Category: Blog

Our trips to Johns Hopkins for the melanoma GVAX vaccine trial have almost become routine now that we are half-way through the trial – two injection visits done and two to go. But I did have another indication yesterday that our efforts to fight off another attack of this dreadful disease are only just beginning.

Thankfully, there was no drama associated with this visit. Our study nurse, Susan, had Robert lie down while the phlebotomy nurse drew all the blood samples – a procedure that made him pass out before the first injections on November 8. This time the precaution was unnecessary as this time there was no similar reaction. And, his blood pressure stayed within the “normal” range at about 135/84 – numbers that are high for Robert but nowhere near the dangerous level that they reached last month.
We met with Dr. Lipson next, and he did a very thorough exam – particularly, palpating every lymph node Robert has left and examining every inch of his skin. He asked about the history of a few “spots,” and that led me to bring up a subject that had been on my mind ever since our meeting with the dermatologist a few weeks ago. As I told Dr. Lipson, I had two concerns after that visit:

First, I asked the dermatologist to show me any spots he was concerned about and help me learn how to recognize abnormalities of concern. As he carried out his exam, he pretty much ignored that request and froze a few spots without showing them to me first.

Then, he said that Robert should have skin exams every four months. When I pointed out that Dr. Lipson had suggested a three-month frequency for the skin observations, the dermatologist repeated that HE felt four-month intervals are all that’s needed.
Dr. Lipson asked why I had the reaction I did – was it because of the advice the derm gave, or because of his manner in giving it? I think Dr. Lipson wanted me to consider an aspect of our health care choices that some people might not give much thought to: how much confidence would I have in this physician going forward? If I had confidence in this man’s skill as a dermatologist, would I be able to  “forgive and forget,” and be content if Robert continues under his care?
It’s a hard circumstance for me to be in. I certainly felt that this doctor gave Robert all the attention he needed during the November visit and thoroughly examined his skin. He communicated well with both of us even though he tacitly declined my request for a teaching session. All in all, I have no reason to doubt his skill and proficiency. Further, I have no reason to believe that there was any deficiency on this doctor’s part that caused Robert’s melanoma to go undiagnosed for so long – if there’s blame to place, it’s with Robert and me. Some of the top melanoma experts in this country have discussed Robert’s case with us in detail and have not indicated that they thought any signs of melanoma went unaddressed in his previous medical care. Melanoma sometimes presents like a cyst and sometimes doesn’t show up on the skin. I don’t believe there were indications of melanoma that any of Robert’s physicians did not recognize.
Dr. Lipson told us, as we already were aware, that Robert is a likely candidate for a recurrence of melanoma, having had the first one. He wasn’t talking about a recurrence at the same site, though he said that’s certainly possible – his concern was about a primary cutaneous melanoma cropping up at another site and growing very quickly. He explained, as has Dr. Sharfman on our two visits with him, that this period (in the first few years) is the one in which new primary sites are most likely to occur, and that’s why most melanoma specialists suggest skin screenings every three months during that period. And so, even if we have confidence in the dermatologist Robert’s been seeing – which we have no reason not to – the education I’m seeking is a good idea. He suggested that we see Dr. Tim Wang, a Hopkins dermatologist who has “made it his mission to educate patients” about what to look for on their own skin. Dr. Lipson said it might not be necessary to see Dr. Wang every three months – another dermatologist at Hopkins could take on that care if we decide not to go back to the guy we’ve been seeing.
It’s not my decision to make, and if Robert decides to continue with the current dermatologist I’ll figure out how to deal with that. But in any case, I do want the education from Dr. Wang and will try to get that arranged for our February dermatologist visit.
Cycle 2 injections
The second set of injections of the GVAX vaccine went pretty smoothly. Both Dr. Lipson and Susan told us that we should expect Robert to have a somewhat more vigorous reaction to these shots – more redness, swelling, and itching. Susan explained that now that the vaccine has been introduced into Robert’s body, his immune system should be on the look-out for it. When the newly injected cells meet up with cells in his immune system, they “have a party” and that causes swelling, itching, and redness. I hope it’s more akin to having a fight than a party – that’s what immune cells are supposed to do. But in any case, the reaction may be more intense this time.
Robert’s reaction when he received the injections was about the same as last month. At the sites on his thighs closer to the groin, he didn’t feel very much as the vaccine went in but did feel a little burning after a while. The injections at the lowest sites, closest to his knees, caused a burning sensation as they were given. This may be because there is more flesh on the upper thighs – just a guess, but it seems like a logical one. Susan explained to us last month that the syringes don’t have exactly the same amount of vaccine (what’s important is that the total amount injected be the same each month), and she uses the higher doses at the higher sites. As far as I can tell, this is all theoretical – the theory being that the fleshier upper-thigh area would be able to handle the higher doses. It seems to work out that way – the upper sites don’t burn when going in but get bigger reactions in the long run.
Susan also noticed the other reaction that repeated this time. After a few of the injections had been completed, she commented that Robert’s breath was beginning to smell like garlic. She explained that this is because of the dimethyl sulfoxide (DMSO) used as a preservative in making the vaccine. DMSO is made by oxidizing  dimethyl sulfide, a by-product of the wood-pulping process known as “krafting.” It’s been used as an industrial solvent for more than 60 years and in medical treatments for 50 years because it is known to penetrate the skin without damaging the tissue. When it is used as a vehicle for topical administration of anti-inflammatories, a known side effect is the development of a garlic taste in the patient’s mouth. Susan has noted “garlic breath” in other patients to whom she has administered the melanoma GVAX vaccine.
So far, that’s the most excitement we have to report for cycle 2. All in all, not a troublesome day.
Call or comment here if you have questions.

