If you have a short attention span, here’s the big news: My Tumor Infiltrating Lymphocyte (TIL) with Total Body Irradiation (TBI) treatment starts next week, on Tuesday, September 27th.

The long version, including historical information, follows below.

My week at the National Cancer Institute (NCI) has gone quickly, but not without some complications.

On Wednesday, I got my scheduled stem cell apheresis, this time through my newly installed Hickman catheter. It was wonderful to not have to get stabbed again with needles for this process, especially as the bruising I incurred last week for the feeder apheresis are in full bloom with all sorts of color.

But the stem cell apheresis on Wednesday was pretty tiring too. As I later found out, part of this was because the process caused my magnesium, potassium, and platelet counts to drop significantly. Contributing to this was that this apheresis also required that 30 liters of my blood (about five time the blood supply in my entire body) to be fed through the centrifuge over a six hour period.

I spent the rest of the day resting and dealing with a related headache, under the assumption that all had gone well with the stem cell apheresis. However, at midnight, deep into Ambien-assisted slumber, I got woken up and was informed that they did not manage to collect enough stem cells (the minimum required by the protocol is 4 million, but 5 million is more ideal), and that I would need to go through the process again on Thursday morning. No further details were available, but I was given another pair of Filgrastim shots, and put on an IV with potassium chloride to help boost my electrolytes (and potassium levels).

So, yesterday morning I found myself in the apheresis center again, for another 30 liters of blood processing. Turns out that the first day produced 2.6 million stem cells, so not a complete failure. Fortunately, yesterday’s collection produced another 2.04 million stem cells, for a total of 4.64 million cells, sufficient not to require additional vampiration (and delay treatment). Because of the unexpected second day of apheresis, I also had to rearrange appointments with doctors from radiation oncology and from the dental clinic. In each case the doctors advised me on the side effects of the radiation treatment (which are potentially significant). But other then sterility and an increased chance of early cataracts, only these effects are generally transient (but could last for many miserable months).

I fortunately had also learned first hand about this from a couple where the husband had finished treatment about two months ago – they learned about be from Melanoma Mom Jamie’s blog, and were wonderful enough to look me up at NCI to see if they could help with any questions I had about the process. Thank you so much Pam and Joe!
In any case, the anecdotal evidence suggests that the aftermath of TBI is well worth it in terms of increased probability of response to the treatment. The amount of response benefit is actually what this clinical trial is designed to help define.

Yesterday, I was also told that I had excellent teeth and dental health. I think that was the high point of my day. The day ended with more potassium infusions, and six units of platelets, both of which helped my blood counts creep towards normality.

I wrapped up my stay this morning with a simulation scan to prepare for my full body radiation treatment (which goes on twice a day for three days, starting October 3rd).

The end result was that I now have a bunch of lines on me, drawn with a permanent marker (fortunately not really permanent), with the critical markings covered by waterproof tape. The lines will be used to align my body with respect to the photonic radiation emission equipment. By the time I’m done with the three days of radiation, my body will have absorbed 12 Grays of radiation, and my lungs only 6 Grays. The Gray is a unit of measure that relates to “rads”. It is a significant dose for full body exposure, but small compared to localized radiation.

As I already indicated in the abbreviated version of this blog above, I learned that I have been scheduled to return to Bethesda on Tuesday, September 27th – so a mere four days from now. The first day will be spent getting me all set up, and I start my five day course of chemotherapy on the next day, followed immediately by the three days of radiation.

Again, the whole purpose of these two components of the overall treatment is to kill my immune system as well as the cell generation in my bone marrow. The idea is that the resulting environment (no immune system) gives the TIL the best possible chance to do its thing – namely kill all those nasty melanoma cancer cells that are still intent on spreading throughout my body, without interference from my own normal immune system.

After the TIL cells are administered, the stem cells will be administered, then I get the mind numbing IL-2 treatment to boost the power of my TIL and stem cells, and then there’s recovery…

I will stay at NCI until it is deemed safe for me to be exposed to much of the world, namely when my immune system has recovered enough to ensure that I will no longer be in danger of infection from the most minor germ. Right now, my return date to Boston, as a bald, easily nauseated, and very tired person, is scheduled to be October 20th, but that date is subject to change based on my recovery, and the on-going entropy that is part of my life these days.

I want to extend a very special thanks to Jamie and Jeff for letting me be part of their nightly take-out dinners during my stay at NCI. Thank you both for your friendship and hospitality.

The few days I have in Boston (I am en route now) are going to be spent with family. In fact, my parents flew in from the Czech Republic yesterday – the original plan being that we’d be spending a couple weeks together. However, the melanoma train stops for no one, so we’re down to only a few days together. But that’s okay, because my train’s destination is NED – No Evidence of Disease. And a pig roast at our house in Bonaire in the spring!

Note: I want to mention to those folks who have been depending on e-mails from me for notification of new blog entries, I will no longer be sending out those e-mails during treatment. And I will not be posting notification on Facebook or Google+ either. My upcoming posts, throughout treatment, if I can manage them, will be a lot more succinct than my usual posts, and to see them you will have to remember to check back here at http://www.jakestake.tv every so often to see what’s new.

 

I write to you tonight from my private (for now) room at the National Cancer Institute (NCI) in Bethesda, Maryland. For those of you who follow this blog closely, you will understand that this means that when I signed the agreement to participate in the Melanoma TIL (Tumor Invading Lymphocytes) clinical trial here yesterday, I was randomized into the arm of the trial which adds Total Body Irradiation (TBI) to the base TIL treatment.

