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