My Clinical Trials-The Journey Continues

User

Posted 02 Apr 2019 at 16:34

I have been sucessfully enrolled into a new phase 1 clinical trial which has an identifier of CCS-1477-01. Here are a few links.

https://clinicaltrials.gov/ct2/show/study/NCT03568656

and https://www.cellcentric.com/clinical/

The trial will look at the safety of a new experimental medication CCS1477 and see what effects it has on me and my prostate cancer. The growth of prostate cancer is highly dependant on hormone signals and the function of the androgen receptor (AR) in particular. AR converts even very low levels of hormone (testosterone) into a signal for cells to divide more rapidly. CCS1477 reduces the levels of AR in prostate cancer cells and may therefore slow the growth of the tumour.

I will be in the initial phase, called Dose Escalation which will find out the highest safe dose that can be given without causing too many side effects. The dosing frequency will also be assessed.

Once the highest safe dose has been established the study will progress to treat several other groups of participents.

There will be basically three arms to this trial.

Mono CCS-1477

CCS-1477 given with abiratone

CCS-1477 given with enzalutimide.

I will be on the mono arm. It is going to be taken in capsule form, the amount and frequency to be determined, although a cycle will be 28 days. CT and bone scans to be performed every eight weeks.

As it is at the very early stages, side effects are unknown, although nausea and fatigue are anticipated.

It is anticipated that about 120 people will be recruited for the study overall, from up to 20 hospitals, mainly in the USA but two hospitals in the UK.

If successful, they think it could help about 80,000 prostate cancer sufferers every year.

Thats it for now, I think. Baseline tests and scans straight after Easter then all systems go!

As before, good or bad I will let you know my experiences.

Best regards

User

Posted 02 Apr 2019 at 16:34

I have been sucessfully enrolled into a new phase 1 clinical trial which has an identifier of CCS-1477-01. Here are a few links.

https://clinicaltrials.gov/ct2/show/study/NCT03568656

and https://www.cellcentric.com/clinical/

I will be in the initial phase, called Dose Escalation which will find out the highest safe dose that can be given without causing too many side effects. The dosing frequency will also be assessed.

Once the highest safe dose has been established the study will progress to treat several other groups of participents.

There will be basically three arms to this trial.

Mono CCS-1477

CCS-1477 given with abiratone

CCS-1477 given with enzalutimide.

I will be on the mono arm. It is going to be taken in capsule form, the amount and frequency to be determined, although a cycle will be 28 days. CT and bone scans to be performed every eight weeks.

As it is at the very early stages, side effects are unknown, although nausea and fatigue are anticipated.

It is anticipated that about 120 people will be recruited for the study overall, from up to 20 hospitals, mainly in the USA but two hospitals in the UK.

If successful, they think it could help about 80,000 prostate cancer sufferers every year.

Thats it for now, I think. Baseline tests and scans straight after Easter then all systems go!

As before, good or bad I will let you know my experiences.

Best regards

User

Posted 30 Apr 2019 at 14:23

Day 1 Cycle 1 (yesterday)

Firstly, dose escalation phase understood. I am going to be in a group of 3 men whose dose is to be taken on Monday, Tuesday and Wednesday. The dose is 100mg and consists of a sigle white capsule. Another group of men may be recruited to take the drug for 4 days etc. until a safe and effective dosage is established. I think Simon is taking the drug 2 times per week.

First impressions? well, absolutely no side effects to report up to now. Had another dose today and final one of the week will be tomorrow.

The only concern is that every treatment option I have had in the last seven and a half years entails me dealing with not the prostate cancer but dealing with the side effects of what I have been given. A drug which works without any adverse effects? Wow, that would be a breakthrough!

Also, in my month without any treatment from last trial has resulted in my PSA jumping over 200 points to over 600 -eeek!

Never mind, I actually feel very good, still pain free and walking on average about 8 miles per day.

Looking forward to see what the stats are like in a months time!

Best regards

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User

Posted 20 Apr 2019 at 19:11

Hi Simon

There will be 2 UK hospitals in the UK running the trial, Sutton and Newcastle (the other 18 are going to be in USA). I am attending Newcastle. Looking at the concent forms I have to bring in with me on Tuesday to sign it definately says it will be dose escalation. I was told previously that the drug company will be specifying which 2 days of week I have to take to capsules together with the strength.

So, bone and CT scans together with an ECG to be given on Tuesday, with lots of blood before starting. I will let everyone knows what effect it is having on me. It will be interesting to see (for everyone) if we will be sharing similar outcomes.

Best regards

User

Posted 22 Apr 2019 at 13:25

Just out of interest, what effect has the drug had on your PSA Level?

Best regards

User

Posted 22 Apr 2019 at 14:28

Hello,

The PSA is stable. There may have been a slight rise but it is difficult to compare old PSA results with new because there has been a change in how it is measured or the calibration. I'm not sure.

I would be very interested to hear how you get on. I was told that there was someone in Newcastle starting the trial. I also know that there is someone from Kent. I live in Leeds. I think that is all of us on the trial. Best wishes Simon.

User

Posted 30 Apr 2019 at 14:23

Day 1 Cycle 1 (yesterday)

First impressions? well, absolutely no side effects to report up to now. Had another dose today and final one of the week will be tomorrow.

Also, in my month without any treatment from last trial has resulted in my PSA jumping over 200 points to over 600 -eeek!

