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clinical trials
Comments
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@hope2022
Sorry for the delay in getting back to you. I have not received the results for my BIODIVA and POWER genetic/biomarker testing yet. I am curious to see if anything pops up. I did notice on my Health app that the results of my recent biopsy notes some positive/negative markers for OC, i.e., TP53 and a couple of others that I have not yet researched. Another place to look if someone hasn't participated in the biomarker study. I mention this because one of the trials I was considering required a TP53 positive marker in order to participate and I didn't know at the time that those notes were with my biopsy report. I am also interested in seeing the correlation between what was reported from my biopsy to what results I get from the other two biomarker studies.
Like you, I would be interested in 1/1b clinical trials, but I would have to be fully satisfied that my oncologist supported it. Of course, no clinical trials would reach the 3/4 phases if they didn't start somewhere and with willing participants. There are success stories. And you know that if the treatment doesn't work or if there is too much toxicity, the trial and/or your participation would be discontinued. You could also call the trial lead and discuss your concerns and their expectations for the drug(s).
Just my thoughts...0 -
@GloHo Would you mind posting anything you find on the TP53 marker? I have it and have done some research on it. I am LGSC and it showed on my biopsy report. I looked into the BioDiva study and it is only for HGSC unfortunately.
I am not eligible for any trials due to the toxicity I had to the one back in the fall and most of them falling in the MEK inhibitor side of things. I am so thankful that you HGSC ladies have so many resources and combos that can be done for you with more and more research and info coming on the horizon. It is truly wonderful to have that.
I wish you well in your future choices of treatment!
@hope2022 I wish you well in your future treatment choices as well
Enjoy the weekend ladies if you can!0 -
@GloHo
Congratulations on your 'stable diagnosis'...what a great place to be. I'm so happy for you!!
I also have a P53 mutation, apparently very common with OC.
My genome sequencing showed the P53, which was also on my original pathology report from 2018.
It also showed -
RBI mutation - no options for this.
HRD positive
MSI status - stable / TMB status - low...these 2 indicate I likely wouldn't respond to immunotherapy.
@Strongwoman
Thank you again for all your inspiring posts!
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@hope2022
Thanks...yes, I am very happy to have a stable diagnosis. I've tried several different treatments over the last year, so to have some positive news with this one is a relief!
Interesting about the MSI, TMB markers re immunotherapy. It will be interesting when I get mine back (should be soon) to see what markers I have.
@Strongwoman
Of course...I'll see what I can find out about TP53 (P53) when I get my biomarker tests back. I plan on asking details about each marker I have with my Oncologist.0 -
Artistry-7 Trial update!
Cycle 3
Week 1
Day 1 (Monday): Bloodwork, Oncologist, treatment (reduced dose of Nemvaleukin Alfa + regular dose of Pembrolizumab)
Day 2 (Tuesday): Treatment continued.Day 3 (Wednesday): Bloodwork showed a slight rise in liver enzymes, but not at a level that would affect the continuation of treatment. Treatment continued.
Day 4 (Thursday): Treatment continued.
Day 5 (Friday): Bloodwork showed another rise in liver enzymes, quite high, and trial board and/or oncologist approval to receive treatment would have to be sought; however, my neutrophils fell to a level that was unsafe to receive treatment. So, no treatment Day 5.
Side effects: The infusion side effects include some chills and aches when I get home. Although I am receiving an alternative antihistamine, they are still a bit sedating, but I was not as tired throughout this cycle and, on Day 4, I was able to stay awake throughout most of the treatment time and even enjoyed a couple of outings (dinner, shopping) following treatment. I was also able to eat, drink and stay awake in the evenings.
Week 2
No blood draw for trial this week - trial protocol discontinues this draw after Cycle 2.
No side effects this week.Week 3
CT scan
Monday: blood (via vein) for trial.
No side effects this week.
Other comments
CT results: Stable (YES!!) (no new lesions, no growth of existing, some reduction)
Even though the immunotherapy drug has been reduced and I am only receiving 4 out of 5 days of treatment, I was very happy to see the positive results.
Trial protocol requires a CT scan every six weeks, so I will be getting another scan following Cycle 5.
Bloodwork: My neutrophils and liver enzymes continue to be affected by the drugs. There was a question as to whether or not I could continue in the trial. The Trial Coordinator contacted the trial board to seek their determination for continuation. In light of the fact that my CT results were positive and my neutrophils and liver enzymes return to normal as soon as I stop the drugs, I was given the OK to continue in the trial. We will, of course, have to keep on top of the blood work and I am sure that we will probably have to revisit the continuation question again at some point in the future.
CA125: I am interested in seeing what my CA125 levels are at this point. I only get this blood draw on Day 1 of each cycle and they have been consistently rising over the last year. I am hoping there will be a decrease to match the stable/some reduction results shown in the CT scan.0 -
In response to @mjmck21 question in Teal Thursday's chat.
Week 1 - Day 1 in each cycle is pretty much a right off. Days 2-4 are a bit shorter because 1) I do not have to wait to see the oncologist, b) I only get more pre-treatment bloodwork on Days 3 and 5, and c) I only get one drug infusion. The trial stops the Day 3 blood draw at Cycle 3. Clinical blood draws (for oncologist review) follows the same schedule as the trial.
Pre-treatment meds are given each day and include: 2 acetaminophen, 2 Benadryl (or alternate antihistamine) and 1 famotidine (heartburn/indigestion). I am receiving the alternate antihistamine - chlorpheniramine. It is my understanding that the pre-meds are not part of the trial requirements - they are given as standard-of-care precaution. So, adjusting doses is possible through your oncologist. Your centre may have a different combo of pre-meds - I'm not sure how that is determined. I seem to be hypersensitive to meds (including over-the-counter meds), so the two acetaminihen and antihistamine make me drowsy. There are no other meds required in the days before or after treatament (no Dex, no Ondanesteron), unless something is needed to counteract a symptom for that individual.
