Compiling My Clinical Trial Playbook

I’m standing under the street light on the corner of Win and Win. I’m sure it casts a shadow behind me, but today I choose to look into the swath of light that shines ahead of me.
I got a call back from Serena who heads one of the clinical trials I’m interested in. Serena was easy-going and fun. It turns she’d transposed numbers from my first call – or I’d gone too fast – which is why she hadn’t responded quickly. She called right back after my second message.
Yes, the trial is open. Yes, I’ll qualify if the drugs I’m on aren’t working.  Yes, because it’s a clinical trial, it’s completely paid for. Yes, it’s as I understood it. They’ll biopsy my tumor, send it to a lab at MD Anderson in Texas to test if for more than 400 mutations (think: doors and windows the cancer cell has on it for the drugs to get into). If the tumor tests positive for any of them, then they have 24 different drugs to throw at it (I wouldn’t be on all 24, just the ones that will “unlock” the door or window they find for my T-cells to get in there and do their job to kill the cancer).
My next step, said Serena, is a CT scan to see what effect the drugs I’m on have had on the tumor. More importantly, it gives the trial folks a starting place where they can measure it and compare it so they know if their drugs are working.
She follows up by emailing me something called an Informed Consent, which I learned at the conference every trial must offer after you speak with them. It tells you in plain English what the trial is about, what’s expected of me, what’s expected of them. It tells me things like they’ll pay for the treatment and in exchange, everything I undergo as part of it, I have to do through their medical team, that I have to let them know right away about side effects so they can respond, that I can jump out of it at any time and that I can always go back to standard treatment (think FDA approved drugs) if I choose and that even though we’ve had this phone call and I have this form, it doesn’t mean we’re moving forward just yet. The consent form is several pages long, but easy to read and understand and I feel much better about the whole thing having it. Somehow it makes me feel like I’m moving forward.
In the meantime, I am putting together a chart in Excel listing all 20 of the trials I am eligible for (I’ve found a half dozen more since the conference). I’m ranking them in the order of most appealing to least. It’s time consuming because the description of each trial is mind-boggling. I have to look up each drug they’re testing to see what it does, what it targets (is it my immune system or the cancer cell? What will it do to it? What side effects might I have because of it?)
Gratefully the National Cancer Institute has an online dictionary that I can plug each drug name or number into. It takes a bit of fiddling, but I don’t give up until I understand it. Then I write a sentence synopsis in my chart about the drug and what it will do. In another column I list where the trial is being held, in another column who is sponsoring it (is it a drug company? A research company? A hospital?). I don’t know if this is important, but it might be a factor worth weighing in on later, so I add it. I have a column for next steps (like the scan or another biopsy or a blood draw or a mouth swab). It’s amazing the different ways they can retrieve cancer cells from the body. I have a column for the type of study – whether it’s a Phase 1, 2 or 3 or just a research trial. Phase 1 trials are searching for tolerable doses of the drug. Phase 2 looks to see how effective the drug is. Phase 3 hones it down even further. Many drugs today are so effective that they’re receiving FDA approval during Phase 2.  Still, as a patient, it’s important to know what I’m signing on for. Phase 1 studies are bigger and will take in more patients, but as they’re looking for tolerable dosages, there’s a good likelihood there will be side effects. That’s usually the trigger point when researchers say “OK, enough. We’ve found the right dosage.” This is a conversation we’ll elaborate on once I’ve been accepted into the study, so I’m only concerned about it now as a way to narrow my choice on the best trial for me.

I’m looking at this chart as my new playbook. Here’s where we’re going if the drugs I’m on aren’t working or once they stop working (and they’re virtually guaranteed at some point to stop working). This feels empowering to me, like I’ve thrown in the Hail Mary pass for a running game.

I’ll see my doctor again in two weeks, where I’ll hand him our new playbook. The way I see it now, he’ll either tell me my numbers are dropping which means the drugs I’m on are starting to work and I can coast for a while, get back to my life. Get back to managing cancer rather than it managing me. That’s a win.

