My Very Own City of Hope: MSS-CRC Clinical Trial #1

As long time readers of my blog know – I have been in a quandary since I was diagnosed with (presumably cured) Stage 1 melanoma in January 2015.  That diagnosis, even though presumably cured by simple day surgery, with zero signs of recurrence ever since e.g. by monitoring with blood liquid biopsy, effectively blocked me from most colorectal cancer (CRC) clinical trials.

Without clinical trials there is statistically an essentially 100% chance I will die of CRC in my 40’s.  I personally find that notion unacceptable.

This blockage from clinical trials was the height of irony (haha Universe – funny one!) since I am a cancer drug discovery scientist and clinical trial education of fellow patients is my passionate advocacy soap box issue.  My first stab at an immunotherapy clinical trial in February, 2015 was literally taken out of my hands as I was about to sign consent paperwork when my melanoma history was noticed.

So my (presumably cured) melanoma was a real problem… it blocked me from most CRC clinical trials listed in clinicaltrials.gov – even ones I was scientifically advocating fellow patients to discuss with their MD’s.

Until yesterday.

Backing up the story a bit…

I am friends with a Professor of T-Cell Immunology – a brilliant guy and a fine human being too.  A powerful combination to have as a friend & scientific advisor! We were meeting to discuss clinical trials and he brought up a trial NCT02636036 “Phase I Study of Enadenotucirev and PD-1 Inhibitor in Subjects With Metastatic or Advanced Epithelial Tumors (SPICE)”.  I told him I loved the trial and had been monitoring it for months but… they clearly excluded people with secondary cancers like my melanoma.

My friend was insistent – he told me to double-check the exclusion criteria.

I had double-checked the criteria off and on for months so I didn’t see the point.  I nodded politely.  But… when I left his office, he had been so insistent (and it is such a cool trial), when I got back to my office, I pulled open the trial’s webpage on my computer.

The melanoma exclusion criteria was nowhere to be seen.  I rubbed my eyes and looked again. Gone.  I carefully looked through the exclusion criteria a third time with a fine tooth comb.

It was gone.  The date stamp on the clinicaltrials.gov record said it has been updated about 2 weeks prior.  I had no idea it had been updated and wouldn’t have known without my friend’s insistent pushing to double-check. This yet again illustrates the power of lucky breaks in the high stakes world of currently incurable cancer as mentioned by the recent STAT News article on my cancer journey.  If my friend hadn’t pushed me on the exact day he did… the rest of the blog post would never have existed.

The trial was listed as “Not Yet Recruiting” in California (2 sites in LA) but one thing I had also just recently observed and learned from a different friend – in the experimental therapy world, you have got to be aggressively proactive since you are not following standard protocols.  So with that fresh example in my mind, aggressively proactive I was.

First I emailed the trial’s contact info that very same day.  Then my oncologist contacted them.  No definitive answers.  At this point, thinking back to my friend’s aggressive proactivity – I changed course.  I knew the names of the oncologists running the two LA trial sites – but not their contact info.  One email I found from a medical paper he wrote.  The other was not found that way – but… I could find via google how his hospital’s email system systematically converted names into email addresses.  A few minutes of detective work allowed me to have his email address figured out. 🙂 I immediately emailed both doctors explaining to them my strong interest in the trial.  Gratefully they both answered immediately.

I made an appointment at the earliest possible date between the two – which turned out to be at the very well regarded City of Hope Medical Center in Duarte, California – in the LA metropolitan area. I talk a lot about Hope… it seemed like a very appropriate place for me to have my first clinical trial  🙂

The appointment was yesterdayIt went very well – I have been accepted into the trial!!

So what exactly is the trial?

The trial is a combination trial specifically recruiting for MSS-CRC that combines an oncolytic virus with one of the deservedly famous anti-PD1 immunotherapy drugs (Nivolumab) to remove immunosuppression.  Oncolytic virus strategies have been looked at for years (this particular virus was first published in 2008!) with somewhat underwhelming results – but I believe the addition of the new PD(L)1 inhibitor class of drugs is making the field poised for a major resurgence.  A fun piece of trivia: My primary oncologist at UCSD Dr. Tony Reid is a co-inventor of this virus – he has studied oncolytic viruses for years! Small world, huh?

oncolytic-virus-cycle_by-antonio-jimenez

How do oncolytic viruses work?