However you look at it, yesterday was not a normal day for Robert and me. We had already cast our ballots, thanks to the early voting offered by D.C. I did an early run to the park with Chewey, and we were off to Johns Hopkins at about 8 a.m. to get the first of four doses of the GVAX melanoma vaccine that will be administered for the clinical trial Robert is enrolled in. It was the start of another one of those days that didn’t go quite as planned.

We checked in at the phlebotomy lab in the Weinberg building at about 9:30, our appointed time. After some initial confusion about who was going to take the blood, we went into the lab with Robert Gray, the nurse who draws samples for our trial. Just as he was finishing the last of his tubes – one of two that seemed particularly big to me – his patient checked out. As in, passed out!
This wasn’t just a case of Robert nodding off in his chair, although he was snoring pretty loudly! I’ll spare you all the details, but suffice it to say it was a frightening time for me with all the flurry of activity that surrounds a “code” in a hospital. Afterwards, Robert’s doctor carefully reviewed all that happened, including his recovery and responsiveness after he regained consciousness, and came to the conclusion that he had a vasovagal response – to what, we are not sure. Essentially, as Dr. Lipson explained, his body was pumping adrenaline, and that started a “calm-down” reaction. Once all the adrenaline was gone, all that was left was the calm-down reaction, and Robert passed out.
Essentially, in a vasovagal response the patient’s blood pressure drops suddenly, causing him/her to faint. These reactions are typically seen in response to anxiety, stress, standing too suddenly, dehydration, or a drop in blood sugar. We ruled those causes out – Robert was not anxious or stressed by the prospect of getting the vaccine, and he has never been squeamish at the sight of blood or having blood drawn. His one previous, similar incident happened when he was being treated for a giant tear in his retina and the ophthalmologist injected avastin into his eye. (I wasn’t there – and am glad, in retrospect, that I wasn’t! It was frightening enough to have it happen in a very fine medical institution, where all the systems and personnel seemed to work very well.)
After my initial, fearful reaction to watching Robert lose consciousness and come back to some semblance of himself, I was concerned that they might not give him the vaccine. Robert regained his wisecracking sense of humor pretty quickly, and Dr. Lipson was quick to rule out a seizure or other condition that could have caused him to lose consciousness. So, after we rested for a while, we all agreed to go forward.
The procedure itself was as we expected. Susan, the study nurse, applied lidocaine on Robert’s thighs in patches about three inches apart, three per leg, and covered each one with a bandage. About ½ hour later she returned, and another nurse arrived from the lab with the GVAX syringes. Each injection took about a minute. After she finished each thigh, she applied band-aids to each injection site. A little after three we were done.
After Robert dressed and we sat a little while longer, Susan came back to check us out. We were home by about 4:30.
Not the day we were expecting. But neither of us is complaining, either. We got what we went for – a chance that, if there are melanoma cells floating around in Robert’s body somewhere, his immune system will react to this vaccine and kill them off. Perhaps we will never know whether it works, but we are ready to complete the study procedures on the chance that these researchers are right.
Tomorrow – a punch biopsy. We plan for Robert to be lying down when they take the blood this time, and I won’t be surprised if the “other” Robert, Nurse Gray, draws the samples more slowly next time.
I’ll post again if there’s anything else to say. Feel free to call if you have questions.