Or he’ll tell my my numbers are still rising, which means the cancer cells are changing quickly to adapt so the drug doesn’t kill them. Fast-changing cells are perfect targets for clinical trials and the drugs they’re testing. So it will be another win.

Which is how I’ve come to be standing under the street light on the corner of Win and Win, changing my outlook so I’m no longer focusing on the shadows being cast behind me, but the brightness that’s in front of me. For now, it’s a great place to be.


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Cancer’s Brave New World is Looking for Recruits

I made the call. That was the first step. No one answered, of course.
So I called again today. And now that I’m beyond the fear, I’ll call again tomorrow.
It’s for a local clinical trial. The gist: Doctors will biopsy my tumor and study the cancer cell for its mutations, looking for doors and windows that my immune system can penetrate to kill it. They’ll give me drugs to amp up my immune system so it’s angry and vicious and looking for cancer blood.
At the Cancer Research Institute Immunotherapy Patient Summit I went to last weekend, they said only 3 to 6 percent of people eligible for clinical trials pursue them. In the past, that was no big deal. A Phase 1 trial, the first of three the FDA normally requires before giving a drug approval, might have only needed a dozen or so people to figure out the dosage needed to kill a cancer.
Today, though, they’re looking for teems of people. And instead of targeting just one type of cancer, these drugs are targeting the immune system which goes after any cancer in the body, so virtually anyone with metastatic cancer – meaning it’s spread to other parts of the body – is eligible.
Making the call means pushing past the fear of the unknown. My oncologist has a Chinese food menu of options for me that are tried and true – not to cure it, but that will contain it. When one stops working, we go to column B and choose the next one. But a clinical trial? That’s no man’s land. Unchartered territory. The great unknown.
Brian Brewer of the Cancer Research Institute assures me that the research is there. That these drugs can be so powerfully effective, they’re gaining FDA approval halfway through Phase 2 testing.
But it doesn’t mean they don’t have side effects. Immunotherapy works by supercharging your body’s killer T-cells, while removing cancer’s cloaking mechanism so the T-cells can find it and decimate it. It seems the body already knows how to kill cancer, it’s just that cancer is doing a great job of hiding from it.
A supercharged immune system, though, can at times go after healthy cells. And there can be life-threatening consequences if you don’t stay on top of it. Most of those side effects can be treated with steroids until the body calms down and the immune system finds its rhythm, researchers and patients on these drugs said at the conference. Still, it’s scary.
And even when these drugs work, researchers are learning those capricious cancer cells find new ways to cloak themselves, rendering the meds ineffective.
Researchers aren’t giving up, though. They’re taking blood draws and sucking out those new cancer cells, taking them apart again, seeing how they’ve changed, devising new ways of targeting them and injecting those new, vulnerable, modified cancer cells back into a person’s body so their immune system can find it again and kill it.
It’s all pretty incredible. And the more I learn, the greater my resolve, the lesser my fear, the stronger I become.
At this point, I don’t know who is more at risk: The clinical trial coordinator who seems to be ignoring my calls or the smug cancer cells who mock my T-cell, giggling and chortling as they say “No one’s home,” when my T-cell knocks.
Just wait. That’s all I have to say.

The things you can’t explain

I’ve just come from the doctors office where my blood test results have broken triple digits (they’re in the low 100s). To put it in perspective, normal is 5 for one of the markers and 30 for the other. I should be feeling like I want to crawl out of my own skin. I don’t.

I keep asking myself  Why? What am I doing in this moment that is keeping me calm? Keeping me from walking out on the ledge? I don’t have an answer. If I did, I’d bottle it. Keep it in a safe place for the next time. Share it with those around me who need it.

Part of it, I suppose, is expectation. I’d already thrown this game in my mind. These numbers don’t matter. It’s the next set that should.  Yet even those I’m not anxious about. There’s something – or someone – deep inside me that’s decided numbers don’t matter. That I’m not going to play the numbers game.

I’ve decided instead, to ask myself How do I feel? (Awesome!) Do I have any pain? (Not anything I can’t explain) Any indication this cancer has gotten ahead of me? (No!) Any indication that the good guys are losing the battle? (Not at all).

