It’s a (tentative) go

I talked to yet ANOTHER person from Karmanos today (so far, I’ve collected no less than six phone numbers from people involved in my case) and he told me that I’ll know next week which cohort of the trial I will be enrolled in. It’s taking longer than normal to get concrete answers about a trial spot because the sponsor (drug company) and investigators (lead oncologists at the cancer centers that are running the trial) need to have a conference call to determine whether the next cohort will be a dose escalation or dose expansion phase. Here’s a quick lesson on Phase 1 trials (to the best of my understanding).

Phase 1 trials are designed to do two things in particular: First, to find the maximum tolerated dose level; second, to identify potential side effects and adverse reactions (called ‘events’). There are usually two parts to a Phase 1 trial—dose escalation and dose expansion. With dose escalation, they start at a low dose of the drug, and with each cohort (new group of people enrolled in the trial), increase the dose until it is at the highest level tolerate by the patients. Once the maximum tolerated dose is established, the trial moves on to dose expansion, which means the size of the cohort increases. (Note: this is an explanation for a Phase 1 trial using a single agent—with multi-agent trials that use two or more drugs, dose escalation is a bit more complicated, and it doesn’t apply right now, so I won’t get into it.)

If the sponsor and investigators decide that the trial should continue in dose escalation, I won’t have a spot in the trial until the next cohort is enrolled in early April (which would likely mean starting treatment in mid-April). If they decide to move into dose expansion, the cohort will increase and I will get a spot in mid- to late-March. Currently, three patients are enrolled for each cohort; once dose expansion is established, this will likely increase to six patients in each cohort. A new cohort is generally enrolled every three to four weeks. If the sponsor decides to continue with dose escalation, I could still enter the trial sooner if one of the three people entering the next cohort fails the qualifying physical examinations.

However it plays out, it’s good news (for more reasons than simply being accepted to a trial). It’s preferable to be enrolled in a Phase 1 dose expansion rather than a Phase 1 dose escalation, as there is generally indication of therapeutic value of the drug by this point, and you have a much better idea potential side effects. If you are enrolled in dose escalation and are in an early cohort, chances are that the dose will be too low to be therapeutic. Basically, you can have the right drug but at the wrong dose level (which is what ultimately ended up happening to me on the MEK inhibitor trial once my dose was reduced—it was the right drug, but the wrong dose). If the sponsor is considering moving to dose expansion, I know that they must be close to finding the ideal dose, which means I shouldn’t run the risk of the trial failing because the dose level isn’t high enough. And if they decide this next cohort will be dose escalation, it’s likely that the cohort after that will be the expansion cohort. Either way, I should be starting the trial at the ideal (as far as anyone knows at this point) dose level.

The sponsor and investigators are having their conference call on March 7th or 8th, so I should know more about which cohort I’ll be enrolled in next week. Of course, there is always the chance that something will come up in my screening exam that could preclude me from the study, but it’s unlikely that will happen. In the meantime, I have a CT scan this week and an appointment with Dr. Siu to go over the results next Monday, so I’ll find out how my cancer is doing on its own, if it’s relatively stable or if it’s progressed since I stopped weekly chemo. I’m actually pretty interested to find out. I was on hormone-blockers for almost a month, and it’ll be interesting to see if they did anything. Tumor regression is unlikely with the hormone-blockers, but not an impossibility.

In fundraising news, I’m at 67 percent of my goal (which puts me at just over $33,515). We’ve got some fundraising activities in the works, which I’ll write more about as the details are defined. In the meantime, you can donate here if you are so inclined. Several people have asked if offline donations are an option, and they are. Contact me if you would like to arrange something. Donations that aren’t made through the site are still added to the total earned, and are reflected in the amount raised on the GoFundMe site.

It’s actually happening, guys. It’s still a ways away yet, but it’s happening.