Mobility: I have a choice between a chair or a bed - I prefer the chair. Yes...in chair through entire time. Get up for washroom or to put something in the garbage (just to get up!). I slept through my Cycle 1 and Cycle 2 infusions, so mobility wasn't an issue.
Side effects: I get the chills and aches after I get home, which is about 5 hours after the drug infusion. However, the other woman on the trial with the same drugs, gets the chills after the two-hour observation time and before she leaves the centre. The chills and aches have been mild, but I usually nap when they start so I don't know exactly how long they last or how severe they are because it is all over after my nap. I usually get settled on the couch, all nice and warm and cozy, before they start and I have found that this seems to help and they don't settle in as much. The side effects seem to have lessened starting Cycle 3.
Feeling: Generally, I feel well. For the first two cycles, I did nap throughout infustion time and when I got home and had no trouble sleeping through the night. Starting the third cycle, I was able to stay awake during infusion and go out for a bit after treatment - dinner, shopping. My energy level is ok. I find I am a bit slower to get started and my legs feel heavy, but once I get my legs going, I get back to normal pretty quickly. My appetite is but I do seem to be a bit off immediately after treatment - the rest of the time, no problem! When I do get home from treatment, I feel lazy! But, when you consider that you are sitting all day, it makes sense. I have some fatigue, of course. I just take that for granted now.
Trial Coordinator: I don't know what I would do without my trial coordinator. She has been critical in helping me to navigate all of the requirements and protocols for the trial. Especially helpful for blood draws, results and communication with the oncologist and trial board regarding my wonky bloodwork. I always make sure I ask her about the bloodwork requirements for the week because chemo registration does not always look or have it in the system! If it's not in the system, she will come down and sort it out. The trial coordinator usually comes to visit me in treatment each day - we'll discuss side effects, bloodwork and, of course, she comes down to retrieve the trial blood when taken. There is a short survey to complete once a week. She will bring the tablet down and leave it with me so I can complete the survey at my leisure. The trial coordinator does a lot of behind-the-scenes work with the oncologist and trial board. She makes sure the oncologist is aware of the trial blood results (these results are not posted to my health portal), she advocates for my care with the trial board, and she will call to alert me to anything out of the ordinary (as per my request).
Good grief...I think that's it. Let me know if you don't understand something or if any more question have arisen because of this long-winded response 🤣.0 -
omigosh @GloHo this is detailed and so helpful.! Thank you and so happy that this is working for you. Could you clarify something? The cycles are 3 weeks. Are the first 5 days of week 1 are in clinic with infusions and the following 16 days are free OR do you receive treatment every week for 5 days in clinic and then two days off and then start the next cycle. If it's the second do you have any time off in between cycles and is there an end in sight i.e. after 6 cycles a break for x amount of time. Since December I have been receiving 'weekly' Avastin/Taxol on Fridays but after three weeks we skip a week which allows for two weeks off where I can go places, recover from side effects, etc. I'm trying to picture how all the logistics work.
I will likely have more questions as you progress and thank you so much for sharing this journey with us.0 -
@mjmck21
Hi there. I'm happy to answer any questions you have.
Logistics for the 3-week cycle
Days 1-5: treatment all week with various blood draws throughout the week
Days 8-21: no treatment
Cycles 1 & 2: Day 8 and 15 trial blood draw (set up a time with trial coordinator) (in and out)
Cycle 3 forward: Day 15 trial blood draw (set up a time with trial coordinator) (in and out)
Logistics for treatment week
The times for the length of treatment days are specific to my centre. Your centre may have a more streamlined process for getting you from A to B to C during treatment days. I've broken down my times below.
Day 1 (8.5 hours)
Pre-treatment blood draw + wait for results (approx. 1 hour)
Oncologist + wait time (approx. 1 hour)
Registration at chemo + wait time for chair assignment + wait for drug prep (approx. 2 hours max.)
Pre-treatment meds (1 hour)
Treatment - Drug 1 (30 min infusion + wait 30 min before next drug infusion)
Treatment - Drug 2 (30 min)
Post-treatment observation (trial requirement) (2 hours)
Days 2 & 4 (5.5 hours) | Starting Cycle 3, Day 3 follows this timeline
Registration/drug prep/wait (approx. 2 hours max.), pre-treatment meds (1 hour), treatment (1 drug only) (30 min), post-treatment observation (2 hours)
Days 3 & 5 (5.5 hours) | Starting Cycle 3, only Day 5 follows this timeline
Registration/blood draw-wait for results/drug prep/wait (approx. 2 hours max.), pre-treatment meds (1 hour), treatment (1 drug only) (30 min), post-treatment observation (2 hours)
Since my blood work has been problematic, my Day 3 blood draw has continued as a precaution.
Side notes for you
I am finding that treatment week does bring quite a bit of fatigue - some from boredom, some due to meds, and some due to my body working harder to fight my cancer. I do have less fatigue during weeks 2 & 3. Also, as I have stated previously, I am finding the side effects quite mild, tolerable and manageable. If I did not have the liver enzyme issue, I would take Tylenol to offset the aches, but I do not want to cause further upset to my liver, so I put up with the aches for the evening. When I wake the next morning, they are gone.
As is true for all cancer treatments, and as I know you know but want to state here for others reading this post, everyone reacts differently to each cancer drug and each centre has their own way of operating. So, this is my personal journey - including all the ups and downs with blood work, side effects and wait times.
I think I covered everything logistic...hope this helps. Let me know if you have any other questions.
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In response to @mjmck21 question in Teal Thursday chat.
Week 1 - Day 1 in each cycle is pretty much a right off. Days 2-4 are a bit shorter because a) I do not have to wait to see the oncologist, b) I only need to get more pre-treatment bloodwork on Days 3 and 5, and c) I only get one drug infusion. The trial stops the Day 3 draw at Cycle 3. Clinical blood draws (for oncologist review) follows the same timetable as the trial blood draws. Let me know if you have any more questions about blood draws - it gets confusing between what is needed for the trial and what is needed for oncologist review.
