Patient Number 1

Kevin here…

We recently posted a link to Facebook etitled: For Patient #1’s wife, melanoma is a thief (don’t let the Phillies fan art in the picture turn you away, no one’s perfect!).  If you haven’t read it:  it is a hard but very accurate account how metastatic melanoma affects a family (esp. the caregiver).  Little did we know that post would foreshadow me becoming Patient #1 on a different clinical trial.  Here’s the super small nutshell on how we got here:

  1. Surgery / skin graft to take out the original mole (wide-local excision)
  2. Test to check if melanoma has spread to surrounding lymph nodes, turns up positive
  3. 2nd Surgery to take out those lymph nodes (parotidectomy / neck disection) 3rd Emergency Surgery to fix subdural hematoma cause by vomiting severely after surgery
  4. 33 rounds of high-dose radiation to head and neck.
  5. Red-tape causes disqualification of randomized Interferon / Ipilimumab trial so Interferon Alpha is chosen as standard of care for adjuvant stage.
  6. High-Dose Interferon Alpha (adjuvant) brings major nausea and vomiting
  7. Recurrence detected in the original location directly within the field of radiation!
  8. 2 cycles of Interleukin-2 at 10 and 8 doses respectively but cancer  progresses.
  9. Fly to NIH (Bethesda, MD) to consult with the NIH regarding TIL therapy with IL-12,
  10. Then fly to LA to consult with UCLA for Anti PD-1 Trial.
  11. Sign up for the Anti-PD1 trial at UCLA
  12. Fly back and forth from ATL to UCLA every 3 weeks to take Anti-PD1, which completed with zero side effects but, cancer still progresses
  13. Attempt to get on a BRAF/MEK clinical trial starting at UCLA and transferring to Vanderbilt – fails over communication issues.
  14. Fly back to NIH to have surgery to harvest cells for TIL therapy with IL-12 – successful.
  15. Get very sick while liver enzymes go wildly out of controlbut calms down on its own and no one knows why
  16. Get kicked off of TIL therapy with IL-12 trial for being “too sick” to complete it.
  17. Start BRAF inhibitor (Vemurafenib) at Emory which is VERY effective and shrinks all of my tumors dramatically
  18. Stop BRAF inhibitor (Vemurafenib) in order to prepare for TIL therapy with IL-12 at the NIH  (now that my liver has calmed down)
  19. After some delays at NIH and no medication for weeks, tumors start coming back, but well enough to be re-instated on TIL therapy with IL-12 trial
  20. TIL cells cause unexpected HUGE immune response which almost kills me, but they reverse it to save my life.
  21. TIL Therapy with IL-12 determined to be not-effective  (likely because they had to reverse it) and cancer progresses further.
  22. Go back on BRAF inhibitor (Vemurafenib) at Emory and add a MEK inhibitor to it then switch to another BRAF inhibitor (Dabrafenib) at UCLA
  23. Symptoms and tumors start getting better for a  few weeks, then tumors come roaring back.

So when you’ve already done all of this, a Phase I trial doesn’t seem too scary anymore… right?  We’ve exhausted almost all of the treatments we know about, including the cutting edge ones.  My cancer has officially “developed resistance” to all the drugs out there for melanoma. Liver area tumors are most likely back and causing nausea / vomiting 2-5 times per day almost every day now.

So after passing some emails back and forth with our UCLA Oncologist we learned of something new, just barely on the horizon, and we do mean BARELY.  It’s called an AKT inhibitor.  As you can see if you follow the link, the trial is not even open yet, unless you know Dr. Ribas at UCLA of course.  😉  The idea is that when BRAF mutant melanomas develop resistance they activate another signaling pathway (which allows the melanoma cells to replicate) called AKT.

While AKT inhibitors have been given to humans to treat other cancers, the combination with a BRAF inhibitor has never been tried.  So I will be Patient #1 for this combination.  Our doctors are hopeful because they have already seen success in human cell lines (these are tissue samples derived from biopsies just like mine).   When they inject the AKT inhibitor and BRAF inhibitor into these cells in the lab, the melanoma cells start dying off very quickly.  Our doctor used the word “hopeful” in describing this treatment option.  So this is good news!

The next steps of the plan include flying home, getting some radio surgery for the brain tumor, picking up the kids, dealing with the tree that fell on our house, and flying back to LA to get started on the new trial.  We hope to start on Tuesday October 22, and our plan is to stay in LA for about two months due to the high number of initial visits and because, you know, we have no idea what exactly is going to happen.

 

 

5 thoughts on “Patient Number 1

  1. Since this is listed as Phase I/II trial, and not just Phase I, did they say they would be administering a therapeutic dose? I’ve read the information you linked and it isn’t clear to me. It seems to me that the goals for Phase I are very modest (as they always are). The Phase 2 goals are slightly more ambitious. I can’t tell though if these are combined or if the Phase 1 trial goes for the first two months and the Phase 2 trial begins after that. It sounds like the latter. They won’t be reducing your BRAF inhibitor during the trial, right? They’ll just add a small does of the AKT to your current treatment?

    Sorry for the questions. Hearing “Phase I trial” is, like you say, “scary.”

    You are a good man, Kevin. I’m sorry you have had to face all of this. Hoping for the best for you.

    • Thanks for keeping up with us. Phase 1 goes for the first two months and then the phase 2 begins after that. You are correct, they won’t be reducing my BRAF inhibitor, just adding to it. Please give our regards to the Martinelli’s.

      • Honestly, there is not a day that goes by that your name doesn’t come up. Camille prays for you at every meal (and from what I understand several more times a day), all of our phones are set to alert us whenever you or Rachel post on Facebook, my RSS feed defaults to your blog …

        You have always meant a lot to us. You are an extraordinary person (both predating and continuing through your illness). Knowing what I know about Phase I trials, I understand that this is yet another example of your generosity and remarkable character.

        Always wishing the best for you, Kevin.

  2. We had a wonderful time with the whole family on Sunday. Nana, Papa, Joshua, Jennifer, Jesse, Rachel, Kevin, Jude, Evie, Sarah, Johnny, Will, Lauren, Joshua’s best friend from college Rob, Rachel, Lilly, Rachel’s neighbor’s daughter Isabella and Moe, our dog. Ten adults inside, seven children and one dog outside – a good time was had by all. Nana and Papa have been blessed beyond belief. We remain ready to provide support wherever we can. Sarah is facilitating the repair to the house, including removal of the dead tree and rebuilding the house.

    We are so grateful for all of the prayers and support from all over the world. We pray for God to continue to protect this family with his ever-comforting wing.

    Love for all,

    Papa

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