clinical trials

GloHo

@Sandi6

It was so nice to meet you and hubby in person and to be able to chat face-to-face. You look very healthy and happy and that curly hair suits you! Congratulations, again, on your 1-year milestone. 

After chatting with you, it dawned on me that your journey from diagnosis to clinical trial is very different than mine and I was wondering if you would be comfortable sharing your journey with us?

GloHo

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

CYCLE 3

So…Cycle 3 was delayed because my neutrophils are too low.

We are trying to arrange treatment for next week. Chemo does not have a chair for me so I am on a wait list and will find out Thursday or Friday when they can fit me in. Of course, there is no guarantee my count will be up to trial requirements by next week, so not sure what will happen in that case. Maybe an injection or another delay?

In the meantime, I’ll share some of my other results with you.

White blood count is very low but was not a determining factor in the delay.

B12 has increased to just above normal. Dr recommends I continue with the supplement to bring the count up more.

CA125 decreased again. It went down 1300.

Biopsy Pathology Report indicates that there is dead tumour tissue or, as they put it, background necrosis suggestive of treatment effect.

CT Chest report is stable - no pleural effusion, no new progressive disease.

CT Abdomen/Pelvis also reports stability with decreased ascites.

My thoughts

Overall, positive reports and it appears the meds are keeping the disease stable.

From previous experience on these drugs, I was expecting issues with my neutrophils and platelets, just not after Cycle 2. My platelet count seems to be remaining stable which is good and one less thing to have to worry about.

The Dr goes through my entire blood report with me and explains why they are not concerned with some of the counts. They can tell they are a result of the meds and that there is no damage to my organs. Amazing!

Delays are always a concern and difficult to deal with for many reasons.

1. There is a break in the treatment schedule.

2. I have to wait for a last minute chemo booking and try to make accommodation arrangements because I travel to Toronto for treatment.

3. A delay changes everything in your personal calendar, including medical appointments my husband has, fun things that you already booked around your current schedule have to be cancelled or rearranged.

4. Holiday planning with family and friends…Christmas is coming!! This delay may actually work in my favour since I had a treatment scheduled for New Year’s Day that will now be pushed to the following week and it won’t interfere with Christmas either.

I mention the delay issues because the nurse and Dr were like…we have to delay. There was no indication that they thought you had a life or anything better to do outside of your cancer schedule and how much the delays affect your life!! While there is nothing that can be done about it, I just felt like they didn’t have a clue. On the other side, you have to be flexible and prepared for these things as best you can. Delays do happen.

GloHo

@Tanja

In response to your post in Let’s Get Started (copy and pasted at the end of this post)

You have obviously done a lot of research and the information you have provided is very informative and helpful.

You are correct that it takes courage and is a very personal choice to participate in trials.

I am glad that my posts have provided you with a nudge to look into clinical trials. When I began my journey, I did not find specific info on trials on the site and decided I would journal my personal experience. Each trial is different, there are many differences and some similarities. It was my hope to present info so that anyone considering a trial would see the process, the scheduling and the time commitment required (especially for us out-of-town participants).

The trial database I usually use is https://clinicaltrials.gov/ . Have you used that database? This site has a filter so you can choose “recruiting and not yet recruiting” so you don’t get trials that are completed.

I obviously want to find something that will work for me but also believe that my participation may help someone in the future.

I told my Onc from appointment number one that I would be interested in doing a trial and at each visit I would ask if anything was available and/or present trials that I had found and thought I might be eligible for. I noticed after a few visits that my Onc proactively started doing trial inquiries on my behalf before each of my visits and was prepared for my inquiry 😁. I just realized that this is where I began proactively self-advocating for my care and I have never stopped 🤣.

I am currently on my 8th treatment and this is my 3rd trial 😁. I am determined!! I did my first trial at 4th line of treatment.

I have also had 4 biopsies. I mention the biopsies because there is some marker info included in the pathology report. Interestingly, each of my reports at different stages of my disease came back with a couple of the same and a couple different markers. My results did not show anything out of the ordinary for HGSOC so no specific marker for targeted therapy.

Speaking of markers…I totally agree that this testing at the outset would be beneficial!

There is a study called Study looking at Biomarkers in Ovarian Cancer (BioDIVA). It is a very extensive biomarker testing study. In addition to a blood draw, a tumour biopsy is required. The study indicates it is for high-grade serous. We have different cancers and I’m not too familiar with clear cell…does it fall under high or low grade? In any case, it may be worth an ask about this specific study. It is available at several cancer centres across Ontario. Now, the results do take time…and I would not put an eligible treatment on hold waiting for the results. If anything pops for targeted therapy, and if there is a trial available for that specific marker, discuss course of action with your Onc.