This is actually a good thing – even with the nasty side effects – because the use of TBI, based on anecdotal evidence, appears to contribute handily to improving the response to the TIL treatment. And, as it was confirmed this morning that the melanoma has now started to spread to my liver and my lungs (small tumors were spotted on the CT scan on Wednesday), I am pushing for every bit of help the TIL treatment can get in killing my melanoma. So TBI is most welcome as a part of my treatment.

The emblem of the surgical unit of the National Cancer Institute

The emblem of the surgical unit of the National Cancer Institute

A short while ago I received my first set of injections of a medication called G-CSF a.k.a. filgrastim a.k.a. Neupogen. The purpose of this medication is to stimulate the growth and release of stem cells into the bloodstream. The careful readers among you may notice that I referred to “injections” in the plural. As it turns out they can only inject a maximum of 2mL of filgrastim per injection site, and my dose is 2.8mL, so they split the dose in two, shot into opposite sides of my belly. I apparently will be getting two shots every 12 hours (at 7am and 7pm), instead of one larger one, for the next five days. Eek.

I guess I shouldn’t be surprised by having to be poked twice as often, as needles have been a big part of my week here in Bethesda. In counting the number of times I have been punctured in the last three days, I get to twelve. Only nine of those were successful. This includes the two belly injections tonight, two sets of drawn blood, three IVs, and two related to my leukapheresis. The puncture wounds on my arms alone make me look like a junky. But that should have changed with the small surgery I had this afternoon to install a double-lumen Hickman catheter (more on that later).

The feeder apheresis, also know as a leukapheresis, was pretty interesting. As described in my prior blog post, the idea was to remove blood flowing through one arm, filter it for the desired blood component, and put the remaining blood components back into my body in the other arm. And that’s pretty much how it worked yesterday morning. All in all, 15 liters of my blood (which is about 3-4 times my total blood volume) was run through the apheresis machine to produce almost a liter of mostly white blood cells. The process ran nearly four hours, and after the initial installations of the intake and outtake needles, was pretty painless.

My white blood cells after the leukapheresis

My white blood cells after the leukapheresis

The filtering process is actually a centrifuge which forces the components of my blood into separate layers, one of which is the white blood cell layer. It’s next to the red blood cell layer, which is why the above bag of white blood cells is reddish in color. The white blood cells will be further separated out in a lab, and then fed to the TIL cells being grown for me, since those cells will appreciate a “homey” environment (namely from my body).

Next Wednesday morning, all the stem cells being released into my body will be collected via a stem cell apheresis, but this time I won’t need to be punctured again. That’s because this afternoon I had a dual-lumen (two port) Hickman catheter installed into my jugular vein.

Diagram of a dual-lumen Hickman catheter

Diagram of a dual-lumen Hickman catheter

The doctor installing the catheter indicated it was 23cm (almost 10 inches) long. It starts in the middle right part of my chest, loops up over my right clavicle, and down again into the vein. At the end of the catheter (the part inside my body) are two openings about 1.5 cm apart, at right angles from each other. The catheter itself has two independent channels (lumen), one connected to each of the openings.

On the end of the catheter sticking out of my body are two ports which can take IVs, but more importantly, can also be used for my stem cell apheresis so I don’t have to be poked again for that (or future apheresis or any IVs other than for CT or MRI contrast injections).

The catheter is pretty uncomfortable tonight – a little bit of pain, plus a feeling like I bruised my neck muscle, but the doctor (and the nurses here) said I would get used to it in a couple of days. Good thing, since I need to continue to keep it in for at least three months.

I also had a dietician come visit me today to discuss my dietary needs and restrictions once I start my actual treatment of chemotherapy followed by the radiation and IL-2. And, even more importantly, the months after treatment where I will be recovering from the effects of the radiation. About half-way through my treatment, I will achieve a point where I am “neutropenic” – having little or no white blood cells with which to fight off any infections or illness, and that will require being extremely careful about what foods I eat (and whose hands I shake).

However, even as my white blood cells come back after the reintroduction of my stem cells, I’ve been told that I will need to maintain a neutropenic diet for about three months after treatment to avoid complications. This cuts a lot of fun and interesting food out of consideration for consumption, so perhaps I should take solace in the fact that I won’t have much of an appetite, as well reduced taste sensation, during my recovery.

An overview of the “can and cannot eat” items in a neutropenic diet can be found here.

After I return back to Boston on Friday or Saturday, I can only count on being there for between five and twelve days, and I’m betting on the lower end of that range based on how fast things have gone at NCI. Then I’ll be back in Bethesda, starting my treatment, and hopefully moving my way through the final step towards NED – No Evidence of Disease!

 

Life is like a whirlwind, at least mine is right now. You get swept up when you’re not exactly expecting it, and you hope you get put down safely and soon.

My previous blog post left things hanging a bit, and I apologize for that. Those of you who get e-mail notifications from me already know, but I got a call last Wednesday afternoon that my cells were already ready. That was just one week after the tumors used to grow those cells were surgically removed from my body. Needless to say, we were stunned by both the good news and the speed with which it arrived (picture mental and physical “happy dances”).

With my surgery wounds pretty much healed now, I am scheduled to depart for Bethesda again tomorrow, and while at the National Cancer Institute (NCI) on Wednesday, I will repeat all the scans and tests I had done in late August – all because those tests fell one day outside the three week window prior to signing onto the protocol. The tests being run include blood tests, an EKG, a chest X-ray, a brain MRI, and a nearly complete CT scan. The next morning I spend about three to four hours getting a “feeder apheresis”, where blood will be extracted from me on one side of my body, materials filtered out to help further feed my grown immune cells (hence “feeder”), and what’s left being put back in on the other side of my body.

