kimblanchard Posted March 19, 2004 Share Posted March 19, 2004 Hi friends, Dave Grant passed on a contact at the University of Wisconsin for the GVAX trial. I contacted them and they answered promptly. Although it does not appear that Bill meets the eligibility requirements, someone else may benefit from this information. Here is the response: Dear Ms. Roberts, Thank you for your inquiry to the University of Wisconsin Comprehensive Cancer Center and your interest in the GVAX clinical trial for advanced stage non-small cell lung cancer. All work-up and treatment associated with this trial needs to be done at our center in Madison, WI. Initially, you would need to visit our clinic to be evaluated for eligibility. If you were determined to be eligible, the procedure to remove your tumor cells would need to be scheduled at our center. Once the cells are obtained, they would be shipped to the manufacturer for production of the vaccine. This process takes 4 weeks to complete. Once the vaccine is ready, treatment with the GVAX vaccine is given every other week x 5 injections with or without low-dose cytoxan every 3 weeks x 3 doses (total time of treatment is 10 weeks). Patients are randomly assigned to either receive or not receive the Cytoxan treatments. In addition to these treatment days, you would be required to be here for a few days prior to and after the first and third injection of the vaccine, and at least weekly throughout the course of the treatment for additional tests and observation. Follow up would then be required monthly for the first two months and quarterly beyond that. I have included below basic criteria that you need to meet in order to be eligible for this trial. I would suggest that you discuss these with your physician and have him or her call us for further details. Diagnosis of non-small cell lung cancer, must have accessible tumor (at least 1x1cm) or pleural fluid (at least 600ml) that can be removed under local anesthetic and used for vaccine production. Must have measurable disease (other than the tumor needed for resection) Must have adequate Pulmonary Function tests (breathing tests) Must have Performance Status of 0-1 (good activity level) Must have adequate blood test results Must not be on blood thinners within 12 weeks No prior gene therapy No pulmonary hypertension or congestive heart failure No active autoimmune disease No prior malignancy within the past 5 years No active or untreated brain metastasis The cost of obtaining the tumor cells needed to make the vaccine is likely to not be covered by your insurance company, unless there is a clinical reason to do this. There are other costs associated with being on this trial that would be billed to your insurance company. I am uncertain as to whether your insurance company would allow you to come here and enter on this trial. If your physician feels that you meet the criteria above, the first step would be to have the following medical records forwarded here for our staff to review: Recent History and Physical Pathology report Recent labs Recent CT scan reports If you plan to have these forwarded to us, please call and let us know to watch for them. Please fax to 608-263-8613, Attention Cancer Connect. Please feel free to call or reply if you have further questions or concerns. Sincerely, Julie Julie A. Fiers, R.N. CANCER CONNECT A Patient and Physician Resource University of Wisconsin Comprehensive Cancer Center 1-800-622-UWCC (8922) Local 608-262-5223 uwccc@uwccc.wisc.edu I hope this can help someone. I am still searching for an answer. Blessings to you all, Peg Quote Link to comment Share on other sites More sharing options...
Elaine Posted March 19, 2004 Share Posted March 19, 2004 Thank you, Peg. Elaine Quote Link to comment Share on other sites More sharing options...
Guest Billie Posted March 19, 2004 Share Posted March 19, 2004 Thank you, Peg for obtaining this information. This is what I found out on my appointment with them on Wednesday, but I never would have been able to explain it so well. Billie Quote Link to comment Share on other sites More sharing options...
ginnyde Posted March 19, 2004 Share Posted March 19, 2004 Peg, Thanks so much for the info and I am sorry that your Bill and my Earl do not qualify under current criteria. How is Bill doing? I hope you are seeing some progress. Is your name Roberts? That is my maiden name. Ginny Quote Link to comment Share on other sites More sharing options...
teresag Posted March 19, 2004 Share Posted March 19, 2004 I wonder why are they charging patients to take part in this clinical trial. Most clinical trials are funded either by NCI or a pharmaceutical firm (for drug trials). Many private insurers (probably most, but I don't have the numbers) will not pay for experimental treatment. If you are on Medicare, it is a given that they won't pay. In fact, a provider is not permitted to bill Medicare for investigational treatments. If you enter this trial, I urge you to negotiate up front with your insurer to get them to pay for it. Ask your MD's office to provide a "letter of medical necessity" that justifies your receiving the treatment. Ask U. of W., or wherever you get an experimental treatment, to help with the insurance process. And find out why the study is not funded, i.e., why insurers or patients themselves are being asked to pay. Quote Link to comment Share on other sites More sharing options...
