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clinical trials
Comments
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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.0 -
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!!0 -
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.
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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 20240 -
Correction to title above
Appraising Medical Trial Experiences of Ovarian Cancer Patients
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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.
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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?0 -
@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!
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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.1 -
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 0 -
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.
https://www.globenewswire.com/news-release/2023/04/14/2647346/0/en/23andMe-Announces-Phase-1-Results-from-the-First-in-Human-Phase-1-2a-Study-of-23ME-00610-an-Investigational-Antibody-Targeting-CD200R1.html
If the above links do not work automatically, copy and paste URL in search engine.0 -
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.
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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!
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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!
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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 SCHEDULEPre-Cycle
Blood draw
Discuss side effects, if any, with nurse/Dr
Physical exam
Dr approves drug orderDay 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.
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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.
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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 orderDay 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.0 -
@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. 🤗
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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 chatChest
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.0 -
How does all this info sit with you and leave you feeling @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.0 -
A STUDY OF 23ME-00610 FOR PATIENTS WITH SOLID MALIGNANCIES
PHASE 2 (21-DAY CYCLE)
This is an immunotherapy treatment targeting CD200R1.
CT Scan/CA125 - Review with Trial Onc
My discussion with the Oncologist was quite interesting. Since my scan showed minor progression, I thought it would be a green light to continue in the trial.
It turns out that the trial Onc was not as enthused about my CT scan as I was. I thought minor progression was good. She acknowledged that minor progression is good but pointed out that there was some new and no shrinkage. She was not certain about continuation in the trial and wanted to wait to see what the CA125 results showed.
We were both expecting a rise in my CA125, we were just waiting to see by how much. Surprise! My CA125 decreased (-200). So, I will be continuing in the trial for another two cycles. YAY!!
I will undergo two more treatments before my next CT scan is scheduled (this trial does scans every 8 weeks).
SO…given the conflicting results, I am still not sure if the drug is working or not.😵💫
She was also concerned about the pleural effusion but feels that it is not large enough to biopsy yet. So, again, next scan will determine which way things are going.
I feel encouraged that the drug may be doing something. It feels good to have a bit of relief…at least until my next scan.
Notes
At my urging, she has agreed to do my CA125 blood test at each cycle. I explained that my CA125 results have been a reliable indicator for me (I understand this may not be the case for everyone), and I use those results to mentally prepare for next steps and my discussion with the Onc. It is understood that we will not make a decision based on CA125 results alone but along with the scan results. Having the test done each cycle will allow me to see if it is trending up or down and by how much. I really had to self-advocate for this - it is out of the norm. Guess I was pretty convincing!🤣
Is the minor progression real or pseudo progression? I was not able to talk to the Onc about this possibility yet. Waiting for next scan.
Pleural effusion…not good but doesn’t seem to be too aggressive? I have a lot more questions for the Onc around this. Pleural effusion increase could also be caused by pseudo progression. Waiting for next scan.
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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
CYCLE 5 TRIAL SCHEDULE
Pre-Cycle
blood draw (includes CA125)
physical exam
vitals
discussion with Oncologist regarding current results and order drugs for infusion
Cycle 5, Day 1
blood draw immediately prior to infusion
infusion
vitals (1/2 hr, 1 hr, 2 hr post-infusion)CA125: My latest CA125 was not available and it was decided that I could move forward with infusion. Turns out my CA125 increased by 500. It will be interesting to see what they say at my next visit.
Pleural effusion: It was decided that I should undergo the pleural effusion drainage (thoracentesis). I showed up for the procedure and was asked to go for an xray since my CT scan showing the infusion was well over a month ago. The xray was a quick and easy process. For the procedure, they put you in a hospital room in the unit and that is where the procedure is performed while you are seated on the bed. The thoracentesis is an ultrasound-guided procedure. They used the ultrasound to confirm the xray results that showed my pleural effusion decreased significantly - to a point where drainage was not possible because it was so small. So…this is good news. Now, to find out why. Was the pleural effusion caused by pseudo-progression or low albumin? Is it the drugs working? Is it something that normally happens? Not having the drainage means that I do not know if the fluid is benign or malignant. But that's okay - I can wait for that result!
