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Lolly
01-20-2005, 05:08 PM
Hello All, I am officially enrolled in the Her2 Vaccine/Herceptin trial at UW in Seattle!

The day was long, 10:00 - 4:30. I met Dr. Disius and Dr. Salazar, then the first hour+ was spent with Dr. Salazar, reviewing the consent agreement and having any questions answered and signing the forms. Then had an exam, chest x-ray, height, weight etc. Then, lunch. Then, blood, LOTS of blood, was drawn. Then, THE VACCINE! After that, the observation period, which was very enjoyably spent visiting with Steph and hearing about SABCS in more detail, plus just sitting and grinning at each other! And then I was released to go home...The staff is superb, I felt very pampered.

Today, I feel ok, just slightly tired which may be a result of the vaccine or the trip, won't know until tomorrow. The injection site is slightly reddened and rashy, but not painful, really, all to be expected and actually a good thing as it indicates, YES, an immune response! I was told that with each successive vaccine, the reaction may get stronger as the antibodies build up in my system. Dr. Salazar asked me to keep a log of my reaction and symptoms, and bring it next visit.

All in all, a very positive experience. Of course, we're hoping this translates into long-term NED, but also I am so happy to contribute to the data, and know that if that I may be helping to bring the vaccine into clinical use!

Will keep you posted.
Love, Lolly

Lolly
01-20-2005, 05:20 PM
P.S. Also received a tetanus shot; if you haven't had one in the last six months they like to give it as a "positive control". If you show response to the tetanus vaccine, it indicates your immune function is good and it can be used as a gauge against the Her2 vaccine response. If you have had one recently, you can still receive the Her2 vaccine, all other criteria being met.

judiek
01-20-2005, 05:44 PM
Lolly,

I think this is such a wonderful opportunity...I wish you only the best. I'm not familiar with your history...are you currently NED? Would you mind doing a brief history. My doctor has mentioned a vaccine trial at Dana Farber. Thanks and best of luck to you

Warmly,

judiek

History

Discovered lump Sept. 2002 (mammo didn’t pick it up)
Dx Oct 2002-just turned 41
IDC and pagets disease, stage 2B, grade 3/3, nottingham scale 9/9
3cm, lumpectomy,clean margins
er/pr-pos, her2 neg, 2/25 nodes w/cancer
Nov 2002-March 2003-FEC (5fu, epirubicin, cytoxen)
March 2003- started tamoxifen
May 2003- finished rads (33tx)
June 2003-CT/PET Scan- clear
Started 3 month check ups w/lab
Dec 2003-complete hysterectomy
Jan 2004-extensive mets, both lungs & liver(labs normal)
Jan -stopped tamoxifen
Feb CEA-23 (0-3 normal) CA27.29-66.1 (0-38 normal)
Feb 23to current-clinical trial, taxol & avastin
April 15th, -CT-significant shrinkage on all tumors/plueral effusion gone
June 8th -CT-all liver lesions decreased in size/lung mets gone
Aug 9th, -CA27.29 is 22.3, CEA is .8)
Aug 9th, 2004-Brain-CT neg, lung mets/pleural effusion still gone, liver mets had slight shrinkage. Largest hypodesne lesion is 2.1cm, 6 others 1cm or less.
Sept 13th-bone scan negative, mri revealed herniated disc.
Sept 27- Ct of brain, negative/lung mets still gone/ 2 liver lesions gone, 4 under 1cm, 1 @1.7cm.
Nov 29-CT shows stable, lungs still clear, liver tumors stable
Jan 11, 2005-CA27.29 23 / CEA 2.9
Jan 18th, Ct shows disease is still stable

pauline
01-20-2005, 05:58 PM
Hi Lolly

So good to hear from you! I've been thinking about you and wondering how it all went.

I live in Australia and I really appreciate being able to participate in this board-not only for the wealth of experience of others in the same boat, but also to hear about the research being done in the USA.

All the very best to you!!!

Onward and upward!!

Pauline

*_Annemarie_*
01-20-2005, 06:14 PM
How many times do you need to go to Seatle for the shot? What is the criteria to enter the trial? I applied for the trial in Pa. but did not qualify due to the HLA markers. You people are a wealth of information! What are oncologist saying about this trial?