The protocol signing (called a “consent”) takes place on Thursday afternoon, at which point some computer is going to determine, randomly, whether my Tumor Infiltrating Lymphocyte (TIL) treatment will include intense total body irradiation (TBI) or not.

If I get randomized into the TBI arm of the protocol, I will be checked in as an in-patient the NCI clinic on Thursday night (while Linda flies back to Boston), and stay there for eight days. Starting at 7pm on Friday, I would get an injection of a drug to boost my stem cell production, and this would continue for the next seven days, twice daily, at 7am and 7pm. During that subsequent week I would also meet with the radiologist, a dentist (because the radiation might impact my dental health), and other specialists. On the following Friday I would go through a stem cell apheresis, to remove a large amount of stem cells in my blood stream. Those would be used later in the treatment to regenerate all my bone marrow cells, all of which the radiation treatment would kill.

Once I leave Bethesda, either this coming Thursday night or at the end of the following week, I will only be in Boston a week or so before returning to NCI to finally start my actual treatment. A description of how that treatment would start is in the blog of my friend, and my hero, Jamie (Melanoma Mom), who is undergoing the same chemotherapy right now that I will soon be going through myself. Jamie isn’t having total body radiation, but is going through a very similar treatment otherwise. Jamie – be strong! We love you and will see you in a couple of days!

Background of TIL
One of the things that kept me off-line quite a bit last week was reading a book that the research nurse for my protocol had recommended. Written about 20 years ago, “The Transformed Cell”, by Dr. Steven Rosenberg, provides an in-depth view of how immunotherapy as a cancer treatment got its launch at NCI. Dr. Rosenberg is “the man” in the world of immunotherapy, as well as the principal investigator in the clinical research study that I am participating in (and I was fortunate enough to meet him the morning after my surgery, albeit briefly).

What fascinated me about the book was Dr. Rosenberg’s detailed explanation about his motivations and his experiments in trying to show that immunotherapy could in fact work to eradicate cancer in a patient. One of the many procedures he helped developed is the transduction of lymphocytes, or in simpler terms, programming white blood cells using gene splicing.

Rosenberg is very forthright about his failures in his book, and the emotional burden of finding himself unable to help many of his initial patients – yet knowing that he was very close to a solution. His book ends (and since this is historical, I’m not giving a lot away) with the cure of a woman using T-lymphocytes which had a gene for TNF (Tumor Necrosis Factor) transduced (injected) into them to make them even better at killing the particular cancer cells the lymphocytes were targeting.

Now, keep in mind, this was 20 years ago. The techniques developed in NCI’s labs then have led to on-going evolution and revolution in immunotherapy around the world, and from all that I have read, Dr. Rosenberg and his team continue to push the envelope. I was pleased to have my new dermatologist in Boston (who specializes in “pigmented lesions”, including melanoma) tell me that Dr. Rosenberg is the Father of Immunotherapy. I am quite sure I couldn’t be in better hands than his, and am very happy I got into his clinical study.

And I’m also excited about my visit to NCI this week, because I’ve been offered a visit and tour of the lab where they grow the cells for TIL (including mine). Apparently this is something offered to every patient, but I’m looking forward to geeking out a bit in my discussions with the lab technicians and specialists.

Other Tumor Factoids
I neglected to mention in my last blog post that during my stay at NCI, I learned a couple of interesting things about cancers from the doctors and nurses there that some of you might be interested in:

– Cancer tumors tend to be quite firm and solid, although that’s not always the case. For some reason I had a perception of tumors being soft and squishy most of the time. However, since they are generally quite firm it explains why doctors will palpate your lymph node regions and abdomen to see if they can feel any solid masses.

– Cancer tumors can be variously colors, although apparently black or dark are more common colorations for tumors.

– There are over 200 different types of cancers, each treated in its own particular way.

Enjoying Life’s Moments
As the above might indicate, I have no idea what my actual schedule is going to be beyond Thursday, until I’ve been randomized. I have already bemoaned the loss of control I feel in terms of planning – something that is really tough on anal retentive and control freaks, like myself. Some of you may recall the Robin Williams movie, “Dead Poet’s Society”, where he taught his students to seize the day (“carpe diem” in Latin). Well, I have been trying to adjust to my lack of control as best I can, and my Latin mottos now include “carpe opportunitas” (seizing opportunities and advantages) and “carpe momentum” (seizing the moment).

One such moment seized was yesterday, as we finally had wonderful weather in the Boston area again, and had learned last week that the annual King Richard’s Renaissance Faire was being held south of us. We set forth to enjoy some hours at the Faire, with one of the major goals being the devouring of large turkey legs. We accomplished that mission handily.

A rare shot - Krystyana, Linda, and Bas all together. Here, getting ready to eat the fare at the Faire.

A rare shot - Krystyana, Linda, and Bas all together. Here, getting ready to eat the fare at the Faire.

Enjoying a massive smoked turkey leg at King Richard's Faire

Enjoying a massive smoked turkey leg at King Richard's Faire

Much to Bas’ consternation, I bought myself a pair of giant butterfly wings which I wore throughout the entire Faire to entertain myself and others with. Bas was convinced my sole purpose in wearing said wings was to embarrass him (he remains firm in this belief, even after numerous explanations to the contrary). At a Renaissance Fair, being partly dressed as a mythical fairy raised nary an eyebrow though. Now, if I wore the wings to Whole Foods or Quincy Market with Bas in tow, that would be a different matter entirely.