Robert is scheduled to begin the GVAX trial at Johns Hopkins next week. If you want to know what it’s all about, and/or why we decided to go this route, this post will explain.

First a refresher – this trial is being done to test an experimental vaccine that is intended to boost the body’s immune system to fight melanoma. Although we know that there are no active cancer cells growing in his body, we don’t know whether there are tiny, inactive cells (micro-metastases) lurking in there somewhere that might decide to become active at some point in the future. If there are, we hope this vaccine will stimulate an immune reaction in his body to kill them.
Robert is at high risk for recurrence of his melanoma because this was a very deep lesion – 9.5mm. That means that it extended down into the dermis, close to where microscopic cancer cells could enter the lymphatic system and might be transported to other parts of his body. So, while it would be nice to think that all the cancer was removed, as the biopsies indicated, our doctors don’t think it’s prudent to count on that. Therefore, they have recommended that he participate in this trial so that he can get the vaccine.
The trial’s purpose is study the safety of the vaccine at different doses. The first study group received a low dosage of the vaccine, and when no serious adverse reactions were found, the second group began to receive higher doses. Robert is in this second group.
The vaccine will be administered four times, at 28-day intervals, beginning on November 6. Each month, the correct amount of vaccine for Robert’s body weight will be injected at six sites on his arms and thighs. One to two hours beforehand, a skin-numbing medicine will be applied to each vaccine site. After the injections, we will wait about a half hour to see if there is a reaction. As long as there’s no bad reaction, he will be discharged.
Two weeks after each vaccination, Robert will call our study nurse, Susan, to report on any side effects he has had from the vaccine. Common side effects are redness, swelling, itching, and/or soreness at the vaccine sites. Less-common side effects are flu-like symptoms, including fatigue, rashes, low-grade fever, and chills, as well as swollen lymph nodes and flare-ups at the injection sites. Susan told us that so far none of the study participants have had more serious side effects.
After the first and fourth injections, we will return to Johns Hopkins two days later for a biopsy of one of the vaccination sites. The biopsy sample will be studied in a research laboratory and/or by a pathologist to look for effects from the vaccine.
One month after the final vaccine, in late February, Robert will have a check-up including blood work. The final visit will be April 23, when he will have the six-month CT scan of his chest, abdomen, and pelvis and a brain MRI in addition to the physical  exam and blood work. I guess that makes April 23 my next, highly anticipated date with N.E.D. …
The Food and Drug Administration considers this GVAX vaccine to be a kind of “gene therapy,” and the FDA wants all patients receiving gene therapy to undergo five years of follow-up, looking for “late side effects.” These annual visits will include physical exams, blood tests, and scans. If possible, we will have the follow-up care with Dr. Lipson here in D.C. at Sibley Hospital, which Hopkins has acquired recently. Dr. Lipson will be starting up a research program at Sibley, which is just a few miles from our house.
So – that’s the scoop! Questions? Feel free to call.

Nearly five months ago I suspended my consulting and freelance business in the face of Robert’s then-impending surgery to remove a large melanoma from his scalp. I was too distracted, not to mention too busy with medical appointments and emotional upheaval, to concentrate on work, and I didn’t want to let any clients down by not meeting deadlines or by handing in sub-par assignments.
Now that the scare of a four- to eight-month prognosis is behind us and Robert’s status is “healthy” and “No Evidence of Disease,” the question comes up from time to time: am I “ready” to go back to work? And the answer is – NO!

I had a very busy summer playing Nurse Ratched in June and July, and then traveling to New England in August and to Asheville and Ft. Lauderdale in September. October has been a waste, basically – I have nothing to show for it. As a matter of fact, this post was inspired by my weekly Saturday phone date with my mother, who (as usual) asked what I had done this week. I couldn’t think of a thing! I was busy all week, to be sure – there weren’t any patches of time when I batted around looking for something to do. Where did the time go?
I’m sure if I thought hard about it I could come up with something useful or productive to report for the last seven days. But off the top of my head, I can only come up with things I didn’t do. Two quickly come to mind: write about the upcoming melanoma vaccine trial at Johns Hopkins, and start the email correspondence with our Thanksgiving crew to plan the menu.
Both of those things will be on my immediate list of tasks. But first, I’m taking on an even more important one – setting priorities for this next period of time, however long it lasts. I’m sure this list will change over time, but here’s my starting point:

