Thursday, September 27, 2012

Melanoma. Moon Shot. Curiosity. The best 5th grade teacher in the world.

 What on earth do these things have to do with one another???  Everything.  And, not just here on earth either!!!

In November of 2011, NASA launched Curiosity (The Mars Science Lab) with the rover landing on Mars August 5, 2012.  Since then, Curiosity has been sending back more data than all other previous rovers combined.  Go, Curiosity!!!  But, I like one particular transmission best.

Back in February of 2011, NASA's administrator, Charlie Bolden, a self proclaimed science nerd who attended a science magnet school when he was a kid, contacted the BEP's (That's the Black Eyed those of y'all not in the know!!!) front man, to see if he wanted to help with the agency's efforts to draw more young students into science, technology, and math classes.  On August 28, 2012,'s new song, Reach for the Stars, blasted across the air waves FROM MARS, back to the earthlings here at home!!!! ( For fun, google the event to check out some photos of brilliant space scientists gettin' down to some orchestral!!!  Too cool!!!)

Then, on September 21, (just last week!!!) MD Anderson Cancer Center in Houston announced a "moon shot" (referencing the can-do spirit of the 1960's Apollo space program) to dramatically reduce cancer deaths from 8 types of cancer in the next 10 years.  The program, to launch in February of 2013, plans to spend $3 billion to fund 6 research teams dedicated to accelerate the time cancer treatments proven by research will be used clinically for patients who need them.  Cancer types selected are:  acute myeloid leukemia, myelodysplastic syndrome, chronic lymphocytic leukemia,  MELANOMA, lung cancer, prostate cancer, triple negative breast and ovarian cancer.  These particular cancers were picked after a year long review by doctors and scientists "because the state of knowledge in the field today is such that if...acted upon with the technologies we have today, there would be a subsequent effect in the level of mortality," according to Dr. DePinno, president of MD Anderson.

But, possibly even more importantly, the Star Base program, an amazing interactive class room that seeks to bring 5th graders greater exposure to the fields of science, technology, and math, hired the best teacher in this galaxy and beyond just this past August.  There, she brings the skills, knowledge, and principles of science and discovery to hundreds of children with incredible enthusiasm and an energy that lets every child know....they CAN....Reach for the Stars!!!!!!  (That's my Ruthie!!!  She teaches ME everyday!)  Just think, she could be teaching the next NASA scientist, the researcher who cures cancer, and tomorrow's hot rapper....TODAY!!!!!

Why do they say the sky is the limit?
    When I've seen the foot steps on the moon?
And I know, the sky might be high,
   But, baby it ain't really that high.
And I know that Mars, might be far.
   But, baby it ain't really that far!
Let's reach for the stars,
   Reach for the stars!
Let me see your hands up!
   Hands up! Get 'em up high. Hands up!
If you really feel alive, 
  Live it up, live it up!!! Reach for the Stars

MD Anderson Cancer Moon Shot

At this point...ANYTHING IS POSSIBLE!!!!  Check out the links above...and LIVE IT UP! - c

Wednesday, September 26, 2012

Running with Rosie


I run with her.
She glides easily along the path,
I love to listen
    even as I pant to keep up.

The clouds point our way,
As do the koi, the wrens,
     the herons.
The roses smile
     as we breathe by.

The builders smoke,
   wearing extra shirts
   as jackets.

Some run
     because they are late.

I run with her.
Because I always have.
Because we are a team.

        is my light.

Saturday, September 22, 2012

People I don't know

I love "people watching". Airports, parks, restaurants, shopping, all provide ample opportunity. However, if you repeat a more than an hour long commute to your workplace for years, as I do, AND you're far sighted, as I am, it is another great place to watch. In fact, it is an even better venue, because you get to meet the same cast of characters over and over. Here are just some of the people I don't know...but kind'a feel like I do....

I like the older gentleman, who walks most every morning, despite some hemi-paresis, on a road not far from my house. His dedication to continue, everyday, inspires me and sets my morning off on the right foot.

I like to think about the guy I've never seen at the Komatsu plant. The one in charge of where they park, and how they position, the newly minted yellow monsters on their grounds. The giant machines are lined up in precise lines and curves, with their massive yellow beaks standing identically tall or reaching forward like the necks of mechanical swans in a perfectly manicured Japanese garden. I wonder if he is also the one in charge of the water that is of an unnatural cobalt color, as it trickles over the man-made rock fall. If so, I would guess he also thought of planting the row of cherry trees along the sidewalk whose blossoms are so beautiful each spring. I bet his house is very neat and very feng shui.

