Tag Archives: clinical trials

Finding Clinical Trials: Tips For Navigating The Void

So anyway, back to being all alarmed and stunned at the gaping chasm in our medical system into which people with cancers that don’t respond to standard treatments fall…

My mom and I were talking about it last night and I was wondering if we are just feeling this incredulous because we’re so emotionally raw and psychologically freaked out.  No, she reminded me, this just isn’t the way it’s done.  Your GP doesn’t tell you to research which antibiotics to take to treat your strep throat. She identifies the best one for you. Yet there is no one anywhere in the system (at least not where I could find them) who’s job it is to research clinical trials on behalf of cancer patients. This is a resource that just doesn’t exist in one of the largest cancer research and care centres in the world, and the implications are frightening. 

It’s true that this is the most unsupported I have felt since that day in March 2008 when I was told I had cancer. But even if the system as a whole has failed me there are many individuals who have not.

I was helped by my oncologist, my family doctor, my family and many friends, the hospital social worker, nurses, and several other people. But none of these people was helping me research clinical trials because it was their job to do so.  It should be somebody’s job. Instead, it was my sister-in-law and some kind women at a breast cancer support organization called Willow  (where she used to work) who eventually found the Montreal study. My sister-in-law. Honest to god, just think about that.  And reach for the barf bag.

So, since I can’t fix the system from my laptop (at least not this afternoon) I think a summary of what we learned in the last couple of weeks is the best, most practical thing I can do for anyone else out there who might encounter a similar nightmarish tumble over the edge of the un-signposted cliff-face of cancer support:

1.   You’re not breaking up with your oncologist.  If your cancer doesn’t respond to standard treatments your oncologist no longer has anything with which to treat you.  However, he/she is still there for you in the following capacities:

  • to discuss ongoing, worsening or new symptoms and test them and try to treat them
  • to connect you with oncologists responsible for any clinical trials available within your hospital network
  • to review any clinical trials you find on your own and vet them for suitability
  • to talk with other doctors, nurses or people on your medical team
  • to process your applications for clinical trials (once you have identified them)

2.   No harm in asking. Remember that the Hippocratic Oath begins, “First, do no harm” – and now proceed to shamelessly use that to your advantage. Even though it is not your oncologist’s job to do it, you can ask him/her to research clinical trials for you. These are busy people, and they are often barely able to keep up with the stuff that falls into their official scope of work, so perhaps they simply can’t make the time to help you.  On the other hand, saying “no” when you know you can help a patient is probably not that easy.  Ask.

3.   Try these on for size, Doc.  It is a good idea to ask doctors what they would do in your shoes.  Once we had a shortlist, I asked my oncologist which clinical trial she would choose, medically speaking (ie: not taking into account geography, financial considerations, etc.) and she told me.  That’s the one we’re pursuing right now.  Many doctors will not be comfortable slipping into your metaphorical shoes, but you know what? Cancer isn’t comfortable.  A good oncologist will at least make an effort.

4.   What’s in it for you?  Many hospitals have clinical trial centres.  The objective at these trial clinics is to populate their studies with suitable patients.  In other words, they aim to match patients to the studies that they have,  and NOT to find the best possible clinical trial for a patient from all available clinical trials. They are only working with the trials that they currently have underway at their own clinic and they will select the trial most suitable for a patient from among those trials. Your job as a patient is to find out if participating in the trial offered will bring any real benefit to you (see Phase Matters, below.)

5.   Phase matters.  Trial Phases are important.  This is what I learned about them:

Phase 1

  • Phase 1 trials are for drugs or combinations of drugs that have had good lab results and are now being tested on humans. 
  • Phase 1 trials are designed to establish the correct and safe dose of the drug(s).  This is done with groups of patients – the early groups get a lower dose, and later groups get a higher dose.  If you get a low dose and it doesn’t affect your cancer you do NOT graduate to a higher dose; you are removed from the study.
  • Phase 1 trials are effective against cancers in ONLY APPROXIMATELY 10-15% of cases. Personally, I don’t like those odds.

Phase 2

  • In Phase 2 the dose has been established and the study is concerned with something called pharmacokinetics – how the drug is absorbed, processed and eliminated.  Basically it’s all about figuring out what the side effects are.
  • If you find a Phase 2 study, it has been effective enough in Phase 1 to graduate to the next level.  Meaning it has worked at least enough to warrant more money being spent on it.

