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beckyg

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My oncologist left me a message late yesterday afternoon. The folks in Tuler called back finally to say I am NOT a candidate essentially because my cancer hasn't spread enough. Basically, they want there to be tumor in the lymph nodes in my neck or armpit--somewhere they can get a sample without putting me under anesthesia. Since getting a piece of mine would involve a bronchoscopy or possibly an incision between my ribs to get at the pleura, they don't want me. I am about to call and see if I can find out if this part of the research protocol or if it is just the Tyler Cancer Center that doesn't want to mess with me for this. Maybe the Dallas location would be more agreeable; or maybe if I can get someone else to get them a sample... Don't know. But I will at least ask the question. I was really discouraged last night about this--I had such high hopes and my options are starting to get fewer and fewer and I am so not ready to die. But this morning I at least have a plan, so I feel a little better. I'll let you know if I find out anything--hard to get answers on a Friday sometimes.

Becky

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Becky,

Here's an idea IF there are different "rules" for the GVAX in different areas... Check Ann Arbor or Detroit...and contact Corporate Angel Network. I know (for a fact) there is a daily shuttle between Lake Jackson, TX and Midland, MI. If you find you ARE eligible up here, let me know, I'll take time off to drive you PERSONALLY to Ann Arbor from Midland.

Becky

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Becky,

I was so hoping that you would be accepted. They got back to you really fast! Keep on with your inquiries. The more you research, the better armed you are. I don't like the fact that they want the "easy" to get to patients. The ones with the worst diagnosis are the ones who need the vaccine NOW!

How do you find out which hospitals are participating in the study? I've been trying to research and haven't been able to find that info.....

Keep us posted,

TAnn

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It seems like Cheryl posted a couple of weeks ago a link to a Cell Genesys page which had the locations on it. I have been trying to find that again this morning and can't--and my copy that I printed out is currently in my car in San Antonio. I did find a site about the trials--look up GVAX and you wiull quickly find pages about open trials, and the lung cancer one was easy to find. I haven't found the info about particular sites today, but I did find a phone number to call for information. I have left a message and am now waiting again to hear what the company has to say.

Becky

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BeckyG:

Dang. I'm so sorry to hear your latest news, but still hoping for better news this afternoon or as soon as possible for you. I know there have been thousands of calls about the vaccine, so you are doing something right to have been contacted. Let us know.

Elaine

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Becky,

From working at NCI, I understand a little bit, I think, of what they need.

They say they would like to pull a lymph node, which would be full of tumor cells and not a lot of other stuff, ie a "rich source of clean cells" since they need to isolate proteins, a certain kind, from your tumor cells, and then 'make' the vaccine from that. The vaccine can only be as good as the cell sample they can get.

I hope the protocol allows for cells other than lymph node and that one of the other centers will be able to take you.

The other thing to remember about trials is they try to keep everything as similar as possible. You could ask the company if they can get clearance for compassionate use outside the trial, that has been done to get around the ineligibility thing.

Wishing you the best.

XOXOX

MaryAnn

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MaryAnn,

Thanks for the tips. So far I haven't heard anything back from the company, but I didn't expect to get an immediate response on a Friday afternoon. The oncologist still has more traditional chemo drugs up his sleeve if this doesn't work out, but I will keep trying a little longer before I give up on this trial--it just seems more hopeful than anything else out there right now.

Becky

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Becky,

Sometimes I think the only way you can get help for a disease is to not have the disease.

Anyway, I know this is not close to you, but I remember it because it is close to us, but University of Pennsylvania is another center doing the trials for GVAC.

Good luck.

Ginny

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Mary Ann:

How does the compassionate use work? How do they choose who to be compassionate toward? This is the first I have heard of this, so I am curious.... And probably insurance companies don't pay, so then you have to pay yourself? I know, I am cynical--lol. But on another board, people were talking abuot the fact that people with money get better cancer care--and I don;t know if it's true or not. I know people outside my HMO get better care lol.