You might have seen stories about anti-cancer viral therapy on popular TV shows over the past few years on shows such as 60 Minutes or perhaps HBO’s Vice.  Oncolytic viruses are common viruses that have been reengineered to preferentially replicate in tumor tissue.  They hone in on tumors, replicate in them, causing them to burst.  Cells bursting?  Yep, that is a fancy medical term to say the cancer cells get killed  🙂

But oncolytic viruses do much much more. Viruses also do a great job of attracting the attention of the immune system in multiple ways, making oncolytic virus therapy an immunotherapy.  As the viruses replicate in tumor tissue – the tissue become highly inflamed and immune system cells become attracted and start to stream in.  At the same time, as cancer cells are killed, they release neoantigens from their mutations, essentially a form of on the spot therapeutic vaccination.

In effect – oncolytic viruses convert MSS-CRC “Cold tumors” into immunological “Hot tumors”.

So… in theory – what this therapy is setting up is a situation of:

  • Direct, preferential cancer cell killing by the virus
  • The virus highly inflames the tumor sites converting my “Cold” MSS-CRC tumors “Hot”
  • As shown in an earlier monotherapy Phase 1 trial, immune T-cells stream into the tumor
  • Neoantigens arising from mutations in the cancer cells’ genomes are released as a local form of therapeutic vaccination
  • Now, in addition… in this new trial, removing immunosuppression with a PD-1 inhibitor after the tumor become immunologically hot and infiltrated with immune T-Cells

Its a Snall World After All_Gary Coleman

How Many Viruses Did You Say Again Willis?

I think I forgot to mention how my viruses get infused into you for these kind of trials.  TRILLIONS.  Infused directly into your body by iv.  To put into context, that is a virus copy for every 10 cells in your entire human body.  Massive doses.  A lot more than someone just sneezing next to you on the subway giving you a bad cold.  Stage IV cancer treatment is not for the faint of heart.

How Does This Tie into My Personal immunotherapy Project?

It may tie in very well  🙂 Once again with thanks to the immunology advice I have received from expert friends… the effects oncolytic viruses have on my tumors may be highly synergistic with my personalized vaccine immunotherapy plans by their: 1.) Breaking down of tumors 2.) Highly inflaming them to activate for immune cell attack 3.) Increasing ability for T-cell infiltration. I will do the current trial monitored by CT-scan.  Ideally it will work well on its own – if it doesn’t – it sets me up well for a subsequent blast with my personalized vaccine!

Plans on a Practical Level

Even though I emailed the same day and even though the trial is still listed in the official clinicaltrials.gov database as “Not yet recruiting” – when I arrived for my first available appointment yesterday, there was already a wait list forming – I am #2 on that list.  It just goes to illustrate that when you design a scientifically exciting trial in a patient population with high unmet medical need – patient accrual for clinical trials is not a problem!

The trial MD estimated that my #2 slot will open up in 4-8 weeks (they only get to dose one patient at a time) and to be prepared to jump when a phone call from him happens.  This is the kind of situation of: they call – you jump – or the slot goes to #3 on the list… I assure you I will have my basketball shoes on 24/7 ready to jump!  🙂

Until that phone call arrives, I’ll continue to tread water with FOLFIRI chemotherapy.  In terms of the actual details of how the trial runs, I’ll keep that for a blog post later this Fall – but it will involve a lot of travel to (and some hotel time in) LA for dosing, biopsies, scans, safety observation etc.

planes-lined-up-on-taxiway

Planes on a Taxiway

My overall strategy over the past year and a half has been to lay the groundwork for trials, working around my melanoma issue.  As I indicated earlier in the post, I have absolutely zero intention of dying of CRC in my 40’s.  Not if I have any say in the matter!

The way I always picture it: My goal is to line up clinical trials like planes on a taxiway… Time for the first flight to take off!

Exciting days lay ahead in the very near future.  To Life!