Pre-treatment meds are given each day and include: 2 acetaminophen, 2 Benadryl and 1 famotidine (heartburn/indigestion). I could not handle the Benadryl and am now getting an alternate antihistamine - chlorpheniramine. It is my understanding that the pre-meds are not part of the trial requirements - they are given as standard-of-care precaution. So...adjusting doses is possible through your ONC. Your centre may have a different combo of pre-meds. I'm not sure how all of that is determined. I seem to be hypersensitive to meds (including over-the-counter meds), so even the two acetaminophen make me drowsy. There are no other meds required in the days before or after treatment like I had with chemo (no Dex, no Ondansetron). I don't know what else people may experience after treatment because my side effects during most of my treatments have been mild and I haven't experienced anything other than slight loss of appetite which was resolved with an anti-nausea med. (Had hand and foot syndrome with Caelyx/Avastin, but I won't go into that here!! Ouch!!)
Mobility: I have a choice between a chair or a bed - my preference is the chair. Yes...in chair through entire time. Get up for washroom, or to put something in garbage (just to get up!). I'm pretty sure I could get up and walk about as long as I'm not in the way. I haven't quite reached that point yet - I was just able to stay awake during treatment for the last cycle...and I had my book to read, puzzle book, etc.
Side effects: I get the chills and aches after I get home...which is about 5 hours after the actual infusion. However, the other woman on the trial with the same drugs, gets the chills and aches after the two-hour observation and before she leaves the centre. The chills and aches have been mild, but I usually nap when they start so I don't know exactly how long they last or how severe they are because it is all over and done with after I've had my 1-2 hour nap. I usually get settled on the couch, all nice and warm and cozy, before they start. I have found that this helps and they don't seem to settle in as much. The side effects seem to have lessened starting the third cycle.
Feeling: Generally, I feel well. For the first two cycles, I did nap throughout infusion time and when I got home and had no trouble sleeping through the night. Starting the third cycle, I was able to stay awake during infusion and go out for a bit after treatment - dinner, shopping. The side effects were minimal. My energy level is ok. I find I am a bit slower to get started and my legs feel heavy, but once I get my legs going, I am back to normal walking without issues in a very short time. My appetite is okay but I do seem to be a bit off immediately after treatment - the rest of the time, no problem! When I do get home from treatment, I feel lazy! But, when you consider that you are sitting all day, it makes sense.
Trial coordinator: I don't know what I would do without my trial coordinator. She has been critical in helping me to navigate all of the requirements and protocols for the trial. Especially helpful for blood draws, results and communication with the oncologist(s) and trial board regarding my wonky blood work. I always make sure I ask her about the blood work requirements for the week because chemo registration does not always look or have it in their system! If it's not in the system, she will come down and sort it out. The trial coordinator usually comes down to check on me each day. We'll discuss side effects, blood work and, of course, she comes down to retrieve the trial blood work taken that day. There is also a short survey to be filled out once a week. She will bring the tablet down and leave it with me so I can complete it at my leisure. The trial coordinator does a lot of behind-the-scenes work with the oncologist and trial board. She makes sure the oncologist is aware of the trial blood results (these results are not posted to my health portal), she advocates for my care with the trial board, and she will call me to alert me to anything out of the ordinary (as per my request).
Good grief...I think that's it. Let me know if you don't understand something or if any more questions have arisen because of this long-winded response 🤣.
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Artistry-7 Trial update!Trial Arm 1: Nemvaleuken Alpha + Pembrolizumab
Week 1 Days 1-5Treatment process: There was a blip in dosage calculation. I received 30% instead of 50% on Days 1-3.
Cycle 4
Blood work: Due to the reduced dosage, my blood results (liver enzymes and neutrophils) were not quite as pronounced as in previous treatments. This allowed me to receive treatment on Day 5 for the first time since starting the trial.
Side effects: Again, due to the reduced dosage, my side effects were reduced - no side effects on Day 5.Week 3 Day 15
Trial blood draw.CA125
Well, this was a very pleasant surprise indeed! My CA125 dropped significantly - by 40% from my highest result in June. (After a year of trying different treatments and not finding anything that worked for me, my CA125 had been rising consistently to levels I had not seen before!) I am nowhere near the magic number yet given that my count was so high, but fingers crossed that this downward trend continues.Side notes
The reduced dosage showed that my body tolerated the drug better - less disruption to my blood work and reduced side effects. So, the Dr approached the trial board to explore the possibility of getting another reduction for me - from 50% to 30%. For trial purposes, I am at the maximum reduction level of 50%, so a further reduction in dosage is not possible. I really do appreciate the Dr's initiative in trying to alter the dosage for me. The level of care (and caring) I am receiving is outstanding and brings a level of confidence and calm to me (= less stress!). I know my care team has my back and I could not ask for a more exceptional team to support me throughout this journey. Feeling so grateful.
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This is wonderful!0
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@GloHo That is amazing! I bet you are experiencing less stress due to the results and care team.
Thank you for exploring this option and journaling it so well. If I had the sane type as you, it would encourage me to explore the same option with my care team. You are brave and inspiring.
Thank you again for being open and sharing your journey. I hope for you too that your CA 125 levels continue to trend downwards.
Take care0 -
Artistry-7 Trial update!
Trial Arm 1: Nemvaleuken Alfa + Pembrolizumab
Cancer: High-Grade Serous Ovarian Cancer
Cycle 5
Week 1 Days 1-5
Treatment: I asked to replace my pre-treatment Tylenol with Ibuprofen. (See my argument in side notes below.) Of course, if this change results in the side effects worsening, we would immediately revert back to the original med.
I also started taking a multi-vitamin. Although I eat healthy (usually), I feel that this whole process takes a lot out of you in so many ways that a multi-vitamin would benefit me.
