Hi all --

I had said we would post ongoing updates from the HPV-16 vaccine trial that Barry is officially entering this month. This is a DNA vaccine developed at Hopkins for possible therapeutic use in patients with HPV-16+ cervical or head/neck cancers. It is only in Phase 1 trial, thus a long way to go for clinical application even if found effective. Right now it is only given to patients who are considered (at time of trial) to be cancer-free post-treatment.

In brief, the hypothesis behind the vaccine is that the immune system of individuals with an HPV-cancer did not recognize (or effectively clear) the virus -- whereas although 80% of us are infected at some time with HPV-16, most of us "clear" the virus and it does not persist in our bodies. The vaccine will, it is thought, challenge the cancer patient's immune system to recognize and attack the virus and tumor cells containing the viral genomic material. It did work that way in the initial animal trials...(though as often said here, we are not mice...)

The protocol is that white blood cells are taken from the participant and tested for response to HPV, both before and after a series of 4 vaccine inoculations. There are 4 dosage levels of the vaccine, no placebo arm. Barry will get either dosage level 2 or 3.

There has been a on-going trial with this vaccine for cervical cancer patients, the final results (that is, did it stimulate the immune systems?) is not known yet as that trial is not finished. However what is known is that, with a larger number of participants, there have been no adverse side effects of the vaccine at any dose level (reassuring!)

Yesterday was only the first step -- Barry discussed the trial again with the study nurse and worked out a schedule, which is complicated by our upcoming trip to Australia in late July-August. It appears that (for this reason) he will not actually get his vaccinations until after we get back. They also took blood for a number of tests and made sure he was up to date on influenza & tetanus shots. And, most importantly, he signed the consent form.

The next step will be a series of skin tests to see if he might react to the (non-HPV) vaccine components,and also a skin test for TB and candida (yeast) -- the nurse said that since almost everyone with HNC had had thrush they all seemed to react to the candida test, no surprise there! A date will be set up for the phoresis (removal of white blood cells, similar process to platelet collection). He will then be good to go for the vaccine inoculations, which will start in September.

Anyway, this is Post #1 -- since not much will happen now until we get back in mid-August -- don't hold your breaths for Post #2!

Cheers,
Gail and Barry

Hi Gail! So if I understand correctly the idea is to vaccinate for HPV16 only in the hopes that that will possibly stop a reccurence in the future or "new" scc caused by the virus? What about hpv18 & all the others? I'm sort of thinking/pondering outloud here. I'm going to have to do a whole lot more reading I can tell. Thank you for the post & have a wonderful time with your trip! Have as much fun as possible & push the envelope! Erik

There are now cataloged over 100 hpv variations. With all those, it is still down to only a handful that are mutanogenic. 16 is the one most commonly associated with head and neck cancers, with 18 being associated to a lesser extent. If you test for too many things at one time, it is difficult to interpret the results that you get. Was the treatment effective because it affected 16, 18, 33, or what? Testing of this sort has to be specific, to rule out ambiguity, and logic dictates that you go after the version that is most commonly involved.

Hi Gail,

I wish your husband luck. How did they dicover he had HPV? I am wondering because I have been told I have it but I have no documentation to prove yes or no. Did you try Anit virals? I have been dealing with SCC for 10 years and too many surgeries to count. Did your husband have sugery and radiation? HOw did you get involved with the study? it would be something I would be interested in. as well but don't know how to get involved with this.

My husband was found to have an HPV-16 SCC because there is a large research program at the hospital where he was treated (Hopkins) and they are now testing all their HNC patients. And, by the way, finding a majority are HPV positive. (Most but not all are non-smokers).

The OCF web site has a lot of info on this -- search for HPV and you will get information as well as recent news updates.

Barry was treated with concurrent chemoradiation, the only surgery was a pre-treatment tonsillectomy.

Right now the trial is limited to those who are within 12 (or perhaps it's 14) months out of treatment and are considered cancer-free by the usual scans and examinations. The first phase, as noted above, is to demonstrate whether the vaccine does, in truth, stimulate an immune response against the virus and at what dosage. If it does, there could theoretically be some benefit to trial participants, by helping them "clear" the virus and thus reduce risk of recurrence. But no one knows if it even works in humans as it does in lab animals.

There is a cervical cancer trial ongoing which will be ending fairly soon and that should give the researchers an initial clue whether the vaccine shows potential.

Gail

If I may ask who your husband's doctor is at Hopkins? I called to make an appointment and I am not sure the person they gave me is specialized in Head and neck. I have an appointment but may not keep it with that doctor specifically. I would like to get tested for HPV but won't qualify for the trail.Thanks for responding

Ann

Ann --

I will send you that info by private message as the Forum doesn't want us to give out doctor's names. However, the HPV-16 researcher is Dr. Maura Gillison, her name is already published on the OCF web site where the role of HPV and HNC is discussed.