1.      Taking “care” of Robert
As I told one of the nurses at Hopkins last week, my main job right now is to see to it that Robert can continue to do what he wants for as long as possible. To some extent that means looking out for his well-being when he loses track of what’s important. I have to walk a fine line here so I don’t become the nagging, fawning wifey I’ve never been – but I do want him to wear sunscreen and a big floppy hat, get some exercise, and do whatever else the doctors tell him to do.
I plan to accompany him on all his medical appointments for the vaccine trial. I also plan to go with him to the dermatologist on a search for any suspicious spots on his body. I want to learn what to look for and photograph any moles or freckles that bear watching, as Dr. Lipson  suggested.

2.      Taking care of myself
I probably can’t do #1 if I don’t do this, so I might as well state this priority near the top of my list.
My gym schedule will undoubtedly slip a bit – I can’t work out four days a week and at the same time go to all those medical appointments, particularly not in weeks when we have to see doctors two or three times. I’ve had a regular morning gym routine for months – muscle training on Mondays, abs and stretch on Tuesdays, active yoga on Wednesdays, and TRX on Fridays. I’ll go as often as I can, and fill in with long walks with Chewey, yoga at home, or some kind of aerobic exercise as I need to.
I also plan to keep working on my diet. I’ve lost about 25 pounds and would like to keep it off. Besides, I like cooking and eating healthy foods. I’m going to try to wrestle some of the weekday cooking away from Robert, even if it means putting up with how he “cleans” the kitchen afterwards …

3.      Working on this website
I registered my name as a URL last winter with the intention of moving my work website there over the following year. When I started this blog last June, I did so at that URL. As we approach time to renew my by-words URLs, I would like to build this website into one that can replace the one I set up when I started freelancing in 2007.
My goal of learning more about Drupal 7 is only partially accomplished. Of course with Drupal there’s always more to learn, and I don’t have a plan for how to do this on my own. But it is important because …
My work website is a mess! It was more important for me to work on it when I was actively looking for clients, but with BNA projects and Risk Retention Reporter taking up all my work time over the last couple of years I have not kept it up. The portfolio is lacking, and I never did make the visual presentation work out the way I wanted it to. But I don’t want to put any more time into it – this website offers me a clean slate.
It’s time to envision what I want my web presence to be, whether I stay retired or not. As I know from working with clients, this is not an easy job – and I don’t expect to complete it by the by-words.com renewal date. But I would like to get it done before I have to think again about whether to “go back to work.” April, after the Hopkins trial is over? We’ll see.
*******************
I think three big ones is enough to articulate in one day. We’ll revisit this topic again over time. 