CT scan: My next scan is scheduled in a couple of weeks.
Trial continuation: It appears that I am now on a cycle-to-cycle decision schedule with the decision being based on my CT scans and CA125 levels.
Side effects: I still have not experienced any side effects for this drug. There always seem to be some up and down to my blood counts when I am undergoing treatment, but there has been nothing significant with this drug.
My Observations
I am still feeling okay and do not have any new cancer symptoms. I am anxious to see whether or not I will be continuing with the trial. There is a lot up for discussion and I have no idea what the Oncologist is going to say. I'm hoping that we can move forward with the next one (Cycle 6) and make a decision after my CT scan.
In addition to the reduced observation time that started in Cycle 4 – from 4 hours to 2 hours, beginning in Cycle 5, the trial schedule is now pre-cycle + infusion once every three weeks. YAY!
Infusions are now being given in the hospital’s chemo unit. This is not ideal because now I am at the mercy of the chemo unit’s schedule and I know we’ve all been there! Yes…a 2-hour delay!When you receive infusion in the chemo unit, they keep you for observation for ½ to 1 hour then send you to the Convergence Unit to finish the observation time. The Convergence Unit will do blood and/or vitals as per your trial schedule.
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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
CYLE 4 TRIAL SCHEDULE
Note: Cycle 4 trial schedule is the same as Cycle 1
Pre-cycle
- blood draw (includes CA125)
- physical exam
- vitals
- discussion with Oncologist regarding current results and order drugs for infusion
Cycle 1, Day 1
- blood draw: pre-infusion
- infusion
- vitals before and immediately after infusion (½ hr, 1 hr and 2hr post-dose)
- observation has been reduced to 2 hours post infusion
- overnight hospital stay - for safety and to monitor how drug affects your body, how your body processes the drug, side effects/adverse reactions
Cycle 1, Day 2
- blood draw and vitals
- discharge from hospital
Cycle 1, Day 3
- blood and vitals (PK unit)
Cycle 1, Day 8
- blood draw
- vitals
Cycle 1, Day 15
- blood draw
- vitals
Side Effects
- no side effects
- blood work not affected
- waiting to see if anything cumulative side effects arise
My Observations
I have discussed my CT results and CA125 results above.
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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
CYCLE 6 TRIAL SCHEDULE
Pre-Cycle
- blood draw (includes CA125)
- vitals
- physical exam
- discussion with Oncologist regarding current results and order drugs for infusionCycle 6, Day 1
- blood draw (pre-infusion)
- infusion
- vitals (pre-infusion, 1/2 hr, 1 hr and 2 hr post-infusion)My thoughts…
I am still feeling ok, although I have noticed some tenderness in mid-section. I am unsure if it is the cancer or bowel…my bowel movements have been slow moving.
My CA125 has increased significantly (+1200). I believe this increase indicates progression. I have a CT scan scheduled for the end of the month - this will show, definitively, the degree of progression.
I have a follow-up/review meeting with the trial Onc the week following the scan. I believe the decision will be made at that time to withdraw me from the trial.
I have spoken to my trial nurse about this and the high likelihood that I will be ending my participation in the trial. I did this for two reasons, 1) she can relay my thoughts about ending the trial to the trial Onc (should make for an easier discussion with the Onc if she knows I have already reached that conclusion and she’s not surprising me with this news) and 2) so all end of trial preparations can be taken care of at that appointment (blood work, paper work).
Next steps: I have already spoken to my primary Onc’s nurse and relayed these recent results and the likelihood I will be done the trial. We have already set up an appointment with my primary Onc for the day following my appointment with the trial Onc.
I also mentioned that there is a trial being conducted out of London (FONTANA) that I am interested in…so my Onc can consult with others about whether or not this trial is appropriate for me before my appointment and we can have an informed discussion about realistic next steps.
Now I wait for the CT scan results that will likely confirm the direction I am headed.
If I am a potential candidate for the trial, I will push to get all the testing done asap. Unfortunately, I know the health system is backed up but am hopeful that the trial coordinator can get me in for what is needed quickly.
