Vaccine Trial

[Belinda]

Hi everyone

I am in Australia - but keen to find out more about vaccine trials going on in the US. My brother works for Qantas so I can travel quite cheaply and regularly to the States if I can get into a trial. So...any info on trials that you are particpating in, contact details, whether they are still recruiting, and Phase 1 and Phase 2 studies that have been completed and what they show...ie just about any info would help. Also, our hospitals have accommodation (often in a nearby hostel or motel) for people travelling long distances for treatment - do US hospitals have this sort of service?

Any advice would be received, and just your thoughts on whether this would be possible/viable/worthwhile.

There are no trials in Australia, and none on the horizon as far as I can tell.

I wanna try ANYTHING to be around for my wee girl and husband! And just to keep enjoying this precious beautiful life.

Also - An SA company is developing a breakthrough treatment for chemo-induced mucosistis, and trialling this in several hospitals. I know one of the company directors and if I get mucositis he's offerred to get some for me to try. Will let you know how it goes. So far I have only one small mouth ulcer and it's stable. Let's see what Chemo II tomorrow brings!

All the best - Belindax

[eileen]

there is a clinical trial going on at Memorial Sloan Kettering in New York City for a herceptin vaccine. It's phase 1 of the trial. The information is on their website.

i'm really not sure if i'd want to be on a phase 1 trial.
i would like to try it but think i'd rather wait for phase 2 when they actually have more information.

[Linda]

Hi Belinda:
THe University of Washington, in Seattle, has been doing lots of work on Her 2 vaccines. Some women on this site are participating. The main doc is Mary Disis. If you search the web and this site, it's easy to find more info. Can someone else post the web address and the name of the assistant (Patty??)??
L

[Margerie]

I am doing the her2 vaccine (DNA plasmid) at Univ Wash in Seattle. They have hotel that will give you a medical rate (about $70 a night I believe) and a free breakfast and shuttle to the medical center. Because the trial is sponsored by the government, they can't offer to pay for any travel or lodging expenses. There are organizations that can help with flights (angelflight, etc.), but sounds like you can have Quantas fly you. The trial is 7 visits to Seattle over a 15 month period.

The research coordinator is Patricia Fintak 206-543-6620 paf3@u.washington.edu

They are terrific!

[eileen]

You can contact Teresa Gilewiski, M.D. here in New York at Memorial:

212 639 5451

They are definitely recruiting for Phase 1 if you quailify.

They will not pay for accommodations.

[Lani]

Most vaccine trials are for stage 4 I believe. An exception is the one out of Wyndber, Pennsylvania(perhaps there are more). I am sure someone can post the info for it. Hard to get to by plane, train, etc and not sure they have one for someone still on herceptin/who have had herceptin. You should check with them--it is called the Joyce Murtha Cancer Center. Try googling it if no one chimes in to provide the missing info.

[StephN]

The U of W has more than one trial. They have different targets and requirements. There is a link in the index of this site for those trials. Some accept early stagers and you just have to be less than 6 months off Herceptin.
(I believe that micheleu and Margerie are stage III.)

Checking with Patty at the number Marge gave is the best bet for sorting out the possibilities.

Good luck!

[Margerie]

Yes, I am stage 3 and the trial I am on allows herceptin, bisphosphonates and AI's.

Here is the link to the bc trials they are recruiting patients for:

http://depts.washington.edu/tumorvac/trials.php?s=s0

[Belinda]

Thank you all so much! I am going to check this out after I am up for it from CHEMO-THE SEQUAL (I reckon it's more persistent and just as awful as the Rocky movies!!!! LOL). That's today. So I have something to focus on through the next few yucky days!!

Thanks again everyone - I am just blown away by your generosity.

Best wishes - Belindax

[eileen]

Belinda,

I'm stage III, 7 positive nodes & I qualify for the herceptin vaccine clinical trial given here in New York at Memorial. I gave you the contact there in my earlier reply.

I'm still not sure if Phase 1 is the best trial to go into. Let me know if you find anything out.

I have an app't there next week with the doctor who's running the trial so i'll try to get more info.

Eileen

[Belinda]

Hi Eileen - would be interested to know what you can find out.


I'm Stage IIB according to my pathology report - there seems to be a fine line between Stage IIB and Stage 3 ( a couple of nodes - under or over 9, I estimate). May be that I am not eligible for a trial but one hint of progression and there I'd be. I'm gonna fight this thing as hard as I can and knowing all the options is good for my head, even if I can't get into a trial now - but you never know!.

Cheers again and thank you to all of you.