 

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The wait is almost over

So I met with the oncologist in Detroit at the Karmanos Cancer Institute last week. It went well — the visit was pretty straightforward, given that I am familiar with phase 1 trials and have a pretty good grasp of the kind of trials I’m pursuing (and why I’m pursuing them). I liked the oncologist, who is kind of a blend of my two oncologists at Princess Margaret Cancer Centre. She’s an oncologist who works in phase 1 trials, but also specializes in gynecological oncology (most phase 1 trial oncologists are medical oncologists, not oncologists who specialize in a particular type of cancer). She told me the phase 1 team meets Tuesday to Thursday, and will discuss my case then. As long as I fulfil the criteria for the trial (which I did on first look, but sometimes things come up in review that can change that) and there is a spot for me, I should be in. Hopefully if there isn’t a spot for me in March, I can simply start in April. I can expect a call from Karmanos on Friday.

This last week has been heartwarming, to say the least. I am currently just shy of $32,000. I have seen friends, family, acquaintances, and strangers pull together to help me raise the money I need if I’m to pursue a clinical trial. I am slowly but surely making my way through the list of people who’ve donated to send out thank yous. With almost 600 donations, it will take awhile, but it is time I am more than happy to spend. If you donated and haven’t heard back from me, forgive me. I will eventually get there!

In case you missed it, my darling Catherine McCormick wrote a beautiful piece for shedoesthecity.com about our friendship and how to be a good friend to someone with cancer. Everyone should read it (and then go read Catherine’s other pieces on the site because she’s a kick-ass writer).

Please keep your fingers crossed that I get into the trial in Detroit. It’s funny — I’m feeling better now than I have in a really long time. Being off treatment for two months has helped my body recover a bit. I’m still not “normal” (I don’t know if I even remember what that feels like, or if I will ever feel that way again), but being only anemic instead of severely anemic really makes a difference in my energy levels. It is also nice not to have the weird constant leg pains that I had with weekly Taxol. But all that aside, I’m ready to get back to active treatment, rather than actively seeking treatment.

Finally, if you are so inclined, please share my fundraiser page. We’re getting closer to the goal, but there is still a ways to go: http://www.gofundme.com/6tl6so

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Fundraising update

This is hard to explain without being embarrassed, but at the urging of my Finance Committee, I have decided to raise the fundraising bar higher. We did not expect to raise this much money so early on in our efforts, and we are humbled and grateful for the outpouring of support.

I know that for those of you who have already donated, or are completists, it might seem frustrating to move the goalpost higher, but in this case, it’s a good thing.

For one thing, there are many people who have reached out who have not been able to donate yet, but still plan to do so. While we could simply keep donations open and allow them to go over the goal, we worry it might discourage people from giving if they feel all of the costs have been met. For another, we wanted a goal that would be achievable over the course of the next several months, with donations coming in slowly over time – we would like that to still be possible. Lastly, we are still planning a large fundraising event (or possibly series of events) to bring in a large chunk of money towards the end..

Here is what the new goal would fund:

- The costs of a longer (9 or 12 month) trial, especially given the expected poor performance of the Canadian dollar over this time period.
- The costs of travel and accommodations should I need to enter a trial overseas, as well as associated costs – flights, visas, hotels, permanent or semi-permanent lodging.
- Unexpected/emergency medical costs in the US/Abroad as my trip will not covered by OHIP.
- My rent at home while/if I’m away so that I don’t have to sublet my room and can return to Toronto whenever I’m able to.
- The opportunity cost of 6-12+ months away from a steady income, should that be required.
- The care and feeding of my pets while I’m away, including any routine or emergency veterinary care.
- The cost of cell phone, long distance and Internet access to stay in touch with loved ones while I’m out of the country.
- Costs that I was planning to cover myself beyond the initial fund goal, such as meals, transit, taxis, my regular medical needs (prescriptions and medical supplies).
- I would be able to afford travel home for visits during any off periods of the trial.
- I would be able to afford to have a loved one visit me overseas to provide support and care should I be required to leave Toronto for an extended period of time.
- I would be able to take a small vacation to rest and recuperate after what has been a very difficult 4+ years of treatment and setbacks.