Blood work: Day 3 blood work showed the usual decline in neutrophils and rise in liver enzymes, but not to the point of cancelling treatment. Day 5 blood work was a surprise this cycle. My liver enzymes did not rise drastically and my neutrophils did not take a nose dive – either of these results would cause a stop in treatment. I was able to receive Day 5 treatment!
Side effects: Days 1-2 my side effects (aches, chills) were present but reduced. Days 3-5 I did not have any side effects. [Note: On Days 1 and 2, I received a red ibuprofen (400 mg cut in half). On Days 3-5, I received a yellow ibuprofen (200 mg).]
Week 3 Day 15
Trial blood draw.
CA125
Another very pleasant surprise! My CA125 dropped again. I am now down 62% from my highest result in June. I am still nowhere near the magic number but am hopeful that this downward trend continues.
Side notes
Pre-treatment meds are provided to lessen side effects of drugs. Each drug has its own cocktail of pre-treatment meds that have been determined to work for the majority of patients. However, I seem to be hypersensitive to certain medications (including OTCs), so I am being vigilant in listening to my body, reviewing my blood results in detail, and weighing the pros and cons of any potential changes I ask for. Of course, there is a discussion with the oncologist about the potential risks of making any changes.
Since the beginning of the trial, I have been asking for changes to my pre-treatment meds due to side effects. In Cycle 1 Day 2, I asked for the Benadryl to be replaced with another antihistamine. Benadryl totally knocked me out. I then asked for the antihistamine dosage to be reduced because I was still feeling very drowsy after taking it. For the latest change, from acetaminophen to ibuprofen, my argument was that acetaminophen is bad for the liver. Even though the dose I am receiving should not cause issues, I felt that, with my liver enzyme results fluctuating like they do during treatment, a change to Ibuprofen, if possible, may benefit me. Fortunately, my Drs have listened to all arguments I presented for these changes and agreed with me. This has resulted in changes to my pre-treatment meds that have definitely had a positive effect on my overall well-being during treatment. This cycle did show a little less decline in liver enzymes, but since we just made the change to Ibuprofen, it will take another cycle to determine if the change makes a difference or not. Who would have thought that these common OTCs (Benadryl, Tylenol) would have such a negative effect on me! So, as a reminder to everyone, YOU know YOU, listen to your body and self-advocate.
I think I drive my nurses crazy because I do a pre-treatment med check prior to receiving them. However, this has proven useful because of all of the changes I have received to date which can and have caused some mix ups. I also know some of the requirements for my treatment meds; i.e., there should be a Y-line hook up (nurses) and a filter on the lines for each drug (pharmacy). I have caught the Y-line hook up miss a couple of times. The nurses will catch it when they go to hook up the drug, but I usually catch it when they are accessing my port and getting me ready for treatment. It is important to know what is involved in your own treatment.
Treatment timeline: Thank goodness for patient nurses! I do give them a run for their money!! Especially when it comes to the timing of my treatment. The trial protocol requires a lot of observation time and I always feel that the nurses are adding time – not true of course! But I watch the time and ask them what they are doing and how long it will take. There is pre-treatment med wait time, infusion time, line rinse time, and vitals timing during the last two-hour observation. I asked one nurse why there is a two-hour observation time because I was thinking that it was unreasonable and the nurses are always commenting on how long it is. But as she explained to me…it is a trial, they are gathering data about what timing would be best when the drug is approved. Geez…that makes sense!
Questions for my Oncologist
Drug tolerance: At the end of the last cycle and throughout this current cycle, I have been experiencing reduced to no side effects. Good or bad?
My next discussion with my oncologist will explore the following:
1) Do side effects of immunotherapy reduce over time?
2) Does this indicate my body has developed a tolerance to the drug and, therefore, is not working for me?
Potential outcomes
1) If side effects do reduce over time, I am excited by the prospect that they may no longer be an issue.
2) If I am developing a tolerance, what is the next step? I have read that your body rarely develops a tolerance when two drugs are given together (Day 1 = Nemvaleukin + Pembrolizumab), but can develop a tolerance when you are receiving only one drug (Days 2-5 = Nemvaleukin). Nemvaleukin was reduced to 50% at the beginning of the trial due to the high spike in liver enzymes and cannot be reduced further. There was some discussion that I may be able to receive the higher dose again if my blood work evened out. This may be an option. If not, I do not have any other options under the trial (I cannot be transferred from one arm of the trial to another). Outside of the trial, I may be eligible for Pembrolizumab (Keytruda) on its own if it is approved and available for ovarian cancer in Canada (or go through the pre-approval for use and financing).
The outcome will not be known until I have been through one or two more treatment cycles and have had a couple more CT scans. I receive CT scans every six weeks in trial and my CA125 is tested on Day 1 of each cycle. I do not have any other health issues that would indicate there are any underlying concerns and my blood work returns to normal as soon as treatment stops. To date, my CA125 has decreased significantly. The CT scans have shown stable. Immunotherapy can take up to six months to show a measurable response in scans. On the bright side, I read somewhere that “many patients who respond positively to immunotherapy have no side effects.”
In the meantime, I am going to enjoy my healthy off weeks and the positives that have come from this treatment so far!!
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Wow @GloHo this is brilliant and thank you so much for documenting the details. You really paint a picture of what this trial could entail ( realize it will be different for everyone) and you are asking all the same questions I have particularly around dose reductions, side effects and pre meds. I will be considered for this trial once my current taxol/avastin treatment no longer works so your updates are very encouraging. I'm just happy for you that the CA has decreased so much. Thank you!0
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ps liver enzymes also seem to be my issue as well. And I have the same reluctance to take Tylenol when I'm in treatment for that reason. I save it for the really big achy days. So I appreciate that you can negotiate a bit for pain killers and I also have a big problem with antihistamines so glad there is some movement on this as well. I hate being knocked out or groggy at all.0
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@HoldingOn @Strongwoman
Thank you both for your positive comments and continued support.