Never mind, I actually feel very good, still pain free and walking on average about 8 miles per day.

Looking forward to see what the stats are like in a months time!

Best regards

User

Posted 30 Apr 2019 at 18:22

Keep up the good work

User

Posted 01 May 2019 at 08:37

Great that you feel well and pain free.

It will be interesting to see how your PSA reacts to the treatment.

All the best.

Ido4

User

Posted 13 Jun 2019 at 19:37

Day 1 Cycle 2

This was just over two weeks ago. The reason for the delay was that it was the day after the last Bank Holiday. There was enormous pressure on the blood results department with two days of patients running through at the same time, so consequently everything was so slow.

When the headline blood results came back, everything seemed OK so the drug was ordered up from the pharmacy. More hours of delay. My PSA results were not back (usually one of the last results to come back anyway) and it was nearing the end of the day so after getting Cycle 2 medication for the month I went home. I thought I would just ring in the following day to find out what it was.

Except I didn't. I got really scared as this drug has (apart from really minor indigestion for an hour on day 4) given me absolutely no side effects. None at all. Every single medication I have had over the last nearly 8 years has always had some negative effect. Not this.

I got it into my head that this medication must not be doing any good and given my high PSA number at the start of Cycle 1 (well over 600) it could easily have doubled.

However, the unit rang me yesterday on an unrelated matter and I plucked up the courage to ask and literally had my fingers crossed whilst they got the info.

Not only had the rise been halted, it was actually starting to come down! Not by that much admittedly only about 20 points but downward directions are always good! I also continue to feel great, a few aches and pains here and there but my quality of life is at a level I never thought I would see again.

It will be crunch time over the coming two weeks, with a bone and CT scan next Tuesday and the results the following week when if all OK, Day 1 Cycle 3 will start.

I will let you know!

User

Posted 13 Jun 2019 at 21:16

Wishing you the best of luck with the trial. I am off trials for now and back on good old docetaxel. Like you, I had a modest PSA reduction after the last dose. Good to know things can go in the right direction!

User

Posted 25 Jun 2019 at 22:21

Day 1 Cycle 3 (or so I thought)

Yup, following bone and CT scans last week, I went today to get the results. As feared, more spread. So thats the end of the trial. Not really suprised, as I have said consistantly from the start, it always felt that it was having absolutely no effect on me. In fact, if it was not me knowing it was a stage 1 trial, so guaranteed to get the drug, I would swear I had received a placeabo.

Unfortunately, right at this time, there are no suitable trial slots for prostate cancer available for me. In any case there needs to be a full month from the last dose before anything else can be considered. I will be back for an exit medical on the 23rd July so who knows, something might come up by then. I believe they are writing to my old oncologist as maybe he could give me something to keep me ticking over until it does.

So everything is up in the air at the moment, and the only thing I can do is to keep as fit and healthy as I can until there is a plan for me.

I have to say though, my quality of life since starting on my first trial some 10 months ago is quite remarkable. I feel great and generally pain free. Having had the opportunity to receive 2 trials I feel very fortunate. You would think that since every treatment given to me right from the very start, some seven and a half years ago has failed, I would be used to it by now. Seems not! Deeply disappointed.

Will let you know what is happening in a months time!

Best regards

User

Posted 25 Jun 2019 at 22:59

Oh Orm, I thought that perhaps with the small drop it might be good news - fingers crossed that someone pulls something out of the bag for you

"Life can only be understood backwards; but it must be lived forwards." Soren Kierkegaard

User

Posted 26 Jun 2019 at 08:57

Sorry to read this.

I hope another trial becomes available in the near future Orm.

Ido4

User

Posted 25 Jul 2019 at 20:27

Had exit 28 day medical earlier this week. My PSA taken last time was up to 1170. Goodness knows what it is now . However the oncologist was quite dissmissive of my worrying about it. The scans showed minimal spread. He said he could give plenty of examples where massive spread has occurred where someone has a stable low PSA.

Unfortunately there are no trials available at the moment "up North" so are writing to the Marsden as a referral.

During the course of my talk with him he said that they suspect that my cancer has mutated way beyond my original biopsy tissue sample. I had a full DNA profile done on my tissue sample last August. The sample is now coming up to eight years old. This could be the reason I have failed two trials.

Hearing all this I could feel a cold sweat running down my face. I was convinced that they wanted another biopsy done. The last one was horrendous.

However, it now seems that a drug company has developed something rather amazing. They have perfected a way to extract full DNA and highlight any mutant cancer cells solely from a blood sample. It needs to be sent to America and will take about three weeks. If and when the test becomes mainstream it could revolutionise diagnosis. It could also be another step in the direction of personalised treatment.

It will be really interesting to see if the cancer had changed some aspects of my DNA profile over time.

In the meantime, I will get a single zap of radiotherapy on my 6th rib which has been aching of late. Otherwise I feel remarkably well. I thought with a high PSA my head would blow off like a pressure cooker. Its not the case!

So I will close off this thread and start a new one with what ever treatment program is offered. Probably be about a month before anything new to say.

Time for a cheeky week away somewhere!

Best regards

User

Posted 25 Jul 2019 at 20:48

That’s great they can do the DNA profile on cancer cells from a blood test.

Enjoy some time away until the results come through.

All the best,

Ido4

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