Hi all --

It's been a while since I updated the HPV (human papilloma virus) vaccine trial Barry's in -- he had his last phoresis a week ago (that's where they harvest white bood cells for the post-inoculation immune response tests) -- a two-hour procedure that the Hopkins people try to make as pleasant as possible but it is hard to make pushing all your blood through a machine and then putting it back in really nice! The movies on a large-screen TV and the body-sized heating pad help.

Barry's now had three of four injections with the DNA vaccine, abslutely no reaction which appears to be typical, although we noticed he has a slight touch of acne on his forehead and back. We met with Dr. Gillison (the principal investigator) last Friday and she noted this, but not sure if it's due to some immune response or just coincidental.

There wll be one more injection of the vaccine and a collection of cells (not a phoresis, though) in about two months. Then the next cohort will start, with the next-highest dose of the vaccine. Dr Gillison said there are only two spots open in the trial now -- if anyone is interested, it's for patients who have had an HPV+ SCC of the oropharynx and who are at least 4 months post-treatment and considered cancer-free. Hopkins will test the tumor for HPV if it has not been done already. There is at least one other member of this forum in the trial.

The analysis of all the results will wait until the whole trial is completed. A similar trial (same vaccine) with cervical cancer patients is being analysed, preliminary results indicate that the vaccine does boost the immune response to the virus and thus could help "clear" the virus from a patient.

This is the crux of the issue: What IS known is that patients who develop HPV-induced cancers somehow have not "shed" the virus like the majority of us (80% of population is infected at some time in their lives but in only a few does the virus stick around and -- years later -- cause cancer). No one knows why this happens, the same individual may have a perfectly good immune response against influenza or other disease virus.

Barry asked Dr. Gillison this question and she said it was a good one, with no clear answer: If you have an HPV+ cancer (cervical, oral) and you are successfully treated, is the virus still present? There is some evidence from cervical cancer that the virus may become inactive (latent) and then, come back. Dr. G. described an ongoing study in which a pathologist is looking -- slice by tiny slice -- at cervical tissue from women who were successfully treated for cancer in the past, no recurrence, but who now (for another reason) are having a hysterectomy. The tissue will be tested to see if the HPV is still present in the cervix, although latent (inactive).

The goal of this DNA vaccine is to induce an immune response against the virus by boosting T-cell recognition -- the ultimate goal being to rid the patient of the virus and thus the chance of the cancer reappearing. In fact, in animal trials the vaccine alone was able to cause HPV tumors to recede.

Once the Phase I of the trial is over, if the vaccine does cause an immune boost, then the next step might be to test against patients with active HPV cancer (probably as an adjunct treatment).

Dr. Gillison confirmed her earlier statements about rate of recurrence of HPV+ cancers (no more than 15%) and that most recur in first two years (which is the norm for HNC). The recurrence is usually in the lymph nodes and whether there was a ND or not doesn't seem to change that much. Barry is 18 months out now so keeping his fingers crossed!

The results of this Phase I trial will start to be analyzed after the end of the fourth (highest dose) cohort so still some time off.

Gail

Gail,

What's involved time wise? Do you think I might be a candidate? I was never tested for HPV but I was a very casual cig smoker and had quit over 30 years before Dx and I was a casual drinker.

Hi David,

Jack is the other member of the forum involved in the clinical trial, thanks to Gail's information in her posts and emails. He is in the same dose cohort as Barry and has also had no reaction to the first 2 doses, with the 3rd one scheduled for next week. Since we are out of towners as you would be, Hopkins is working with us to minimize the number of times we need to go there in person.

The first step was to have the tumor slides sent to Hopkins for testing to see if they were positive for the HPV 16 virus. I followed the link for Hopkins clinical trials that Gail gave us and called the research nurse to find out how to do that. She emailed me the forms to take to our local hospital and they sent the slides to Hopkins following the protocol outlines. That process took about 2 months, but once the tumor came back positive things moved very quickly for us.

We arranged a consult with Dr. Gillison Oct 14th after obtaining and sending Jack's entire medical records from the surgeon, the RO, the MO, as well as his biopsy reports and PET/CT scan results. Dr. Gillison reviewed the records, examined Jack, discussed the clinical protocol and study particulars and based on all that accepted him as a patient. He had blood work and a chest X Ray at Hopkins during that visit and would have received the flu shot and tetanus if he hadn't already had them.

Once we signed the consent the research nurse set up the first phoresis that Gail is referring to - for Jack that was done on Nov 1st as well as minor skin testing. Jack had his first vaccine on Nov 29th and the second on Dec 14th. We are going back on Dec 27th for the 3rd. The next visit is his second phoresis scheduled for Jan 18th, followed by a check up on Jan 29th. There's a lot of flexibility on the check up date, we're just trying to accomodate our rescheduled anniversary trip. After that he doesn't have to go back until Mar 21st for the booster shot of the vaccine and then I think it's 3-6 months going back down there. The study is over a 2 year period.