There is one other thing I am contemplating doing…contacting my former trial coordinator now to alert her to my potential return to the London trial scene and try to find out how enrolment is going for the ovarian portion of this trial. I do not want to confuse things so I will have to be sure she knows this is just me doing my thing (she’ll understand 🤣) and that I have not spoken to my Onc about this “yet.”
I have been proactive in my self-advocacy and have done everything I can to expedite next steps. Because of this, I feel relaxed and am not fretting about what’s next and how long everything will take…I have started the ball rolling! 🤣0 -
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
WITHDRAWN FROM TRIAL
Participation dates: May-July 2024
CT scan showed progression again. Although the increases are still within the stable range, the trial Onc and I mutually agreed that withdrawal at this time was appropriate.
CA125 increased again +1000.
I will have telephone follow ups for the trial at 1 month and every 3 months (not sure for how long).
NEXT STEPSStandard of care drugs: Gemcitibine, Topotecan
Trial: I have an appointment with a PMH Onc at the end of Aug to discuss potential trials available for me at this time.
I will also discuss other drugs that may be available outside of the standard of care regime - we’ll see what, if anything, pops.My Thoughts
Overall, the trial experience at PMH was positive.
Their blood lab was easy and quick to access and the results came quickly. CA125 was the longest wait and took approximately 24 hours.
The PK blood team was also excellent. They are a portable blood draw unit that come around to wherever you are to draw trial blood.
Both units were excellent at finding and accessing my veins. The PK team was also very good at getting my port to work if I had a blip
The Phase 1 trial team was excellent. Everyone seemed happy to be doing what they’re doing. Greeted patients, answered questions and took turns with the weight/vitals task.
My assigned trial nurse was great. Before the trial even started she went over and above to get things done. She was always attentive to my feelings, thoughts and requests.
The Dr was okay. I only saw her at the beginning of each cycle. I had to advocate for the CA125 to be added to the trial cycle blood draw. I had to convince her how important it was to me, the patient. She finally consented but I was not happy that it didn’t happen immediately.
The trial medical team were assigned different days of the week. You didn’t always see the same Onc but if anything came up they would consult with your primary trial Onc. I felt that all bases were covered.
I was very disappointed that there was not an ovarian Onc on the team or available to ask specific disease questions - especially since a second ovarian cohort was added to the trial.
The chemo unit is the same as all the rest with delays! For trial patients with observation time following infusion - they kept us in the chemo unit for an hour after infusion (I think that may be protocol to cover responsibility for the patient after infusion) then they sent us to the Convergence unit. The convergence unit is responsible for the trial patient for the remainder of their observation time. This includes ensuring that trial blood and vitals are taken as per trial schedule.
Travel to/from was a bit crazy. It felt like I no sooner got home then I was packing my bags to go again. I got used to the traffic but there was no way I could drive to-from London-Toronto on the same day of an appointment.
The PM Lodge was excellent and very affordable. Newly renovated. Each room could accommodate two people and I often bunked with another patient. Many TV rooms/lounges, pool table, dart board, piano, puzzles, computers, crafts and exercise rooms, and a social and/or bingo night during the week. Two options for three meals per day (two-week cycle). Some days dining staff makes oatmeal for breakfast and soup for lunch or dinner in addition to regular menu. Nice large dining room with microwave, toaster, hot water, cold water, ice, juice available after hours. 3rd floor lounge has a little kitchenette with toaster, kettle, Keurig (bring your own bread, tea, coffee pods).
Shuttle bus to/from PMH and Sunnybrook. PMH schedule had more trips per day then there were to Sunnybrook.
The social part of staying at the Lodge was great. I was always in and out but I always ran into someone I had met who was staying there for a longer time.0 -
Thank you @GloHo for posting your experience with your trial. I find it interesting to read and all the planning you do in the background to get ready for the next scenario instead of waiting for them to come to you with it. You are definitely a planner and it is admirable all that you do and the advice you are able to impart on our members due to your own experience in all the trials you have trialed thus far. Even the rejections and why you are rejected helps someone to make decisions and/or come up with questions to discuss with their own team.
