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Clinical trial vaccine


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Has anyone tried this? We saw the oncologist today and we are still waiting for his results of additional pathology tests. He sent 25 slides of tissue for analysis. He thinks my mom will get radiation to the medestinial area and then possibly participate in the following study. He also mentioned Iressa. Basically he needs the results to see which he thinks is best. Just curious if anyone has done this

Name of Study: Phase II Study of TGF-B2 Anti-sense Gene Modified Allogeneic Tumor Cell Vaccine in Patients with Stages II-IV Non-Small Cell Lung Cancer

Sponsor: NovaRx

Description: The purpose of this clinical trial is to determine the effectiveness of an experimental vaccine for patients with Stage II, III or IV non-small cell lung cancer whose disease has not been controlled by other therapy or who currently have no measurable disease. The vaccine consists of lung cancer tumor cells that have been genetically altered to block transforming growth factor beta (TGF-B2), a substance known to weaken the immune system.

Patients will be randomly assigned (by computer) to 1 of 3 dosing groups. The patients in each group will receive at least 4, and up to 16 monthly injections of vaccine at Hoag Cancer Center.

To be included in this study, the following basic criteria must be met:

At least 18 years old

No evidence of disease or may have measurable tumor of a certain size

No history of spleen removal

At least 4 weeks since chemotherapy, surgery or radiation therapy

Additional criteria may apply

Trial listing updated: 12/10/03

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I am looking into this one too. I contacted th Mary Crowley Medical Cetner in Dallas about the GVAX trial. I was inelgibible for it, but thy proposed this one to me, and it looks like it may be a fit. I am in the process of gathering records for a consultation there with them.


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I just posted about this trial in the general section. The only thing about this trial is that it has not been validated. It does not appear to have any serious side effects, other than flu like symptoms and maybe some itching around the injection site. The only other thing is that you can't do this trial if you have done Iressa or any other immunolgical therapy. The vaccine is made from other people's cancerous tumor cells, rather than your own. Keep us posted on your mom's success.


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I just e-mailed them about that. I didn't mention Iressa in my communications with them yet, so Cheryl's comment about Iressa was news to me. I hope it isn't a problem, but I fear it will be.

I am off to talk to the oncologist about chemosensitivity testing before I go have my bronxchoscopy on Friday. It just makes so much sense to me and I am tired of taking chemo that doesn't do me any good.

I'll let you know what he says.


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All I can say is good luck to everyone in getting into the trials!! :)

Cheryl--I did see your post and the first time I read it, it was over my head, like zoom :) Then the oncologist yest mentioned a trial. I said oh, I read about people mentioning something like GVAX. He looked at me and said "i havce no idea what you are talking about." I guess this trial is different :)

Such baby steps, at first chemo and side effects were over my head and now I could ramble off different treatments :) Same with the surgery. I am now in the learning process of clinical trials and radiation. How do oncologists learn all of this stuff????? They treat all sorts of cancers and all these big words :)

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Hi Andrea,

Just sent you a PM. Hope all is going well for your mom and your family. The game plan is surgery. I want to change doctors. I am trying to find a Primary Care doctor. My insurance is Cigna. They contract with Hosg and Cedars... Please let me know who your mom's primary doctor is and I can check them out...

Thank you and hugs for you ((((Andrea))))


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I heard back from the research nurse at Mary Crowley late yesterday afternoon and he said that Iressa was not a problem for this trial--the only requirement is that I have to have been off Iressa (and all cancer treatments for at least a month. I asked him about the changing requirements that Cheryl mentioned, and he said that he knew there was a proposal for changing entrance requirements but he didn't think that it would allow samples to be taken fro inside the lung, but he would check on that.


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For one of the links you need acrobat to read the pdf file. The other one is wrong.

To understand alot of this you can study "the central dogma". It is the theory of how genes are expressed as proteins.


http://web.indstate.edu/thcme/mwking/gr ... ctors.html

The research below says that TGFbRII is a tumor suppressor so you would want that to be expressed.

Another article says TGFb2 is a immunosuppressive so you do NOT want that expressed. The TGF vaccine is an anti-sense vaccine so it reduces the level of TGFb2

There are a number of transforming growth factors that have been identified: There are TGF-alpha and TGF-beta types


http://www.supplementquality.com/effica ... ancer.html

Reduced expression of the transforming growth factor receptor type II (TGFbRII), a key inhibitor of epithelial cell growth and tumor suppressor gene, was frequently reported in many types of tumors including non-small cell lung cancer (NSCLC). With 43 independent pairs of tumor and paracarcinoma tissue samples from the patients of primary NSCLC, we carried out PCR-DGGE screening for DNA variants over the coding sequences of TGFbRII gene, immunohistochemical (IHC) assay of TGFbRII expression, methylation-specific PCR analysis and semi-quantitative RT-PCR. No variation in the whole coding sequence of TGFbRII gene was detected but the IHC experiment revealed the reduced or lost expression of the gene in 44% (19/43) of the tumor samples. The methylation analysis on the 19 pairs detected frequent occurrence of methylated TGFbRII promoter in the tumor tissues whereas the most of the paracarcinoma tissues were free of the methylation. The reduced TGFbRII expression was highly significantly associated with the methylation event (P < 10-4). The RT-PCR analysis demonstrated a clear agreement between reduced TGFbRII expression and decreased mRNA level of the gene in the tumor tissue samples. In conclusion, TGFbRII plays an important role as a tumor suppressor in NSCLC carcinogenesis. The defected expression may serve as one of the most important molecular mechanisms in explaining the progression of the disease. In particular, aberrant 5?CpG methylation of the gene has explained the down-regulation of the gene at a transcriptional level.

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