I don't like the 'special' Signal Mountain folks who think they don't have to get in the far right hand exit lane ahead of time, but can cut others off at will. Luckily, as I leave home before 7 am, I miss most of them. Drivers from 0645 and 0700 are much nicer than those who drive afterwards.

I like the girl with the long blond ponytail, red polo and khaki pants, who works at the Georgia welcome center. Every morning she walks the grounds, looking for debris left by visitors and removing it so that others may enjoy the pretty, lush, green field. She is very punctual and I can judge my own progress by her location. I worry about her feet though. In that thick grass, the early morning dew would surely leave her shoes wet all day.

I like the young guys in the Hubble Glass truck. The driver is steady. The two passengers are either talking animatedly, with broad gestures or are slumped on each others shoulders in deep slumber. I wonder which state of being the driver prefers.

I really loath NCHKPEA, in her grey Honda Accord, with her strangely black hair spiked up like a chicken. She is a bully. I watch her whiz in and out of traffic, tail cars who have absolutely nowhere else to go, as if with her being a jerk behind them, all the traffic in front of THEM will suddenly dissolve and a magical path for her royal specialness will automatically appear.  I may be guilty of driving too fast on occasion. But, I don't drive mean. There was a grey Accord crashed and backwards in a ditch near my exit once. I was certain it was her. It wasn't. Oh, well, since school is back in session, I leave earlier than I did in the summer and have not been plagued by her jerkiness lately.

I like the older lady who walks with a forward tilt...everyday....rain or shine...round the Kroger parking lot, down Walnut Avenue, with a turn on the side road and round again. I wonder how many circuits she makes. She worries me a bit when she crosses at one of the lights. Her hesitating steps are like an invitation for disaster to more 'special' people who think that they have a unique pass that allows them to turn in front of oncoming traffic, even though their light has already changed, and, I fear, barrel into little old ladies. Wonder if she would like to walk with my friend on the mountain. "Now, Harold, you know we have to walk in this direction!"

I like the guy in his faded blue work shirt who drives the slightly disheveled yellow Chevette toward Chattanooga around 530 pm. I get to see him, elbow out the window in most weather, tooling steadily at no great pace, in the far right lane if I get out of the office on time. His car always reminds me of a bumble bee, with its two broad black stripes from nose to tail and its steady high pitched hum.

I like the guy in the red Smart Car.  He actually looks a bit like Mr. Bean.  Surely, he must be buffeted by all the 18 wheelers on the road!  But, he just tools along, unperturbed.

Thanks to all my fellow travelers.  You have kept me entertained.  To some of you....PLAY NICE!!!  To all of you, I wish you the best, wherever the road may take you. - c

Friday, September 21, 2012

Pati...her amazing melanoma video. What IS one life worth?

Melanoma Treatment Options: What is it Worth to Extend ONE life?

A woman, just a bit younger than myself...dealing with Stage IV melanoma for the past two tears, while working as a professor and mother of two children (ages 5 and 10 years) in Europe has started an entire melanoma awareness and advocacy group, almost single handedly, there. She is amazing. Please check out a video she made. Link above. She echos things I think about...a lot.

Love - c

Sunday, September 16, 2012

More than 20 trips to Moffitt in Tampa...

...and counting.  With this many trips under our belt, we have this down.  But, there is always something to amaze and entertain us in our travels.  The drive down to Atlanta was pretty uneventful, with Brent having to apply his imaginary, super brake only a few times.  We got to the airport in good time, and because we were traveling Delta rather than our usual Air Tran, due to better flight times, had to use the "red" side of the terminal.  Pros:  With Delta we could pick our seats when purchasing the ticket and the previously mentioned better flight schedule.  Air Tran had canceled one of its afternoon flights, apparently.  Cons:  Delta flights were much more crowded, as was the parking, which was full in the daily rate section!!! And, HORRORS!!!!  The gate we had to use had no Atlanta Bread Company!  Their veggie sandwich has become a pre-flight staple!!  Had to make do with Popeye's fried chicken.  The flight was ok.  Why do I always have to share my seat...literally!!!!...with large people?  Oh, well....