I am looking forward to seeing what may be next for you, why and what it looks like when you meet with your team next. Thank you for all the encouragement you impart on our fellow Teal Sisters as they navigate their own trials and/or try to find ones applicable to them and their own unique journey. Your information is vast in this category.
In the meantime while you wait, what have you been up to and filling your days? How is that puppy of yours?
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A STUDY OF THE PKMYT1 INHIBITOR RP-6306 IN COMBINATION WITH CARBOPLATIN AND PACLITAXEL FOR TREATMENT OF RECURRENT TP53 OVARIAN AND UTERINE CANCER (GYNEREP)
PHASE 1/2 (21-DAY CYCLE)
6 CYCLES ONLY
PRINCESS MARGARET HOSPITAL
Consult with PMH Oncologist to determine next steps in my journey. Standard of care drugs or trial?
It was determined that I am eligible for a Phase 1 trial.
Screening process
CT scan
Biopsy
ECG
Blood
Vitals
Screening appointment with DrTrial schedule
Cycle 1
Pre-treatment: blood, ECG, vitals, Dr
Day 1: treatment (with pre-meds)
Day 8: blood
Day 15: bloodCycle 2
Pre-treatment: blood, ECG, vitals, Dr
Day 1: treatment (with pre-meds)
Day 2: biopsyCycles 3-6
Pre-treatment: blood, ECG, vitals, Dr
Day 1: treatment (with pre-meds)CT scans: every 6 weeks for the first 5 months then every 12 weeks until end of trial
MY NOTES
Above is an overview of the trial schedule.
This trial is focussed on gynaecological cancer only. A definite positive in my eyes.
Trial is 6 cycles only with 2 biopsies required.
RP-6306 (Lunresertib) is an oral drug. There are 4 arms for the trial drug. The nurse believes I will be in the arm that requires you to take the trial drug continuously for the first 14 days in addition to Carbo/Taxol every three weeks for 6 cycles. I am not certain of the exact details, i.e., one or two per day or dosage. I will provide details in my Cycle 1 posting.
Link to one article about trial drug activity in gynaecological cancer:
This trial is combining RP-6306 with Carboplatin and Paclitaxel.Interesting that I will get to try Carbo/Taxol again even though I have been identified as platinum resistant. (They took a very close look at my timelines for each treatment-to-progression stage I experienced.)
Pre-treatment meds are given and are at the discretion of the trial Onc. Given my previous experience with Benadryl and Tylenol, I will be requesting alternate drugs.
Carbo/Taxol side effects - for me it was hair loss, fatigue and blood counts dipping. I am aware that each new round for the same drugs (Carbo/Taxol) could result in totally different side effects.
RP-6306 - side effects for the trial drug are skin rash, anemia, nausea/vomitting. This is an early phase trial drug, so we’ll see what I experience.
The first four weeks will be crazy with travel to Toronto and accommodation requirements but after Cycle 2, it is every 3 weeks which is a lot better!
Overall, I am anxious to see how this drug combination works at this stage of my journey. I am glad to have the opportunity to rechallenge CarboTaxol.
I am beginning the screening process with a CT on Sept 6, a biopsy on Sept 9, screening appointment on Sept 10 and Cycle 1 starts Sept 17.
As was true for my previous two trial postings here, I am writing about my personal experience. Experience of others may be different. It is my hope that anyone with an interest in any trial, will take away an idea of trial schedules (each trial is different), things you should ask about prior to trial start and things you may have to self-advocate for.
I am grateful to have this platform where I can be open, transparent and honest about my own thoughts, feelings and fears.
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A STUDY OF THE PKMYT1 INIBITOR RP-6306 IN COMBINATION WITH CARBOPLATIN AND PACLITAXEL FOR TREATMENT OF RECURRENT TP53 OVARIAN AND UTERINE CANCER (GYNEREP)
PHASE 1/2 (21-day cycle)6 CYCLES ONLY
CYCLE 1 - PRE-TREATMENT
Blood draw (main lab)
Clinic (Onc) (7th Fl) - vitals, weight, physical, review blood work, Onc approval to move forward, sponsor approval of trial registration, order drugs
Note: Had to wait over 2 hours for sponsor to approve my registration for the trial
Interestingly, my CA125 decreased by -500. This was before my treatment. I was not expecting it to go down, especially since there was such a large increase for my last result.