Now, also worth a mention here, is the genetic component of this testing. This is a tough one because you have to decide whether or not you are going to share these results with others who may be at risk for hereditary disease [siblings, children and grandchildren (both male and female), cousins, nieces, nephews]. A genetic counsellor is available to help you work through the complexities of this decision.

Even if you have had the biomarker testing, each trial will also do their own testing. I have had blood, CT, ECG, ECHO, and/or biopsies to determine trial criteria eligibility at time of registration for the trial.

Still alive and functioning 🤣. I think this amazes me the most! I was cancer naive when diagnosed and really didn’t know what to expect - I was scared, sad and angry. I am, after 5 1/2 years, still considerably well. I do not have symptoms or pain and I have experienced very few side effects to all of the drugs I’ve had thus far. It is a difficult journey and, when I hear that a drug is not working and there is progression, like you, I wonder what’s next and how long (or if) it will work. When I get this news, I have to admit there are tears and feelings of anger. I let myself feel whatever emotions I have, internalize my reality, and then I am able to move forward. I usually have a positive outlook and continue to keep the hope that treatment will, at the least, stabilize my disease for a while.

As @Alwayslearning says “Knowledge is power” and I hope this missive imparts some knowledge that will lead to personal empowerment throughout your journey. There is also power in numbers and this site is truly amazing in its simplicity at bringing us all together - to ask the tough questions, to share our experiences and wisdom, and to offer support to each other.
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TanjaNovember 1

@GloHo I just read your clinical trial story…. Very impressive and what strength to make it through all the up and downs. This gave me courage. I forgot under which subsection I read it, so I wanted to text here ( the site with all the sub topics is a bit confusing). I checked for clinical trials at PMH and Buffalo, US and learned pretty fast that it is difficult to get into these trials - eligibility, trials are ended, or- US - too expensive. It is also very encouraging that you are still alive and functioning. I am always worried that if drugs don't work, the end is in near sight.

I am in 2nd Carbo and paclitacel + Beva cycle for OCCC (Tp53 positive) recurrence and equally already look for clinical trials as I am expecting becoming platin-resistant any moment. I had a good talk with my MedOnc at PMH. Similarly to an earlier comment by someone, I remain shocked by my experience so far that tumor genetics and testing is done on a need-to-know basis. 

So, when I had the discussion about newest and best trials for my clear cell tumor, I learned the following that I want to share: It appears that immune therapy works best for those with MMRd - mismatch repair deficiency. And I read somewhere that this is because these tumor cells look more foreign to our immune system. Since, I am proficient, meaning I don't have MMRd, immune therapy is not a good option for me. My hope that immune therapy could rescue me in the future was immediately destroyed- but then who knows what will be developed in the future. It appears the antibody -drug- conjugates - ADC are the new kid on the bloc. These drugs consist of an antibody that targets a specific protein that is over expressed in your tumor. This antibody is linked to a strong cell toxin which is released when the antibody docks onto the protein. Since the tumor has more of it, the idea is that the tumor gets more toxic drugs than the rest of your body. On such famous drug is Mirvetuximab directed agains folate alpha receptors.

In respect to my tumor, she mentioned to test it for HER2- human epidermal growth factor receptor 2- which can be expressed in all solid tumors , also in ovarian cancer. As per literature, it is associated with poor prognosis. Apparently there is now a ADC against HER2 which is trastuzumab deruxtecan. After the discussion, I thought why wasn't this tested earlier. It is not a mircacle drug but can stabilize disease and prolong progression free survival. The more I think about it, we should all be tested for all therapy and prognosis - relevant markers, right at the beginning and then treatment should be immediately tailored to this. I guess, the problem is that we don't have miracle drugs..




Sandi6

@GloHo it was so lovely meeting you in person. Always great to have an authentic conversation.
My move from my local hospital, in London, to a clinical trial at PMH was not straightforward.
My oncologist explained that I was full of cancer, the frontline treatment isn’t working, so I wasn’t given the 6th dose. He also told me that I wouldn’t live more than a couple of months and I would be referred to a medical oncologist.

Feeling stunned and overwhelmed, I frantically researched for options!!! Fronds had been raving about PMH for months so I researched their referral process.
I then called my family doctor and requested a referral be made for a clinical trial at PMH. It was only a few days until I had an appointment.
im grateful for the opportunity for a longer life. Loving every minute of it.

We really need to advocate for ourselves, and quickly as time isn’t necessarily on our side. I’ve been diagnosed with ovarian carcinosarcoma which is very aggressive so time is important!

Wishing everyone healthier days ahead 💕