Down to Tampa, and red is right!!!!  The "red" side of THAT terminal has the best rental car area with the easiest exit to drive out of in the direction we wish to my opinion!!!  "Helpful" floor walker man, in the car park, points out the TWO, count them...two...available 'compact' options in Alamo's very fluid lineup.  To my consternation, both were smelly! One in a cheap perfume air freshener trying to cover nasty kind of way, and the one I settled on, in a plastic, newly unwrapped, shower curtain liner fashion.  It was a relatively new, plastic, Kia, Rio.  Pretty zippy and fun, much like a go-cart.  I liked it.  Brent used his special brake a bit more.

We had decided to fore-go Waltz...which seemed to be suffering the effects of his absence the last time we were there...which makes me feel a bit know visit Columbia again. We got there easily in a pretty significant down pour, to which Brent declared in the particularly up-beat tones he utilizes frequently on these trips, that, "It is moving south!"  Ok, Mr. Weatherman of amazing observational powers during the MIDDLE of a storm!  We shall see.  So, we sat in our plastic car in the parking lot, chatting and waiting for the storm to move south, so that we could take a walk about Ybor City and then have dinner.  Sure enough, Mr. Weatherman was right. The rain abated and we walked along the pretty cobbled sidewalks amid a few art places, Cuban cigar makers, bars, restaurants, defunct versions of same, and tattoo parlors until we ran out of road and it started to mist again.  We made our way back to Columbia for dinner.

The dancers were practicing in tee shirts and tights with great stomping and enthusiasm, but were not for show, as we were ushered by them to our seats in another section.  I like the area we were placed in the best, as it looks more like a garden with white stone walls.  The sangria was WITHOUT flies this time. I was not hungry since Popeye's was still sitting like a greasy lump in my tummy, so Brent decided to order a couple of their tapas dishes and the paella for us to share, which, per the menu, requires a wait of at least 30 minutes, in order to give me time to gain an appetite.  Our waiter with obvious New Jersey overtones, made various recommendations and admonishments, but finally approved of our order.  While waiting, we filled out our card to designate the charity of our choice that Columbia would be giving a portion of our bill to.  They do this every September, which is petty cool and the second time we've gotten to partake.  On his return to our table, our waiter took our paper for the charity (on which you note your own address) and reported conspiratorially, "Well!  We've got someone from your neck of the woods in the kitchen!"  "Really?" we ask, thinking....who on earth could that be?  "Uh, huh!  Emeril!!!  He's here filming for his new show!"  "Ohhhh."  We try not to look too incredulous.  But, he quickly moves his little Tampa/Yankee self along, so we don't have to worry. (I presume he means Emeril's TV show, The Originals, where Emeril highlights restaurants that are iconic in various cities and towns.)  So, what's the deal?  New Orleans.....Tennessee.....all mixed together in that chocolate gooey middle that is the portion of the United States, vaguely in the center, below the Mason Dixon Line.  Oh well...his take on geography left us puzzled and laughing.

Dinner was sign of Emeril, our neighbor and pal, though.  We made our way to our fav La Quinta, to try to get some rest before our fun at Moffitt in the morning.  It was not to be. At midnight, new neighbors moved in with barking, squeaky dogs, running and yelling children, but even more dismaying....adults who had to shout back and forth in the hall about ice buckets....for over an hour!!!  Brent finally called the front desk to ask that things become slightly quieter, and around two am, they did.  REALLY felt like giving a big shout out, outside their, very quiet door at our fun, let's go to Moffitt time of 0700!!!!  But, I restrained myself.

All went well at Moffitt.  Easy stick and vampire like blood draw in the CRU.  I'm telling you, some of the best nurses EVER work there...and I've known A LOT of nurses.  Our exam/chats with Dr. Weber and others, I've already reported.  Then, it was back to the CRU for the 30 minute anti-PD1 infusion, followed by the 30 minute saline rinse (so to speak), and 30 minutes more of vital signs (now decreased from the original 1 hour per the newly signed trial contract!!!).  All went well, although this is the second time in a row that I developed a small bit of urticaria (hives) to my face during the infusion.  It faded pretty quickly.  I've got to remember to premedicate with Benadryl!!   Then, we were off to the airport.