Be that as it may, it was a very nice way to spend the better part of a day with my loved ones, and my wings lifted me even higher.

Me with my butterfly wings at King Richard's Faire

Me with my butterfly wings at King Richard's Faire

 

Today marked my third surgery of the year.

The first surgery, almost exactly five months ago, was to confirm whether I actually had cancer (it did).

The second surgery, about four months ago, was to try and confirm whether the cancer had spread (it had), as well as try to remove it surgically (didn’t work).

Today’s surgery was not about verifying or fixing anything, however. It was to remove cancer tumors from my body and use them to create a cellular therapy, using my own cells to fight the metastatic melanoma growing in my body. This was explained a couple of blog entries ago.

What I did not discuss in that blog entry last week, because I didn’t know, was that the firm lumps immediately below my lymphadenectomy scar (surgery #2) were not scar tissue as we had believed, but instead were new, growing melanoma tumors. Three tumors, as best as we could tell via touch. That determination was confirmed via the CT scan I had taken last week while I was here at the National Cancer Institute’s (NCI) Clinical Center.

The impact of this new determination resulted in a change in my surgery today. Originally the thought had been that the 3cm+ tumor in my right iliac region, spotted during a CT scan a month ago, would be the tumor removed for harvesting immune cells. But now that tumor, along with other smaller ones in my groin lymph nodes, remains within me, to be used as references to determine whether my upcoming treatment has been successful.

So instead, this morning, around 10:30am, surgeons removed a chunk of biological material almost the size of a baseball from my upper thigh, consisting of the aforementioned three tumors and surrounding tissue which was of questionable state and use (like old scar tissue). They also removed the new melanoma mole that had been forming (which had achieved a respectable 6mm in diameter after only six weeks) near the original mole site.

The size of the extracted mass was intimidating when I learned about it. I have been told there may be a permanent “dent” in my thigh once healing completes.

But what’s really important is that the folks here at NCI now have sufficient amounts of my melanoma to try and harvest the immune cells they need to help treat and hopefully cure me of my cancer.

The next step is that we need to wait a couple of weeks to see if they were able to harvest the necessary lymphocyte cells from my tumors.

I am going with the assumption they will be successful with that step, in part because that’s the assumption here at NCI as well (though no guarantees, of course).

Once enough cells have been grown, I will come back to Bethesda, sign the agreement for the treatment, and then be randomized into either the normal TIL treatment or the one with radiation, as I discussed last week.

In the meantime, I will have a couple of weeks during which the wounds from today’s surgery can continue healing up (I haven’t seen them yet, but will soon enough). I am already able to walk around (albeit slowly), with only a small bit of pain from the surgical areas.

I will be released tomorrow so I can fly back to Boston with Linda in the evening. I must admit that the prospect of the flight is a bit unnerving, though, because I was only able to secure a window seat on the flight back (Hurricane Irene related flight cancellations resulted in very heavily booked flights all this week). I hope I’m able to work a deal with someone (either the airline or another passenger) for a left-hand side of the plane aisle seat so I can stretch out my right leg.

But even if I can’t negotiate a better seat, I’ll manage – it’s a small thing in the grand scheme of things. The really important thing is that I’ve taken another step – a very critical one – on the path to NED (No Evidence of Disease).

Please note I probably won’t post another blog entry until I have heard back from NCI about my TIL cell harvest results, which may be in the next two to three weeks. Until then: To NED!

 

I just got the call from the Fellow at the National Cancer Institute confirming that they want me to be part of their program. I was also told that my surgery to remove one or more tumors for harvesting lymphocytes is scheduled for Wednesday. Apparently the surgery is not a very invasive (and pervasive) surgery, so I would only have to spend one night in the hospital, if that.

So we’ll be flying down early tomorrow morning (getting flights was a bear because of all the catch-up the airlines need to do after this past weekend’s crazy number of flight cancellations), and returning to Boston on Thursday evening.

I’ll try to post more once I finish my round of meetings tomorrow afternoon at the clinic.

 

Our few days earlier this week in the Washington, D.C., area – which were centered on my scheduled testing and interview at the National Institutes of Health’s National Cancer Institute (NCI) – have been dizzying. And shaky, as we got to experience an earthquake during the process. It wasn’t a big deal, but it was interesting to go through and observe, including the mandatory building evacuations.

The Mark O. Hatfield Clinical Research Center at NIH, seen after our evacuation after the earthquake

The Mark O. Hatfield Clinical Research Center at NIH, seen after our evacuation after the earthquake

The actual physical tests and examinations performed this past Tuesday at NCI were routine – taking my blood (13 different vials, though), an EKG, chest X-ray, and a urine sample.

Linda and I also spent time with a social worker who explained how treatment at NCI worked: it’s free to the patients, as it is a federally funded research facility, and they will even take care of transportation costs for the patient (but not the spouse or children of the patient) from anywhere in the U.S., as often as necessary. There’s also a small lodging stipend ($50/day) for the patient’s hotel room if the patient is an outpatient.

One of the benefits, in terms of treatment and medical care, of not having to deal with the costs of such care (personally or via insurance companies) is that there’s no wait or delay in waiting for pre-certifications or considerations about the expense of tests that may or may not produce useful results.

That philosophy became evident on Tuesday afternoon (after the hubbub from the earthquake we experienced had settled down), when the new Fellow (a term for a doctor on a long term rotation) assigned to me suggested I could have surgery in the next couple of days to remove my largest tumor to use in harvesting lymphocytes (immune cells) which would later be used to fight my rapidly spreading and growing melanoma.