I know when I was researching this trial, the first place I came to find real-life experiences was to this site. I did not find anything. Not surprising since this is a new treatment/trial. There was also very little on the positives/negatives of trials others had been through. Although this is very specific to one arm of Artistry-7, my type of cancer and my personal experience...I thought by documenting my journey it may help others when they are considering a trial. At the very least, I hope it opens up the conversation with their oncologist and gives them some feeling of being knowledgeable about what could be involved in the trial process. Each trial is different, each drug has different side effects and time commitments. I think this may be one of the more involved processes given that I receive treatment for an entire week. I just completed cycle 5 and am just starting to get comfortable with the time commitment. It is also my hope that others in trials will document their experiences in the interest of helping others. It is very difficult to find information on trial drugs...unless you read through the reports from previous phases of the trial (daunting text and data!). I know I would have found real-life experiences very valuable at the begining of my research on trials and it would definitely have armed me with a myriad of questions for my oncologist.
If someone is just starting to research specific trials, know that you not only should speak to your oncologist, but you can contact the lead investigator listed in the trial protocol document to answer your questions. The lead investigator has such an in-depth knowledge of the trial and all of the phases to date, that they would be able to answer your specific questions pretty quickly. There are also resources available on the OCC site that you may find helpful, like the videos available about clinical trials and Research Forums.
Entering a clinical trial may not be for everyone, but it is a path that I had decided to follow soon after my diagnosis. I informed my oncologist immediately of my interest so that he could keep an eye out for available/upcoming trials and, if I became eligible for a trial at anytime during my journey, he would not hesitate to present the option to me. FYI: It has been four years since my initial diagnosis and I have been through successful and unsuccessful treatments before I became eligible, as per trial criteria, to begin this trial.
There are also biomarker clinical trials that you may be eligible for. Unlike clinical trials with drug interventions, these trials require a blood draw that is then tested for different cancer biomarkers that may lead to targeted treatment for that specific biomarker. There are some clinical trials that do focus on some of these biomarkers, but there are still biomarkers that do not yet have treatment options available. The data gathered from these biomarker trials will help inform the focus of future research and clinical trials. Note that these tests may also lead to discovering genetic mutations that could be passed on to your children or grandchildren (male and female). This is a whole other realm of our journey...if you test positive for a genetic biomarker, do you want to tell your children that they may be at risk? Do your children want to know if they are at risk? Of course, there may be no mutations, but other positives may come out of this testing. Weigh the pros and cons for your personal situation. Timeline: I had my testing done mid-May and am still waiting for the results. I was told that they could take 10-12 weeks, so I should be getting my results (via my oncologist) soon.
If there are any Teal Sisters out there who are finding it difficult to navigate the world of clinical trials or who are having trouble taking that first step, please know that I am here and would be happy to help you start to explore your options or answer some of your questions from a patient perspective, if I can. You can send me a personal message through this site if you'd like to keep it private.
I know I have been wordy on the topic of clinical trials...I find it therapeutic to document my journey and am hopeful that the information will be helpful to others! Thanks for listening. 😀0 -
@mjmck21
Well...that was a quick response to my posting...just saw your comment!
Unfortunate that you are also having the liver enzyme issue but it's kind of nice to know that I am not the only one navigating this issue through treatment. You really don't hear a lot about it. Have you had any other testing done regarding liver enzymes? Do your results return to normal after treatment? What has your oncologist said about it? I would be interested in hearing more details on your experience.
So glad you are finding my journaling helpful. I am especially pleased to see that the information on pre-meds adjustments is pertinent to your situation as well. At first I was under the impression that absolutely nothing could be changed during a trial...and was pleasantly surprised to find out that pre-meds were under the advisement of the treating oncologist - not driven by trial protocol. Another example of the positives of self-advocating, asking questions and not assuming that things are carved in stone. I am reluctant to cut the pre-meds out entirely because there is a reason they are given. I am just glad that I was able to negotiate down to minimal doses and alternative drugs - definitely been good for me.
I hope to get back to some of the Zoom meetings this fall and I hope to 'see' you somewhere. I found that I was becoming too focused on my disease/treatment/side effects (so easy to do without realizing it!) and my disease-life balance was way out of whack so I decided that I really needed to 'give it a rest' and enjoy and plan things that I want to do. We went to a nearby community musical production recently and even though I swear I was the only one in the auditorium wearing a mask, it was blissful to be immersed in the production and do some sightseeing for the day. I think I have turned a corner and have already booked a local music tribute show for October. I am also looking for travel options, but every time I pick a destination, there's some sort of catastrophy, and I have to put it on the back burner. Even somewhere as simple as Las Vegas...the strip was flooded! And Greece...wild fires! New Orleans...chemical fire! Nashville...Tornado/severe storms! Good grief...it's all in the timing isn't it? Oh well. I will continue to find things nearby for the winter months and start exploring my travel options for the spring. This will give me something to do over the winter and something to look forward to! I also have to explore travel insurance options. I am going to try Medi-Quote first...see what the result is and whether or not it suits me.
Always grateful for your ongoing encouragement and support.
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@GloHo
What wonderful news to see your ca125 trending in the right direction...so happy for you!! Thank you for such a detailed account of your trial after each cycle. I had no idea that so many things could be adjusted or changed during a trial. Lots of great information for anyone considering a trial.
I have been on Gemcitibine since the end of March, but always keeping an eye on trials for when it is not effective anymore.
My ca125 has been more of a roller coaster on this drug than previous chemo drugs. We all know what that is like.
I have learned a lot from all of your posts, so thank you again for taking the time to document your journey!0 -
Hi @hope2022
I hear you...it is always difficult trying to get in rhythm with each new drug, both with CA125 results and side effects, if any. I rely on my CA125 results as a precursor to my scans, but with immunotherapy, the drugs take longer to show what is happening...can be up to six months. How have your scans been since March?
Thanks for your comments and so glad that you find the trial info interesting. I am trying to convey a real-life experience, including what goes on in my head! It certainly is a process and, as is true with any new treatment, it takes time (often months) before we know how well a drug is working (or not).
