Are you currently (or have you been) in a Clinical Trial?
Comments
-
Dee, it REALLY sucks when we have additional medical issues that have nothing to do with our cancer, but impact our quality of life all the same!, I have a really painful knee due to an old injury and osteoarthritis so that limits my mobility, and I have double vision from a cranial nerve palsy that may or may not resolve on its own, so I've been wearing a stupid eyepatch since June! The three year old me wants to stamp her feet and scream it's not fair it's not fair!
0 -
I have decided to move forward with the clinical trial AZD9833 (oral SERD) with the everolimus. In ways I wonder what the heck I am getting myself involved with! I read what others have shared about trials yet I still remain shocked at how much is involved with clinical trial participation. I did not realize the extent of the required scans, tests, and rules. For example.... I thought I would be menopausal and start the trial within 2 weeks after finishing my last treatment (xeloda). I then tested as premenopausal, so instead I was required to get another ovarian suppression shot and wait 1 month. I will start the trial on the 22nd. I've been on non-stop treatment for 4.5 years (metastasis happened while on stage 2 treatment). So, being off treatment has been a scary change. My onc scanned my lungs and liver and checked my tumor markers after 2 weeks off. Luckily, everything was stable. Yesterday, I had multiple scans and all sorts of blood tests all day long for trial prep. The results showed that I still remain stable, so it will be mentally easier to wait another week for the start of the trial. On the first day of the trial, they will monitor my heart at the cancer center for 10 hours straight! Ugh. I will have this repeated again 2 weeks and then 1 month later. In addition, there are numerous more visits involved beyond standard of care. I do work full-time, so this is going to be trying. I am grateful for the opportunity to try a trial tho. Hopefully, it is a good choice, and I will be on this board for a while
0 -
Kattysmith - I love that “ 3yo in you wants to stomp”. I’m sorry about the eye patch and other issues. I deal with old uncle Art too. 😉
KarPC- congrats. That sounds like a great trial!! Keep posting your progress. It takes a lot to get started in a trial. Glad you pushed through.
Dee
0 -
Hi KarPC, yes, I found the experience of getting into a trial and being on it quite onerous too! At the beginning I had some scans that needed repeating because they needed to be within 2 weeks of trial start and one of my scans was just a few days too old so I got another dose of radiation /sigh/. My MO also point blank told me to quit my school program if I wanted to do the trial due to the time commitment (honestly I would have needed to quit for other reasons anyway). I have to go in person once a week for a clinic visit with the trials nurse where I have a physical exam and often there are a bunch of questionnaires for me to fill out about quality of life and symptoms etc (& then treatment is the next day). I have to keep track of all symptoms and report them and also can't take any medications without prior approval. My trial does CT scans every 8 weeks (which is more frequent than my standard of care)
I hope your trial goes well & you have a great response to the med!
0 -
Thank you Dee & Moth! I appreciate the well wishes and wish you both the best on your trials. ~Kar
0 -
Good luck, KarPC!
Kattysmith, it is not fair!
Dee, any help with the headaches, yet?
I can sympathize, moth.
On my trial I have to go to the cancer center from three to five times per month. It's the price I pay to live. Faslodex injections are every four weeks; blood draws, doctor visit, and herceptin infusion are every three weeks; PET-CT and CT with contrast are every nine weeks; and echocardiograms are every twelve weeks. Add to that appointments with endocrinology and dermatology to deal with side effects and side-effect-med side effects. Then every three months to surgery for ERCP stent replacement (cancer caused a bile duct stricture). Also support group or counselor phone/video appointments to help me deal, total of five per month, from home. I do a lot of schedule wrangling. And I have to keep a daily log of side effects and meds. So when someone asks if I work, I think to myself, my job is staying alive. For the times in between appointments. It's worth it. But civilians have no idea.
0 -
Shetland..."my job is staying alive".
I like that statement.
0 -
I sympathize with "my job is staying alive." I have wondered if I could get away with saying "case manager." Seems legit.
0 -
Does anyone have info on this trail?