The mere suggestion that they wanted to operate on me indicated that my acceptance into the so-called TIL (tumor infiltrating lymphocytes) protocol was almost a given at that point. That was a huge relief.

As part of our meeting with our Fellow, we also met with the Attending doctor who has worked at the NCI immunotherapy clinic for the last decade. Fellows rotate out every year in July, while the Attending doctors rotate every month or so, incidentally. They gave me a physical examination, palpating me to see if they could feel any tumors (and they thought they could feel some around my lymphadenectomy site). They also confirmed that the rapidly growing mole that I had on my right thigh, located about 1.5 inches from the old melanoma mole, was a new melanoma, as I had surmised a couple of weeks ago.

One initial idea raised at this meeting had been that they might try a radical surgery to remove both the large 3cm+ tumor found on the scans last month, as well as any other lymph nodes, in the hopes this might eliminate the cancer from my system, but after the examination and the identification of the mole they agreed that survey was not the way my cancer could be dealt with as I likely had some “melanoma channels” throughout which the cancer had spread and continues to do so. No surprise there – I already knew that instinctively based on how aggressive my melanoma has been.

In order to help determine the best course of action, as well as provide data that was incomplete in my records, I was asked if I could come in the following day for a brain MRI and a CT scan of my abdominal and thigh regions. We had fortunately tacked an extra day and a half to our trip when we planned it, so I was able to stay at NCI all day yesterday (Wednesday) for those two scans, which were arranged for me by a uniformed research nurse who is our direct link with any information or support we need on the medical side.

At the end of the day I exchanged e-mail with our Fellow, and she informed me that the CT scan did confirm that all my tumors were continuing to grow (again, no surprise there), but that from a treatment perspective, this was helpful as it provided more potential samples, as well as reference tumors to use to see if the treatment was working once started. However, surgery was not happening this week, as she and the Attending wanted to present my case formally to their colleagues at the weekly Monday staff meeting, and solicit ideas on how to best proceed with my tumor resection and subsequent treatment.

The clinical protocol, which is really a clinical trial, discussed with everyone on Tuesday has several steps.

First is the harvesting of lymphocytes from a tumor. They need at least a 2cm wide tumor to do this, and my largest tumor is quite a bit larger than that at this point. This is an invasive procedure but in the case of my tumors in the lymph nodes is less tricky than removing a tumor from an organ which thankfully my melanoma hasn’t gone there yet.

Next, the labs at NCI extract the lymphocytes and grow them. They use Interleukin-2 (IL2) to help “boost” the cells as they breed them. This process takes a couple of weeks or so, if it is successful.

Once it is confirmed that the lymphocytes are replicating and growing properly, I would get flown down to NCI to be formally admitted into the clinical trial.

For those of you interested in the details, the link to this trial is here. There is also a really good FAQ here.

In case you also are interested, the rather scientific title of the trial is “Prospective Randomized Study of Cell Transfer Therapy for Metastatic Melanoma Using Tumor Infiltrating Lymphocytes Plus IL-2 Following Non-Myeloablative Lymphocyte Depleting Chemo Regimen Alone or in Conjunction With 12Gy Total Body Irradiation (TBI)”.

Once I signed the agreement to participate in the trial, a computer would flip a virtual coin to randomize me into one of the two arms of the trial. The first arm is the basic TIL treatment, while the second arm is the basic TIL treatment with total body irradiation (TBI), namely three days of extreme radiation treatment. As I understand it, the purpose of the trial is to determine whether or not the radiation component increases the cure rate appreciably or not across a wide range of people. The current belief is that it makes a small difference, but this trial will help quantify that difference. That in turn will help determine whether the amount of difference is significant enough to justify the abuse of the body the radiation treatment adds to the process.

If my virtual coin flip put me into the arm with TBI, I would stay as an inpatient for a week at NCI while they extracted stem cells from me. These stem cells would be grown and stored for reinjection after the radiation treatment was over, since the TBI would kill all the cells in my bone marrow, which include cells which generate all of my white blood cells (for fighting infection, among other things).

This initial visit would be shortly followed by another visit to actually perform the core part of the treatment.

First step in the treatment would be to have five days of chemotherapy to kill my immune system and create a vacuum to allow my boosted lymphocytes to both have a more dramatic effect on my melanoma tumors (as well as individual bits of melanoma floating in my system) as well as prevent my body from just reabsorbing the injected lymphocytes without letting them perform their intended function. Note that the chemotherapy would be unlikely to have any effect on the metastatic melanoma in my system.

The chemotherapy side effects would be much the same as for traditional cancer chemotherapy, including full body hair loss, nausea, fatigue, etc.

If I were in the TBI arm of the trial, the chemotherapy would be immediately followed by the full body radiation, which has a pretty nasty set of side effects, some of which overlap with those from the chemotherapy. The radiation side effects can (and likely will) last many months, or even the rest of my life (including infertility – fortunately not something I am concerned with at this point in my life). The radiation would further weaken my immune system in order to make my reintroduced lymphocytes more effective.

Once my immune system was wiped out, the lymphocytes would be administered via an IV, and if I were in the TBI arm, the harvested stem cells would be administered as well to help my bone marrow regenerate to rebuild my immune system.

I would then go on a short course of intensive IL-2 (up to 15 doses, given eight hours apart) to further boost the lymphocytes now in my body, to help them better battle my cancer cells. After that it would be just a matter of time to recover from the nearly two week abuse of my body in order to try and cure the cancer.