Our day at Johns Hopkins on Friday turned out to be shorter than we expected – they called at the last minute to say not to come until 10. We were very busy (yes, a little “hurry up and wait”) until 3 p.m., and we left with only one reservation – that we still didn’t have much more information than we left home with. 
We met first with Susan Sartorius Mergenthaler, who went through the “routine” with us. We got a potential schedule for what the trial will be like if Robert passed all his tests later in the day. We were able to push the proposed schedule for the first injections off until the first full week in November, allowing Robert to get past his deadline for a cert. petition to be filed in the Supreme Court on November 1 without interruption – and also allowing for our Thanksgiving travel schedule not to delay some of the follow-up tests.
Susan then walked us through every little detail of the “informed consent” document that Robert had to sign before anyone else could carry out their tests. Now we were ready to see Dr. Evan Lipson, who “poked and prodded” to make sure there were no enlarged lymph nodes lurking around in Robert’s body. He also asked a million questions about medical history and gave us advice about follow-up care regardless of whether Robert is accepted into the study. Some of his advice we had heard before – sun screen, wide-brimmed hat, regular check-ups with an oncologist (he suggested every four months), dermatologist visits every three months, and in between those visits, check all over Robert’s body regularly to see if any spots look suspicious, or look different from last time we saw them.
Here’s what was new: Dr. Lipson suggested that if we see something suspicious, we should take a high-quality digital photo of it so that we can compare the baseline with what we see in another month or two. This we can do – it’s just a question of getting in the habit … Also, Hopkins did not do a thorough skin exam with a Wood’s lamp, as I expected – we should go to Robert’s dermatologist for that, particularly since he has been looking at Robert’s spots for the last few years. We will make that appointment as soon as possible.
Next we met Robert Gray, the phlebotomy nurse, who inserted an IV before taking several vials of blood to make sure our Robert is healthy enough to be in the study. After having an EKG, we scurried to get to Radiology in time for the afternoon schedule.
Let me stop for minute and say something about the people in the cancer center. Every receptionist and accounting person we met smiled and was pleasant, gave us time for questions and answered every one. The professionals – the nurses, Susan and Robert, as well as Dr. Lipson – wanted to know who we are as people even before they talked to us about the reason we were there. It did not seem like idle chatter – they really wanted to know about both of us. I have spent plenty of time in other medical institutions and don’t remember having such a pleasant experience.
Radiology was – well, efficient! First Robert had to drink 24 ounces of “stuff” for the CT scan. Then we had to wait a little while, and then they took him in for a very quick tour in their fancy machine. Down the hall we went to the MRI section, where we waited a very short time before they were ready for the test. This one took a while – and it was very noisy, even in the corridor where I was waiting but even louder for Robert. I lost track of time, but I think it may have lasted about 45 minutes.
After we got dressed, we waited about 10 minutes for the MRI technicians to make a copy of the study for us. We picked up the disk from the CT scan on our way out.
Our next stop was Bertha’s – our favorite Baltimore restaurant. It’s a short drive down Broadway from Hopkins to Fells Point – good thing, because it was after 3 and we were pretty hungry by then! Robert was allowed breakfast but no food afterwards, to keep the sugar he had to drink focused on any cancer cells that were active in his body. Although we believe and hope there are none, we don’t want to confuse the radiologist reading the CT scan into thinking that metabolic activity in his stomach is some wayward melanoma cells lurking there …
At Bertha’s, of course, we ate mussels! That’s what one does there … well actually, some people were ordering other things. We just couldn’t figure that one out …
Our ride home was longer than it should have been, probably a combination of rush hour traffic leaving Baltimore between 4:30 and 6 but also because an unexpected storm came up through Montgomery County. We weren’t home until about 6:30 – yes, a long day, but at least it didn’t start at 7 a.m.! And, there was a lovely hour spent at Bertha’s … we hope to be back there soon!
Of course, radiology at the end of the day – and on a Friday – means we got no instant gratification. Susan will call us when she has results. And, we will post the results here as soon as that happens. In the meantime, please call if you have something else to talk about … we really do like to talk with family and friends, and we particularly want to share whatever’s going on with you.

We got our schedule for Oct. 19 at Johns Hopkins – what a busy day that will be!

8 a.m. – Labs

9 a.m. – meet with Susan Sartorius, the nurse who’s organizing the study

10 a.m. – meet with Dr. Evan Lipson, melanoma specialist

11 a.m. – meet with Robert Gray, a nurse in the Weinberg Cancer Center (not sure what for …)

12:40 – CT scan

1:50 – MRI

2:20 – Tesla MRI
Don’t ask me what it all means, or who’s going to do what. I only know that it will be a long day – we will leave home by 7 a.m. and not return until sometime during the afternoon rush hour. And, that Robert will get a thorough going-over. 
Luckily, Loren will most likely be available to come visit Chewey – if not, we’ll figure something else out. 
If we still have any energy, we’ll go to the Kehila adult oneg that night – the speaker is a Kosher baker with a new cookbook, and I’m not sure we’ll be able to resist!
Believe it or not, I’m looking forward to this. Crazy, huh? It’s amazing how a good scare can keep you focused on what’s important in life!