Yes, I know there are terrorists inside my body, just like there are terrorists in this world, in the state I live in, judging by the news I watch. And yes, they are a threat. Wrong place, wrong time, I could take on collateral damage. Could be game over.

The best I can do is be vigilant. About what goes into my body, what goes on my body, what goes into my head, my mind.  I can’t say what it is that I’m doing today that I don’t always do.  I really don’t know what is keeping me resolute.

I am heading for a conference in two days about clinical trials and new immunotherapy drugs that use the body’s own immune system to fight these rogue cells. It won’t offer answers, but it will offer a direction, one that I’ve chosen to take. A direction that’s unknown, that’s fraught with uncertainty. But where I am has no answers either. So I’d rather forge a new path than tread a worn one that only keeps me where I am.

As a wise woman once told me “When there are no answers, there are choices. And your choices will change, just as you will be changed by them.” Somehow, that advice is less frightening at the moment than the idea of staying stuck on the corner of No Answers and What If.  I’ve made my choice. What If, here I come.


Fourth and goal and in need of a win

cancer goalsIt’s early September, the beginning of the final quarter of the year, and I’m looking at where I am in accomplishing my goals.

This year’s goals were pretty much the same as last year’s: Finish my novel. Finish renovations on our 1860s home.  Complete a few side projects like faux graining a cabinet or putting a quilt applique on some threadbare bedding. I admit, I know nothing about the last two, which means there’s a learning curve involved that’s slowing me down. Truth is, there’s a learning curve to all of this.

My inbox is filled with advice, templates to download, steps to take to move me forward. Everyday I take time to read those emails or fill out the forms, put a plan together. For a week or two I even put the time into acquiring the habits I need – whether it’s blogging or spending a half hour writing 500 words in my novel or making dinner at home every night for a week with fresh vegetables from my garden. Then I’m all high-fiving myself over finally getting through the mire and moving on with my life.

Until…I get to my monthly oncologist’s appointment. And then, my life gets derailed. January was “Let’s look under the hood.” February was scans, March results, April why don’t we try something new, May was getting health insurance approval, June dawned a day of promise as my number shot down, pain shot up with the new drug. July was managing side effects and trying a lower dosage, August was the reality that July’s strategy didn’t work so we’re back up to a higher dosage and looking for new alternatives, like clinical trials.  And here I am in September wondering where the year went and why I haven’t accomplished anything.

To be fair, I have accomplished some things. I did run a half-marathon with neighbors who became better friends in April. I did a triathlon in June and several 5K runs with a new group of friends.

Another good friend reminds me that I’ve continued to work on my novel, interviewed several famous people for stories I got paid to write, kept up with friends, have launched a campaign to run for borough council, researched cancer treatments and signed up for a conference to educate myself about clinical trials. I’ve mentored kids who live on my street. Volunteered to help judge a baking contest so I could write about it in my novel. I’m taking an online college course on doping, as the issue is a prominent theme in my book.

Still, I have a pile of magazines beside my bed that I can’t seem to get to read. And while I’ve had a lot of great lunches with friends who have helped me craft a plan or make a connection to move me closer to my goals, I still don’t feel like I’m making any progress.

So as I sit down to figure out how I’m going to accomplish in the remaining three months of the year what I couldn’t seem to do in the past nine months, I also ask myself how do I live alongside this disease and stop it from running my life as I’ve let it? How do I send it to the corner for a timeout so peace can reign in my classroom for the remainder of this period? And when will I be done with this lesson so I can move on?