Thank you again so much for your donations and please share this page widely. I am touched, blessed, etc.

http://www.gofundme.com/6tl6so

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I’m overwhelmed

I don’t know how many times I’ve said that over the past 12 hours. I’m absolutely stunned by the outpouring of support from everyone — and not just the financial support. Every share on Facebook and Twitter, all the beautiful, amazing, kind things people have written about me…you guys have buried me in an avalanche of love. And not just people I know — dozens of people I’ve never met have donated and shared kind words of support and love. It just goes to show I keep very good company, and my company, in turn, keeps good company.

Illness is often an isolating experience. There is so much you have to go through alone, so much you can’t share, no matter how you try. But this experience has reminded me that I am surrounded by the most incredible people, that I am supported by a wonderful community.

There is so much more that I want to say, but my head is spinning from the events of today. It is reassuring to know that finances will not be a barrier to entering a trial, even if I have to go further afield than Detroit (but please, please, please let me get Detroit). In less than one day, you have donated more than 50 percent of the funds I need to finance approximately six months of treatment. “Thank you” seems so inadequate, but it is all I have. And I promise I will send a personal message to every person who has donated, but forgive me if it takes a few days. I have a lot of messages to write.

I would be remiss to end this post without including a link to my donation page, so here it is: http://www.gofundme.com/6tl6so

Thank you, thank you, thank you. Thank you for every cent, but thank you even more for all the love and kindness. My heart is full.

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The state of things

So I’ve spent the last few weeks looking into my treatment options and the news has not been great. Novartis, the makers of MEK162, the drug I responded to so well last year, won’t provide the investigational drug outside of clinical trials to anyone other than people with BRAF-mutated melanoma. My doctor could prescribe me GlaxoSmithKline’s Mekanist (trametinib), the only MEK-inhibitor currently approved by the FDA/Health Canada, but the drug costs $10,000 a month and the province won’t cover it through the Exceptional Access Program. GSK could provide financial aid, but claim they can only provide financial assistance if the drug is prescribed for the condition it is approved for (once again, BRAF-mutated melanoma).

The Special Access Program allows doctors to request access to investigational drugs in development, but it’s up to the pharmaceutical companies to decide whether or not to comply with the request. In most cases, the drug companies decide against providing the drug.

Trying to access “personalized” medical treatment when personalized medicine has not, as my oncologist said, “hit prime time, yet” is maddening. How are doctors and hospitals expected to provide personalized medicine when drug companies make n-of-1 trials so difficult to execute?

I’m not completely up the creek, though. My clinical trials oncologist looked in to a trial I might be eligible for in Detroit. It’s an ERK-inhibitor, which means it works on the same pathway as a MEK-inhibitor, but further downstream. The trial is for a first-in-human drug, pills taken every day for three weeks, then with a week off. My regular oncologist thinks this is a pretty good option for me (better than the virus trial, which hasn’t opened yet but should be recruiting in a few weeks). It’s the closest good trial option that I’m eligible for.

The trial has it’s drawbacks, namely the cost and the travel. If I get in, I’ll have to spend the first five days or so in Detroit, then one day a week after that for the next two months (if you last longer than two months, visits decrease to once every two weeks). The drug company covers most of the costs associated with the trial, but not all, which means that if I want to go through with the trial, I’ll have to ask for donations to help me pay for extraneous expenses. As it stands, my visit to the Karmanos Cancer Center next week will cost me $400 (it would have been $700, but I’m getting my blood panel done in Canada to save the expense of having it done in Michigan) plus travel.

I hate that it is so complicated trying to obtain treatment when no other standard of care exists. I hate that I most likely have to leave the country for treatment. I hate that I have to ask for financial help. However, I am happy that this Detroit option exists for me, and that I have an oncologist who took it on herself to look into clinical trials for me. Some things aren’t right, but others are nearly perfect.

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Crowd-sourcing treatment options

To everyone who has offered to help me argue for compassionate-care access to a MEK-inhibitor, thank you. Less than 24 hours after my last post, a friend contacted someone she knows at Novartis on my behalf and he, in turn, is contacting Novartis Canada. Maybe this will be an unusually uncomplicated situation where the drug company generously grants me access to the drug without too much agitation. But if I need to agitate, it’s nice to know I have a lot of you willing to use your voices and work your connections.

