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clinical trials

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  • Artistry-7 Trial update!

    Trial Arm 1: Nemvaleuken Alfa + Pembrolizumab

    Cancer: High-Grade Serous Ovarian Cancer

    Unfortunately, this is the end of my journey on this trial.

    Cycle 8

    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 (decreased during week)

    CA125: Increased slightly.

    CT scan: This CT scan reports “slight progression.” However, it is a matter of interpretation and what my oncologist sees is much different. There is definite progression and I have been removed from the trial because the drugs are not working. This is supported by a rise in my CA125 over the last two tests and minimal progression in a previous CT. From what I read and tried to interpret from the report myself, I concur with my oncologist.

    Next steps

    I will begin weekly paclitaxel in a couple of weeks.

    There are currently no Phase 2 or Phase 3 trials available for me at this time. My oncologist has reached out to see if there are any Phase 1 trials that may be appropriate for me.

    My thoughts

    I am exploring combination drug treatment options for the last three standard-of-care treatments available to me (weekly Paclitaxel, Gemcitabine, Topotecan).

    I had some reservations about continuing with my current oncologist now that the trial has been discontinued, but she has proven to be attentive, patient and emailed several contacts regarding potential trials while I was still on the phone with her. I still have some reservations, but I am going to give her a chance. I also know she is very agreeable to me getting a second opinion if I feel it necessary.  

    I hope this journalling of my experience in this trial is helpful to others considering participating in one, both now and in the future.
  • So, I have been busy trying to find a trial I am eligible for. Unfortunately, there are no trials available for me at this time (including Phase 1).

    I found one trial that I followed up on. On the surface, it was very clear that I did not meet the # of trials criteria - I had had too many lines of treatment. However, I have reviewed so many different trials and each has its own unique set of inclusion/exclusion criteria AND exclusions to those rules, that I felt it was worth clarifying my interpretation of the criteria for this particular trial. Basically, I was not sure if a clinical trial was considered a “systemic” line of treatment. After all, the drugs are not approved for systemic use, so maybe that treatment would not part of the equation. Plus, I had read in another trial that clinical trials were excluded from the # of treatment criteria. Unfortunately, for this trial, the clinical trial was included as a line of treatment, so I was deemed ineligible for participation. 

    As a result of this latest search, I want to be sure that anyone looking at trials not be too quick to exclude themselves. As mentioned above, all trials are unique and do not follow the same inclusion/exclusion criteria. Some trial criteria are very clear, while others leave room for interpretation. So, if you are not certain…ALWAYS ASK. 

    If you ask and your oncologist interprets the criteria in the same way you do, give a little push and ask your oncologist to contact the trial Dr for confirmation. The other option is for you to contact the trial contact directly with your specific question. In my case, the trial contact directed me to work through my oncologist to get the information clarified. My oncologist made the call and my ineligibility was confirmed. 

    Good luck on your search!! 

  • Artistry-7 Trial update!

    Trial Arm 1: Nemvaleuken Alfa + Pembrolizumab

    Cancer: High-Grade Serous Ovarian Cancer

    End of Trial Follow-up 1

    The Artistry-7 trial protocol required lots of bloodwork, a urine sample, and an ECG for end-of-trial data. There will be another follow-up in the next few months.

    The BIODIVA study also wanted lots of bloodwork because my treatment is changing. 

    The bloodwork draw was done in order of priority...Oncologist bloodwork, then trial, then BIODIVA. Because they were doing a vein draw for blood, and even though they had to poke two veins to get more blood, they could not complete all of the vials for BIODIVA, but they were okay with that. 

    CANNABIS SURVEY: The lead oncologist for BIODIVA is involved in a survey regarding cannabis use and I was asked if I would be interested in doing a Cannabis survey. Of course I am! This is not connected to the BIODIVA study, it is its own separate study. I will do the survey in the next couple of days. After researching a few articles on CBD for ovarian cancer, I am very interested in seeing where this will lead. I am also wondering if I have found an oncologist who is willing to investigate/consider the use of turkey tail mushroom therapy. I mentioned it to the coordinator who thanked me for the info and indicated that was exactly the type of information they are looking for from patients...they welcome the opportunity to explore/consider alternatives. I don't know why I was approached at this time, but it makes me wonder why this survey is not available to all ovarian cancer patients no matter where they are in the treatment process. It is an optional survey, so patients can decide whether or not they are interested in doing it. I know that in a lot of surveys if someone is not interested, they will not complete the survey. This is unfortunate because it is important for studies to know not only why some patients are interested but also why some are not and, perhaps, how many are indecisive and why.