We got to our gate earlier than we had hoped, despite the horrible nightmare that is security in Tampa.  Seriously, Atlanta has been recognized as the world's busiest airport in passengers since 1998 and in landings and take-offs as well, since 2005, with 92 million passengers moving through in 2011 and almost 1 million flights (923,991 to be exact). Meanwhile, Tampa dealt with 33,000 flights and 16,732,051 passengers last year (see wikipedia if you don't believe me!!!). Despite these facts, getting through security in Atlanta is a piece of cake compared to Tampa with their security workers trained in the mode of Barney Fife crossed with I'm-Gonna-Sit-on-My-Ass-and-Show-YOU-Who's-in-Charge-NOW!!!  It makes passing through their "security" simply BIZARRE!!!!!  So of course, as I was getting the requisite Tampa pat down, B was in detention, goofy boy, because he had left my unfinished bottle of water in his jacket pocket and it was discovered...yes, indeed, more than three ounces of objectionable his jacket was x-rayed with his shoes in his standard issue, grey bucket.  Anyhow, we made it through, to find that an earlier flight with Delta is not a thing to be had.  They book every flight to the gills, and then some.  So, we chilled and chatted until our regularly scheduled flight.

The flight was fine.  Found our car on its unfamiliar side. Decided I felt fine enough to make a run for supper and a few groceries at the Dekalb Farmer's Market on the way home.  Traffic was amazingly light and we made our way with few difficulties.  Just when we thought we were home free, and dealing with our last significant challenge, turning left across two busy oncoming lanes with no turn arrow, with cars zooming past us through the green light, we see it...before our very eyes...oncoming idgit lady, turns to her left directly into the people heading in her direction past us.  I cover my ears!!!  B grabs hold of the OH SHIT handle in the ceiling...but, oddly enough....fails to apply his magic brake....and...BOOM!!!  OH, YEAH! She is rammed full force, to her right side by folks zooming past us.  I was just afraid someone was going to end up spinning around and heading into us....having had some dealings with that before!!!  But, no....they were suspended in time.  But, only for a moment...this is Atlanta, after all.  Folks started zooming around us and the two dead cars like ants in a disturbed ant hill.  Never mind that there was no space to be zooming in.  "GO!!!!  They look fine!  GO!!!!!", shouted the calm, sweet, ever caring and concerned doctor and philanthropist to my right!  "Just go!!!"  So....GO we did.  We had a delicious dinner at DeKalb...better than anything we've ever had in Tampa and for both of us...a mere $17.00.  We picked up a few things and made our way other excitement to be had.

Until next time.....whatever you do....just GO!!!!!!! - c

Ran 3 more miles today...

....and pruned two butterfly bushes into submission while Brent ninja'd all the branches away. Then, we made a trip down the mountain to a nursery where we got a Brown Turkey Fig, 2 perennial geraniums, and an Indian Holly Fern.  B dug holes for me in the back shade garden for the last three and planted the Fig for me in the front sunny area.  Meanwhile, I cooked oven roasted chicken thighs with lemon, onion and thyme with roasted cauliflower and maduros for tomorrow. For tonight, there was rice, grilled asparagus and tuna, along with roasted portobello mmushrooms, all flavored with a soy/ginger/lime/fish sauce/sesame oil dipping sauce.  Pretty good, I have to say! is back to work tomorrow.  Enjoy your week - c

Saturday, September 15, 2012

1 week post anti-PD1 infusion....

...and I am doing pretty well. Put in 2 miles with B and Z yesterday and made a quick trip to and from Knoxville to see the kiddo's and deliver their new phones!  Ran almost 3 just now...had to cut it a little short to avoid yappy little dogs who drive Z crazy. Wouldn't want him to think they are possums and smush'em!!!  Shoulders and wrists remain achy, but...pain and discomfort won't kill you!  The weather is lovely, blue, and bright here today and we will be attending a wedding later this afternoon on the mountain.  Wishing you a beautiful life together, Hayley and Brandon!  Happy days - c

Thursday, September 13, 2012

5 days post anti-PD1 infusion...