-Tom

45 Comments on “My Very Own City of Hope: MSS-CRC Clinical Trial #1

  1. So happy for you! There is no substitute for advocating for yourself in situations like this. Way to show us how it’s done!

    Liked by 1 person

  2. Wow you never fail to amaze me and put the H in HOPE
    Please let me know if I can help in anyway.
    I am available for caregiver help any time you need it.
    Chrissy

    Liked by 1 person

    • Thanks Chris! Wish you lived closer! I’ll be doing the LA trial by myself but I know a number of Southern California/LA people that have offered to help and occasionally check in on me to make sure I’m still breathing 😉 Exciting stuff!!!

      Like

  3. Dr Tom – I am happy for you. Hopefully everyone reads yor posts and knows they can eventually get into a clinical trial. Yes, lots of hoops you have to jump through but it can be done. You know the system, so the rest of the folks here hopefully have someone to advocate for them. Best of luck to you, hoping it works!

    Liked by 1 person

    • I agree Karrie – the trial system is not set up to be patient friendly (and they wonder why accrual rates for cancer clinical trials are so low!) – that is one reason I blog extensively about things like my trial experiences. Not so much to advocate that people follow the exact path I am do (that is between them and their MD) – but more importantly to illustrate by example some of the roadblocks I hit and what I did to successfully get around them – as general guidance for whatever trial a patient and their MD are interested in.

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  4. I think your writing about this is so very important. The world of clinical trials is so daunting and confusing to most people. The truth is we have to advocate for ourselves, as difficult as it may be. Going through cancer treatment can feel like a full time job and then having to weed through all the treatment options on top of that – pretty overwhelming. Most people don’t understand how to do it. Not the way it should be. Your writing will help educate and hopefully make change.

    Liked by 1 person

    • Thanks Rob!! As a scientist I am absolutely thrilled. As a patient I am simultaneously thrilled and feeling like Gary Coleman as illustrated in the blog post ha.

      Like

  5. You are the pioneer and the rest of us are watching you blast into the future. I hope and pray this goes well so possibly the rest of us may one day benefit from immunotherapy instead of remaining on chemo for years. Such exciting news!

    Liked by 1 person

  6. Once again, you have shown us all how we have to be proactive for ourselves and never give up trying to find something that will work.

    Liked by 1 person

    • Exactly true – if there was a single character trait that I think is important for a Stage IV patient, I think “proactive” would probably be my choice. It is so important whether you ar doing standard of care choices or entering the world of experimental therapeutics! Your medical oncologist is a highly trained quarterback giving his or her medical advice and coordinating all the various medical team activities. But the patient has to be the head coach of their own care.

      Like

  7. Soooo happy for you, Tom! I love oncolytic viruses too. A kick-ass combination you’ll get. All body parts crossed for you!!! —Maia / Cee Cee

    Liked by 1 person

  8. What wonderful news, I only recently starting following you and I am so impressed with all your research. I am stage IV and currently on my last option of treatment and the next step will be a clinical trial. I now know that I have to equip myself with much more knowledge about my cancer

    Liked by 1 person

    • Knowledge is so important… I have some resources that may help you and your oncologist with the upcoming experimental therapy decision making. Friend me and PM on Facebook if interested!

      Like

  9. Great news for you Tom! I am really happy for you, I know how the melanoma issue was crating a major obstacle for your access to trials. One question for you: in the criteria is specifies four lines of treatment completed. Does this include as in my case chemoradiation prior to surgery, then surgery, then chemo, then another chemo post recurrence? Sorry for asking such banal question but my current doctor is very unhelpful when it comes to trials and I want to present him with some answers rather than be on his mercy for those. Also, if you need anything while in LA area, I am here and would love to help you in any way: food deliveries, fresh juice, homemade grander cookies, visit to cheer you up. Just let us know. Best wishes from me and my family, Joanna

    Liked by 1 person

    • Hi Joanna- The prior therapy criteria is a bit complicated so I won’t try to answer here in the fear I could mislead you. In general they are referring to systemic drug treatment not surgeries. But this is a great question for a trial’s MD to answer since they will know the definitive rules.

      Thanks for the LA offer – I will be doing the trial by myself so visitors may be welcome! PM me on Facebook as the trial start approaches and maybe we can meet up!