When I first set up this site, I configured the New User settings so that people could register for an account but I would have to approve any new accounts before the user could gain advanced access to the site – to blog, for example. I want my family, friends, and colleagues with my same interests to be able to post their thoughts on the site. However, that experiment is now over – I found at first that some new account requests were coming from robots, but lately I’m annoyed by the number of requests I’m getting from people who are interested in “cars” or a jumble of characters, and that people were claiming to be my family, friends, colleagues, or clients when – clearly – they were not.
So, as of now, if you want me to set up an account for you, please use the contact form or one of my email addresses (if you know one!) to ask me to do that. I will follow through if I know you, or if you send me a working email address and links to web pages convince me you are interested in discussing melanoma, drupal, or publishing/journalism/blogging.
I consider this experiment with allowing people to set up their own accounts a success even though I’m changing course. It gave me a chance to see how this work on a client’s site if the client wanted to encourage a lot of users and traffic on a site. I know how that works now. I’m done with that experiment!
For this site, my main purpose was to keep my family and friends updated on Robert’s melanoma treatment – and it’s served that purpose well. A lot of my friends and family have registered already, and more folks who haven’t registered come to the site from time to time for updates. I will continue to use it that way, and to research other topics related to melanoma. (For example, I plan to write about immune response – it’s so interesting to me that Robert’s body tried to get rid of the cancer on its own, and I want to know how we can keep his immune system fighting hard once the vaccine trial is over.) 
I also encourage users who want to share information or experiences about melanoma, journalism, blogging, and/or drupal to participate in any discussions that interest them.
I’m not particularly interested in giving a soapbox to people who want to hype their own sites or discuss topics I don’t find engaging. I also am concerned about the possibility that unknown users would access my website for other purposes. There’s so much devilry going on on the web now – I don’t want to encourage that here.
So, as of now, I’ll set up accounts. I may still be annoyed by people seeking accounts, but at least I can delete their emails without having to remove their website accounts.

For those who were looking for an update from Robert’s first follow-up appointment – sorry, it will come a little late. That’s because he is hoping to enter the GVAX vaccine trial at Johns Hopkins, and the earliest appointment when they can do all the screening on one day is October 18. I’m happy that we know what’s next, but unhappy about the delay – I was looking forward to another date with NED long about now!

With the “watch and wait” follow-up, patients are screened quarterly with a Wood’s lamp. In this screening, the dermatologist examines the patient’s skin with a special light that highlights any contrast in pigmentation that indicates melanocytes have been destroyed by an immune response, indicating an early-stage melanoma. They also have follow-up PET/CT scans twice a year. Following that schedule, Robert would have been screened and examined (poked, prodded, etc.) last week, and at least we would know that there is no skin metastasis and none of his lymph nodes are enlarged – in other words, he would still be NED. The PET/CT would have been ordered in December.
So, we’ll wait until October 18 for his first follow-up exam. The good news (to me, at least!) is that he will also have a full complement of other scans and tests that day – including the PET/CT scan that otherwise would be given in December and an MRI of his body, including his brain. We expect these scans to be much more detailed and inclusive than the tests he otherwise would have 90 days after surgery.
The screening that day will repeat many of the tests he had during his pre-surgery physical, including standard blood tests and kidney and liver-function tests, an EKG, and blood tests for Hepatitis B and C as well as HIV. Bad results on any of these tests could knock him out of the study, even if none of the scans turn up evidence of melanoma.
But we’re fully expecting everything to go smoothly from here on out. And assuming all goes well, his first vaccine injections will likely be scheduled for the first or second Tuesday in November.
Guess who might make good use of early voting in D.C. this year?!
Call or email if you have questions. We’ll answer them if we can.

We had our last visit with Dr. Convit yesterday, and Robert no longer needs to keep his skin graft covered. There is still a scab over a small portion of the graft, but Dr. Convit said it should fall off naturally. It’s OK to wash his head in luke-warm water and to shampoo the entire site (hair or no hair …). No more bandages. No more Nurse Ratched! Yay for me! Progress for Roberet  indeed!
I will miss our periodic visits with the plastic surgeon because he has been the most encouraging and upbeat member of the team we have seen at Washington Hospital Center. But I’m glad we are moving on to what’s next …