kimblanchard Posted March 19, 2004 Author Share Posted March 19, 2004 Hi Ginny, Yes, our last name is Roberts. As far as Bill and how he is doing - thank you for asking. Since Bill was released from the hospital he has been in extreme pain and not eating for over a week (due to nausea). Yesterday I did manage to get him to eat a few spoonfuls of food and the pain is starting to get under control with a change in medicine. This is progress! The doctor is ordering another brain MRI to see if the tumor is growing there once again and causing Bill to feel this way. I guess tumors in the brain can cause nausea. Bill is thinking that if he gets the nausea under control he will then get radiation on several bone tumors before beginning any chemotherapy (to help pain). The doctors are not very encouraging about the chemotherapy working, but I look at it this way - they didn't think the last chemotherapy would work, but it did for awhile. I contacted the doctor at IU Med Center for his opinion and he said if Bill gets strong enough he should try it, but only if he is strong enough. He feels that the chemo they are suggesting is very tough on your system. I continue to research options such as the University of Wisconsin GVAX trial. There just has to be an answer. Also, thanks Teresa for your input. You make alot of sense. Blessings, Peg Quote Link to comment Share on other sites More sharing options...
Elaine Posted March 19, 2004 Share Posted March 19, 2004 Thanks for the update, Peggy: I know how discouraging drs can be. It should be up to Bill what he wants to do and what he is able to do. It is HIS decision. I didn't realize it, but Drs can and DO refuse to treat people. How can that be? I don't understand.\ I lived for several years in Indiana. Lafayette and Indianapolis. Indianapolis was nice. Pls take care of you, too and so glad to hear the pain is lessening. I also dont understand why people are being asked to pay for the vacinne. What's up with that I wonder. Elaine Quote Link to comment Share on other sites More sharing options...
ginnyde Posted March 19, 2004 Share Posted March 19, 2004 Peg, Why aren't they considering Iressa again for Bill? Carolyn Flournoy's husband was just given Iressa for the 2nd time. Ginny Quote Link to comment Share on other sites More sharing options...
Guest Katie Posted March 20, 2004 Share Posted March 20, 2004 Peg- What about the clinical trial going on at the Mary Crowley Medical Research Center at Baylor- where ALL those "breaking news" articles were written about...this is the place where it all happened!! One of the WORLDS largest gene therapy investigative sites with clinical trial protocols involving gene and cellular therapies for patients with advances cancer. Their web site is usoncology.com and their phone # is 214-370-1822. It's worth a shot and if you keep trying - everywhere you can- someone WILL say yes and someone WILL help, I have to believe that. Please let me know if there is anything I can do on my end. Even lend you guys a place to stay if they agree to see you. (but you'll have to put up with a 6 year old and a baby! ) Love for you both, KatieB Quote Link to comment Share on other sites More sharing options...
Carolyn Flournoy Posted March 20, 2004 Share Posted March 20, 2004 Peg...Saw Ginny's post to you and thought I would put my two cents in. Jim is going back on Iressa. His CT scan last Monday showed progession of disease. He's had no luck with any combination of chemo yet. But he's needs a break for now. Jim also has pain (the dry heaves about once a week) But not as severe as you describe Bill's pain and nausea. Jim has not lost weight and is able to do social things.(no work or activities that take alot of energy)............. ............................ I know Bill already tried Iressa. But if I remember right he did feel well while he was on Iressa. Was told by the onc.'s nurse that the doctor tried Iressa on other patients for the second time after chemo. She said she doesn't know why but after chemo Iressa seems to work better. Bill might give it a try while you search for other options. Carolyn Quote Link to comment Share on other sites More sharing options...
bluebayou Posted March 20, 2004 Share Posted March 20, 2004 Hi Peg, I'm so sorry to hear about Bill's nausea. As you might have read from my posts, this has been a big problem for me for the past 2 months of so. Zofran, Decradon, Stemtil countless other medications haven't helped and am in a bad way. The reason for my post Peg is simply to let you know I understand what u and Bill are going through and if I should be so lucky as to come across something that works, YOU will be the first to know. Praying very very hard for Bill.. God Bless us All, Francine Quote Link to comment Share on other sites More sharing options...
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