University of Washington Study

[brian]

Just to update those of you that are following the U of Wash vaccine trials the trial for the HLA-A2 vaccine study has been suspended for two weeks. My wife was to go out this week and Dr. Salazaar advised us that the local Human Subjects arm of the FDA placed a suspension on the study pending a review of the qualfications of all of the applicants.

According to Dr. Salazaar the government will do this on occasion and that the study should continue in two weeks. We have made our plane reservations for next month and we are looking forward to the next treatment.

[Alicia]

Brian
I have called and emailed Andrea York with no success. Does my doc have to do this before she will respond??? Any info would help immensely. Alicia

[Lolly]

Hi Alicia
I've e-mailed Andrea several times in the past and gotten prompt replys but since Brian posted the information about the review of the trial she hasn't answered my last e-mail and it's been over a week. I think maybe while the department is under review the staff are possibly on leave or Andrea is on vacation...Don't know but I am sure when she's back in her office she'll be in touch.
Lolly

[brian]

Ladies

Lisa and I have not heard from either Dr. Salazar or Andrea regarding the study at this point. We are going to attempt to contact them today. I will post on the site when we hear anything.

[Marianne]

I have been in a trial at UW for a vaccine and am just finishing up with my final visit in October. I have always dealt with Andrea; however this week I received an email from Dennis James (UW Tumor Vaccine Group) " saying ""Andrea has taken some time off""" and he will be scheduling my next appointment scans etc.

I guess a phone call to that department might be the best way to find out what's happening with the current trials.

Marianne

[Kim in CA]

Thanks for your post Marianne

I guess that would explain why I have not received any replies to my emails to Andrea.

I am also enrolled in the trial and was supposed to go for my 4th vaccination on Aug. 31st. If I had not seen Brian's post on this board and called Dr. Disis my husband and I would have flown up there for nothing. Dr. Disis thought that someone had already notified me the trial had been suspended.

I had already booked all my flights to Seattle so this is really frustrating not to mention how dissapointing it will be if we don't get to complete the study.

[Esther]

I am REALLY curious as to what has happened. I was in for my Herceptin/Navelbine treatment today and was talking to one of the nurses. I go for treatment to Loma Linda University in So CA they run alot of studies also.

The nurse said that they had never had a study ground to a halt like that by the FDA or otherwise. They frequently get the Drug co or reps checking patient files but without any interference in treatment.

I'm wondering if someone in the study had an adverse reaction to the vaccine?

[brian]

Ladies "

We talked to Dr. Salazaar last night and the study is moving forward. She indicated that the ""Human Subjects"" arm of the study temporarily halted the study on the fear that the vaccine could cause your body's immune system to attack the her2 receptors in a patient's heart or other muscles of the body. Apparently" " her2 receptors are found throughtout the body in various types of cells (particularly the heart).

One of the main points of investigation is to test for heart toxicity. So the ""Human Subjects"" group wanted to insure that all participants met the MUGA scan criteria of the study to ensure that no patient with a weakened heart would be admitted to the study.

All said and done the study is to proceed as normal" however anyone not making the MUGA scan criteria in the future will be denied access to the study.

[Alicia]

Thanks Brian
I'll email Andrea again and see if I get a response! Alicia

[Lolly]

Just an update; I've been in contact with Dennis James U.W. Tumor Vaccine Group. He's been very prompt about answering my questions this last week. All seems to be back on track for the trial.
Lolly

[Brian]

Dear Ladies:

Lisa and I are headed out to Seattle this weekend to take our third treatment. Glad to see this has restarted.

Good Luck and God Bless!
Brian

[Brian]

Dear Ladies:

Lisa and I are headed out to Seattle this weekend to take our third treatment. Glad to see this has restarted.

Good Luck and God Bless!
Brian

[Lolly]

Eric and Lisa
I'm hoping your trip goes well and inching closer to heading up there myself if all goes well! Hope our paths cross soon.
Love Lolly

[Brian]

Just an update on my wife's progress. We had our 4th treatment on October 26th. During the course of the treatment we had occasion to review the results of a blood test taken at our last visit. To our great surprise and happiness Lisa after her second treatment was developing antibodies as a result of the treatment. In talking to Dr. Disis on the matter this is the desired result and we hope to increase the immune response with the additional treatments.
In sum this should mean if the hypothesis is correct that Lisa is developing immunity to the Her2/neu positive cancer that we have been battling for 13 years.
We are exstatic! This sort of treatment offers hope to all women battling this awful disease. Fight on ladies the more time you have the more chance that the wonderful people like those at the University of Washington can develop a cure.