The amount of time for recovery from the highly weakened state depends greatly on a number of factors, but the trial documents suggest for the non-TBI arm it should be two to three weeks in the hospital. For the TBI arm, it would be that plus four to six months of recovery to overcome the recurring fatigue, nausea, and other side effects that will undoubtedly arise.

There would also be return visits back to NCI every four to six weeks for scans to see how effective the treatment was. That would go on for a year, with semi-annual visits after that.

The one thing that this arduous treatment offers that so far we had not heard is the possibility of a near total cure. Statistically this has occurred in approximately 50% of the subjects, but that’s a heck of a lot better than the odds with traditional adjuvant treatment for melanoma, which in most cases, if it works, only seems to put off a subsequent recurrence to a later date (albeit potentially a much later date). And that difference – between a cure and a delay – is what will make this TIL treatment – with or without TIB – worth all the sacrifices necessary to get through the treatment.

In closing, I would like to also give special thanks to my new friend Jamie. Jamie blogs as Melanoma Mom (http://melanomamom.blogspot.com) and has been getting treatment at NCI since March for metastatic melanoma (read her blog for details). She and her husband Jeff are incredibly well-informed about various trials and protocols at NCI, as well as the logistical issues of being an in-patient at NCI. And Jamie is taking part in a rather revolutionary treatment herself starting in about two weeks at NCI. She, Jeff, and their beautiful baby boy, Kai, were kind enough to get together with us on Tuesday night (they live only 20 minutes from NCI). We learned so much from her and Jeff, and are thankful to number them among our friends now.

One simple thing Jamie taught us that I can easily share with you is a toast when you share a drink with others: “To NED!”

NED is an acronym for “No Evidence of Disease”, and that’s Jamie’s goal and my goal for our respective melanomas.

So please hoist your glasses to NED, often and with gusto! I know I certainly will!

My next post will be once my treatment course and schedule solidify just a bit, hopefully early next week.

 

As you might recall from the prior blog entry, we have been in an anxious waiting period to see if the National Cancer Institute (NCI) at the National Institutes of Health (NIH) would even agree to see me for their Adoptive Cell Transfer (ACT) research program for metastatic melanoma.

I am pleased to report that NCI contacted me last night and today confirmed that I have an appointment to come in for a full battery of testing and screening in about 10 days. We’ll be in the Bethesda, Maryland area (just outside of Washington, D.C.) for several days, working in a bit of rest and relaxation before and after the testing, which I have been told is quite intense.

The testing will determine whether I am a good subject (biologically speaking) for their research protocol. I have been told by the staff at Mass General that I should hear back about my acceptance (or not) a week or so after the testing has been completed, so by the end of August or beginning of September.

If NCI were to go ahead with me as a subject, the soonest I could be scheduled for any invasive procedure (e.g. surgery or biopsy) would be four weeks after my last dose of Sylatron, because that’s how long they have determined it takes to completely leave my system. With that in mind, I did not take my final (eighth) induction-level Sylatron dose last night, meaning that I will be “clean”  on September 1st.

I don’t know that I will have anything more to report until after my screening, but I am relieved to at least have gotten my foot in the door at NCI for now, and will hope the screening shows I am ideal for their program.

In the meantime, I expect my energy levels to slowly start coming back, along with my appetite, as the Sylatron works its way out of my system. That should mean I can enjoy some nice meals with friends in the DC area when I am there. Woo hoo!

By the way, by odd coincidence, shortly after I finished my blog entry on Wednesday discussing ACT, I came across news that the same sort of process had been using to successfully tackle incurable leukemia, which is an indication of how powerful this process can be when it works. Details are here from CBS News.

 

Riding the Melanoma Roller Coaster   August 10th, 2011

It’s only Wednesday, but each day since the week started has been filled with dramatic ups and downs of a roller coaster, at least in terms of options and prospects for the on-going treatment of my melanoma.

When I started the week, based on a meeting with my oncologist last week, I was under the assumption that the 3cm melanoma tumor that recent CT scans found in my right groin region would be surgically removed, and possibly some questionable lymph nodes in my left groin region as well, to be determined by the PET scan I had last week.

My 'get out of jail' card should I have been detained for being radioactive after my PET scan last week

My 'get out of jail' card should I have been detained for being radioactive after my PET scan last week

However, yesterday morning I met with my oncological surgeon, and he advised against surgery because the results were not likely to make an impact against the spread of my cancer, but carried a high risk of tissue morbidity. Translated into English, that means that surgery would only increase the amount of lymphedema that I have in my right leg, and would likely give me lymphedema in my left leg, without any real benefit in terms of dealing with my cancer.

He did, however, confirm that the enlarged lymph nodes in my left groin were 80-90% likely to be melanoma after reviewing my PET scan (which also did not reveal any new areas of concern beyond those identified in the CT scan).

By the surgeon’s estimation, the spread of melanoma to my left groin qualified as metastasis, (albeit relatively minor in the grand scheme of things), as it meant the melanoma had spread to another part of my body from the original site in my right groin, probably via the blood stream (and maybe the lymphatic system). While cancer staging at this point is perhaps a bit subjective, I appear to have progressed to Stage IV melanoma (albeit Stage IV-A), meaning I now officially have metastatic melanoma.

The surgeon, after consultation with my oncologist, indicated my best option at this point would probably be systemic treatment, likely to be Interleukin 2 (“IL2”) and/or ipilimumab (also known as “ipi” or “Yervoy”), but that would ultimately need to be discussed with the oncologist in greater detail.