...and I want to be one of the Bangin' Rackettes with Clairy Browne!!  Weekend = tired. Monday worked but felt crappy and my sweet (and I really mean that!!!) nurses one by one...said..."You look tired!"  "You don't look like you feel good!"  "You're pale.  Are you ok?"  And ultimately..."Why are you here???!!!"  Oh, well. Worked anyway.  But, thanks to an awesome boss, (who would have let me off, period....just can't stand to do that to already scheduled patients!) I left an hour early since my last hour wasn't booked yet.  Anyhow, had really nasty muscle calf myositis with the flu...or generalized muscle soreness with a fever.  By Tuesday I was better, with the more expected arthralgias...most in my wrists and ankles, but the sore muscles were resolved.  Wednesday was pretty ok and today: I ran 2 miles with Z, picked up limbs, pruned some shrubs, made a bouquet from the last of my roses, picked the last cherry tomatoes, did laundry, paid bills, tidied the house, changed bed linens, made braised chicken thighs in Riesling for supper, roasted a pork tenderloin to take to the kids tomorrow, and grilled zucchini and peppers to go in quinoa for tomorrow's supper.  It is finally cool and breezy I also cleaned the porch and set it up for chillin' after work.  Anyhow, in my next life I will definitely come back as a lounge lizard!!!  Lovin' Clairy Browne and the Bangin' Racketts. Check them out!  You'll feel better the minute you hear matter what ails you!

...I'm gonna write what I want you to do to me in a letter.  I'm gonna write it for good or for bad or for  worse or for better.  I'm gonna write it for you so that you can be my me get head.  Darling, I'm writing you a love me get out....of my head! 

Love 'ya! - c

Sunday, September 9, 2012

I am tired now....

I do not enjoy the sort of posts I have felt obligated to share today, they hurt my heart and my head.  I am doing ok.  Feeling rather tired, as though I did 5 miles AND the cardio AND abs INSANITY workout yesterday....which I most certainly did NOT!!!  I'd better get the house together and laundry done so I can be back at work tomorrow.  But...I promise stories of the adventure that is travel to Tampa will come.  Enjoy your Sunday. Love - c

Info on test for PD-L1 and the availability of anti-PD1

As I mentioned in my June 10th post, I agreed (as did most other patients in my study) for BMS to test my tumor for the expression of PD-L1 on its surface.  The presence of this ligand on tumors, as reported June 2, 2012, New England Journal of Medicine, from the BMS-936558 anti-PD1 study of patients with a variety of tumor types, indicated that 25 of the 42 patients [tested] had tumors that were positive for PD-L1. "Of these 25 patients, 9 (36%) had an objective response. NONE of the 17 patients with PD-L1 NEGATIVE tumors had an objective response....These preliminary results must be interpreted with caution..." Yada yada yada!!!! this point well as innumerable anxious melanoma patients would like to know if their tumor expresses PD-L1 or not.  Since, given the data (minimal though it is), it is unlikely that a tumor WITHOUT PD-L1 would respond to anti-PD1, while a tumor that does have that ligand....might.

So....Where's the test?  Where's the result?  Dr. Weber still does not have the results himself.  He says that BMS keeps giving him the run-around, saying that they have to create a test that is valid, reliable, etc. (Important to be sure.) Currently, he is under the impression that he might get results in October.  When will I get results?  On MY tumor?  Probably....about never.  I am told that to give me results is tricky because this is still an experimental test on an experimental point about an experimental ligand whose implications are unclear, ambiguous, and with questionable import.  SERIOUSLY??????  Do you think, that at this point in the game, there are any folks in this study who do not realize that this is all a crap shoot?????  Do you not see that we deal with the ambiguities of the whole entire thing.....DAILY?????  Is it not clear to you peeps, that I, and all my fellow ratties, sign, and acknowledge said crap shoot papers, repeatedly...putting in writing that we KNOW this is an EXPERIMENT and the outcome is best?????  You think, at this point, that we will not be able to comprehend that the results of this test for PD-L1 were acquired with a new technology, yet to be fully proven?  You think, we are unable to realize that the ramifications of the presence of PD-L1, or not, on our tumors, is not fully determined?????  I'm not sure what any of you really think, but, I suspect you know we understand all the bull, much better than you do.  However, here's the rub...for you and think we will run for the hills and leave your study in the lurch, and seek better treatment elsewhere, if we learn our tumors are negative for PD-L1.