It looks interesting but I don’t have a solid tumor to biopsy, I will still ask my Mo about this
0 -
Stillhavehope, looks like another kinase inhibitor similar to Roche's ipatasertib. You have to be chemo naive in metastatic setting so it's another one where you need to get into the trial right after met dx. Interesting tho. I agree the kinase targets might be a part of the puzzle for tnbc
0 -
Thanks Shetland for the good wishes. Your schedule sounds extensive! I agree that trying to stay alive is a big job. It's especially demanding since we research our own trials and treatment options. ~Kar
0 -
to you all and to the most important job a person can have!! 0 -
Shetlandpony/Lumpie and all - when applied for SS disability I actually said something like “it is a full time job just managing my health care and the issues that arise from the complications” I love “ I am my own case manager.” 😂 Going to use that one
Thankfully, my migraines have improved after 2 weeks of fighting daily attacks. I went on a muscle relaxer for the burning flank pain which is slowly easing up.So I don’t know if it is the beta blocker and/or the muscle relaxer that helped with the headaches but I will figure that out. (Saw an article that said beta blockers help lesson heart damage from chemo which is my next line) anyway...I am starting to feel like my old self. 🙌🏻
Local MO wants another brain and cspine MRI. Just to be sure. Getting that tomorrow. Ugg scanxiety-mostly about the flank pain making the 1.5 hour scan super uncomfortable.
Monitors- Thanks for the vertical hug! I really am glad to be a part of this caring, supportive group!
Dee
0 -
Dee, I'm so glad to hear that you are feeling more like your old self again!
Good luck and best wishes in each and every way on your MRI today!
Katty
0 -
can you ladies help me. I am trying find thr name of the trial where it takes out your white cells and does something with them then re injects them into yiu. Specifically one that is open for Her2- ER+ and is being offered at Bethesda MD???
0 -
Nicole,
There are three current trials at NIH using this type of technology that I had flagged (there may be more, but these are probably the first you should look at). They are all in the lab of Dr. Steven Rosenberg (famous guy for this -- think Judy Perkins) and I think they are all recruiting.
nct03412877 (this is administration of autologous T-celles genetically engineered)
nct01174121 (this is short term cultured autologous tumor infiltrating lymphocytes + keytruda)
nct04102436 (this is another T cell engineering trial using some kind of a system to express T cell receptors)
I'd look at all of them -- I think the one you are talking about is the middle one. All require some length of hospital stay.
Also, take a look at this one: NCT03272334 -- it's the UVA trial that I was looking at -- they do something similar but then they infuse some drug that they've come up with.
Hope this helps --
0 -
Thank you Bev I found it...it is the "middle one"....
0 -
Week 3 of cdk2/4/6
My RBC counts have dipped into low category for the first time in any treatment. Iron levels are ok so it is the drug. It is an expected SE. WBC are low too, but ANC is fine. Liver enzymes are good!
I am still experiencing the left flank pain especially at night. Nothing on the last ct scan to explain it. X-ray doesn’t show anything. Urinalysis is fine so they ruled out kidneys. Taking muscle relaxers and pain med and using the heating pad. Now I’m constipated and taking senna and dulcolax. 🥴
Latest MRI of brain is clear! Lots of arthritis in cspine scan but no cancer. Migraines are under control but the beta blocker has caused my bp to dip really low in the morning. Got a call in to discuss what to do.
I have the second biopsy in 2 weeks and I am not looking forward to it. I am in the biopsy cohort so I agreed to have it to be on the trial. Hopefully this flank pain will be under control by then.
I’m done with the long visits to SCRI for the trial blood draws. The rest of my weekly trips are shorter days. I will learn early December if it is working.
Dee
0 -
Dee,
On balance, it sounds like things are going well. Where will they be doing the biopsy, since you mentioned flank pain?
Hope you continue to work out the ongoing issues, which sound like they are solvable. Hang in there!
0 -
Dee awesome you are doing good!! Thanks for keeping us posted. So happy clear brain scan!!
My scans are tomorrow...
0 -
Here is the NIH trial I have been following and was invited to submit. It is about to open up. Very interesting protocol of new immunotherapy plus vaccines
Phase I/II Trial Investigating the Safety, Tolerability, Pharmacokinetics, Immune and Clinical Activity of SX-682 in Combination With TriAdeno Vaccine Regimen and M7824 (TGF-b "Trap/PDLi; Bintrafusp Alpha) in Advanced Solid Tumors (STAT)
https://clinicaltrials.gov/ct2/show/NCT04574583#contactlocation
Cohort 1 is for any solid tumor and will accept 20 patients. There is also a triple negative cohort.
here is an article about SX-682 http://syntrixbio.com/two-new-reports-show-sx-682-blocks-key-immunosuppressive-tumor-cells-to-enhance-checkpoint-inhibitors-and-nk-based-cell-immunotherapies/
I will keep it in my bucket if I need to try another trial before a platinum combo. My MO said if I am excluded from staying in the CDK 2/4/6 due to minor progression and have good liver enzymes, she would support another trial.Maybe someone here could qualify and be able totry this promising trial.