Gail

Hello Gail,
Do you know if there is anywhere a person can go to have their tumor samples checked for HPV locally, such as a hospital, cancer center, some kind of lab? I also have the info to send samples to Hopkins, do you have any idea how much it costs to have it checked for HPV if insurance will not cover it?
Have you heard of any correlation between having an unknown primary and HPV positive tumor? Thanks for any info-Cindy

Insurance will not cover it as it is not part of treatment and does not at this time change treatment modlities. There is no published evidence that unknown primaries have any relationship to hpv.

Just out of curiousity, since your neck dissection was a few months ago, who decided to keep frozen tissue samples (in a condition that that could be analysed for any variety of purposes, by a laboratory at some time in the future) and for what pupose would they have kept those samples since a treatment plan had been established? I ask this because there are several tissue banks for tumor samples around the US, but as a rule patients do not know that their tissues have been saved in those collections of samples, they have no access to them, and they are only used for research purposes as a rule.

Our local hospital (where my husband's cancer was diagnosed and where his tonsillectomy was performed) told us it keeps cancer tumor samples for 5-10 years and this is about what Dr. Gillison told us is "usual but not universal" for many pathology centers. She contacted this hospital when Barry entered treatment at Hopkins and they send a sample cut off the original tumor block for HPV testing. They had also cut another set of slides for us to take to Sloan-Kettering when we went up for a second opinion. I got the strong impression that this sort of cooperation was fairly common -- the local hospital had a well-established protocol for sending pathology specimens around.

I do not know how much it costs to be HPV-tested if you pay for it yourself, but the lab can tell you -- they can use formalin-preserved samples as well as the original path slides if necessary. It is a DNA test.

Gail

Brian

I also thought I had read or heard that the tumor samples were kept for a certain number of years, I hadn't checked to be sure this was the case. I was just curious on the HPV angle.

I actually don't know if there is any advantage to knowing if the cancer was HPV related at this point anyway, I guess especially with a nonsmoker you wonder where it came from!!

gail,

thanks for your reply and I will look into that.Hope you had a good time in Australia. I saw and oncologist this week and he said I am not a candidate for radiation but that my only option would be this clinical trial at Hopkins. I told him I thought you had to be cancer free and he said not necessarily but that he would talk to the doctor at Hopkins. I have yet to hear from him but will in all likely call myself and try and speak with someone about the trail and if needed make an appt to go up there myself. I hope this works since this seems to be my only hope. I still don't know if I even have HPV but hopefully I can get that testing and find out for sure.

Hi everyone --

Here's our next update on the Hopkins HPV-16 vaccine trial. Barry went up on the 25th for a physical exam by his MO, chest xray, some blood work (CBC) and a skin test (tetanus and candida). All the tests were normal, his blood counts in fact are normal in almost all respects.

The next day was not too much fun, as he had a leukophoresis. This was a harvesting of white blood cells for initial immunological testing. This is done much the same way as platelet collection, for those who have donated platelets -- over two hours his blood was passed through a machine which differentally took out white cells and returned the rest to his body. The nurses at the hematology unit were great, the "victim" lies in a recliner with a heating pad, covered with blankets, and watches one of a huge collection of DVDs on a big screen TV. The nurses leap to bring water or juice. Barry was concerned about this (the idea of having one's blood taken out and put back in IS a bit disconcerting) but it went well and he really didn't feel anything much. He was a bit light-headed for a few minutes, so he sat and watched the end of the video. Then we went up to the Hopkins cafeteria and had a big lunch of Swedish meatballs, rice and green beans. The security guard -- when you pass him to go to the cafe -- always jokingly says, "good luck, hope you come back" but actually the food there is very good. It was our first stop after Barry had his radiation morning treatments, but in those days he could only eat the soup!

The next step is his first vaccine inoculation, this will be the third week of October. Then two more inoculations at two-week intervals, and then a final one 12 weeks out. There will be another leukophoresis as well, as well as tests for HPV in serum and blood, and other blood work.

Eventually the pre-and post-vaccine white cells will be tested to see if, after the vaccinations, Barry's immune system has an improved response to the virus. This phase of the trial uses four concentrations of the vaccine (no placebo) to see which produces the best immune response. We do not know what level Barry has gotten. The concentrations being tested are based on animal trials and a cervical cancer trial which got underway last year.

The upside for Barry is that the initial trials indicate that the vaccine helps the body "clear" the virus so it may do the same for him. There seem to be no significant side effects, at least in the short term.

While at Hopkins we were told that the rate of participation in cancer clinical trials is very low and that this is hampering a lot of testing of new treatments. I should mention that the Hopkins trial is still recruiting, you can go to their web site and search for HPV head and neck cancer trials.

Gail

Hi all --

Next update on HPV-16 vaccine trial -- today was the day for Barry's first inoculation with the new vaccine. The day started (as usual) with blood taken and vital signs (good news, he's gained a couple more pounds since last visit) -- then a physical exam and chat with MO, then up to the chemo section where the inoculation is actually given. Although no one (so far) has shown any initial side effects, they are being careful and so they monitored him for an hour afterwards, vital signs (pulse, breathing, temperature and BP) every 15 minutes after receiving the vaccine. It was a non-event, fortunately, and after an hour we went to lunch and then a final check-in at the two-hour mark.