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How cancer takes your life (1)

The Magic 8-Ball Answer

I built you to weather this stormAm I the only one who had a Magic 8-Ball whose only answer was “Future unclear, Try again later?”
At least that’s the only one I recall , which is precisely the answer the universe is shouting at me these days.
Since my last post I have received my latest blood tests which show that after a month on the lower dosage of this drug Ibrance my numbers are still creeping up. And I’m doing just what I said I’d do. Next month I’ll go back to the higher dosage and endure the painful side effects while I await information on a new clinical drug trial for immunotherapy – a drug that teaches your own immune system to recognize and kill the cancer cells.
I have a plan, I’ve activated it, I should be fine, right? So why does it feel like I’m standing on the corner of No Answers and What If?
My mother, the greatest catastrophe thinker of all time (really, she missed her calling. She should have gone into disaster preparedness. ) puts a name to what I haven’t been able to.
“What if this cell is drug resistant?” she said. “What if nothing kills it?”
And the knot in my stomach tightens.
I have lunch with a friend whom I learn has a great depth of spiritual knowledge. She believes we’re here to fix something we missed the last go around. She suggests that I’m going through this so that I can tell the story. That through it, others will find their own strength and hope. And the knot releases a while.
This morning I run into my pharmacist while walking my dogs (Yes, Frenchtown is a bit like Mayberry that way.) I ask him about ketosis strips as I contemplate pursuing a Ketosis Diet that calls for fasting intermingled with high protiens, high fats, minimal carbs. The theory goes that all cells consume glucose – including cancer cells. When there’s no glucose, cancer cells can make their own for a while, then rely on glutamine. But healthy cells can survive on ketones – produced by this diet – while cancer cells whither and die of starvation. Yes, it’s a drastic change. And I know this all sounds a bit crazy. Crazy is where you go when you run out of plausible answers.
It’s usually about this time that I start a rant, er, I mean conversation with God, who usually does all the listening while I talk. But this time he sends me a message to help me untie the knot:
“I built you to weather this storm,” he says.

Knowing how the story ends doesn’t untie the knot in my stomach

I will prevailThis is a story that starts with an ending. The one I’ve chosen is that I will prevail, cancer will not defeat me.
That’s the thought that grounded me as I gripped the steering wheel in the hospital parking lot last week coming out of an appointment where my doctor rattled me.
See, I’ve started this new drug called Ibrance. My first month’s results were astounding, but with it came bone-shattering pain. So my doctor and I agreed we’d dial back the dosage, and while we were at it, I’d take a break so that I could time the start of the drug with the rest of the cocktail I’m on. As far as I was concerned, it was a tacit agreement that my numbers would likely go up that month, but we had such a game-changer that it was OK to take a loss because there was a long season ahead and we had a great shot of winning the series, to use a baseball analogy.
So wasn’t I floored when I went in last week and my numbers were up. But suddenly my doctor was talking about nixing the drug, opting to bring in the brute squad – IV toxic chemo. The kind of stuff that makes you nauseous and tired, that over the long haul can cause leukemia and scar your lungs and make your nails brittle or stop growing. And I’d be on it for the foreseeable future.
“It seems to be well tolerated,” he said.
I remind him I’ve been off the Ibrance for three weeks, these numbers were to be expected.
“Can’t we just give it a chance?”I implore.
“Oh yeah,” he said. “This is just if these numbers keep going in this direction.”
Our visit is short. Less than five minutes, which makes it hard to think quickly enough to make my case. Hard for me to even comprehend what he’s saying…or what he’s forgotten.
That he’s forgotten story line. But I haven’t. And that’s what I remind myself on the way home. This drug IS working. I AM healing. My numbers WILL go down. I AM going to be OK – because in the end, everything turns out OK. (Note to self: If it’s not OK, it’s not the end.)
By noon the next day, I have delivered to my doctor a well thought-out letter reminding him about the story line and offering a new plan of attack should we need it. I have found three immunotherapy trials to pursue if, for some strange reason, it turns out he’s right. I ask him to put together a new team – one with a microbiologist, a geneticist, and researchers. It occurs to me that there’s a huge disconnect in the treatment world that keeps people like me from those who may have an answer. I want to talk to them.
I go through the stories I’ve clipped out about promising research and I start Googling names, places, looking for contacts, I put together a spreadsheet. I reach out to friends in the pharmaceutical business and ask them for their contacts.
I sign up for an immunotherapy conference, only to learn I’m on a waiting list.
I have a plan and it’s a good one. I will call to get my blood test results early rather than wait until my next appointment. If the numbers aren’t good, I’ll put it into action. I’ll go back to the higher dose while making calls on the drug trials. I’ll be in one by fall if that’s the way it needs to go.
So why do I have this gnawing in my gut? Why is it that I can’t shake this anxiety? Uncertainty is the name of the game in recurrence. I know that. And numbers…well that’s just a throw of the dice. They’ll go up, they’ll go down.
Why have I let my doctor rattle me? He isn’t the wise and powerful Oz. He’s just a man behind the curtain, one who’s busy and at times forgetful.
And I already know how the story ends.

