Hi all --

Barry ges up today for his *last* visit in this phase of the trial. They will take blood and look at his injection site, so essentially a non-event. We have noticed an increase in forehead/back acne in the week after each injection -- not obvious except to us -- which might mean an immune response or perhaps a reaction to some "carrier" component of the vaccine.

We see Dr. Gillison in June, by then most of the cohorts (dose levels, there is no placebo arm) will be done but not sure when results will be available.

Dr. G. seems pretty confident that we should do well -- the follow-up for this trial is 12 years!

Re recognition of HPV, I have seen far more mention of this on web sites to do with oral cancer than in the year after Barry was diagnosed. However, many doctors are still unaware -- any oropharyngeal cancer, esp tonsillar, should be tested. Dr. Gillison feels tonsillar cancer is probably a "surrogate" for HPV+ cancer, at least in non-smokers.

Hopkins can do the testing if your hospital can't, and they can use the original pathology slides (which are usually kept for 5-10 years) if no tumor sample is available.

Gail

Hi Gail - Rick is just beginning the HPV vaccine with Dr. Gillison so I will keep the info flowing for everyone. We just had all of the premlinary bloodwork, etc. done. Glad to hear it all has gone well. One of these days, we need to meet!

Hi all --

It's been a while since I gave an update (how about one from some of the other Forum folks who are enrolled?)...that's because it's been a while since anything happened.

We met last Friday with Dr. Gillison for a checkup and blood sampling -- she pronounced Barry "healthy as a horse" or words to that effect so that is good news.

Re the trial, all cohorts have been enrolled and they are starting on the last phase -- each dose level (of 4) has to complete their inoculations and Drs have to be sure there are no side effects before going to the next dose, so this takes a while. A bit longer than expected, but it is still going well -- no side effects of any note.

After all the cohorts have had their inoculations, then the hard work of the blood/serum analysis begins and then, analysis of the data. Hopefully this will show that the vaccine does boost immune response to the virus and that the subjects' blood shows reduced levels of HPV markers after vaccination.

This is because the worry is not so much a recurrence of the original cancer, which is relatively low for HPV cancers (at least in the first 5 years), but that the virus could go dormant like HIV or chicken pox and pop up years later to cause more problems. There have been a few patients, for example, who had cervical cancer years ago and now present with oral cancer due to HPV.

Thus the potential for a therapeutic vaccine which will help HPV-infected cancer patients shed the virus.

Gail

Wow I just read this whole thread, thats very exciting news indeed. Glad to hear everything is going so well.

Has there been any research done as to the average timespan between possible HPV infection and when the oral malignancies occur as a result?

There is no answer to your question, and no logical means to obtain one at this time.

Not to disagree, but Dr. Gillison has told us that they suspect the lag time between initial HPV infection and appearance of cancer can range from 5-20 years, she told my husband he probably had the infection 10-15 years before his tonsil cancer developed. Now -- I do not know on what this is based, assume work with cervical cancer as the HPV-oral cancer link is relatively new.

As to how long it might be (if the HPV goes "latent") and then reappears, as Brian says, no one knows and it certainly has not been studied long enough to answer this.

Having said that, I spoke last week to a woman who had cervical cancer (treated successfully) 20 years ago and now presents with a tonsillar cancer which is probably HPV+ (being tested at Hopkins).

Gail

You are not disagreeing with me, but restating essentially what I said based on my routine conversations with Dr. Gillison and others in the HPV research community. Everything is a best guess at this time, and none of those guesses are based in any clinical evidence. I would hardly consider the range of 5-20 years meaningful at all, and her statement reflects what she clearly has stated, they (all the current researches in this realm, not just her team) just have no real knowledge of what the situation really is. We do not even know if it actually goes latent, or if it is that people are constantly reinfected after their immune system clears the virus. For that matter if it does exist in some latent or dormant form, we have no means to detect it with certainty while it is so. We have no clue as to why it seems to persist in some and not in others. Like I said, nobody actually knows very much and there is no data to answer that question from. In your example of the 20 years past cervical cancer patient, there is no means today to know if during that period of time the virus was dormant in her, or if she did not have it at all during that time and was reinfected more recently to her oral cancer diagnosis, or what. Noone can tell you the pathway that a form of the virus might take from cervical to oral, or oral to anal, or anything.... The answer is no one knows enough to do more than speculate on possibilities at this time. I think that Gillison's answer to you of that many years in the possible span described, is her way of saying that she can't really answer your question.

The data is not drawn from the cervical world, as I have been told there is no data published which defines the actual identification of HPV exposure moment (no one until recently has been looking at this because the GYN world has not routinely been testing patients for HPV or collecting data), subsequent incubation time, or the time necessary for all the possible genetic cellular alterations necessary to occur, (and avoid immune system response), to finally become a full blown cervical malignancy. What is not known far exceeds what is known, and the answers are not immediately at hand. The question cannot be answered in any meaningful and useful manner.

Hopefully, the ongoing trials will provide some more concrete information about the progress and management of what seems to be developing as a distinct subset of OC. If the ultimate goal is a cure or vaccine for the causal factor itself... i.e. HPV, and the interim goal is dramatically increased awareness about that factor; then I can guarantee you that throngs of people are going to start asking these and many other questions as it relates to their perceived risk AS that awareness level rises.

For years the mainstay of concern when it comes to STD education has been HIV, which has had the lion's share of attention, and rightfully so. Now the public is being made aware of a new and serious threat, and learning that their risk of developing it is on an order of magnitude substantially higher than they ever could have perceived with any other major STD. We are going to begin seeing an entirely new demographic of concerned individuals that fall outside of the "norm" for what is considered the typical age AND risk factor for this group. And these are people that will want answers to their questions.

I believe that though it should be handled with caution, and despite the fact that is definitely in a preliminary stage, its still pertinent information... I also think Dr. Gillison et al should be commended for their dedicated and expedient response to this crisis. Hopefully the information provided earlier in this thread will prove fruitful and this can be treated from a more chronic standpoint. As a side effect, I believe awareness about the disease as a whole will also increase dramatically, and that is a major step regardless of what factors cause the disease to begin with.

Just my opinion of course.

Hi all --

Just another quick update on the HPV vaccine trial at Johns Hopkins. We met with Dr. Gillison again for the routine 3-month check-up (everything good) and she told us that the final cohort would be through their vaccinations in a month or so. At that time they will start doing the analyses of the blood samples, which will show whether the vaccine results in an immune "boost" against HPV and if this boost is dose-dependent. Barry got the second dose level of 4, there was no placebo arm. No one has had any side-effects.

If the results are positive, the Phase II trial will be designed. Not sure what this will look like, that is, whether it will include patients with active HPV+ cancer.

Well, we are off again on another trip -- this time to Uganda for birdwatching and also, Gorilla trekking. Leaving Friday, back in a month. Just remember, there is life after this disease! Barry and I wish everyone well and "see" you in September - which will be exactly two years after the end of Barry's treatment so a big milestone!

Best,
Gail and Barry

Thanks for the update and have a great trip.

Take some pictures for me.

I'm thrilled that you guys are enjoying "life".

Jerry