Because we are out of towners, we were allowed to go to our local doctor-with the Hopkins study form - to be checked 48 hours after the skin testing and the first injection, as well as the "off" weeks in between injections to examine Jack for any allergic reactions. That has been a big help because he can run over to the local doctor for an in and out visit a lot more easily than going back to Hopkins. It's the only reason we're able to participate from a distance and handle 48 hour and weekly follow up.

So yes there's a fair amount of time involved in doing this but they will work with you. Blood work needs to be done at Hopkins and that is taken care of the morning of our visits. Since we usually come in the night before we take advantage of the Hopkins rates at nearby hotels, and they have a travel bureau that works with out of towners.

Hope this helps,
Regards JoAnne
PS...and the crab cakes are fabulous

Thank you for the update, Gail. I have been very interested in all your posts concerning this trial.
When Mike was first diagnosed in July, I brought up the subject of the HPV connection with each doctor. I'll never forget how they looked at me like I was from Mars. Then, each one gave some extremely lame response.
I didn't know if Mike had HPV, I thought they might want to test for it. I knew it did not change anything, he still had SCC BOT, his treatment would be the same.
I also knew from reading on the National Cancer Institute web site that increasing numbers of younger, non or light smokers and drinkers where getting Oropharynx cancer. And they were reacting significantly better to standard treatment protocol.
Your in depth reporting on the trial helps satisfy my curiosity on the HPV connection. Which Mike's doctors failed to acknowledge.
Thank you Barry and Gail for being participants in the study and for the well written reports. Keep us posted!
Ginny
(Mike's wife)

Thanks Joanne,

I'll wait for the info you spoke of from Gail. I'm willing to see if mine was caused by HPV and take it one step at a time.

Hi Gail,

I would like to thank you for taking the time to post your updates. I have been following Barry's trip through this study with great interest. It's amazing how many of my colleagues had no idea about the connection of HPV with oral cancer. Because of your postings, I am able to educate them.

And Joanne, I'm happy to see that Jack is part of the study, too and I commend all of the paticipants who will more than likely help to have a positive impact on so many people's lives.

I have been participating in an ongoing health study run by Harvard since I was a student in dental school in the late 60's. Until I got my cancer, my questionaires were pretty routine as I was a healthy guy till then.

Jerry

Actually, it is amazing how many doctors (even at Hopkins, the "hotbed," so to speak, of HPV-HNC research). Barry went to see a neurologist there to have his benign essential tremor checked out, as he had not seen a specialist about it for about 3 years. Had it worsened over time and if so, should he up his meds? When he told the doctor that he had been treated at Kimmel for throat cancer the first thing the doctor asked was, "oh, were you a smoker?" -- Needless to say, we both enlightened him !

The answer on the tremor was it had not progressed. He also asked what chemo drug Barry had. We told him that Barry's chemo drug (carboplatin) rarely caused peripheral neuropathy, nevertheless he also tested Barry for that -- compared feeling in his feet to elsewhere, etc.-- and found no problem.

Now, David -- JoAnne's answer pretty much sums up what you have to do. I would start by googling Dr. Gillison and getting her contact email, and start from there. There IS a lot of time involved, we are up and back every week or so but as JoAnne noted they will work with you and you local doctor to reduce the time demands if you live out of town. However there is no compensation involved so there is the issue of travel costs. Under certain very limited circumstances insurance may reimburse for trial participation but I would not rely on that happening.

Gail

Hi Gail, it is amazing at the lack of knowledge on this in the medical field but through people like yourself who are willing to share information things will change. You are really making a difference. I know the doctors at Princeton and Philly are following Jack's case with a lot more attention because of the viral connection, and our surgeon's office has already referred another patient to Hopkins.

I appreciate all your help in finding out about this trial and spreading the word on the HPV 16 virus. It gave us an answer to the "why" question and that alone provides peace of mind no matter what the future brings. Jack and I were happy to meet you and Barry at Hopkins and here's looking forward to a successful conclusion to Dr. Gillison's research for all of us.

One day we'll even be included in those great commercials on the HPV virus. Enjoy your trips.

Regards JoAnne

I talk with Maura Gillison all the time, send me an email and I will send you her contact information.

My husband is a patient of Dr Gillison's and will be starting in the next group of the HPV vaccine clinical trial in January. We will keep you all informed as we begin our next phase.

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Marty, caregiver - stageIV SCC/left tonsil/3lymph nodes/35XIMRT & 35/cisplatin/tarceva-08/06/neck dissection ll/06