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