Thanks for your continued support and I wish you the best with your Gemcitibine treatments.0 -
@GloHo
The first scan in June showed a slight decrease in my tumours...CA 125 had risen in April and went down in May.
I just had a scan on August 16th which showed the cancer was stable...of course was hoping for another decrease.
My ca125 had risen in June and again in July and then down in August. I'm keeping a close eye on my symptoms as they seem to be a better indicator of what the cancer is doing than the ca 125 test at this point..oh boy!!
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@GloHo
Re: liver enzymes. I have had increases with AST, ALT and GGT from the beginning because my Stage 4 disease spread included 'caking' on the lower lobe of my liver but it could also be treatment related. I'm not always clear what is causing what and even when the disease is reduced on the liver as it has been this summer AST can remain high. It seems to recover fairly quickly given a break in treatment but has only reached normal a range a few times and then just barely. Bilirubin has remained normal. Treatment pushes the disease back and then the toxicity drives it up again. Like a seesaw.
I love that you have been able to negotiate premeds. Its my bane as well and as I mentioned I have been able to get a reduction in Benadryl. All drugs and alcohol affect me more than most people. But this week is the first time that by 5 pm I was able to do something other than lie on the couch drugged until bedtime. I went out and watered my garden! So I am hoping that should I be accepted into this trial I would like you feel like doing more at the end of the day.
Concerned that a clinical trail would have little room for adaptation so this is very good news. Again thank you so much for documenting this. Once this current regime no longer works for me I am to be referred to this trial and at first it seemed very intimidating with QOL issues but I can see from your journalling that while difficult to be out of commission for 5 out of 21 days, its better than it seems - or at least you are an example of how it could be. I have consistently been able to manage exercise and movement for about an hour a day (sometimes broken up in 10 minute bursts) depending on where I am in my treatment cycle. Even if stretching or Tai Chi for 5 minutes at a time is all I can manage I will do it. The sarcopenia I suffered at the beginning and everything I have read has convinced me that maintaining some muscle and endurance is a component of longer survival but also I can manage anxiety and depression and prevent some pain by continuing to move. Right now I am able to ride an ebike or walk for an hour, do strength training or swim 20 min (slowly) because I have had a 4 month break in treatment. This will diminish over the next month but I still have a wide range of activities that I do depending on my symptoms. I have not reverted back to the extreme muscle loss I experienced at my diagnoses and surgery. I do not want to. Being bed/chair ridden for 5 days is difficult for me to imagine but I am starting to see from your posts how I may be able to manage this again, if I were to be included in this trial.
Thank you!0 -
@hope2022
Rollercoaster for sure!! Often the worst part of our battle is the waiting to see if a drug is working and having to go through so many ups and downs during treatment sure is frustrating! It’s interesting to see that your CA125 is fluctuating. Mine either goes up or down. Do you know if that is common for or unique to Gemcitibine? Your scan results sound encouraging though. Of course, listening to our bodies is our best indicator. Although I often find it confusing in trying to determine whether it is the disease or some other ailment that needs tending to. I have been at this for over 4 years now…I think it’s positive me…always looking at the potential of an alternative ailment first rather than disease progression. Tis the life we live…making the best of the ups, dealing with the downs and moving forward with strength, endurance and positivity as best we can.0 -
@GloHo
I agree, waiting for results to see if the drug is still working is real tough, that's for sure! I try hard not to dwell too much. Having things to look forward to is so important. I was lucky enough to get away and have some fun trips over the summer. A little wine tasting in Osoyoos in June (before all the fires), Bowen Island, so peaceful and serene...and beautiful Victoria, which is a place I just love!! Heading to Harrison Hot Springs on my next week off from treatment. For me, being away has helped a lot in dealing with the ups and downs with the ca125 over the last several months.
I don't know if the fluctuating ca is common with Gemcitibine. In the past if my ca increased 2 months in a row, it meant disease progression. Anyways, something I will talk to my doctor about at my next appt.
I hear you about not always thinking it's the cancer when we are feeling a bit off. It could be just about anything!
I know it's hard not to go to worst case scenario.
Staying positive for the most part is so important with this disease. I've tried to to do that over the last 5 plus years and like I mentioned not dwelling on it too much...distractions are good.
Enjoy your weeks off from the trial!!0 -
@mjmck21
Thanks for the info on your liver enzymes. I see our situations, although similar results, are different. My issues are definitely drug-induced. Do you see a liver specialist (oncology) in addition to your regular oncologist? I have been considering asking for a referral but am not sure there would really be any benefit to having to see yet another doctor if I don’t have to. The trial lead oncologist has a gastro background, so he does have some knowledge, and being the lead for the trial, he is keeping oversight on the patients in our centre on the trial and I have no doubt he would be forthright if something reaches a distress level. I know my own oncologist consults with him about my case too.
I am so glad you took the summer off and were able to do things without the constant back and forth for treatments. And the trip you managed to plan and take sounded awesome! I am in awe of your ability (tenacity) to even do a little exercise during treatment. I also believe exercise is important, but I haven't been able to get myself back into a routine for the last few months. It's not because I am unable to physically, but something in my brain just isn't firing up my desire to do it. I have been thinking about it a lot more recently, so I expect that I will get back into it soon. I have actually asked chemo if a treadmill or bike is available for those of us who feel up to doing some mild exercise during treatment rather than sitting in the chair for extended periods of time. (They think I'm crazy!) Of course, I can see the liability side of that, but still...it would be nice to have the option.
Your responses and specific questions have resulted in creating a more fulsome picture of this trial process. As I read your latest post, I realized that I started my commentary after the selection process...and there is information regarding the selection process that may be helpful for those of you considering applying for Artistry-7 or other trials. So, I am now going to go back to the very beginning and another massive missive will be coming from me with Selection Process details in the next day or two. It may actually be a good thing that I am going back to that process after having started the trial because I can now provide advice for things that could be explored before treatment begins rather than during the trial.
It sounds like you are back in treatment now. I hope your treatment continues to bring positive results your way.