Belinda

[Margerie]

Belinda- I had 5 + nodes and am considered stage 3A here in the states. Anything over 4 nodes automatically means stage 3 - see nccn guidelines. Hope this helps!

http://www.nccn.org/patients/patient...t/4_stages.asp

[StephN]

I was staged 2B and had 8 positive nodes. My initial tumor was small however, at under 1.5 cm. I was T1 and N2, which by the new standard would change me to 3A.
Interesting how they have adjusted things upward in the 6+ years since I was diagnosed.

Stage IV now and forever, so that will not change!

[eileen]

Does anybody know if it's better to wait for Phase II of a clinical trial so they have more information at least about the doseage?

Hi Belinda,

I called the number Eileen gave at Sloan and spoke to Deidre, one of the nurses. She couldn't give me much information about the trial but did say they would send out a package of material explaining the Phase I trial if I were eligible. I'm not, as one must be at least Stage II. It's something like three shots every three weeks and some blood taking to check on the T-cells. That might be doable for you, as we have two international airports close by: Kennedy and Newark. Also, you cannot be on herceptin concurrent with the vaccine. I am due to go off herceptin in September, and I asked if they were likely to be gathering subjects then and she said 'probably.' I believe they need an additional twenty to twenty-five volunteers.

The nurse's name is Deidre and her number is 212-639-5451

[Barbara2]

I contacted Patty from the U of Washington trials in Nov. of 2006 to see if I could be in a vaccine trial. I am stage 2b.

She told me the eligibility criterion requiring that participants be Stage III or IV is stringent, and therefore I wouldn't be eligible for the current study. Early phase studies (I and II) typically include more advanced stage patients, as the primary purpose is to look at safety and survival. She added that their later studies were likely to include earlier stages.

I had asked her also for more info about their trials. Here is what she said:

"Our vaccine is a breast cancer antigen specific vaccine (versus a cell based vaccine). DNA serves as a delivery method for the HER2/neu antigen.

The primary difference between our plasmid DNA vaccine and Windber's E75 vaccine is that ours is gene-based (in the form of DNA) and theirs is peptide-based. One of our other trials(for Stage IV patients only) includes a peptide-based vaccine. The difference between Windber's E75 vaccine and our peptide-based vaccine is that ours uses three peptides, one of which is E75. The other two peptides have also been shown to induce a strong immune response. We give all three together in the vaccinations (along with GM-CSF) because some people respond to different peptides."

I plan to call again soon to see if they have anything available yet for stage II patients.

[eileen]

Barbara,

This sounds like the same trial that is being given at Memorial Sloan in New York.
I'm stage IIIA & I qualify for the trial but I'm very hesitant about going on a Phase I trial. I feel that they have very little knowledge about the doseage & side effects.
What is your feeling about going on a Phase I trial as opposed to waiting for Phase II? Does anybody else have any recommendations?

Also Sloan Kettering will only pay for the medication and not for the treatment so your insurance would have to be willing to pay for most of the costs. Of course if I knew the vaccine would prevent my cancer from returning I would do it at any cost but there are no guarantees.

[eileen]

Margerie,

You said that you were currently on the clinical trial for the her2 vaccine.
How long have you been getting the vaccine?
Any side effects so far? Is the hospital you're doing the trial at paying for your treatment?
I think we are the same stage (IIIA)
Are there any advantages of waiting for Phase 2 of this trial?

[Jo-Ann]

Hello, I am a newcomer and newly diagnosed in February with her2/neu positive too, metastic stage 3, I think, with lymph node involvement and also spread to my liver and lungs. I am waiting for the oncologist to choose the treatments (had to wait for all of the test results). I am going to enter a trial (HKI-272??) and where I go is affiliated with the National Cancer Institute. I love my doctor, she is so positive and honest, the best relief was when she told me I will be around. Before that, frozen in shock for weeks, unable to eat, sleep or move. I am only 106 lbs to begin with. I am a widow with 4 kids, the youngest is 7. Life is tough enough but anyway, I am in New Jersey and would recommend Dr. Deborah Toppmeyer to anyone. I have gone through cancer with my husband and my Dad, unfortunately, neither made it. I was very selective in choosing a doctor and in my opinion, the larger more comprehensive centers seem more equipped and up to date with trials and treatments than the private oncologists, not that they are not good, just more treatment options at a facility geared for cancer. I am unsure of the accomodations for travelling patients but here is the link to the Cancer Institute of NJ site http://www.cinj.org/CINJNetwork/patients_com.htm. Dr. Deborah Toppmeyer can be reached at 1-732-235-9692. Although I am just starting down this path to the unknown, I feel that it is worth a call. "No such thing as can't" is my motto and there are a million opinions available. I wish you all the luck in the world. PS. I found a way to get the insurance company to pay for travel & lodging and they would have paid for living expenses too for 3 months if my husband made it to his bone marrow transplant at Johns-Hopkins in Baltimore Maryland. They at 1st said sorry, multiple myeloma is not in our list of covered diseases. They wanted to cover nothing at all. I said sorry, next time I'll pick a disease in your book & network! I fought them and said lack of documentation does not justify denial and I demanded MANAGED CARE. I won. Managed care assigns a mediator who brings out of ordinary expenses to the meeting table and they approve or disapprove accordingly. From then on, they basically paid for anything that was necessary.