  • GloHo
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    A clinical trial about clinical trials 😁
    If anyone is considering participating in a clinical trial and want an opportunity to input your personal experience on a trial - check this out. 

    Appraising Medical Trial Experiences of Cancer Patients
    NCT05801795
    NOT YET RECRUITING - Expected start date is April 2024
  • GloHo
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    Correction to title above

    Appraising Medical Trial Experiences of Ovarian Cancer Patients
  • Strongwoman
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    @GloHo I checked it out but didn't find much info and/or links to follow it further...perhaps I am missing something?  Quite possible as the way it goes some days.  I did find this which I found interesting......
    "Analyzing Factors of Patient Involvement in Ovarian Cancer Clinical Trials"
    So they are doing a study on patient involvement in OCC trials?   Interesting....wouldn't they have that data already?  I am confused.  :/
  • GloHo
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    @Strongwoman
    I believe these are both for information gathering purposes (online) from people going through the clinical trial process starting from the beginning of a participant’s decision to enrol. To see what works and what doesn’t. What roadblocks are. What is good/not good about processes, etc. There is still a lot of apprehension around clinical trials and I don’t think participation is as good as they would like or need to get fulsome data for some of these trials. 
    Does that make sense?
  • Strongwoman
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    @GloHo It absolutely makes sense.  I know when I was looking, I was like do I qualify, do I not?  Am I one of those in between ones and a maybe?  I feel that this is great that they would take the time to see the perspective as a patient and want to attempt to iron out any kinks in it.  I know some also look at doctor reviews which we all know cannot be trusted.  A lot of the time it is mostly negative and rarely do you find positive ones online.  That could also be a roadblock to some trials.  I think location and time it consumes is another concern for patients.  For example, do they have someone that can take them/pick them up and what is the time commitment etc.  It's wonderful.  I will be very interested to see the results from this and what they will end up doing proactively to possibly fix the roadblocks being encountered.  Thanks for sharing!  <3
  • GloHo
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    Phase 1/2 Study of 23ME-00610 in patients with Advanced Solid Malignancies

    Princess Margaret Hospital

    My Cancer Type: High-Grade Serous Ovarian Cancer (Note: In this trial, they are exploring the effects of this drug on several cancers, not just ovarian).

    Part A (Phase 1) - Complete

    • dose escalation phase 
    • determine maximum tolerated dose
    • recommended phase 2 dose selected

    Part B (Phase 2) - Currently enrolling participants

    • dose expansion phase
    • patients receive recommended dose

    Process

    • Primary Onc submits request to PMH
    • PMH reviews and sets up pre-screening appt

    Pre-screening (2-3 hours)

    • bloodwork
    • meet with nurse/Dr to discuss medical history and do a physical exam to ensure you are an appropriate candidate for a trial (they want to “see” you in person)
    • Dr then determines if there is a trial available/which trial is most appropriate (I think this has already been determined at the PMH review earlier in the application process)
    • Comes back into room to discuss trial criteria and schedule to determine patient interest
    • Nurse contacts trial sponsor to see if there is space available in the trial
    • If space available, move to screening process

    Screening process (3-5 hours)

    • Tests to ensure you meet specific criteria (blood, ECG, ECHO, CT)

    Biopsy 

    • required for this trial
    • results not shared with Dr or patient
    • cannot start trial until biopsy complete 
    • treatment can begin as soon as the day following biopsy

    Genetic Testing

    • tissue/blood/saliva collection is required
    • results not shared with Dr/patient
    • for study purposes

    Optional Genetic Reports

    • Study sponsor, 23andMe, is offering participants a subscription to their Health and Ancestry Service 
    • separate from main study and decision does not affect participation in main study
    • separate consent forms for health and/or ancestry participation
    Comments
    So far, the process has been okay aside from a couple of hiccups that arose due to another issue I had. The trial nurse has been extraordinary and has bent over backwards to get this trial started for me!
    Biopsy was done at Toronto General (as was the ECHO). I had no issues or complications during or after the procedure. Had a bit of tenderness at biopsy site the following day.
    I am having an issue with getting blood return from my port but the trial nurse has indicated that they will get someone to take a look and get it going again. 
    I have not yet had the saliva collection or the discussion about the 23andMe service being offered. I will probably join the service…I am curious. 
    I have already had genetics testing via BioDiva, so I have results from that and am not concerned that this trial does not disclose the results. 
    I start Cycle 1 next week and will post about my experience. 
  • Strongwoman
    Strongwoman Moderator
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    Thank you @GloHo for sharing this experience with all of us. Thankful you will be initiating this treatment next week and will look forward to your updates as well. 
    Take care <3
  • GloHo
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    Since the drug, 23ME-00610, is in the initial stages of testing, there is not a lot of info on it.