Phase 3

  • Phase 3 studies are the final phase of testing before a drug goes to market.  Essentially, the dose and side effects are established and now it’s about ironing out the kinks before lots of money will spent on marketing the drugs to hospitals as standard treatment. And you just know they don’t spend money on stuff unless it’s going to work for a lot of people.
  • Phase 3 studies often involve multiple lines of treatment, meaning they are testing combinations of drugs to see how they work together. From a layman’s point of view, I like the idea of more drugs.  Just say YES, YES, YES.

6.   Take a number. Unfortunately it can take several weeks between identifying and beginning a clinical trial.  In general, 4 weeks must have elapsed since your last treatment and you must meet a litany of study-specific criteria.  You must also provide bloodwork, and other tests like CT scans, ECGs, MUGAs, etc.  The study will also want to access your records and archival tissues.  The good news? You can apply to multiple clinical trials at once, so that if one gets held up you at least have the option of beginning another. But cross-reference the eligibility requirements carefully (especially for specific drugs) to ensure that participation in any one study will not make you ineligible for another study.

7.   Everyone wants a piece of you.  If you apply to multiple studies simultaneously be aware that they may all try to access your archival tumour slides at the same time. These are samples of your disease cells that the hospital preserved at the time of biopsy and/or surgery – and your samples may be limited.  You must be sure that you communicate to the archivist which study gets priority access, otherwise the one you really want to get into may be bumped by your back-up clinical trial just because the latter got there first.

8.   Help, I need somebody.  The research, the meetings, the phone calls, the follow-up, logistics, financial considerations, psychological implications, and oh by the way you’re supposed to be resting and rebuilding your immune system…  It’s so frigging overwhelming.  You can’t do it alone, and you don’t have to.  I don’t care what your circumstances are, You. Are. Not. Alone.  For one thing, if you’re reading this you have access to the internet, which means access to other people.  Help is out there.  Just contact your hospital social worker, or the Canadian Cancer Society, or one of your local cancer support agencies. They can help you find someone to advocate for you, support you, talk you through it – whatever you need.  The nice thing about being hit with the cancer stick (the “nice” thing? did I just write that??) is that there is a LOT of support out there for us. 

9.   Smashing things works. I never knew how good it felt to get mad and break things, especially when it feels like there is literally nothing else you can do. I highly recommend you get yourself a Rage Box.   

 

I’m sure I’ve missed some things but that’s all for now.  This is the part where the resting and the rebuilding of the immune system happens: I’m taking a nap.

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Found: A Clinical Trial! Also Found: Glimmer of Hope

Torturous as yesterday’s post was to write, I had to do it. Thanks to everyone who managed to pluck up the courage to reply to the unrepliable with comments and e-mails.  Apologies to everyone who felt paralytic or overwhelmed (I think that’s all of us) but this was only ever going to be a very bumpy ride. Lifejacket is under the seat and there’s a barf bag in the seat pocket in front of you – let’s hope we don’t need them too often.

For the moment, the sun is actually beginning to emerge from behind the dark clouds for a change: we have found and are applying for a clinical trial at last!  The study sounds promising — the most promising of all the experimental drug trials we were able to find — and there is a study site in Montreal, which isn’t totally ideal, but it could be worse, it could be much farther from home.  It could be outside Canada.  I’m not sure how swift the enrolment process will be or how we are going to handle the financials or logistics, but I’m already feeling so much better and more hopeful just knowing that there is a plan underway at last. 

It’s amazing how much difference a little glimmer of sunlight can make.  We are going to be doing something.  And it might actually work!!

Unfortunately, getting to this point has been excruciating and, as anyone who read yesterday’s post can attest, the process has forced me to face the grimmest realities.  Among them, and second in grimness only to confronting my own mortality, was the realization that our medical system completely fails in its support of patients with cancers that don’t respond to standard treatment.  

The transition from a supportive, comprehensive cancer-care system to the bleak no-man’s-land of post-standard-treatment was so sudden and jarring that it took me a while to realize that I had in fact been left to my own defenses.  Apparently the system just isn’t designed to take you any further than approved drugs and standard treatments, so if you have to go the non-standard route, you have to navigate it yourself. 

Meaning it is up to the patient to research and choose her own clinical trial.  The patient, who in the majority of cases does not have a medical degree.  The patient, who is reeling from the news that there are no more treatments for her.  The patient, who is probably grappling with gigantic questions like “Am I going to die?”  The patient, who hopefully speaks English fluently, knows her own medical history intimately and is handy with the Internet.

Aside from the basic impracticalities of this situation, it has the psychological effect of leaving the patient out in the cold.  It sends a message of hopelessness.  It says: your cancer is so bad, we’ve given up.

