sharing this. Do you still have the link or information for the trial that you did?
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I am wondering if there is an active Topic for immunotherapy? I confess I am still not the best at navigating the BCO site, plus there are some topics that tend to be more active than others.
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and another question... I am wondering if there's anyone out there who has done immunotherapy with a MDM2 mutation? There are some studies (compelling, though small) that indicate that people with MDM2 mutations tend to fail our of PD1 treatments, or even hyper progress on them. I am curious if anyone with a MDM2 mutation has had success with immunotherapies. thanks!
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hi kidmanling
The trial was with Dr.Leisha Emens out of Johns Hopkins I do have the nurse coordinators email if you want to pm me I’ll pass it along.
Kristin
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Party- I could not find anything indicating that the trial is still ongoing? when were you treated?
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thriving mama, is there any MDM2 trials? My cousin has it and this is what Foundation 1 stated:suggest that MDM2 amplification may predict a short time-to-treatment failure on anti- PD-1/PD-L1 immune checkpoint inhibitors, with 4/5 patients with MDM2 amplification 71 and 2/3 patients with MDM2 or MDM4 amplification72 experiencing tumor hyperprogression, amplification of MDM2 or MDM4 was not associated with shorter progression-free survival (PFS) in a retrospective analysis of non-small cell lung cancer (NSCLC) outcomes with immune checkpoint inhibitors (hazard ratio of 1.4, p=0.44)73. The latter study reported PFS of >2 months for 5/8 patients with MDM2/MDM4 amplification 73.
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Kidman - I understand there are some early stage trials for MDM2 inhibitors, or Nutlin analogs. I haven't looked into them much.
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Following up on my previous post... It appears both EGFR and MDM2 mutations are linked to PD1/PDL1 failure and hyper progression. I found an article that has more details: http://clincancerres.aacrjournals.org/content/23/1...
I'm curious if anyone has experience with PD1/PDL1 drugs with EGFR or MDM2 mutations?
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thrivingmama, thanks for the information. It makes me think of 2 things: 1.inhibiting MDM2 might help to active the immune system to attack tumor cells. 2. MDM2 mutation might be likely to affect blood. I wonder if you have/had any blood problem( red blood cell, plalate counts low, fibrinogen low etc?) my cousin always have blood problem whenever tumor progress, and it doesn’t seem to happen to other BC patients often, so I wonder if it’s related to this mutatio .
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just in case somebody might be interested, someone posted on fb this trial is looking for more candidates.
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Thanks Daniel- that is Abemaciclib with Immunotherapy (Keytruda), which could be a really worthwhile option for those considering trials that do not involve chemo... they have not released their trial numbers in awhile, it would help to know how people in the trial are faring thus far!!
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FYI: Just read the exclusion criteria for that trial. If you have had more than two chemos as part of stage 4 treatment, you are not eligible.
Drat.
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BlaineJenn- Daniel's link is to a phase 1b trial for immunotherapy (I-O) plus Abemaciclib, +/- an AI. If you notice, that trial ends this fall, so perhaps they will be announcing a phase 2 sometime this summer? Not sure how the transition from phase 1 to phase 2 work, and if there is overlap?- also, I've noticed that the conditions/exclusions they put up for a phase 2 can be very different from the phase 1. Of course, some new I-O trials may pop up that are a better fit with your treatment history.
In addition, there is the I-O plus EP4 trial that could be a great option and is pretty much open to all comers, but in that case the requirements go in the other direction, ie it requires that you have run out of standard treatments!
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Kidmanling, when cancer impacts bloodwork as you describe above, and is not related to the treatment itself, it may mean that the bone marrow is involved, which is pretty common with bone mets to varying degrees. Tumor location can play a part in how progression presents in blood work and metabolic/liver panels. Tumors in different locations trigger different types of results outside normal ranges.
Update on the Erdafitinib FGFR inhibitor trial: I started 2.5 weeks ago. So far, only symptoms are mouth sores, acid reflux and the worst being extreme constipation accompanied by abdomen / back pain and spasms which has resulted in a few rough days. My liver enzymes and alkaline phosphatase shot up quickly in the first two weeks of the trial, which is not typical for me, even when I have progression. Prior to starting the trial, I was required to be off treatment for 4 weeks and my liver enzymes and alkaline phosphatase improved or remained relatively stable within or near normal range during that time. Erdafitinib is known to begin to work rather quickly so I am praying the flare is a good sign and not an indicator of a sudden progression after starting this medication. Fingers crossed.
The trial intentionally looks to push one's phosphate levels higher and out of normal range. I was tested at the 2 week point and if my phosphate levels didn't meet the specific out of range threshold the trial is seeking, my dose would be increased from 8mg to 9mg, with 9mg being the maximum dose for the trial. I ended up not needing to increase my dose. I will continue with 8mg unless side effects require my MO to lower the dose. I believe that the trial wants phosphate levels high because it is an indicator that the mechanism of action of the drug is working (although whether that mechanism of action stops the cancer is another story). The drug is intended to inhibit/prevent the phospforylation process that cancer cells go through to grow, whereby a kinase acts to attach a phosphorus group to a protein to in essence commence cancer growth. Will keep the group posted on my progress.
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JFL, thank you so much for posting updates about the trial! I really hope everything goes well for you and Erdafitinib works for you. I also have the FGFR1 amplification and am really hoping we can all have something in our arsenal for it.
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JFL, thanks for the update, and I hope your SEs are managed quickly. I'm sure you know all of this, but push the prune juice and Milk of Magnesia for the constipation and Senecot is a good softener. At one point during AC back in 2015, I had to get on my knees on the bathroom floor to push a BM - felt like I was giving birth! Take Nexium or drink a small amount of baking soda dissolved in a cup of water for the acid reflux. A wedge pillow helps, too. Mouth sores are awful. There is a steroidal mouthwash they can give you.
Best wishes for a great outcome on this trial!
Katty
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JFL, I've had to deal with mouth sores on afinitor and probiotics cleared them up. Maybe you can check with your onc to see if you can take a daily probiotic?
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Kidmanling - no, I haven't had blood work when I have progression. I'm hoping they start studying MDM2 inhibitors with immunotherapy.
JFL - thanks for the update! I had been thinking about you and wondering how the trial combo was going for you. Good to hear that your AlkP levels are where they want them, and hoping that all signs are that the drug is working well and quickly! Do you get any tumor markers tested? When is your next scan? hope it's killing lots of cancer!
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Thanks, all, for the comments and suggestions for the side effects! I go back tomorrow to have bloodwork retested (out of caution by my MO, not part of the study).
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Update - I had the bloodwork today and the results warranted my MO stopping the medication for at least 4-5 days. The drug causes high phosphorous levels and they should be high to indicate the drug is working. However, now mine are too high. I also have drug- induced hypercalcemia which is likely causing most of my side effects. Also my liver enzymes and alkaline phosphatase have jumped since last week, My MO thinks it is a tumor flare as even my worst progressions have not caused major jumps like this in my ALT, AST and ALK or moved this quickly. I am just a mess but feel relatively good! I do not like treatment breaks but do not want to mess around with electrolyte imbalances which can be dangerous.
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JFL,
Sorry you are dealing with hypercalcemia and other side effects. I hope these all subside quickly so you can get back on treatment.
We are all hoping for very good results for you. Thanks for the update
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JFL - sorry to hear that you are dealing with hypercalcemia and jumps in your LFTs. On the brighter side, good to know why you are having the side effects and that they believe it is tumor flare. Hopefully a short break will get your levels back down and then you can continue. Do you have reliable tumor markers? I wonder if that could be a way to monitor response too?
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How is everyone's trial going?
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