[Cynthia]

Friends,

I wanted to chime in to say that I participated in the Walter Reed/Windber E75 trial (a six month trial I completed two years ago; I am now receiving a booster once every six months). The very preliminary results of this Phase 1/Phase 2 trial were announced in San Antonio this past November. I happened to be there and was asked to participate in a news conference. Here is a link to the article so that you can learn more about the vaccine (and yes, I am the "Cynthia" in the article):

http://www.sciencedaily.com/upi/inde...e-analysis.xml

As you will see in the article, they plan to roll out a multi-institute phase 3 trial in the near future. I understand that it may include different peptides other than just the E75, though I am not certain about that. I also understand that this trial is a bit different than U of W in that it requires that you be NED to participate. The theory is that the vaccine may have a better chance of working when cancer is only active on the microscopic level rather than in a detectable tumor form (the idea being that the vaccine may be able to beat back small cancer cells but not an active tumor).

This trial is tricky because it is more easily available to military and military dependents. The Windber, PA site is for civilians. You can learn more about Windber by going to the clinical trials page of this great forum. I will past information from the Windber website below. The contact person there is Maureen Pavlik (her email is referenced below).

All the best,

Cynthia

The Joyce Murtha Breast Care Center is currently collecting and storing breast cancer tissue samples for anonymous analysis, and is enrolling eligible civilians from across the country in one of two clinical trials.

Clinical Trial E75 Breast Cancer Vaccine

The purposes of the study are: (1) To test the development of an anti-cancer vaccine called E75 which may hold promise as a preventive therapy for patients at risk for breast cancer or recurrence of breast cancer; (2) To determine the best dose and number of shots of the vaccine; (3) To learn more about the side effects of the vaccine and how it affects the immune system.

To be eligible for one of two trials, an individual must have:

• been diagnosed with breast cancer with or without lymph node involvement
• tumor that expresses Her2neu in node positive trial only
• completed standard surgical and medical or radiation treatment
• no current evidence of disease
• no autoimmune disorders
• no involvement with other breast cancer clinical trials
• a screening process with the vaccine nurse for additional blood testing criteria

The trials are conducted at Walter Reed Army Medical Center and Windber Medical Center for civilians. Active participation requires monthly clinic visits for up to six months, and telephonic monitoring for five years. For further information, please call the Joyce Murtha Breast Care Center at (814) 467-0044 or toll-free (866) 253-4703 and ask for the vaccine nurse.

Principal Investigators

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MAJ Matthew Hueman, MD
Department of Surgery
Walter Reed Army Medical Center
6900 Georgia Ave. NW
Washington, DC 20307-5001

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Dianna Craig, MD
Joyce Murtha Breast Care Center
Windber Medical Center
600 Somerset Avenue
Windber, PA 15963

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Through the efforts of the Windber Research Institute, world-class scientists are now working closely with the Joyce Murtha Breast Care Center to track and identify those 'markers' in an individual's blood that may predispose her to breast cancer. Tissue banking and microarray technology are being carried out in the Windber Research Institute; these advances in research and molecular biology enable our scientists to store and study thousands of samples of tissue which may help facilitate the understanding of breast cancer. And understanding a disease is often the first step in conquering it.




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For More Information:

Joyce Murtha Breast Care Center
of Windber Medical Center
Windber Medical Center
600 Somerset Avenue,
Windber PA 15963
Tel: (814) 467-0044
Toll Free: (866) 253-4703
Fax: (814) 467-0725

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• Diane Pringle, RN, MSN: Executive Director, (E-mail: dpringl@conemaugh.org)
• Marian Bellack, RN, BSN: Case Manager (E-mail: mbellac@conemaugh.org)
• Maureen Pavlik, RN, BS, CCM: Vaccine Case Manager (E-mail: mpavlik@conemaugh.org)</TD></TR></TBODY></TABLE>