As for what that is – Robert is on the list to begin a clinical trial at Johns Hopkins of the GVAX vaccine that is being tested in melanoma. This type of vaccine has been used safetly against other kinds of cancer. There’s actually now starting to be some evidence that the GVAX vaccine for pancreatic cancer improves patients’ lifespans, but for us the evidence is less important than the possibility that it will do some good. 
The study procedure is somewhat tedious in the beginning, and right now we’re in the “wait” stage. The folks at Hopkins are working with our insurance company to see how much of the treatment costs will be paid through insurance (thank you, BBNA) and how much Hopkins will pick up. Once that has been settled, we’ll go to Baltimore a few times for screening and testing. This will include the three-month full-body scan with a Wood’s lamp (for an explanation click here) to make sure no more melanomas have cropped up; PET, MRI, and brain scans to look for other active cancer sites in his body; a full set of blood tests and EKG; and a review of the pathology specimens at Hopkins. We expect all of this to take place in September/October and the series of four monthly vaccinations to begin in October or November.
It’s not been determined yet whether Robert will be in the second or third study group. The second group receives only the high dose of the vaccine and the third group also receives injections of cyclophosphamide one day before each vaccination. There is one more slot in the second group before the third group begins to be treated. If someone else moves along more quickly Robert would be in the group that receives the low-dose chemotherapy drug as well. (My July 24 post discussed cyclophosphamide and other factors we needed to consider before deciding whether to enter the trial.) If he ends up in the third group, it will mean two trips to Baltimore for each vaccination rather than one. On the other hand, it appears that the cyclophosphamide would be beneficial.
We might prefer to be in the third group, as long as it doesn’t delay starting the vaccines too long. There is a deadline – the vaccinations must begin within 4 months of when he was determined to be free of disease. There’s some question about whether that falls in October or November … we are awaiting word on the actual deadline.
We did take some time to consider a peptide vaccine trial that’s starting up at the University of Virginia. This clinical study is just beginning, and the procedures are much more involved – a big factor for us because Charlottesville is so much further away than Baltimore. I think the deciding factor for Robert was that the screening for the peptide vaccine trial includes a sentinel node biopsy of the vaccine site. (Robert explained this procedure in an email I copied here on June 12.) He’s not too keen on going through that again …
September is a busy month. I’ll be in Asheville for Gabriel’s birthday, and later in the month we take off for the Society of Professional Journalists’ annual convention. Mix in there the High Holidays and several work deadlines for Robert – plus whatever we have to do in Baltimore – and we’re looking forward to October! But we can always take time to talk with family and friends, so if you have any questions about any of this, just give us a call.

Our trip to the University of Pennsylvania was valuable in two ways. We got a good synopsis of Robert’s melanoma – what’s positive, what’s negative, what’s the bottom line. And, we got a run-down of all the options for treatment, including some we hadn’t heard about before. We have one more piece of information to put into the mix, and then we’ll be ready to decide what’s next.

The Stanford report added some details, and Dr. Schuchter explained them to us. On the plus side:

The pathologists saw tumor-infiltrating lymphocytes in the melanoma, meaning that Robert’s immune system was trying to eliminate it.

They called the patterning of the lymphocytes “brisk,” which is good – it means there were a lot of them.
On the downside:

The tumor had a high mitotic rate – five dividing cancer cells in a square millimeter of tissue (5/mm2). That means it was growing and adds to the risk.
The most important factor, as we’ve known, is that this tumor was thick – 9.5mm. Any melanoma bigger than 4mm is considered high-risk, and the size alone is enough to mean that the patient has Stage II disease. Dr. Schuchter said the thickness and high mitotic rate present in Robert’s case “trump” the other factors, including our old friend NED (no evidence of disease, or the absence of any sign that the cancer spread beyond the top of his head).
The worry is that this big, deep, mitotically active tumor may have given off some micrometastases before it was excised. We have no way of knowing whether it did.
Dr. Schuchter said many people with Stage II disease and melanomas this big choose the “watch and wait” option. For at least the first year or two they have skin examinations with a Wood’s lamp every three months and PET/CT scans every six months to a year to find any evidence of metastatic disease as early as possible. The biggest risk of recurrence is in the first three years, so the stretch between observations lengthens after that. After five years the examination frequency drops to annually.
For those who want to be more proactive, there are only a few options at Stage II. The chemotherapy agents now available, most notably forms of interferon, have not improved the outcomes enough to outweigh their nasty potential side effects. A promising new drug, ipilimumab, is not yet approved for Stage II, and while its side effects are not as bad as those seen with interferon, they are can be severe.
Researchers have been working on different types of cancer vaccines for a number of years. One is the GVAX vaccine being used in the trial at Johns Hopkins that we have been talking with Dr. Sharfman about (see Another perspective on the vaccine trials, 7/24/2012). Another ongoing trial, at the University of Virginia, is testing a melanoma peptide vaccine.
Dr. Schuchter said she prefers a vaccine trial for someone with Stage II melanoma rather than ipilimumab because of ipi’s side effects. She will find out whether the peptide vaccine trial includes Stage II melanoma patients, and if so, we will give that option full consideration.
Meanwhile, Robert is on the list to be screened for the Hopkins trial. Dr. Sharfman said it would be a few weeks before they are ready to begin, as they enter new subjects into the trial one-at-a-time. We’ll update you here when there’s more to say.