    Some info links about this new drug, results of Phase 1, and info re Phase 2. 


  • Strongwoman
    Strongwoman Moderator
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    Thank you @GloHo
    As always, you provide so much information and what can be choices for yourself and others out there. Thank you for taking the time to document in such detail your journey with your trials.
     :) 
  • GloHo
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    A STUDY OF 23ME-00610 IN PATIENTS WITH ADVANCED SOLID MALIGNANCIES

    PHASE 2 (21-DAY CYCLE)

    This is an immunotherapy trial targeting CD200R1

    Sponsor: 23andMe

    My Cancer Type: High-Grade Serous Ovarian Cancer

    I am in an additional cohort of ovarian cancer patients added to the main trial. This cohort receives a lower dose of the trial drug.

    Article link:

    Trial Schedule

    Cycle 1, Day 1 (7-8 hours) + overnight hospital

    • blood (main lab)
    • physical exam (clinic)
    • vitals (clinic): pre-infusion, and 30 min + 1 hr + 2hr + 4 hr post-dose
    • blood (clinic): pre-infusion, immediately after infusion, 1 hr, 2hr, 4 hr post-infusion
    • infusion
    • observation up to 4 hours after infusion + overnight hospital stay for safety and to monitor how the drug affects your body, how your body processes the drug, side effects/adverse reactions, etc.

    Notes: Day 1

    • go to clinic after main lab blood draw
    • wait time for blood results
    • talk to nurse about blood results, side effects, if any
    • Dr visits for physical exam and discussion. If all ok, drugs are ordered for infusion.
    • blood and vitals are taken throughout your stay as per trial schedule

    Cycle 1, Day 2 (1 hr 30 min)

    • Blood and vitals (clinic)

    Notes: Day 2

    • talk to nurse about side effects, if any
    • Dr visits for physical exam and discussion. If all ok, you are released from hospital.
    • you are assigned a hospital room when you arrive on Cycle 1 Day 1 - blood, vitals and infusion are done in your room - you are released after your Day 2 blood and vitals are taken and you are not experiencing any issues (minimum 20-24 hours after infusion)
    • there is flexibility for you to “wander” around the hospital (go down to get coffee, snacks, etc.), just be sure you do not miss the scheduled blood draws or vitals

    Cycle 1, Day 3 (1 hr 30 min)

    • blood and vitals (clinic)
    • talk to nurse about side effects, if any, talk to Dr, if necessary

    Cycle 1, Day 8 & Day 15 (1 hr 30 min each)

    • blood (main lab)
    • vitals (clinic)

    Notes: Days 8 & 15

    • go to clinic after main lab blood draw
    • wait time for blood results
    • talk to nurse about blood results, side effects, if any, talk to Dr, if necessary

    Side Effects

    • no side effects
    • blood work not affected
    • waiting to see if anything cumulative arises

    My Observations

    I opted to go to the main lab for my initial blood draw the evening before Day 1 so I wouldn’t have the waiting time on Day 1 for results (best laid plans…don’t always work out). Of course, my first day of trial, all UHN hospitals had a power outage affecting their computer systems. They had to do everything manually. My blood results from the previous day could not be accessed. It was slow going. I did not get my infusion, which was scheduled for 9:45 am, until 3:30 pm.

    I have found the team to be organized, flexible, caring and understanding

    Blood draws are done in the main lab and/or in the clinic:

    • blood draws in the main lab are for both the Oncologist and trial research
    • blood draws in the clinic are for trial research only

    For main lab blood draws, they are done via vein. So, again, we are experiencing small and elusive veins with often more than one poke required to catch one for the blood draw.

    Wait times to get blood draws in the main lab have been minimal in the morning - I usually get called in before I even sit down.

    I was experiencing issues with my port, so the clinic blood team (PK team) fixed that. However, it looks like my port will only be accessed every three weeks. PMH still uses heparin lock for ports. Hmm…odd since every other hospital I've been to has changed to saline lock as per a research article published in 2022 that states "No statistically significant difference was found between heparin and normal saline in reducing catheter occlusion. Heparin is not superior compared to normal saline." I have not had an issue with accessing my port since I began the trial and the use of herparin lock for my port. Interesting…but I am only beginning Cycle 2, so we'll have to wait and see.