While the idea of not being able to rid my body of obvious signs of cancer was a disappointment, I must admit I felt extreme relief at the idea of not having to go through surgery again, and dealing with the painful aftermath of a catheter and the pain and annoyance of drains and bed rest and recuperation.

So, imagine my surprise this morning when I met with my oncologist and he proposed a course of treatment that might well include exactly the same surgery the surgeon advised against.

There was a big difference in intent however, namely that the removed tumors in the proposed surgery would be used to cultivate t-cells (immune system cells) which had been shown to be effective at fighting my melanoma to some small extent. These immune cells would be bred to create a much greater number of t-cells, and also boosted to make them more effective in order to create a highly tailor immunotherapy treatment specific to my exact melanoma mutation. This is considered a gene-based therapy, tailored to the individual the original cells came from.

This treatment, while still deemed experimental, has had a much higher success rate in dealing with metastatic melanoma than any other sort of systemic treatment, including IL2 and ipi – on the order of 42-60% prevention of near-term recurrence. The systemic treatments have success rates in only the single or low double digits individually, and slightly better if applied in series.

But there’s a catch.

The special treatment therapy, which is known as either Adoptive Immunotherapy or Adoptive Cell Transfer, is only performed by a small number of facilities in the U.S., and is not covered by insurance because of its experimental status, which means that the facilities themselves foot the bill, which in turn makes them highly selective. The most advanced facility for this special protocol is at the National Cancer Institute (NCI) in Bethesda, Maryland, under the guidance of Dr. Steven Rosenberg, and the program is highly selective, looking for a number of biological factors in candidate patients.

My oncologist believes I meet the desired profile (including being relatively young, in good health (not affected by the metastatic melanoma, that is), having metastatic melanoma, and having resectable (removable) melanoma tumors that are at least 4cm in the aggregate (combined)).

So, right now the hospital is contacting the NCI to submit me as a candidate for this protocol. I am told I may hear back as early as next week as to whether or not I pass the initial hurdle as a potential subject. If I pass that first level of screening, I understand I would need to fly down to Maryland to get a new set of scans as well as some tests, and if the clinical team finds my situation meets their admittance requirements, I would be scheduled for surgery at NCI.

Once my existing cancerous nodes were removed, the researchers at NCI would attempt to grow a batch of modified t-cells which would then be put into storage for use if (or more likely when) my aggressive melanoma showed up again on a future scan. In the meantime, I would continue on some sort of systemic drug treatment for my melanoma in the hopes that it would prevent recurrence. That drug treatment could still include the Sylatron I am currently on, or be IL2 or ipi (or some others as well).

If the NCI does accept me, one of the other benefits is that it will cover all the costs of my testing, surgery, and t-cell manufacture, and insurance would therefore not be involved (although it would be involved for my on-going systemic treatment at Mass General Hospital after the surgery).

If the NCI doesn’t accept me as a subject for their protocol, my oncologist and I will discuss more advanced systemic treatment, which may well start with a course of IL2. The 3cm+ tumor I have would be used as a reference to determine the effectiveness of such treatment. Clinical trials for drug combinations to combat melanoma would be a further option.

As far as my existing systemic treatment goes, I have been told to take my last induction-level dose of Sylatron tomorrow as scheduled. Considering how weary that high dosage has been making me, I will be glad to have it over.

For now, all I can do now is wait and see what the NCI says and not make any fixed plans or set any expectations more than a day or two out, since anytime I try, things change. While I may hear back next week about my initial acceptance or rejection, there’s no guarantee it will happen that quickly.

Personally, I hope the NCI accepts me. Even though further surgery intimidates me, the potential of the Adoptive Cell Transfer protocol to provide me with a future cure (at least as much of a cure as is possible with metastatic melanoma) is very appealing, for obvious reasons.

For the medical geeks among you, here are some links on the Adoptive Cell Transfer Therapy and the system drugs listed above:

 

This was originally meant to be a blog entry about my upcoming radiation treatment, and the tattoos I now have (three small dots) to align the linear accelerator beam, among other things.

The James M. and Ruth P. Clark Center for Radiation Oncology at Massachusetts General Hospital

The James M. and Ruth P. Clark Center for Radiation Oncology at Massachusetts General Hospital

However, at the same time as I was getting set up to start radiation treatment for the end of August, I also had a set of CT scans performed to see if my cancer had metastasized (spread) elsewhere in my body. I got word Friday evening that some areas of concern were found in my scans, but that I would need to wait until Monday (today) to learn the specifics.

Needless to say, there was a lot of stress floating around our apartment, as we feared the worst from the scans.

However, in today’s meeting with the oncologist, we learned that what the scans showed was that my inguinal (groin) lymph nodes are enlarged. In particular, deep under where I already had about 20 lymph nodes removed in my right groin, there is a lymph node that is over 3cm in size (well over an inch), and a number of smaller lymph nodes nearby are larger than they should be as well.

In my left groin region are several lymph nodes that are in the 1.5cm range.

The CT scan cannot tell if any of these lymph nodes are cancerous, but 3cm is huge, and the probability that it is cancerous is almost certain.

The good news is that there was no sign of abnormal growth anywhere other than my lymph nodes, which my doctor says he still considers a regional manifestation, and not distant metastases. That means, for what it’s worth, that I’m still technically Stage IIIC, and not Stage IV.

The actual details of what happens next are still to be worked out once my oncological surgeon returns from vacation next week (I meet with him next Tuesday morning), but I am now scheduled for a PET scan on Wednesday, and the results of that scan will help determine what action should be taken with respect to the swollen lymph nodes in my left groin, such as getting a biopsy or simply removing them outright.