Cancer Moonshot? What the heck does it mean?

cancer moonhsotMy cell phone pinged all day yesterday with texts from cancer organizations I’ve supported alerting me to tune in to the Cancer Moonshot Summit.
I didn’t, of course. Life was too busy and the truth is, I still haven’t figured out how it will benefit me. I know it has something to do with getting researchers cheaper access to currently approved drugs so they can test them with other drugs. This I understand more than most because cancer isn’t fought with just one drug. I’m currently on three different ones, each aimed at targeting the cancer or protecting my body from the cancer in a different way.
And even with the promise of immunotherapy around the corner – a drug that will teach my body’s immune system to kill the defective cancer cells on its own making it the closest thing to a cure – my doctor has told me it still just won’t be that one drug, but an addition to my cocktail.
I also understand that this “moonshot” is suppose to make all researchers play nice and share their findings rather than hoarding them in hopes that they’ve stumbled upon a lucrative secret they can sell to hungry pharmaceutical companies looking for their next blockbuster drug.
So then, is the moonshot just politicos fighting politics?
Today I was besieged with questionnaires from those same cancer organizations asking me if I’d participated in a clinical research trial (No, I haven’t) or was I offered the chance (Yes, I was) and if so, why didn’t I (Because I’d rather go with the devil I know than the devil I don’t).
I spent a good deal of today reading through the news stories trying to figure out what it all means. What I found is that it may mean more money for research, it attempts to remove red tape for researchers but it really doesn’t promise a cure because cancer is a term used to define defective cells that are too diverse.
Perhaps instead of moonshot – which would mean we’re shooting for one destinatlon – they should rename it galaxy shot, which might give us a better clue about the scope of what they’re hoping to achieve.

Change comes from new habits, from acting as if, from experiencing the inevitable discomfort of becoming.

Hope, the Ship We Sail Upon

breast cancer hope Hope. That’s really what this blog is meant to be about. I think sometimes I forget that as I struggle day-to-day with the newness of recurrence and how I am trying to fit it into my life.
Hope is the raft that promises that there’s a shoreline awaiting me after cancer has torn my boat to splinters. It fuels the belief that I will live into my 90s despite the threat of this disease. And that I will be active and healthy until my last day.
Hope drives my optimism that something like a cure lies around the next bend. It may not relieve me of this condition, but it will allow me to live with it.
Hope is what allows me to smile, even when I smell like a refinery from the chemicals injected into my body to defeat those pernicious cells and everything tastes like metal.
Hope allows me to make plans – like running for town council or writing a novel or finishing renovations on our historic home.
Hope reminds me to enjoy the sunshine and focus on the things going right in my life – like making a living as a writer in a small, river town with neighbors who are supportive and friendly, the golden threads woven intricately into the fabric of my life.
Hope has drinks with me at outdoor patios with my family and friends as the sun sets on the river on a Friday night, when I speak giddily about the people I’ve talked to that week, whose story I’m grateful to have been able to tell.
Hope is that quiet voice on the bad days that says “you’ll get through this. You will prevail, no matter what.”
Hope is the belly laugh I have with good friends about days gone by, that at the time seemed dangerous and dark and now, looking back, seem hysterical.
Hope are the neighborhood children who knock on my door wanting to go for a walk with me and my dogs, to make a fire and go for ice cream, reminding me that life is too short not to stop, take time out and enjoy it.
In then end, these forces remain: faith, hope and love. The greatest may be love, but hope is the ship that we sail upon and faith is the wind that fills her sails.

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