So, folks keep asking me...."When will the test for PD-L1 be available for us like the BRAF testing currently is, so we can make more informed decisions about taking anti-PD1 or not?"  My answer....not soon.  It all depends on when BMS (or some other company) is ready to put it out there.  And that, depends on many things.  It depends on how well their anti-PD1 product really does in its Phase 1 trials.  Then, how it does in Phase 2 trials.  And then, what the correlation between those results and the presence of PD-L1 on those tumors turns out to be.  For all the folks who want anti-PD1 to be magically available TODAY....I have some sobering news.  While there is talk, of starting Phase 3 trials as early as 2013 with a BMS statement regarding a 'registrational development program' in which they are reportedly trying to move via a filing they have made with the FDA, 'from early clinical development in Phase 1 trials straight to a Phase 3 registrational program and expect the registrational trials for melanoma to begin at the end of this year, early next year'.  The Phase 1 trials are not completed. In fact, they are not even close.  Take my trial for instance. It is set up to last 2 1/2 years from start to finish. Some of us have been in that trial for almost 2 years.  That's just the first group.  They didn't start ENROLLING the third group until around January or so of this year.  In March, only one patient was two doses in, in the 10mg/kg group.  So, that means, that the results for my study, that started treating patients in 2010 will not be reported out, with final results, until the last patient (yet to be enrolled!!) has completed 2 1/2 years in the study.  At best, that will be roughly in 2015!  At, best.  Sorry.  But, that is the sad truth.

So, when will anti-PD1 be made available?  When will a test for the PD-L1 ligand be out?  I don't know.  And, it is very frustrating be the rat...with no say or voice in the decision.  Well....maybe a little voice!  I'll keep speaking, if you keep reading.  Hang in there my friends - c.

Available melanoma trials at Moffitt, in Tampa, Florida

While interested folks will be much better served by checking out national sites for cancer trials and the Moffitt web is a partial listing of melanoma trials currently ongoing at Moffitt.  I do not profess to know which are currently recruiting.  If you are interested...CALL!!!!! EMAIL!!!  1-888-MOFFITT (1-888-663-3488)

Phase 1 trial with multiple peptides and escalating doses of anti-PD1 (BMS-936558) for patients with Stage III/IV resected melanoma (my trial) and the sister arm that is for Stage III/IV unresectable melanoma.

Variations of the above trial...some with vaccines, some without, some specifically for patients who have failed ipi.

Pilot study (? phase 1) of Oncovir Poly IC:LC and peptides +/- CP870,893 at one of 5 dose levels for Stage III/IV resected.

Phase 1 study of MK 3475 (Merck's anti-PD1 product) for unresectable Stage III/IV with measurable disease.  Reportedly in open recruitment.

Phase III, Resected, Randomized trial of ipi vs include 1,500 patients.  (Poor little ratties!!!!!!)

A randomized Phase 2 study of Yervoy (ipi) with Sylatron (peg interferon) for patients with unresectable Stage III/IV melanoma.

Ipi 3 mg/kg vs ipi 10 mg/kg for Stage III/IV unresectable.

Trial with a RAF kinase inhibitor for Braf + patients with measurable disease.


Biochem with combination of:  BRAF inhibitor + cyclophosphamide + high dose IL2 + fludarabine

A trial that combines HSP 90 (heat shock protein 90...a chaperon protein that promotes stability in other proteins) and BRAF inhibitor for Stage III/IV unresectable patients.  (Background:  this is to see if the duration of response to BRAF inhibitors can be extended with this combo.)

Hope this helps.  Errors may abound...but please, call!  Check out any options that might be available to you!  c

New informed consent for my trial..opens at least 4 slots for Stage IIIC resected melanoma patients!

Being a lab rat is a funny, rather demeaning position to be in.  Choices are participate or not.  The rat may wish to make changes in timing, requirements, pain control, information access...oh well, too bad so sad!!!!!  NOT gonna happen!  On the other hand, you may walk into the office for treatment and be handed an "updated" consent form that you have to sign for the study you are already in and have already signed an agreement for.  In other words, the rat cannot change the rules in the middle of the game...but the organization, investigator, drug company...CAN.  And so, I signed.

On the good side...the new consent is much clearer.  It makes the breakdown of the study into three groups of 10 patients understandable, stating, "one group will receive a dose of 1mg/kg, a second group a dose of 3mg/kg....." etc., rather than the vague "escalating dose" comment in the prior form.  Well, done.  I give my personal team of Brent and Ruthie, and the dedicated nurses of the CRU, full credit for that clarification!!!  HA!

