Trials and Tribulations

“Your labs are good. Your scan says there may be slight growth, but we don’t think so. And by the way, your trial is closing on May 30th.”

I can’t even accuse my medical team of burying their lead, as all three announcements are big news. I’ve been in the PHA trial now since November 4 of 2015, a year and a half.  Although they’ve proved toxic to most everyone else in my trial, the drugs have kept my disease in check with very manageable side effects. Treatment of my exceedingly rare cancer, a roller coaster for the first year and a half, had become almost routine to me. And now, this.

The trial sponsor, Tiziana Life Sciences, has decided it has collected enough data to stop gathering information about how milciclib maleate works against cancer. Now, they’ll crunch all their research findings and try to get approval in the US and Europe. But what does that mean for me and for the single other person in the United States who’s still in this trial? (There are a few dozen still in the trial in France.) I have some answers, but it seems like a lot of this is going to be made up as we’re going along. First, I signed a paper saying I understand that the trial is ending. Tiziana says it will continue to give me its very expensive drug as long as it keeps working and doesn’t start causing unacceptable toxicity. I’ll get the drug under what’s called compassionate use, for which I am extremely grateful, as it would cost about $12,000 a month if I had to buy it off-label. But before I get too comfortable with the knowledge that I still have access to the drug, Dr G told me there’s a chance a big pharma company could swoop in and buy the drug. Then, all bets are off. A new big company with layers of bureaucracy may or may not let me continue to have the drug for free. They would not owe me anything; I didn’t help them research anything. But that’s for another, hopefully far off day.

For today, all of the other documenting that I’ve been doing in the trial is going away. No more filling out drug diaries or getting labs every other week or knowing that brains bigger than mine are looking for anomalies like stratospheric glucose numbers that could signal coma or Diabetes. Dr G is talking about stretching my every 6 week CT scan schedule to every 16 weeks. All at once. I told him that was kind of scary, and he seemed surprised. Back in 2001 when I finally finished chemo and my Taxotere clinical trial, I had this reaction for the first time. After eight months of regular doctor visits, infusions, monitoring, etc etc etc, I was finished with treatment. I was thrown out of the proverbial cancer care nest. As gleeful as I was to be finished, there was a bit of feeling like I was about to freefall out of a tree. It threw me a bit off balance. Here  I am again, but in much spookier circumstances with potentially spookier effect. I told Dr G that 4 months seems like a long time to go without a scan. I asked if the tumors start to grow, say a day after my next scan, will the growth be slow? He said yes, but it seems to me that letting rogue cells go wild, even slowly, for 4 months gives them a big headstart over my Next Big Defensive Move. Anyway, my trials nurse, Colleen, seemed doubtful that the company will give me that much product at one time so this may already be a dead plan. But can you imagine, I am actually asking for MORE CT scans? Cancer turns everything upside down.

Although pharmaceutically, nothing is changing for me, the rug has been pulled, not out from under me, but enough to make me stagger back a few steps. This will NOT be a point of worry for me, as there’s nothing I can do to change this situation. But even though both Dr G and Dr Rajan (my NIH doc whom I still  run everything by) say it’s not time to start looking for what’s next, I’m looking for what’s next. And I have to believe there’s a reason Dr G told me about a new trial he’s about to launch.

And in the chair next to me is my friend, Mike, who’s been in Dr G’s Keytruda trial for exactly two years. And two years is exactly how long the Keytruda trial runs. Therefore, Mike just had his last infusion, and there’s nothing next for him. Merck has no compassionate use clause that he got to sign. There’s no protocol for what comes next for folks in this trial (you may remember I was briefly in this trial, til Keytruda gave me Diabetes). No maintenance schedule, nothing. He could try to get the drug through compassionate use or by going out of the country, but I think that could affect future trial participation.Dr G says there’s no data proving a maintenance schedule would work anyway. At  the risk of sounding ungrateful which I am definitely NOT, it seems like the companies that stand to make millions of dollars from research on Mike and John (who’ll be in Mike’s boat in a few weeks) and others could have some kind of plan for what happens to them/us on day 731. As Mike wondered, is he just supposed to wait until the cancer comes back to pick the fight back up? We agreed that sometimes, being the guinea pig, well, it sucks.

We know that we are out there with proverbial machetes in the woods, making first tracks into a world where doctors are trying to figure out how to slay the beast. We know this is uncharted territory and no one has a map. We appreciate the opportunity to let researchers put experimental drugs into our systems on the chance that it might buy us a few more years or months and help others who will tumble down the same path. But in times like these, when the system is finished with you, you remember that despite your doctors, your family and friends who are right there with you, this fight is yours. Mike’s. John’s. Mine. This is not a complaint. This is not self-pity. This is our reality. Whatever’s next will come, and we’ll tackle it with knowledge and experience and stubbornness and strength and a good attitude and positivity, because that’s what we do. But we had time to get used to a bit of routine with our experimental drugs. And it sure would be nice to not have to make life or death decisions for a bit. Defy.