    Each time you visit, you will see whichever Dr is assigned to clinic that day. I expressed my concerns that 1) I was not assigned to an ovarian cancer oncologist as my primary oncologist for the trial and 2) that the Dr we see each time may not realize the importance of a symptom or side effect as it relates to ovarian cancer if that is not their area of expertise. Example: I asked one Dr how often I would get my CA125 test and she was absolutely clueless about this biomarker for ovarian cancer. This was very concerning to me and qualified the concern I had already expressed. I let the nurse know that this was the type of thing that I was afraid of and that I would ask for a second opinion if I felt it necessary. Self-advocating…again!

  • Strongwoman
    Strongwoman Moderator
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    @GloHo Self advocating becomes so tiresome. Yes, I, too would be concerned if an Oncologist had no idea either what a CA 125 was for OR the importance/relevance of having it tested. I know you will persist through with this but am deeply saddened that you have to.

    Thank you for your detailed notes and know they may help someone down the road.

    Hang in there!

  • GloHo
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    A STUDY OF 23ME-00610 IN PATIENTS WITH ADVANCED SOLID MALIGNANCIES

    PHASE 2 (21-DAY CYCLE)

    This is an immunotherapy trial targeting CD200R1

    CYCLE 2 TRIAL SCHEDULE

    Pre-Cycle
    Blood draw
    Discuss side effects, if any, with nurse/Dr
    Physical exam
    Dr approves drug order

    Day 1: Infusion 

    Day 8: Blood draw + nurse/Dr

    Day 15: Blood draw + nurse/Dr

    Side Effects: none to report

    NOTES

    Additional Cohort
    I asked why this cohort was added to the original trial. Found out that there was over enrolment of ovarian cancer (OC) patients so, once they filled the original cohort, they decided to add this cohort.
    Obviously, the need for OC trials is at an all-time high!!

    Self Care I was still concerned about not having an Ovarian Oncologist on the team and feeling like potential OC symptoms could be overlooked. Originally I was told that this was my primary care team - but not having access to an OC Onc just didn’t sit right with me. So, I asked again. The nurse asked one of the Drs to speak to me about it. I discovered that they are not treating my OC specifically, they are gathering data for the trial and if I had OC-specific questions or concerns that I should speak to my primary OC Onc. They do, of course, look at how your specific cancer is responding to treatment. Good grief! So, now I have to try to set up some appointments with my primary Onc. I am going to try to set them up via telephone and strategically place them after a CT scan which is when decisions will have to be made depending on the results. Either way, I would like to touch base with her and I’m pretty sure I can get in to see her fairly quickly should something of concern come up.  I find it disappointing that an OC Onc is not part of the team, especially since an additional cohort was added to the trial. I’m on the fence about not having any OC Onc available for consult for trial participants. I can contact my primary Onc…I know her and she knows me and my history. It makes sense. But, for such a huge research centre you would think that a patient-first strategy would be in place. The last trial I was in was OC-specific and at my home centre, so these issues did not surface for me. I am feeling fine and do not feel like my cancer is progressing aggressively - is treatment working or at least slowing progression? Have to wait for CT. 

  • GloHo
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    The following are my observations on a few things trial-related.

    Clinical Trials - things to consider

    Phase 1/2 - usually no standard of care treatment remaining. Some trials may be more strict on this rule than others.
    Progression - there is usually a washout period of approximately one month between last treatment and start of trial. If you are in progression, that will continue until you begin the trial drug and, if that drug is not working, your progression may be slowed or may continue. For me, this has been weighing on my mind, but if you are out of options, the benefits may outweigh the risks. Talk to your care team, in length, about what this means for you. CT - scans are usually more frequent during a trial than they are under normal care. Scans are used to determine whether or not the drug is working (measure of progression, stability or reduction). This trial has a scan at 8 weeks and, if progression noted, another scan in four weeks if you decide to continue in the trial.  Schedule - review the trial schedule to ensure you are fully aware of the trial time requirements. Each trial is different.

    Accommodation
    The Princess Margaret Lodge is available for out-of-town patients of PMH and Sunnybrook. The residence recently reopened after a major renovation. For a nominal fee you have accommodation (with mini fridge and private washroom), three meals a day and 24-hour security. The facility is clean and offers a variety of recreational rooms for residents. There are a couple of computer rooms, a billiards room (with dart board), a quiet room, a games room, a piano room, a craft room and several lounges with TVs - including lounges on the resident floors that have a small kitchenette. There is also an on-site laundry room.  There are two beds in each room and if the facility is very busy you may have to room with another patient. So far, I have not had a roommate.  Although the Lodge is not “open” on weekends, you may still book accommodation. There is no dining or shuttle services on the weekend. There are some restaurants in the area and public transportation is easily accessible from the Lodge. Of course, there is always the option of food delivery and Uber to get you around. 