It also makes it very clear that apart from a few bits of lab during screening and scattered among other visits, the leukapheresis, the peptide vaccines, and the anti-PD1 drug, BMS-936558, and your insurance company will pay in full for EVERYTHING else.  They make it clear that if you have been "injured as a result of your participation in this study," Florida law limits the liability of Moffitt in this circumstance and they will certainly NOT "pay for lost wages, disability, or discomfort."  Additionally, you should..."be aware that your health care payer/insurer might not cover the costs of study-related injuries or illnesses."

The new consent also tells us that patients like us have "a greater than 1 in 2 (50%) chance that [our] melanoma will return." And, "there is no known therapy that is likely to cure your melanoma or increase your survival. If your melanoma had spread to the lymph nodes but not other organs, then alpha interferon...could increase your survival by a small margin, about 1 in 50." This makes me bonkers!!!!!!  Does this not fly in the face of the graphs and report by Weber I just put up on the prior post?????!!!!!!

The only real and beneficial news in the NEW CONSENT is that:  NOW...this trial is open for resected stage IV melanoma patients like myself AND...STAGE IIIC RESECTED patients, as well!!!!

While, I will continue to do my best to improve the way lab rats are treated....after all...we're people too!!!!, I am glad, and consider myself "lucky", given my circumstances, to be in this trial.  The new opening for Stage IIIC patients to participate is great.  But, where the heck are the Stage IV resected peeps who could have signed up?????  I see so many demands for anti-PD1 trials on all the forums, and yet, in order to fill the seats, this trial, as well as some others at Moffitt have had to add Stage III patients to their protocols.  I really don't know the answer to my question.  Are Stage IV melanoma patients with no evidence of disease really few and far between?  Do we pass into the non-resectable category too quickly for many to make it into a trial?  Are we lackadaisical about the need for additional treatment?  Do we hide our heads under the covers and pretend that, "OK, got rid of that pesky melanoma, and am now good to go!"?  Do local oncologists mislead patients about melanoma and the odds of recurrence due to their lack of knowledge about that particular subset of cancer patients?  I don't know....but if there are some interested Stage IIIC/IV resected melanoma patients out there.....there are still some open slots (4...we were told) for you.

Is interferon still an appropriate treatment??? Study of ipi on Stage III/IV resected melanoma patients...

To me the question this raises, is why, given the increasingly weak justification, the denial of ipi (and perhaps in the future, anti-PD1) as the standard adjuvant therapy for Stage III/IV melanoma patients is allowed to continue.  It will take many years, and innumerable additional deaths of human lab rats in the "control arm", to satisfy pseudo-scientific and bureaucratic requirements at our current rate.  Is this appropriate?  Humane?  Reasonable? Tolerable?  I think NOT!!!!!!!
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1 year progression free survival, Stage IV Melanoma

These are 1 year, progression free survival curves for patients with Stage IV melanoma. As Dr. Weber noted in our conversation, most of these patients progressed by 4-6 months.  It seems that this shows the substantial benefit of therapies like ipi and anti-PD1 as opposed to none and others.  Yay??????????

Survival Curves for Stage IV melanoma

This is a composite of data from 42 phase 2 clinical trials in patients with Stage IV melanoma.  It was published to be used as a benchmark for determining whether studies should advance to a phase 3 setting.  As you can see, when you take the 0.5 point, and move it over to the curve, median point of death is around 6-7 months.  Cheery, huh????

My anti-PD1/vaccine trial "results"

I am now more than 21 months into my Stage IV, NED (resected), 1mg/kg anti-PD1 (MDX-1106 or BMS-936558...your choice) trial with peptide vaccines at Moffitt.  For those of you just tuning in:  I have been considered a Stage IV melanoma patient for 35 months and was first diagnosed with melanoma in 2003.  I have never had any treatments other than this one and surgeries.

We did our usual Thurs/Fri trip to Tampa and all was well.  There was the fun, the silly, and the sad as usual, but for now, here are the things we learned.

OUTCOMES at this point in my cohort:  So far, it seems, as I reported in June, two patients died early on in the trial.  One of the deaths was subsequent to brain mets that had not been noted when they entered the trial and I am not certain of the cause of death in the second. In total, 6 patients out of the 29, have progressed. One, whom I've mentioned before, experienced spontaneous regression while being watched to determine treatment, and continues to remain stable with NO ADDITIONAL TREATMENT given as yet.  The other 5 are reported to be doing well on regimens of ipi (now yervoy) or BRAF inhibitors. The remaining 21 of us....carry on.