This is a strange situation to be in. I really didn’t think I would run out of treatment options so soon, especially not at a time when I feel relatively well (other than the side effects of the ascites, or the side effects of having the ascites drained — I’m in a considerable amount of pain right now as my muscles and organs find their ways back home, but that’s expected and that’s also what narcotics are for). A lot of people have told me how brave I am for making the decision to stop treatment, but I don’t feel ownership of this decision; in many ways, the decision was made for me by a simple lack of options. I think I always thought that when I stopped treatment, it would be a decision I’d make after deciding the treatment was worse than the disease, after side effects became too much to tolerate. But I’m physically capable of tolerating more treatment right now, there just isn’t any treatment (easily) available to me. And I don’t count more cytotoxic chemotherapy — which has a poor performance record in treating low-grade ovarian cancer and, more importantly, a poor performance record in treating my low-grade ovarian cancer — as a viable treatment option.

I feel a bit lost.

I also feel sad, but mostly I feel angry — angry that there aren’t more options for people like me who run out of options long before they should, angry that the research machine doesn’t operate in such a way that individual doctors have more of a say in how to treat individual patients who don’t fit the mold of typical patient or typical research subject. I’m angry that I feel like I have to grovel and beg for some pills that maybe, just for awhile, could give me some stability in my health. I’m angry that so much of my head space is taken up by thinking about cancer, leaving little room for me to think or care about anything else. But I also feel blessed and privileged to have an extended community of people who are willing to help me through this, in various ways, however they can.

 

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Not much left to do but wait

I take offense to the idea that I am “battling” cancer (sorry, Dad, I know you have talked about me fighting cancer, but I just don’t see it that way). I’m not engaged in warfare, I’m living my life with an illness. If this were a war, I would have raised the white flag long ago. But it’s not a war; it’s a biological process gone awry. It’s important to remember that this is not a war because I don’t want the decision I made today to be construed as “giving up.”

I saw my oncologist today, and as expected, weekly Taxol was doing fuck-all. My disease has moderately progressed despite the poison we’ve been pouring on it. My cancer just doesn’t respond well to chemo. It’s a low-grade cancer that came back as high-grade but which still acts like low-grade, which means chemo is generally going to be a bust. So when my oncologist asked if I wanted to try a different chemo, I said no. Because I’m not going to put myself through something that is just going to make me feel shitty and likely do absolutely nothing to prolong my life.

I figured we would be talking about clinical trial options today, and we did. Or rather, we talked about the lack of clinical trial options. I’m ineligible for all the Phase 1 trials because I’ve either done them, don’t have the right kind of cancer, or am excluded because I’ve already been on a MEK inhibitor. The irony is bitter: I can’t go on the drug that will help control my cancer because I’ve already been on the drug that could help control my cancer. If anyone knows how to get on a clinical trial or access experimental treatments through a back door even if they hit the exclusion criteria, let me know. Because I sure as hell don’t know how to do it.

The trial I’ve been waiting for, the immunotherapy trial that uses a live virus to turn the body’s immune system against the cancer, is still not open. There is still a mess of red tape to cut through, and funding issues now, to boot, and this trial — which should have opened back in September or October — is now on hold until at least March or April. Which could mean May or June, the way these things work. That’s the only trial I’m eligible for right now. All I can do is wait for it to open. Hopefully that happens in my lifetime. (Poor attempt at dark humor, but guys, what else am I supposed to do? I’ve already spent most of the day crying.)

So while I wait, I’m starting anti-hormone therapy, which has a miniscule chance of doing anything useful, but has minimal side effects so it doesn’t hurt to try. It helps stabilize low-grade ovarian cancer sometimes, so might as well see if it does anything for me. At least it won’t feel like I’m doing absolutely nothing.

I’m not going to lie, I’m in a pretty grim place right now. Choosing to forego treatment is not an easy decision to make. But I’m not interested in in pursuing treatments that are unlikely to do anything but affect my quality of life just so I feel like I’m not “giving up.” And I will happily undergo treatment again, just as soon as something appropriate comes along, or I figure out how to get Novartis to give me access to the only drug that has ever worked for me.

Until then, I wait.

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