      Like

  10. Oh such incredible news!!! I am so very happy for you! I will be anxiously awaiting your follow up posts. Just this morning I was out for a run and thought to myself, “I am not dying of this disease (CRC) in my forties!” I am so with you on that! I wish you the most success possible.

    Liked by 1 person

      • Tom I am so happy that you are going to the trial. I try to read everything you put out and I know you will lead the way to curing crc. I know you will because you have the knowledge and bravado that you share with everyone. Bless you!!
        e the one because you have the knowledge and the bravado

        Liked by 1 person

  11. Oh this is incredible. Love this approach for MSS-CRC! Tony must be pumped too with his research background in oncolytic viruses. Perfect storm Tom! Best news of the year. Turn those tumors hot – it just makes sense for checkpoint therapies in indications like MSS-CRC. Where do the MEK inhibitor or even ibrutinib (relieve immunosuppression mechansims). Stopping here and giving you a high five! To life!

    Liked by 1 person

    • I value your opinion highly so thank you for the strategic vote of confidence!! I have asked a number of highly experienced scientists about the strategy – the feedback has been 100% positive. Now it will be time to see if scientific prediction translates into medical success in the clinic. Only one way to find out….. 🙂

      Like

  12. What an answer to prayer, Tom!!! I’m still praying for you daily! I’m so happy that you felt so compelled to be so proactive, that the limitation was removed, and that you are so high on the list. Jenise

    Liked by 1 person

  13. Congratulations and best wishes fron the other side of the Pacific!
    I am Chinese and heard of your story from the Internet. You are so optimistic and inspiring!
    My father was just diagnosed of IIIc stage non-small cell lung cancer with no mutation of EGFR and ALK (the two most common mutations). His oncologist told us that he had at most two years left. That really broke our hearts. But I won’t give up looking for hope! You mentioned blood genome sequencing and personalized vacciness, will that be feasible In China?

    Best Regards
    Yifan

    Like

    • Hi Yifan, China is very technologically advanced so yes I assume both blood genome sequencing and experimental efforts at personalized vaccines are available there – I just do not know the system in place in China to grant patients access – every country is different. Best of luck and thank you for commenting & reading all the way from China!

      Like

  14. Im trying to find info about a new trial, im stage 4 chemo is not working , so im trying to get into azd6244 and CsA. Do u have any info

    Like

  15. Go Tom. Wishing you great success in this study. We are somewhat in the same boat and in the process of looking into TIL study at NIH now. Sounds very similar.

    Liked by 1 person

  16. Wow! this post had me glued…your sticktoitiveness is so incredible..you are in our thoughts and prayers.

    Liked by 1 person

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  18. I wish you the best of luck, Did you not try to see if you’d qualify for NCT02788279? I mean this is a Phase III trial at the top of the list for new MEK inhibition trials for CRC-MSS. No experimentation for dosage acceptance. Very promising Phase 1b results.

    Like

    • I agree its (very small) Phase 1b results were promising – if you look through my old blog post list, I wrote a total of about 4 posts just on this one trial due to its potential scientific breakthrough. There were a number of strategic reasons (not scientific) that I decided to go in a different direction with my preliminary clinical trial planning. I am technically ineligible for NCT02788279 due to my second malignancy (Stage 1 melanoma) but a compassionate use exemption is certainly possible in this case.

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  20. Hi Tom and thank you for sharing interesting news about mss crc. I am searching the net for news about immunotherapy / virus therapy and found your blog today. We have no trials for mss crc patients in Norway yet. We are looking abroad since we feel that the treatmentpolicy in our country are lagging behind. We have a trial starting up with with encorafenib and binimetinib and as for now this is our only hope for my 40-year old husband Jørgen with crc spread to liver and skeleton. Not the expected way to start the 40ies, we found out this June.

    I wish you the best of luck with the trial and will be following you here.

    Like

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  25. Hi Tom, I am also diagnosed with stage 4 colorectal cancer and I am only 39 years old. I hope this treatment works for you. It certainly gives hope that someday it will be available in Belgium too. Good luck! Grtz An

    Like

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