ECG (main lab)
Note: Some confusion – I was supposed to get ECG on infusion day but there was a question when a Dr would be available to review/approve, so added it to pre-treatment schedule so no delay on infusion day
Note: Drugs could not be ordered until ECG was complete and reviewed by OncDRUG PICK UP
Trial pharmacy – pick up trial oral drug
RP-6306 – 56 pills = 2 pills twice a day for 14 days
Note: 1.5-hour wait
PMH pharmacy – pick up oral pre-treatment drugs
Emend (anti-nausea) – 3 pills – take one pill one-hour prior to Paclitaxel infusion and one on each of the following two mornings
Odansetron (anit-nausea) – 2 pills – take one prior to Carboplatin infusion and one in the evening
Note: approx. 45-minute waitMY OBSERVATIONS
The total time for today’s visit was 9.5 hours at the hospital.
There was a 2-hour wait for the sponsor to approve my registration to begin trial
I had to go back down to main lab for an ECG (it’s normally done immediately following morning blood draw) and then return to Onc to review/approve and order drugs
I had to wait at both the Clinical Trial pharmacy and the main pharmacy for my prescriptions to be filled
Future visits should be at least 3 hours shorter now that the glitches have been worked out.CYCLE 1 DAY 1
Blood draw (main lab)
Note: This blood draw is RP-6306 pre-dose draw for the Onc to review and approve treatment.Take RP-6306 trial oral drug
Note: This drug has to be taken at least two-hours prior to administration of pre-treatment famotidine infusion.
Blood draw (7th fl)
Note: This blood draw is taken one-hour post-dose RP-6306 for trial purposes.CHEMOTHERAPY (3rd fl)
Oral medications
Check in and advise reception what time you took trial drug and that you have to take Emend one-hour prior to infusion. Reception will put note on chart and chemo nurse will advise you when to take it.
Ondansetron is administered 1 hour prior to Carboplatin infusion (2nd infusion). Chemo nurse will advise when to take it.
There are a couple of blood draws, for trial purposes, throughout infusion schedule. PK team will come to you to do the draws and take your vitals.
Pre-treatment IV medications
Benadryl – one does before Paclitaxel and one dose before Carboplatin
Note: I usually ask for an alternate but figured I’d be in chemo all day so I could sleep it off. This was true for the first dose but, for the second dose, there was not enough time to sleep it off so I was drowsy in the evening and went to bed very early.
Dexamethasone 10 mg
Chemotherapy Infusions
Paclitaxel
Carboplatin
Oral drug
Take Ondansetron the evening of infusion.CYCLE 1 DAYS 2-14
Take two RP-6306 trial oral drug in the morning and eveningCYCLE 1 DAY 2
Take Emend oral drug in the morningCYCLE 1 DAY 3
Take Emend oral drug in the morningCYCLE 1 DAY 8
Blood draw (main lab)
Clinic (Onc) (5th Fl) - vitals, weight, physical
Blood results: The Onc reviewed my results with me.CYCLE 1 DAY 15
Blood draw (main lab)
Clinic (Onc) (5th Fl) - vitals, weight, physical
Blood results: The Onc reviewed my results with me.MY OBSERVATIONS
Because my drugs have to be timed to infusion and pre-treatment meds, my infusion time begins pretty much on schedule (no delays!).Chemotherapy days are long…from 6-9 hours. This is due to two blood draws, wait for drugs to be prepared and infusion times.
I am going to self-advocate for a lower dose of Benadryl for Cycle 2. Apparently, this is part of the trial protocol and, therefore, there is trial sponsor involvement in this decision until Cycle 3 (different from previous trial).
I did not experience any side effects from the trial drug and/or paclitaxel/carboplatin other than loss of hair. My blood counts, so far, have been pretty stable. We’ll see if the cumulative effects of chemotherapy cause blood issues.