Thanks

Elaine

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Here's the list of sites for GVAX trial:

It's Fay A.

Guest

Posted: Tue Feb 24, 2004 1:48 pm Post subject: contact info for GVAX Trial

--------------------------------------------------------------------------------

here is info on GVAX Trial:

Trial Name: A Phase 2 Randomized Study of GM-CSF Gene-Modified Autologous Tumor Vaccine (CG8123) ("GVAX® Lung Cancer Vaccine") with and without Low-Dose Cyclophosphamide in Advanced Stage Non Small-Cell Lung Cancer

Trial #: D-0031

Objectives

• To evaluate the safety and clinical anti-tumor response to vaccination with GVAX® lung cancer vaccine administered with and without immunomodulatory doses of cyclophosphamide, a chemotherapeutic agent.

• To evaluate the improvement in quality of life focused on cancer-associated symptoms

• To evaluate the feasibility and consistency of vaccine manufacturing using a new closed-system manufacturing process

• To evaluate progression-free and overall survival of patients treated with GVAX® lung cancer vaccine with and without cyclophosphamide

Eligibility

• Non small-cell lung cancer, stage IIIB/IV

• No prior treatment with gene therapy

• Accessible and adequate tumor source for vaccine production with measurable disease to evaluate following tumor procurement

Treatment

Tumors from planned surgical resection will be processed and made into the treatment vaccine. Prior to treatment, patients will be randomized at a ratio of 1:1 into one of two treatment groups, Cohort A and Cohort B. Patients in Cohort A will be treated with GVAX® lung cancer vaccine only and patients in Cohort B will be treated with GVAX® lung cancer vaccine plus a single dose of cyclophosphamide administered one day prior to the first, third, and fifth vaccine treatment. Patients will receive intradermal (beneath the skin) vaccine injections every two weeks for up to eight weeks, for a total of up to five vaccine treatments. The duration of this study, including follow up, is approximately two years.

In order to assist you and your physician with determining whether this trial is appropriate for you, select major eligibility criteria are listed above. If you live near a listed clinical trial site and believe you may be a candidate for this clinical trial, please contact the clinical trial site directly for additional information, including detailed eligibility criteria. The contact information is listed below.

Participating Clinical Trial Site

Mary Crowley Medical Research Center

John Nemunaitis, M.D.

3535 Worth St.

Dallas, TX 75246

Contact: Ned Adams, RN

214.370.1815

Tyler Cancer Center

Donald A. Richards, M.D.

910 E. Manning Blvd.

Tyler, TX 75702

Contact: Linda Dunklin, RN

903.579.9800

Cancer Centers of Florida

Barry Berman, M.D.

1111 Blackwood Avenue

Ocoee, FL 34761

Contact: Patricia De Leon, RN

407.292.3042

Providence Portland Medical Center

Helen Ross, M.D.

Chiles Research Institute

4805 N. E. Glisan

Room 5F40

Portland, Oregon

Contact: Teri Doran, RN

503.215.6412

Albany Regional Cancer Center

James Arseneau, M.D.

317 S. Manning , #330

Albany, NY 12208

Contact: Michele Butler, RN

518.489.2607

University of California

Mount Zion Comprehensive Cancer Center

David Jablons, M.D.

1600 Divisadero Street, Fourth Floor

San Francisco, CA 94115

Contact: Bob Kuhn, Study Coordinator

415.885.7333

University of Wisconsin Comprehensive Cancer Center

Joan Schiller, M.D.

600 Highland Avenue

Room K4/636

Madison, WI 53792

Contact: Cancer Connect

800.622.8922

Cancer Care Northwest

Stephen Anthony, M.D.

605 W. Holland, Ste 100

Spokane, WA 99218

Contact: Jeanne Fuller, RN, OCN

509.464.5137

University of Colorado

Health Sciences Center

Karen Kelly, M.D.