Dee
0 -
CDK 2/4/6 trial week 4
My bloodwork is ok but showing low HG. I am officially anemic. If it gets below 7, I will get an infusion at SCRI. WBC is low. Platelets are low. Liver enzymes are great. ANC is good too. Stomach issues- every time I eat my tummy feels so full for hours so no appetite. Wish that meant I could lose some weight. 😉
I still have the right side flank pain, Tues I got trigger point injections which helped some. Will get a low spine MRI with ortho to see if my old L4-5 spondilolistheses is the culprit. It’s just a pain area that I have never had before and I have had this for 10 years. Ortho recommended lumbar Steroid epidural. They usually work for me and keep me from needing a spine fusion.
Migraines are getting less. It’s nice to feel almost normal. I keep hoping that this trial will get me to stable disease and PFS.
Next week is the 2nd biopsy, for the trial. I am not looking forward to that.
Dee
0 -
AlabamaDee, for your flank pain, have kidney stones been ruled out? Fyi, a KUB (kidney urterer bladder) CT is super fast, no contrast.
I'm glad your migraines are improving. These weeks must have been pretty hard, Dee. So many things and pain. Definitely keep an eye on the anemia. I dropped below 70 once and struggled to walk up a flight of stairs. Awful feeling of being weighed down and exhausted.
I'm really hoping you see great results from this trial! I've forgotten - is it blinded or do you know if you're getting the experimental drugs?
0 -
I'm meeting in Nov with an RO to discuss a radiation trial called STOP: stereotactic radiotherapy for oligo-progressive metastatic cancers https://clinicaltrials.gov/ct2/show/NCT02756793
The randomization part - ugh. I don't want to be in the control arm lol. I want the SABR!
0 -
AlabamaDee - I'm glad that your migraines have improved to the point that you feel "almost normal." I hope that your docs will find something to improve your right side flank pain. Mostly, I hope that the CDK2/4/6 is wiping out your cancer!
Moth - I LOVE the name of your trial, "STOP." I understand the need for the randomized trials, but it's so hard to enter a trial knowing that we might get randomized to the control arm. My current trial, DESTINY Breast04 of Enhertu, is randomized 2:1 for Enhertu versus physician's choice chemo. I was fortunate to get the treatment arm and will be hoping and praying that you get the SBRT arm!
0 -
Gotta get a word in for the trials: I was in the DESTINY trial, too. I was randomized to the control arm and I didn't mind at all. In my branch of the trial, Kadcyla was the control arm and I had not had it yet so that was fine with me. Worst case, you get what you would have gotten anyway. You might get a new drug... but those are not yet FDA approved so they are not without risk - and they don't always work. And in most trials you can switch to the new/trial drug if the standard of care does not work. (Destiny was one of the few that did not allow switching arms - bummer.) On the trial, I had access to new docs and new perspectives - which I considered to be a real plus. I also got some extra screening (brain scan) which I would not have gotten otherwise. About the only down sides are that on-boarding can be a bit time consuming, sometimes the trial locations is less convenient and the schedule can be rigid.
I just had to chime in because I am a bit evangelical about clinical trials. I have been in two now. I think they are a big win (even though the drugs I was on were not long term successes for me). Enhertu has given many of us more time and comfort and I am gratified to have played some tiny part in making it available. I hope more people consider participating in trials.
0 -
New Phase I trial at National Cancer Institute:
https://www.cancer.gov/about-cancer/treatment/clin...
it's open to metastatic breast cancer patients --
Metarrestin (ML-246) in Subjects With Metastatic Solid Tumors
0 -
MOTH- they don’t think it is kidneys because they looked at my ct from just a couple weeks before and saw nothing there and urinalysis is fine.
Question- can you get SBRT without being in a trial? My local RO was very willing to do SBRT to the single lung met and said she would do it again if another lesion showed up in the lungs but she wasn’t on board doing SBRT to the liver. I was offered a clinical trial like yours at MDACC at the beginning of my metastatic journey- systemic or SBRT to the 2 liver tumors (flip of the coin) I declined because I was still hoping for surgery at that time.
Lumpie- I feel similar about helping others through a trial. Mine is phase 2 so I get the drug. My arm is trial drug only. The next arm includes an estrogen blocker. Glad you are so “evangelical”
De
0 -
Just popping in to say a brand new approach to immunotherapy was published in October issue of Cell.
A group at Mt Sinai developed a drug that activates myeloid progenitor cells in the bone marrow, and studies in mice and non-human primates show it is safe and effective either alone as well as in combination with checkpoint inhibitors, they say it will be ready for clinical trials "soon"...
https://www.cell.com/cell/fulltext/S0092-8674(20)31300-3
https://www.eurekalert.org/pub_releases/2020-10/tm...
0 -
Cure...will this be for TNBC or HER2-??/. I don't see anything about breast cancer in there
Did I miss it?0