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Artistry-7 Trial update!
Trial Arm 1: Nemvaleuken Alfa + Pembrolizumab
Cancer: High-Grade Serous Ovarian Cancer
Selection Process
Going back in time…there are many things to consider when you are exploring clinical trials. I want to provide some details regarding the selection process specific to Artistry-7.
TIP: Start a list...write down everything that crosses your mind when you first consider applying for a trial – the list will be very useful to begin your conversation with the oncologist.
Clinical Trial Team
When I decided it was time to begin a trial, I was switched from my surgical oncologist to a medical oncologist. At my first appointment, I was introduced to my clinical trial team: Oncologist, Nurse Practitioner, Nurse, and Trial Coordinator.
Medical Team
If you are experiencing something worrisome and depending on the severity, either go to the hospital immediately or contact someone on your medical team.
Trial coordinator
The trial co-ordinator will work directly with you to help you navigate the world of trials and to keep the trial process moving and on track. The trial coordinator is a very valuable resource during the entire process. They are your first-line contact for anything trial-related. They ensure that the trial process is followed and they work with both your oncologist and the lead trial investigator to explore and/or resolve any issues that arise. You can contact them directly with any questions related to the trial. They cannot answer/resolve medical questions. You will see your trial coordinator regularly throughout each cycle. Blood work taken for trial purposes only is not available on your health portal. However, you may ask the trial coordinator to share results with you.
Trial Inclusion/Exclusion Criteria
Discuss the trial inclusion/exclusion criteria with your oncologist to determine if there are any red flags that may preclude you from participating. If you are experiencing any issues that you think may affect your participation in the trial, you, your oncologist or the trial coordinator will contact the lead investigator for the trial directly to get answers and determine your eligibility. The trial uses the grading system for adverse toxicities to determine eligibility (continuation), so do not assume that you will be excluded until you have investigated the issue.
If you are currently on medication, discuss with your oncologist and trial coordinator to ensure that it will not interact with any of the trial drugs.
Pre-trial paperwork
a) Pre-Screening Informed Consent Form (6 pages) – essentially, permission to obtain your tissue sample. The form also contains pre-trial information regarding your choice to participate; what you are being asked to do, why the study is being done; risks and benefits of providing a tissue sample; privacy and confidentiality of your personal information and test results; and conflict of interest. Read the release you are signing and be sure that you understand everything it contains. Contact the trial coordinator if you have any question.
b) Study Information and Informed Consent Form (24 pages) – your agreement to participate in the trial. This form outlines, in detail, everything about the trial. Read the release you are signing and be sure that you understand everything it contains. Contact the trial coordinator if you have any questions.
Pre-Trial Tests
You will undergo several tests to obtain a baseline prior to beginning the trial.
a) Blood work – to obtain pre-trial baseline. The first blood draw is massive – there were at least 15 vials. I have a “Power Port” (port-a-cath) which made the blood draw a lot easier for me. If you are having a vein draw and think you may have issues with the draw, ask the trial coordinator if you are able to split it up over a couple of days. The trial coordinator was present at the draw and was handed the vials directly for trial purposes.
b) Tissue sample – either from archival tissue or a fresh biopsy. I opted for a fresh biopsy. The biopsy was ultrasound-guided and I only experienced a bit of discomfort following the procedure. I opted for a fresh biopsy because I wanted to be certain that they had enough viable tissue samples for not only the trial, but a couple of biomarker studies I had also signed up for. The trial coordinator was present during the procedure and was handed a tissue sample directly for trial purposes. Your PD-L1 biomarker will be tested from this tissue sample. Your results will not preclude you from participating – this information will be entered into the trial database for research purposes. FYI: My PD-L1 count was very low.
c) CT scan – to obtain pre-trial baseline.
d) ECG – to obtain pre-trial baseline and to ascertain that you meet trial parameters for participation.
Of course, your overall health is the priority throughout the trial. If you require any tests outside of the trial schedule, they will be done.
Randomization
The trial protocol states "Investigator's choice chemotherapy include one of the following: pegylated liposomal doxorubicin (PLD), paclitaxel, topotecan, or gemcitabine." This means that your oncologist can select any of the four standard of care drugs for the randomization process. Discuss the options with your oncologist so that an informed decision regarding this option can be made.
For me, Caelyx (PLD) was off the table. In discussions with my oncologist, I knew that her choice for the standard-of-care option in the randomization process was going to be Gemcitabine.
Protocol Flexibility
I have provided details in previous posts but, with 20/20 hindsight, I realize that some of these things can be dealt with before the trial begins
a) Trial drug(s) – there is some wiggle room in trial drug dosing. Nemvaleukin Alfa can be reduced to no more than 50%. I do not know about Pembrolizumab, I am still receiving maximum dose.
b) OTCs – each drug has its own cocktail of pre-treatment meds. Pre-treatment medications fall outside of trial protocol and are the responsibility of the oncologist. So, if you are aware of your sensitivity to any of the pre-treatment OTCs, it would be wise to negotiate changes with your oncologist prior to beginning the trial.
c) Treatment scheduling – may be adjusted to accommodate for statutory holidays that fall in your treatment week. You will receive treatment the following week.
- There is a 72-hour timeframe from oncologist exam and blood work to Day 1 treatment. I have not explored alternatives yet, so am not sure what the trial protocol will tolerate. There may be a workaround in order to keep treatment on schedule.
- The trial coordinator does not work on statutory holidays (there is always an oncologist available and chemo is open). The trial coordinator is required on Day 1 due to the blood work requirement. I have not explored alternatives yet, so am not sure what the trial protocol will tolerate. There may be a workaround in order to keep treatment on schedule.
- When you are made aware of your potential start date, sit down with a calendar and mark off the three-week cycles to see if you run into any delays due to Statutory Holidays (Mondays and Fridays) and address them before the trial begins. You can adjust your start date to try to avoid some delays, receive treatment at week 4 when a delay is encountered or try to negotiate a workaround with the oncologist and trial coordinator to keep treatment on schedule.