I believe I wasn’t totally abandoned only because I and my family reached out repeatedly for help to my oncologist, the hospital social worker, my amazing family doctor, a clinical trials nurse, and many, many other people.  I’m deeply grateful to all of them for their help, but I’m still stunned and alarmed at the totally unacceptable failure of a system I believed in and trusted with my life. 

But enough about all that for now. Really, I can be all stunned and alarmed later.  Right now I just want to enjoy the sunshine.

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Lurching Towards a Plan

As I mentioned in my last post, it appears that once you drop out of the realm of standard cancer treatments, the system isn’t designed to support you quite in the same way. I don’t think anyone knows exactly what to do with me.  And it’s extremely unnerving.

This predicament is many-layered and messy, and it has occupied my time and energy for the last several days, but I’m not going to go into a lot of detail for two reasons:

1) I tried to write this post detailing exactly what happened (or didn’t) and it ended up being about 5 million words long, and

2) I don’t understand exactly what happened (or didn’t) and I don’t want to write anything unfair or untrue. 

Suffice to say that as the fog of our initial shock lifted, we surveyed my situation and found that it was a total crash site. We needed a plan — knowing what the next steps would be and who was leading us through them was the key to getting my fear, despair and uncertainty under control. But we didn’t have a plan.  We had a piece of paper with a web address (clinicaltrials.gov) and some search parameters written on it, but no real understanding of what comes next.

Admittedly, we were in shock when we heard the news that my cancer does not respond to standard treatments so it’s possible we were given information that just didn’t register, but we left the clinic without really knowing what to do and the result has been confusion, insecurity and a (possibly misplaced) sense of abandonment. And of course, a little rage.

However, we’ve since made some progress identifying clinical trials and other options, mostly by communicating with my oncologist and enlisting the help of friends, my hospital’s excellent social worker and my very caring and capable family doctor.  I’m blessed with incredibly supportive people in my life who are good at networking and handy with the Internet.  They’ve been researching, calling doctors and other people who might be able to help, and generally just sleuthing around to try to find promising programs and clinical trials that I might be eligible for.  I can’t emphasize enough the importance of having people to advocate on your behalf when your head is spinning and you’re lurching unsteadily between terror, rage and optimism like an emotional bride of Frankenstein on newly cobbled-together legs.

Meanwhile I’ve made some changes where I can – every little thing counts and I decided that if there was going to be a pause in my treatment I may as well use it to detox from all the chemo and try to rebuild my immune system.  Actually, my mother decided that and I agreed since it’s widely acknowledged that there’s no point in disagreeing with my mother when she has decided something.  So I now take about three handfuls of vitamins and supplements a day and have finally and begrudgingly cut back on meat (fois gras is technically poultry,) alcohol (champagne is technically bottled happiness,) and sugar (I cannot be expected to give up chocolate entirely.) 

Plus my friend Todd is a nutrition-fascist with a juicer and a lot of experience with cancer diets, so I spend my days knocking back his crazy cayenne- and tumeric-spiced leafy green/dark berry cancer-killing concoctions.  They’re actually not as bad as they sound, and no, I have not spiked them with vodka. Yet.

In short, things are moving more or less in the direction of action, though I wouldn’t say I have an actual plan since we haven’t yet identified the clinical trial for which I’m going to apply.  

I do have my eye on one promising experimental drug in particular, but there are no trials for it in Toronto, and while we’ve always said that we would find a way to go wherever the right treatment is, right at this minute I have no idea how we would manage to do that, logistically or financially. But I’m trying to just think about things one step at a time, and today’s step is to see what there might be for me in Toronto.  This afternoon we’re meeting with the head of clinical trials at my affiliate hospital to see if we can match one of their current studies to my case. I’m somewhat optimistic – after all it is one of the top five cancer centres in the world – but my approach is to find the clinical trial that has the best chance of pushing this cancer back from whence it came, not to try to find the closest match of the most conveniently located trials available.

So once we have an idea of the most promising studies, wherever they may be, we need an informed review of them all and a fairly quick decision.  Ideally I want to know what treatment I’m starting (and when and where) by the end of this week.  That might sound like a tight turn-around but I’ve got a mean mother of a metastasis taking up a little more real estate in my body every single day and I need to do something about it before the whole neighbourhood goes ghetto. My rib continues to hurt, my cough is much worse, and my breathing is hampered by the pressure of the lymph nodes on my bronchial passageway. This cancer has become symptomatic – I can feel its progress – and quite apart from what that’s doing to me psychologically, it’s wearing me out physically.

I know I need rest and peace, but I won’t be getting either until I have a plan.