In 48 hours he goes up again for a skin check (for rash, etc.) and then in a week, the same, then another week and the second injection. (Four total).

We did find out he is in the second cohort so is getting second (of four) vaccine dosage.

No one is quite sure if (and where) HPV may linger in the body of a person who has had apparently successful treatment and has no detectable cancer. That is actually being investigated in another study Barry's in -- where they are looking at HPV markers (DNA and DNA fragments) in blood and sera of patients pre-, during and post-treatment over some years. Study is still ongoing, and not sure if any preliminary results yet.

Gail

Gail, I was a non smoker and a social drinker. I find this post, which I just read in it's entirety, extremely interesting. I live in Fl and would love to vol but I assume the distance would negate that. Please keep us all informed.

I intend to follow this discussion closely, since I, like so many, can not pinpoint a cause for my SCC. I have a question....(this is a place where we can ask what we need to know, isn't it, without worrying about proprieties??): I went to the gynecologist yesterday for a routine annual exam. I asked him to check for HPV, and he said that was what a PAP was.....and when I said that I wanted to be tested for HPV-16 specifically, the nurse said that they had gotten a paper recently telling them that they had to do a second collection for that test.

Is a vaginal sampling an adequate test for HPV that might relate to my oral cancer? Or do I need a blood test?

Another question: Several posters have mentioned that most people have HPV at some point. I thought that it was an STD. I would have no way of contracting an STD, and I wonder how so many people have evidence of it in their systems.

I would love to be part of such a study. I can see that I would need to live close to the major medical center where the study was taking place, since so many visits and tests and treatments are required. I do not live near such a place. Darn.

You need a new GYN if he/she is that far behind the 8 ball. A pap smear is a brush cytology looking for dysplasia not HPV. Even at that, it is only about 50% effective as a test, and the cervical exam is essentially visual and tactile, just like the oral cancer exam... event the precancerous lesions are the same since the disease in both cases is SCC most of the time. You need to read through the tons of HPV stuff on the site and the past postings here to get up to speed with all this, but briefly;

There are more than 100 varieties of HPV, only a dozen or so are know to be mutanogenic. Even if you get one of these like 16, 18, 33, etc. there is no guarantee that you will get cancer from it, many people are able to shed it from their body without consequence. It can remain dormant in your body for decades, so unless you have been celibate for at least that long, you could have contracted it long ago. While the most common sexually transferred STD, they are looking at other mechanisms of transfer, since it does not require a fluid transfer to happen like HIV. Anyone that has ever had sex could be a carrier and not know it; hence the new HPV vaccine is given to young girls before they become sexually active. Vaginal sampling is all that is necessary to test you for it, though knowledge that you have it is of dubious value given all that we do not know about it. There is no such thing as safe sex to prevent transfer, condoms do not prevent it. But your GYN saying that they had just gotten a paper about HPV, a virus that is the primary known cause of cervical cancer for decades, speaks volumes about this doctor. Your question about how many people have the virus in some version (the vast majority some benign version) strikes me as odd... who on this board has not had sex in their life time? Who thinks that our young people abstain from sex as teenagers? HPV is at epidemic proportions in our society because we are a sexually active people. Thank goodness that most of the strains are benign, and that even those that get one of the bad ones have a strong chance that their immune system will get rid of it before it can do serious harm.

Brian.....thanks, as always, for your generosity in sharing your knowledge. Several clarifications: My doctor knew all about HPV, of course, but he did not know about the advisory from his lab that he would need to send in a separate vaginal sample besides the one for the PAP test. They used to do the two tests from the same sample. So he had to collect a second sample.
Also.....I didn't mean that I didn't understand how people get HPV.....I just felt that since my husband and I are and have been totally monogamous all our lives, ( a little Puritan, perhaps) that I couldn't see where I would get it. My husband is a physician, so I suppose that he could have come into contact with it somehow. I guess we'll wait and see if I actually have it. I asked to be tested mostly out of curiousity, since there is nothing to do with the information at this time. But I do not have a clear causative factor for my SCC either, so I am trying to do some detective work in case I have any sort of recurrence. I do not think that smoking 37 years ago is the cause, though my surgeon says that it is.

I'll read what's already in the archives before I ask more questions, but thanks for getting me started. Thanks.

Hi all --

Another update from the ongoing Hopkins HPV vaccine trial -- nothing dramatic to report, probably a good thing! --- but Barry had his third (of four) injections of this new vaccine last week, and the injection site check-up today (nothing, as per usual).

Now we wait a few weeks and they will do another phoresis, this to check whether his immune system has responded to the "challenge" of the vaccine. A final inoculation is given 3 months out, and then more blood work, again to check for immune response. At this time the next cohort of trial participants, who are getting the next highest dose of vaccine, will start. If they experience negative side effects, then the dose will be lowered. However the cervical cancer trial (with same vaccine, started over a year ago) none of the dose levels showed negative effects but we have been told that all levels showed an enhanced immune response, a good result.

We won't be told what Barry's individual response to the vaccine is, but all the data will be pooled to assess what dose is most effective.

Will post more when there is news...

Gail