    Shuttle There is a shuttle (weekdays only) from the Lodge with scheduled times throughout the day to Princess Margaret and Sunnybrook. 

    Travel, Accommodation and Food Reimbursement (Toronto)
    Consider travel time, cost of gas, parking, food and accommodation.
    Accommodation (minimal if staying at the Lodge), food and cost of gas for travel over 40km or 80km are reimbursable via Canada Revenue Agency (CRA). I have not gone through that process yet, so cannot offer specifics on this. Be sure to review the CRA medical expenses rules prior to travel so that you know exactly what is allowed and claimable (with or without receipts, etc.).  There are some hotels that offer medical discounts. You have to show proof of appointment. These are, of course, substantially more expensive than staying at the Lodge. 
    One of the benefits of staying at the Lodge is the social interaction with other cancer patients from across the globe. 

    Travel, Accommodation and Food Reimbursement (Other Cancer Centres)
    It is my understanding that most major Cancer Centres have travel, accommodation and food policies in place. Be sure to ask your care team what is available at that centre.

    Please note that I am only reporting on my personal experience as an out-of-town patient to Toronto. Reimbursement policies vary by trial and/or cancer centre. Be sure to ask your trial team about everything! A lot of questions up front will help to avert confusion and surprises as you move forward. 

  • GloHo
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    A STUDY OF 23ME-00610 IN PATIENTS WITH ADVANCED SOLID MALIGNANCIES

    PHASE 2 (21-DAY CYCLE)

    This is an immunotherapy trial targeting CD200R1

    CYCLE 3 TRIAL SCHEDULE

    Pre-Cycle
    Blood draw
    Discuss side effects, if any, with nurse/Dr
    Physical exam
    Dr approves drug order

    Day 1: Infusion

    Side effects: none to report

    NOTES
    I will be having a CT scan before Cycle 4. This will inform next steps for me.
    I have arranged a telephone consult with my primary Onc just to get her take on the results before I discuss with the trial team at my Cycle 4 appointment.

  • Strongwoman
    Strongwoman Moderator
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    @GloHo Thank you for reporting the info about the PML. It is good info to know if I had to go myself or if we have another Teal Sister that is far away and had the need to stay by the hospital. I had no idea something like this existed and your notes on it are amazing. Thank you again for sharing it.

    Sounds like there are some hiccups with this trial esp the lack of a OC Onc weighing in on any of the info. Especially given the extra info on the amount of interest from OC patients wanting to be in this trial. It is truly interesting what you find out and then trying to rationalize the info. Thanks again!

    I hope your scan shows either stabilization or shrinkage. I am thankful you will speak with your Onc about it before you have another treatment at PMH or meet with their doctor. It will make you feel more re-assured.

    Again, thank you for sharing your notes with us all. 🤗

  • GloHo
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    A STUDY OF 23ME-00610 IN PATIENTS WITH ADVANCED MALIGNANCIES

    PHASE 2 (21-DAY CYCLE)

    This is an immunotherapy treatment targeting CD200R1

    CT Results
    I set up an appointment with my primary Onc to discuss my CT results. Unfortunately, the results were not available and she is away at a conference and timing does not allow for another appointment before my trial appointment, so we had a nice check-in chat

    Chest
    A small to moderate pleural effusion (not new). No other changes.

    Abdomen
    FINALLY…got my Abdomen CT results. 
    I have extensive peritoneal disease (metastatic site) - this is not new to me. I have some areas of minor progression and small ascites (similar to previous). 

    Notes
    Trial continuation? -
    So…is the trial drug slowing progression? If offered the opportunity to continue on the trial…I believe I will. It is my understanding that the next CT will be in one month (given the progression report). I would welcome a scan sooner rather than later so that we can stay on top of it. I am hoping this trial drug keeps the cancer at sloth speed for awhile!!
    CA125 - I have not had a CA125 test since the beginning of the trial and I had to remind them at my last appointment that I wanted one at this point. They added it to my blood requisition for this week. I am going to ask for the CA125 at each pre-cycle blood draw. It has been a reliable indicator of rate of progression for me. 
    Progression - My history has been minor progression - minor progression - minor progression - until I reach that 20% benchmark for change in treatment. I am on my 7th treatment.

  • Strongwoman
    Strongwoman Moderator
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    How does all this info sit with you and leave you feeling @GloHo

  • GloHo
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    @Strongwoman
    Clear as mud!! For now, I am focussing on the positive. A glimmer of hope with the CA125 decrease.