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More Ways to Find Clinical Trials

Thanks to readers’ comments, I learned about a few more super helpful resources for tracking down clinical trials…

This one is on the Livestrong site – very easy to use. I found five matches: http://www.livestrong.org/site/c.khLXK1PxHmF/b.4169727/k.9BEA/Clinical_Trials/apps/s/link.asp

This one is extremely comprehensive: http://clinicaltrials.gov/ct2/search

And this site lists clinicaltrials.gov and many others: http://www.centerwatch.com/clinical-trials/listings/

Many thanks to Jodi & Duckie for the links!

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Breastcancertrials.org

My dad found this clinical trials website for me when my doctor and I talked about looking at clinical trials that might have long application processes (the idea being that I don’t want to get caught with a treatment that isn’t working and face a long wait time for a clinical trial.)  Our deal is that I will look up any trials that I might be interested in and my oncologist will vet them to see if they are appropriate for me, and help me with applications as needed.  Shortlisting trials for my specific disease is made easy by the website which has you fill out a comprehensive medical history first, and then filters the posible clinical trials you might be eligible for accordingly. Thirty-eight came up on my list — everything from trials for new drugs and targeted therapies to stem cell transplants to power-of-prayer studies — and there is an e-mail notification option to alert you to any new studies that come up.  

Of course, the hope is that my current treatment will work for me & I won’t be needing these trials, but I’ve been treatment-hopping for a while now and am beginning to see the wisdom in adopting the Boy Scouts’ credo.

While this site lists U.S. clinical trials only, it does have a link to other non-U.S. sites. I found it very user-friendly and thorough. Check it out or pass it on… www.breastcancertrials.org

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Hunting Dragons Again

Yesterday was one of those great days: In the afternoon I met my niece, who is perfect and amazing – just a miracle of life wrapped up like the world’s most beautiful burrito in my arms – and in the evening I ate lobster with a friend who always makes me laugh and inspires me, having herself recently kicked cancer’s a**.  Needless to say I slept soundly.  Smugly, even.

Alas, this morning I came screeching back into cold hard reality at full-speed – right back into the routine that somehow never becomes routine:

  • 9 a.m. needle to the port in my chest – check
  • Extraction of 6 colour-coded vials of blood – check
  • ECG – check
  • IV fluids & drugs for about 2 hours – check
  • Review bloodwork results with my nurse: all counts low, especially platelets. Am instructed to rest as much as possible, and to avoid getting any deep cuts or gashes. Cancel my sword-fighting plans this weekend – uh, check

This evening I’m scheduled for my first CT scan since beginning the clinical trial. They’ll scan everything from head to pelvis, looking for any sign of further metastasis (please, no more) and of course, measuring the growth of the ol’ neck lumps (please, no more than 20%). 

I’ve already choked back half the gigantic bucket of nasty chalk-juice, which, by the way, some jerk had the audacity to brand “E-Z CAT” – probably a relative of the jerk who came up with branding Fox News “fair and balanced.”  Now I shall proceed to eat everything in sight before fasting begins.  Then I’ll nap, if I can possibly quiet my mind, and later my husband will take me back to the hospital for the freaky sci-fi space capsule scan.

And then? 

Well, then we just wait. Probably until Monday. We wait and try to enjoy our weekend as much as possible, hopefully avoiding “deep cuts and gashes” or any manner of flesh-wound, and also trying not to think too much about the results.  This of course is like trying not to breathe too much.  

I really want to stay positive and only think of good things (my family, my new niece, lobster dinners) but the truth is I’m terrified.  Still, if there is something to know, I’d rather know it.  Can’t fight it if you don’t know it’s there, right?  And maybe there just won’t be any surprises.  Maybe the test drug is working, in spite of seemingly enlarged neck lumps, which yes I have stopped touching all the time.  Mostly. 

Anyway, on with the dragon hunt.  Again.

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The Jabba Approach

lumps? what lumps?

lumps? what lumps?

 

I had this thought that if I gained a whole whack of weight the cancer lumps might appear smaller in relation to the fatness of my neck.

I already have a weakness for potato chips and the occasional cheeseburger. I could just go carb supernova – a strict diet of potatoes and pasta and all things battered, fried and buttered, rounded out with a daily tub of fois gras and washed down with cases of pop and kegs of beer. If I could keep it up for thirteen days (and not go into cardiac arrest)  by the time they do the CT scan the lumps will look miniscule in comparison to my five chins.  They may not even be able to find them in there.

On the other hand, it’s possible they have more scientific measurements than How big do the lumps look compared to her neck-fat? In which case I’d just be gigantic and lumpy and no closer to the goal of cancer obliteration.

Back to the drawing board.