Anschutz Cancer Pavilion

1665 N. Ursula Street

Aurora, CO 80010-0510

Contact: Lyn Magree, Study Coordinator

720.848.0676

Hackensack University Medical Center

Harry Harper, M.D.

20 Prospect Avenue

Suite 400

Hackensack, NJ 07601

Contact: Diane DenBleyker, RN

201.336.8455

University of Pennsylvania

833 W. Gates Building, H.U.P.

3400 Spruce Street

Philadelphia, PA 19104

Contact: Adri Recio, RN

Phone: 215-573-6760

Vanderbilt University

Vanderbilt-Ingram Cancer Center

David Carbone, M.D.

Clinical Trials Office

491 Preston Building

Nashville, TN 37232

Contact: Cancer Information Program

Phone: 1-800-811-8480

Additional clinical trial sites are expected to be added over the coming months as the GVAX® lung cancer vaccine study is expanded.

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Becky,

The folks in Dallas ar Mary Crowley are VERY nice. They sent little brochures for us to distribute at the booth in April and when we called them they called us right back. You should check into their trial.

Good luck and good bless

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Becky,

I hope you are right and other locations have different protocol standards. I know that the University of Wisconsin Comprehensive Cancer Center is doing the GVAX trial headed up by Dr. Schiller (DaveG's Doctor). Possibly he could talk to here on your behalf and see what she thinks about your case.

I also know that Angel Flights has a terminal contact at General Mitchell field here in Milwaukee, and I would be more than happy to pick you up, and you and your family can stay here with Keith and I. We are about 1 hour from the facility, but it is an easy drive; all highway. Otherwise if you wanted to stay closer, I will help you find good lodgings.

Good Luck

Carleen

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Becky,

I hope you are right and other locations have different protocol standards. I know that the University of Wisconsin Comprehensive Cancer Center is doing the GVAX trial headed up by Dr. Schiller (DaveG's Doctor). Possibly he could talk to here on your behalf and see what she thinks about your case.

I also know that Angel Flights has a terminal contact at General Mitchell field here in Milwaukee, and I would be more than happy to pick you up, and you and your family can stay here with Keith and I. We are about 1 hour from the facility, but it is an easy drive; all highway. Otherwise if you wanted to stay closer, I will help you find good lodgings.

Good Luck

Carleen

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Dear Becky,

I spoke with the Cancer Care Center in Spokane, WA about getting my mom in for the GVAX trial. They told us that they either have to get a sample from a soft tissue mass in her lymph nodes (but this was ruled out because my mom had it radiated and that can't be done) or they have to be able to pull fluid from the pleural effusion. She told me they have to be able to get 600cc of fluid in order to make the vaccine. My mom first has to check with her oncologist about getting the fluid tested to see if it is malignant. They were informative and helpful. I am praying this will be something for you. Don't give up! Blessings to you.

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Becky,

I'm so glad you're aggressively pursuing this! The info from Fay and Mary Ann is probably helping so many other "lurkers" here, too. :) I've been "here" since January, and I'm still amazed at how supportive everyone is, and how much information is passed on to those who need it.

I hope you will find a way to participate in the trial, and if not, I hope there's something else out there for you that will knock the socks off those cancer cells!

BeckyCW

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To clarify:

I first heard of the compassionatte use exceptions when I worked with the doctors who did the first human gene therapy trials in the US, at NIH. I had heard the doctors discussing going "off protocol" for compassionate use for another protocol. I believe you would have to appeal directly to the head honcho for clearance, whether it is the doctors running the clinical trail at NIH or the director of clinical trials at the instittue/facility running the clinical trial. It would have to go through a board for approval or clearance, since it is not yet cleared by FDA. I know they will invoke it when it is a last chance thing, my doctors worked in pediatrics for the most part. They do communicate with the directors implementing the clinical ltrials in various research centers. Don't start with the people who can only say no, go straight for the top, and ask there. They'll know the route you have to go and the approvals you have to get. I only know it is possible. I hope this helps.

XOXOXOX

MaryAnn

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