Sheila
01-20-2005, 06:32 PM
Lolly
So happy for you...wish I could have had the opportunity to be in the vaccine trial....I am hoping for a big success for you. Pamper yourself!
Hugs
Sheila

michele u
01-20-2005, 07:21 PM
Lolly,
Are you stage 4? Just wondering if that's why they let you stay on Herceptin and vaccine

StephN
01-20-2005, 07:51 PM
GO LOLLY!
(She was being so brave - a perfect subject!)
What a great opportunity to meet you and your darling hubby at such an auspicious occasion! My first "outing" after Gamma Knife ...

You know (and for others asking) that my med onc here in Seattle has had me in mind for a HER2 vaccine trial since I was first diagnosed over 4 years ago. That gives an idea how long this trial has been in the making and how good they feel about the information they see coming - from the mouse models over 5 years ago to the first humans and into the FDA approved stages.

For the stage 1 trial I got those nasty liver mets to knock back, so it was no go - then for stage II of the trial they put in the HLA-2 requirement that my body did not meet. So, I guess there will be something else down the line, if all goes well with these brain mets.

To answer one of the questions - they DO have MORE than one vaccine trial at the U of W here. One is where you cannot have had Herceptin for more than 6 months to begin the trial. The one Lolly is in participants can be on maintenance for any period of time.

Lolly
01-20-2005, 09:58 PM
Michele and Annemarie; I'm Stage 4 NED, and to to qualify for this particular vaccine trial one must be Stage 4 and either NED or have stable disease, be HLA-A2 positive and be receiving maintenance Herceptin.
JudieK, are you able to navigate the site ok? If so, go to the Community page, then to Members Stories, where you'll find my story. Let me know if you have trouble going there.

Here's the trial information below, for those who are possibly having trouble navigating around the site (the link is posted on the "News"page along with another of UW's trials):





University of Washington Health Sciences
Research Studies Seeking Volunteers

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Research Studies : Study Details Home | Back

Reference: 038845B01

Study Title:

Phase I-II Study of Combination Immunotherapy for the Generation of HER-2/neu (HER2) Specific Cytotoxic T Cells (CTL) in vivo
Study Description:

This study is looking to see if we can use your own immune system to destroy cancer cells by recognizing a protein on the cancer cells called HER-2/neu. In normal cells HER-2/neu helps signal the cells to grow and reproduce. But, in the type of cancer that you have, the cancer cells produce too much of HER-2/neu, causing them to grow uncontrollably. One way to stop the uncontrolled growth of these cells might be to encourage your own immune system to generate an immune response against the HER2 protein. This may be done by immunizing you with a vaccine against HER2. This is a phase I/II study designed to evaluate the safety and potential anti-tumor effects of a HER-2/neu peptide-based vaccine.

This is an outpatient study. The first 9 months of this study will take place at the UWMC. Volunteers will be asked to come to UWMC for an initial screening exam (9 hours) to see if they qualify to be in the study. If they do, volunteers will receive one vaccine a month for 6 months (3 hours each visit). Volunteers will have blood drawn once a month for 3 months after the final vaccine. Furthermore, volunteers will need to be drawn by their regular physician to send to our lab 3 and 6 months after their final visit with us.

Eligibility Criteria:

1. Volunteers must be at least 18 years old.
2. Both males and females are eligible to participate.
3. Volunteers must have metastatic breast cancer or ovarian cancer in remission.
4. Volunteers must be taking Herceptin.
5. Volunteers must be off chemotherapy and steroid therapy.
6. Volunteers must be HLA-A2.
Exclusions (conditions that would prevent a volunteer from participating in this study):

1. Enrollment in other treatment trials.
2. History of heart disease.
3. Active autoimmune disease.
Location:

University of Washington Medical Center
Seattle, Washington
Principal Investigator:

Mary L. (Nora) Disis, MD
School of Medicine
For further information about this study, please contact:

Patricia Fintak, Study Research Nurse
(206) 543-6620

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Last reviewed: 14 January 2005. Last updated: 14 January 2005 gs.

wlward
01-21-2005, 12:57 AM
Dear lolly
This is so exciting - its great that you have had a red response at the site.
Keep us posted as I know you will

love
Lindaw