This brings me to a couple of other things I would like to point out…
Blood work outside of treatment weeks – blood draws for trial purposes only are required on Day 15 (and Day 22 if treatment was delayed). The dates and times are scheduled directly with the trial coordinator (no oncologist appointment required). I believe this is flexible and can be adjusted (or even missed if necessary).
CT every six weeks – with the state of the health care system, it is very difficult to get appointments for imaging.
- Ask your oncologist to submit a request for your next CT on Day 1 of the cycle immediately following your last CT.
- If you have special requirements, i.e., port, ensure the oncologist marks this clearly on the requisition so that a nurse can be available to access/de-access the port for the IV contrast. I also have to add a note that my appointment needs to be within chemo hours so that they do not book me when a chemo nurse is not available. (My local hospital is a chemo satellite site and the hours are limited.) I have also had an emergency nurse come down to either access my port or find a vein for the IV contrast.
- I also have oral contrast for my CT scans and always ask my oncologist to add this note to my requisition. The rules seem to differ across hospitals, and I have been caught with it not being noted on my requisition, then being told that I do need oral contrast for the imaging they are doing and then having to sit in the CT waiting room to drink the oral contrast and then wait two hours before the CT can be done.
I tried to keep this as concise as possible (really, I did!) and on-topic. I apologize if I wandered, am off-topic or missed anything. I will keep my journalling going, so there may be new tidbits as I move through this trial process. If you have any questions, let me know.
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Artistry-7 Trial update!
Trial Arm 1: Nemvaleuken Alfa + Pembrolizumab
Cancer: High-Grade Serous Ovarian Cancer
Cycle 6
Week 1 Days 1-5
Treatment: Received treatment for the entire cycle, Days 1-5.
Blood work: No blood work on Day 3. Day 3 results have been consistent, so we decided to forego Day 3 blood work and wait until Day 5 to determine treatment status for Day 5. My liver enzymes are still a bit elevated and my neutrophils did not drop as much as in previous cycles. Day 5 treatment was approved and received. Note: Day 3 blood work is not required by the trial after Cycle 2 – I continued this blood work out of caution because of my liver enzyme and neutrophil counts so that my oncologist and I could make an informed decision about continued treatment.
Side effects: I am able to control my side effects now. I know they start about 5 hours after treatment, so I am able to prepare for and offset them. About ½ hour before my side effects (chills, aches) are to kick in, I put on an extra sweater and use a heating pad to warm myself up. This has been effective in keeping the chills at bay, as well as lessening the aches. Fatigue still affects me during treatment week and I sleep for 2-3 hours each evening. Sleep is good for a hard-working body – mentally and physically. I try to eat something as soon as I get home from the hospital following treatment because the side effects and fatigue are not conducive to eating. As soon as treatment week is over, I am pretty much back to my norm.
Week 3 Day 15 This blood draw, for trial purposes only, is no longer required for the remainder of my treatment.
CA125: Dropped again but not significantly. Still, a downward count is welcome.
CT scan: Report indicates progression. However, when I spoke to my oncologist, she indicated that because the growth is under a certain percentage, my cancer is considered stable. Apparently, it depends on the technician writing the report.
I was surprised by the progression result because my CA125 has decreased by 65% since I began treatment...so I was expecting a much different result. Having the Dr tell me now that my cancer is considered stable, makes more sense. So, I will continue treatment. I am almost at the six-month mark where they say you should be able to determine whether or not immunotherapy is working. The next couple of blood work results and CT scans will be monitored very closely and will determine whether or not treatment is working and whether or not I continue with the trial.
Questions for my Oncologist
It is not lost on me that there was some growth.
What if…it is true progression? What’s next? The Dr suggested that I could participate in another trial if one is available, or I could receive treatment with weekly Paclitaxel or Gemcitabine. So, I am now going into research mode to prepare myself for next steps. Hopefully, later than sooner!
Is it pseudoprogression? The Dr did not feel that this was a consideration given that my status is considered stable at this time.
Side notes: In my research regarding my progression result, I found the following... pseudoprogression. Pseudoprogression is a phenomenon in which an initial increase in tumor size is observed or new lesions appear, followed by a decrease in tumor burden; this phenomenon can benefit patients receiving immunotherapy but often leads to premature discontinuation of treatment owing to the false judgment of progression. (National Institute of Health).
Pseudoprogression is common with immunotherapy treatment. Interesting to know!
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Artistry-7 Trial update!
Trial Arm 1: Nemvaleuken Alfa + Pembrolizumab
Cancer: High-Grade Serous Ovarian Cancer
Cycle 7
Week 1 Days 1-5
Treatment: Received treatment for the entire cycle, Days 1-5.
Blood work: My liver enzymes are still a bit elevated and my neutrophils did not drop as much as in previous cycles. Day 5 treatment was approved and received.
Side effects: Chills (manageable), aches (manageable), fatigue
CA125: Increased slightly.
CT scan: scheduled for the beginning of November
My thoughts
With the increased CA125 and no significant improvement in my CT scans – I am barley staying stable, with some minor increases - I spoke to the Dr about the potential that this could mean immunotherapy is not working and we may be looking at progression. She concurred.
I have one more treatment prior to my next CT scan. I will have another CA125 test at my next treatment and when we have the results of the CT, we will be able to determine what is going on.
I just had my Covid booster (Day 15 in my cycle, as discussed and approved by my oncologist)...so I am hoping that the side effects are minimal and my body is ready for treatment next week.
Next steps
In the event that I am experiencing progression, I have limited options left for consideration. I have researched clinical trials again and there is one (maybe two) that I want to discuss with my oncologist. The trials are in Toronto, so I will get to live with my son and family on an as-needed basis during treatment.
In the event that I cannot participate in a trial (do not meet criteria or cannot delay treatment for one month), the standard-of-care drugs left for treatment are weekly paclitaxel, gemcitabine and topotecan.
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