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A STUDY OF THE PKMYT1 INIBITOR RP-6306 IN COMBINATION WITH CARBOPLATIN AND PACLITAXEL FOR TREATMENT OF RECURRENT TP53 OVARIAN AND UTERINE CANCER (GYNEREP)
PHASE 1/2 (21-day cycle)
6 CYCLES ONLY
CYCLE 2 - PRE-TREATMENT
Blood draw (main lab)
ECG (main lab)
Clinic (Onc) (7th Fl) - vitals, weight, physical
Blood results: The Onc reviewed my results with me and approved move forward for treatment.
My CA125 decreased by -2150.DRUG PICK UP
Trial pharmacy – pick up trial oral drug RP-6306
PMH pharmacy – pick up oral pre-treatment drugs Emend and OdansetronMY OBSERVATIONS
The total time for today’s visit was 5-6 hours at the hospital.
I arrive early for my morning blood draw and ECG to ensure results are available for my Onc appointment (approx.. 2 hours). There is always a wait time to see the Onc (approx.. 1-2 hours). There is also the wait time for drugs at both pharmacies (approx. 1-2 hours)I was complaining about being tired so the Onc ordered a B12 blood test. It turns out that my B12 was half of what it should be. Given the low count for my B12, the Onc wrote a prescription for me and I am now taking oral B12 each morning.
CYCLE 2 DAY 1
Blood draw (main lab)
Take RP-6306 trial oral drug
Blood draw (7th fl)CHEMOTHERAPY (3rd fl)
Oral medications
Advise Chemo reception you have taken your trial med and that you have medication to take one-hour prior to first infusion.
Ondansetron is administered 1 hour prior to Carboplatin infusion (2nd infusion). Chemo nurse will advise when to take it.
Trial blood draws and vitals during infusion schedule.Pre-treatment IV medications
Benadryl – one does before Paclitaxel and one dose before Carboplatin
Note: I was negotiated a lower dose for each administration of Benadryl.
Dexamethasone 10 mg
Famotidine
Chemotherapy Infusions
Paclitaxel
CarboplatinOral drug
Take Ondansetron the evening of infusion.CYCLE 2 DAY 2
Biopsy scheduled as per trial protocol
Note: I chose not to receive the sedatives and underwent the biopsy with the local freezing only. I had discussed this with the Dr in the biopsy room prior to making a decision. The biopsy went well and I did not experience any after-biopsy pain.
Note: I have received my biopsy pathology report. I read it but it is confusing to me so I will discuss with Onc at my next appointment.CYCLE 2 DAYS 2-14
Take two RP-6306 trial oral drug in the morning and eveningCYCLE 2 DAY 2
Take Emend oral drug in the morningCYCLE 2 DAY 3
Take Emend oral drug in the morningCT SCAN
A CT scan will be scheduled every 6 weeks. I am currently awaiting my results which I will review with my Onc at my next appointment.MY OBSERVATIONS
I was able to self-advocate for a lower dose of Benadryl for Cycle 2. Unfortunately, I cannot yet negotiate for an alternate and/or no dose due to trial protocol. Starting Cycle 3, there is more flexibility and I will be self-advocating again to change the Benadryl dosage and/or request an alternate. I have been advised that I may be able to do no dose anti-histamine prior to Paclitaxel but an anti-histamine must be administered prior to Carboplatin.I have not experienced any side effects from the trial drug or paclitaxel/carboplatin other than loss of hair. Waiting to see if the cumulative effects of chemo will affect my blood counts.
I did have a rash on my forearms and some itching on my belly following my biopsy. I reported it to my trial nurse. I believe I had a similar reaction after one of my previous biopsies. The forearm rash did not last long, but it was very itchy. Then, throughout the next couple of days, I had a very itchy belly and some random itches on my legs. I think it may have been the antiseptic they use to disinfect the biopsy area. Since my biopsy was scheduled the day immediately following treatment, it is hard to determine what the cause was – trial drug or biopsy antiseptic. We’ll see if anything happens following my next treatment.
I have been taking B12 every morning. I seem to have more energy and my appetite has also improved. Is this a result of B12? I will see what my B12 blood count is at my next appointment and will also discuss with the Onc.
I am anxious to see if my CA125 drops again.
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