The much larger lymph node in the right groin, however, will definitely need to be surgically removed, along with the other enlarged lymph nodes in the vicinity of that one. The thinking is that I will only have one surgery to deal with nodes on both sides of my groin, and that will require a bit of planning and decision making next week.

So, instead of starting radiation treatment at the end of August, I will likely be recovering from yet another surgery, with lots of mandatory bed rest, and hopefully no drains (or only short-lived ones). I will then get my planned radiation treatment once my wounds have had time to heal for a couple of months.

That in turn throws a hoped for trip to the San Francisco area in late October into disarray, as well as plans we had to return to Bonaire for a short visit this fall.

In terms of my adjuvant treatment, the current thought is that I have not been on Sylatron long enough for it to necessarily have made a real difference yet, so I will likely be sticking with the Sylatron immunotherapy treatment for the foreseeable future (although probably suspended in the time around my surgery). At present, my Sylatron symptoms are the same as before – minimal appetite and significant fatigue. My white blood cell counts are still not great, so we’ll have to see if I take my next dose on Thursday or not.

I keep hoping that I will have some stability in my life, but every time I think I’m getting there, a new twist arises to completely change things. I am grateful the latest problem is “only” more cancer in my lymph nodes as opposed to cancer in my organs, but I would have been a lot happier if there were no new signs of cancer at all. It’s certainly a bumpy ride on the melanoma train.

I’ll post my next blog entry after my meeting with my surgeon next Tuesday. Maybe I will even add a video blog at that time (I am too emotionally drained right now to do a video blog with this post – sorry).

 

Thanks to inspiration from a discussion with my friend Ellen Horne at WNYC, I’ve decided to try to complement my written blog with a video blog. Should you find yourself bored by reading my missives, an abridged version of this written post can be found in the video blog, accessible below.

I just returned from several days in New York City, where we dined very well at mostly excellent restaurants, explored a couple of museums, attended a wonderful musical, and met up with friends we hadn’t seen in a while (and missed several others, unfortunately).

It’s not clear that the trip would have been as enjoyable had I not had my Sylatron immunotherapy treatment for my melanoma cancer suspended due to an alarmingly low white blood cell count (see the previous post). I also took the step last Friday to try acupuncture as a way to reduce both the fatigue and appetite loss the Sylatron had induced. I believe the combination of the acupuncture and the lack of a fresh dose of the drug last week allowed me to eat my way through my New York stay.

At the same time, I found that my energy reserves were still not the best, and that I required daily naps. The realization that I might need regular blood tests during the course of my many month or even multi-year treatment with Sylatron, along with the inherent side effect of fatigue, led me to another conclusion, supported by my doctor. Namely, that my plans for an expansive three month trip to Asia and Australia this autumn would not be really viable. So we’ve unfortunately had to cancel our planned tour to Vietnam and Cambodia in November, and stopped all of the related trip planning to the other side of the world. All to be revisited at some future date, hopefully.

This decision goes deeper than might be apparent, as it is a sign of things to come, namely the inability to plan grand and lengthy things because there is so much uncertainty, even in small things, beyond a certain distance in time.

Mark Beckelman, the recently deceased mentor and friend I mentioned in my prior post who gave me hope when things seemed bleakest after my diagnosis, shared with me that he was happiest when he was living in the moment and living his life. I have come to learn that “living in the moment”, as Mark described it, is pretty much a necessity when you have a life threatening disease, especially where the treatment is fluid, affected by physiological factors as well as chance. Planning for more than three months into the future probably falls outside of “living in the moment”, so, at least for now, I will try to limit my planning to the nearer term, and in smaller chunks that can be more realistically achieved even when other factors change.

On the bright side, as we have proven to ourselves with this week’s NYC trip, I can travel closer by (this hemisphere), and will therefore, hopefully, be taking short trips around North America, including a trip to the San Francisco area in late October which will include (fingers crossed) a dinner at Thomas Keller’s The French Laundry, and visits with many friends we’ve not seen in a long time. My radiation treatment should be over by then (more fingers crossed), and hopefully I will fall into a more manageable routine with less external variability.

With respect to my treatment, I went in for a blood test today, and my white blood cell count had returned to a low but manageable 2700 cells per cubic milliliter (up from 1900 early last week), and my oncologist said I should resume the full induction dose today, not a reduced dose as I was previously told. I will get tested again in about 11 days, as part of a meeting I have scheduled with him the afternoon of August 1st.

At that meeting we will also go over the results of my next set of scans, scheduled for next Wednesday, which will hopefully show that I have not had any visible spread of my cancer to the rest of my body.

These scans, which will take place every three months for the next couple of years after detection, and then get spaced out to being semi-annual or even less frequent over time, are an event of high anxiety for every cancer patient I have spoken to or whose words I have read. They serve as a double edged sword, as the hope is that the scans will be clean, reaffirming that the cancer treatment has worked (and is working), but at the same time they could be the harbinger of really bad news, namely that visible tumors have appeared.

This will be my second set of scans since my diagnosis, and I’m anxious and hopeful that I will hear that my scans are clean (again) when I get the results back from my oncologist on August 1st.

I also meet with my radiologist next week to start planning my radiation treatment for trying to kill any cancer cells that might remain in the vicinity of my excised lymph nodes in my right groin. Assuming nothing unexpected happens between now and early August (like bad scans), this will result in more scans to create a simulation of my treatment areas as well as a body mold to hold me firmly in place while a computer controlled radiation emitter accurately zaps only those parts of me that need the treatment.

More on that in my next post, as I learn about the process.