New Therapy Shows Promise - Hope This Hasn't Been Reported Before and Thus Isn't a Bore

sailor_on_a_lee_shore
sailor_on_a_lee_shore Member Posts: 52
in Colorectal Cancer #1

Just read the article at the link below that I got notice of in an email.  As I said in the title, I hope I'm not breaking "old news" and therefore you all don't find this boring.  If so, I apologize in advance for wasting your time. 

On a side note, can anyone comprehensively explain the trials process while attaching a time line to that procedure?  Just wondering when we might see this therapy put into the arsenal of colon cancer drug therapies. 

In addition, is there a "fast track" process for drugs that show particular promise with particularly low toxicity and or benign side effects similar to what was done for AIDS drugs?

http://www.cancernetwork.com/conference-reports/aacr2013/content/article/10165/2137210

In an associated story:

http://www.cancernetwork.com/conference-reports/aacr2013/content/article/10165/2137220?cid=intraarticle. 

Last question is: both studies are focused on "solid tumors."  What are they referring to when they say "solid tumors"?  Is colon cancer included within the definition of solid tumors?"

Rick

Comments

  • coloCan
    coloCan Member Posts: 1,944 Member
    #2
    As you can see by this other "solid Tumor" phase I trial

    CRC is included

     

    www.medicalnewstoday.com/releases/258888.php

    There have been articles on a significant number of drugs undergoing phase 1 or 11 trials presented at this AACR conference that may be of use in the future against CRC, such as this one as well

    http://medicalxpress.com/news/2013-04-soy-based-compound-tumor-cell-proliferation.html

     

  • coloCan
    coloCan Member Posts: 1,944 Member
    #3
    coloCan said:

    As you can see by this other "solid Tumor" phase I trial

    CRC is included

     

    www.medicalnewstoday.com/releases/258888.php

    There have been articles on a significant number of drugs undergoing phase 1 or 11 trials presented at this AACR conference that may be of use in the future against CRC, such as this one as well

    http://medicalxpress.com/news/2013-04-soy-based-compound-tumor-cell-proliferation.html

     

    also,as per NCCN

    "Solid tumors refer to a solid mass of cancer cells that grow in organ systems and can occur anywhere in the body." They are either epithelial tumors (or carcinomas) or sarcomas. This is in contrast to " liquid  tumors",which occur in the ,blood,bone marrow and lymph nodes.

  • steved
    steved Member Posts: 834 Member
    #4
    interesting

    Good to hear of new stuff coming through but tend to not get oo excited about phase one success as it doesn't that often translate into clinical sucess. Unfortunately for most cancer drugs going through the phases takes years and I am not aware of any fast tracking- here is something I stole from another sire that explains the phases quite well:

    Clinical trials involving new drugs are commonly classified into four phases. Each phase of the drug approval process is treated as a separate clinical trial. The drug-development process will normally proceed through all four phases over many years. If the drug successfully passes through Phases 0, 1, 2, and 3, it will usually be approved by the national regulatory authority for use in the general population.

    • Phase 0: Pharmacodynamics and Pharmacokinetics
    • Phase 1: Screening for safety
    • Phase 2: Establishing the testing protocol
    • Phase 3: Final testing
    • Phase 4: Postapproval studies

    Each phase has a different purpose and helps scientists answer a different question:

    In Phase 0 trials are the first-in-human trials. Single subtherapeutic doses of the study drug are given to a small number of subjects (10 to 15) to gather preliminary data on the agent's pharmacodynamics (what the drug does to the body) and pharmacokinetics (what the body does to the drugs).[18]

    In Phase 1 trials, researchers test an experimental drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

    In Phase 2 trials, the experimental treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

    In Phase 3 trials, the treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow it to be used safely.

    In Phase 4 trials, postmarketing studies delineate additional information, including the treatment's risks, benefits, and optimal use.

     

     

    So still a long way to go for any of these but at least some hope that new things are in the pipeline each year and good to hear immunotherapy being focused on,

    steve

     

     

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