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Teamwork

So about this 20% business.  

 

Today I am in hospital today for Cycle 2, Day 1 of the clinical trial, and I had a word about the whole 20%-growth-and-you’re-out thing with Naz, my incredibly competent, compassionate and sensible nurse.

 

She sat down on the bed and looked me in the eye, and asked in a way that I hope I remember to employ when reasoning with my future teenager: “Well, what would you want to do if the CT scan were to show that these lumps are growing?  Would you want to continue with a drug that isn’t working for you?”

 

No, I admitted, I would not.  I would however like the drug and I to be given a fighting chance of working together toward the common goal of cancer obliteration (apoptosis!) before we are ripped asunder. I’ve tried chemo and radiation, and now I’d like a fair shot at the wonderful world of HDAC-inhibitors.  Perhaps they could just adjust the dose?

 

Negative.  This clinical trial, as Naz explained, is at a stage where the dose has been firmly established based on things like toxicity tolerances and disease response, and they’re just not going to give me more than I’m getting right now, period. But they do want to give the drug a chance to do its thing, which is why they’ll wait a full two cycles to see if it’s working.  

 

A full two cycles. That may sound generous but it boils down to just four doses total, next Wednesday’s being the last. The CT scan is already booked for the following week, August 26th.  Clearly Panobinostat and I are on the clock.

 

Take heart: I actually think we can do this.  I’m going to go with the idea that this is the beginning of a long and mutually satisfying relationship between me and Panobinostat, rather than a whirlwind summer fling.  Bonnie & Clyde, Batman & Robin, Leanne & Panobinostat.  I do the tough talking — Shrink, damn you. You’ve got 2 weeks to make like a couple of raisins and shrivel — and Panobinostat is the muscle.   

 

Cancer, you’ve been warned.

 

 

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Meanwhile South of the Border…

So, while I’m anxiously rubbing* my growing neck bumps and freaking out about possibly getting kicked off my beloved Panobinostat study, it appears that in the U.S. they’re having so much difficulty getting willing candidates to sign up for clinical trials that it’s actually hampering cancer research.  

 

(Luckily I’m too busy losing my mind at the idea that I might be taken off my clinical trial to digress into a rant about American doctors who choose not to even try to enlist patients in clinical studies for financial reasons.)  

 

In addition to discussing the clinical trial conundrum in the U.S., the article also explained the reasoning behind the drug-therapy-first, surgery-later approach to treatment – which at least served to help me better understand why my lumps have been left in my neck.  

 

It’s an interesting article, you can find it here: http://www.starnewsonline.com/article/20090803/ZNYT04/908033008/-1/HURRI

 

 

*About the neck bump rubbing: my husband opined that we should stop touching the neck bumps all the time. He says, in his French (and male) way, that we might be “arousing them” and encouraging them to grow. So funny — and maybe sensible?

 

 

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20%

My neck lumps are growing.  Or at least the one on the side is.  There are two, one deep in the neck right around the scar where they biopsied the original lump, and another one poking out at the side. They used to be lymph nodes and are now tumours, and frankly they scare the hell out of me so I touch them all the time to see what they’re up to.  Evidently they’re up to no good.

 

Problem is, yesterday I found out that if my tumours grow by more than 20% I’m off the clinical trial. Finis. Apparently 20% growth means that my body is not responding to the study drug and in a clinical trial if your body isn’t responding, it’s sayonara study subject, next please.

 

When I found out about the 20% growth cap, the internal panic-valve immediately opened and the inner freak-out commenced.  Off the study?  No more tumour-targeted miracle drugs to precipitate cellular suicide? No more sci-fi magic potion??  It would be too overwhelming a disappointment to contemplate, or even to be able to call a “disappointment” without grossly understating what it would do to me psychologically.

 

I know there are other options, like chemo, radiation and possibly even surgery –  all of which I have previously had, and in spite of which my cancer metastasized.  The bottom line is that I’ve put so much faith in this study and been so excited to be a test subject for this new generation of cancer drugs, that going back to more conventional treatments might feel a little like trading smart bombs for mustard gas.  Whether that’s a warped perception (wouldn’t be my first) borne of mistrust and frustration that the cancer metastasized is a question for another day.  Today I’m about 20% more concerned with just staying on this study because, whatever the treatment is, I just don’t want to be declared “unresponsive” again.  It terrifies me.

 

So these bumps have got to stop growing — or, preferably, start shrinking. They just have to. Any suggestions?  I’ll do anything.  Rub voodoo salves on them, drink yak urine, hold crystals up to my neck, whatever, I’m all ears.  And neck bumps.

 

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