Dr. Weber remained positive about these results, saying, basically, that given the expectations of survival in this high-risk group we were "doing better than predicted" and based on historical data, after 6 months, at least half of us in this group would have been expected to relapse.  In other words, at least 15 of us would have been expected to relapse prior to this point in the study.  (See slide on next post.)

Sadly, these outcomes remain "excellent" in melanoma world.  Dr. Weber has already determined in prior work, that ipi as an adjuvant treatment for Stage IV, resected melanoma patients, produces at least a 60% survival over 5 years, so one could expect that anti-PD1 therapy which has triple the response rate of ipi, would have similar or better results.  Obviously, we lab rats have yet to prove that out.

For more on that point, check out the article:
Extended dose ipilimumab with a peptide vaccine:  immune correlates associated with clinical benefits in patients with resected high-risk stage IIIC/IV melanoma.  Journal of Clinical Cancer Research, 2011, February 15.  Authors:  Sarniak, A.A., Weber, J.S. (and others).

Which basically states, "Adjunct [ipi] following resection of melanoma at high risk of relapse appeared to be associated with improved outcome compared to historical reports."  (See set of slides in upcoming post.)

The only other solid point we discovered about my trial in particular was in regard to the vaccine component.  I asked Weber why he had decided to use the vaccines in addition to anti-PD1 in my trial as well as in some of the new ones at Moffitt.  He stated that he was just using them to generate antigen specific T-cells so that they can be utilized as indicators of the effects of anti-PD1 on T-cells.  When I asked how that was working out, he replied that the dosage levels (1, 3, and 10mg/kg in my group) showed no increased effect on T-cells as the dosage increased.  A little disconcerting for folks thinking they might get more benefit with greater quantities of medication.  (Although this was already being proven in the prior study of anti-PD1 that I reported on earlier.) Also a bit disconcerting for those of us who thought perhaps we would acquire a double whammy with which to attack our melanoma with the combined effect of the vaccines and anti-PD1. These same vaccines were used in combination with ipi in a prior study and demonstrated no effect.  However, Brent continues to hope that for some folks, a positive effect from the peptide vaccines is there...if hard to calculate...since they did work for the mice!!!

See c

Sunday, September 2, 2012

21 months....melanoma free

CT scans (neck, chest, and pelvis) along with an MRI of the brain done yesterday, show "no substantial change" from the last scans, (way to CYA my little radiologist friend!) leaving me NED for 21 months now. Good news, obviously. That means I will head to Tampa next week for more anti-PD1 and a visit to the World of Weber. Brent and I will try to procure as much info as possible and share it here on our return.  Lately, there has been a dearth of information on the coming availability of anti-PD1 or any other substantial melanoma news in the literature. Though it does seem that both the BMS and Merck products are producing positive effects in melanoma patients, both companies are refusing to comment on when their drugs will be seeking FDA approval, nor are they offering their treatments for compassionate use. Both do have trials on-going and are doing more bit by bit. Amplimune appears to be recruiting for their anti-PD1 product and have some trials in which brain mets are not an eliminating factor. Apart from those tidbits, I have little more to offer. Perhaps I will have more to share next week.  To celebrate, B and I did errands yesterday and tons of yard work today! Did run a couple miles with the monster before pruning roses, weeding flower beds, and ripping out B's done tomatoes. Oh,'s the little things!  Love - c

Saturday, September 1, 2012

To new peeps and old...

...much love! To my newly found, old peeps (and I refer to our duration of friendship over time only!!), it has been great to hear from you! I can hardly believe it has been 30 years since those high school days. I wish each and every one of you my very best and continued success in all that you do.  To my old peeps who have blessed me with their tolerance for my daily shenanigans, day after day after day, I give my thanks for the blessings you bring to my life. To the peeps I have grown to know and who continue to join my life along the way, I can only hope that I provide some light and support for you, as you have for me. To the peeps I have accumulated in other countries, using Google Translate and other devices to read these apologies. My crazy descriptors give English speakers pause, so I know my jargon must be difficult for you at times. I hope I have helped you find information you needed in your search. To those who want to battle melanoma in every corner, in every way...I'm your girl.

To you all:  push hard, love each other, and don't forget to breathe. Love - c