Friday, Oct 19th was a day of decisions. Sherri, Pam and I went to meet Dr. Ian Thompson for a early appointment (9:00 AM) . What a sweet guy! We have been so blessed to have wonderful physicians come into our lives!. It has made this experience so much easier. Dr. Thompson did a quick assessment and then told us that I was eligible for a stage 3 clinical trial. Now, in the past, I have heard of clinical trials through different sources and through some support sites, I have heard of other cancer patients being involved in them. He said that a nurse who manages these trials would give us the whole story. He went on to explain what the radiation process involved, and what we might expect... and again, like physicians must feel obligated to do, he reviewed the statistics on survival rates in months.. In the end, I felt that we all really like Dr. Thompson and felt comfortable with every one there.
More on the Clinical trial.. These clinical trials are done in order to advance treatment. They must go through many different committees and boards in order to advance to stage 3 trials where they are working with real patients who are eligible. Stage 1 and 2 are the testing stages where the do the animal studies, laboratory studies, and are reviewed by the many different boards and panels in order to advance. This clinical trial I am eligible for is involving the dosing regimen for the temazolomide which is the first line, standard chemotherapy drug now used for glioblastoma brain tumors. If I choose to participate in this study, I will be randomly chosen to receive either the standard dosing and treatment, or an experimental dosing.. these different dosing regimens will be analyzed through the trial to see if the experimental dosing helps in the treatment of this cancer.
We spent close to an hour talking and asking questions about this trial, how it might benefit me etc.. Chemotherapy has a bad reputation of course as being toxic and making patients very sick, so this is a concern. I spent some time later last evening of course consulting with my Friend, Kevin Swiss, Ph. D. who is a chemist, scientist and very smart man whom I am blessed to have as a friend. After a very head heavy evening of reading the 100 plus page description of the clinical trial, talking to friends and family and doing some research on the Internet, we decided that participating in this trial would do nothing to harm me, and would very possibly help me. We are going to talk to Dr. Congdon who is the chemotherapy Dr. about this Trial next Wednesday. This will be our first appointment with him and again, several people at the radiation center here in Bellingham said to us, "You are very lucky to get Dr. Congdon, he is fabulous!".
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3 comments:
Richard & Sherri,
We just heard the news and we're stunned. Always these challenges pare our feelings down to the most important ones. Love is SO apparent between you, around you, and in you.
We send our love too, and want to help in any way. Cooking, errands, whatever. We'll be calling.
Much love & prayers,
Brian & Steph
Hi Richard, I wrote a quick clinical trial 101 about what you are doing and what is behind it. I think we owe it to our reading public to inform themselves their networks on clinical trials...
These clinical trials are done in order to study new or existing drugs for new or different indications, determine optimum treatments, try out new regimes, and to advance treatment. They must go through many different committees and boards in order to advance to stage 3 trials where they are working with real patients who are eligible.
Preclinical stages, typically for new drugs, are in which animals under carefully controlled conditions are tested to examine the drug effects and maximum safe and tolerated dose of the medication in relation to the human.
Stage or Phase 1 Cancer clinical trials are where 10-20 gravely ill individuals with a certain cancer(typically without other medication choices) volunteer to take medications to examine the effect of the drug on their bodies - they are truly guinea pigs for the betterment of science. Information obtained relates to how much dose they can tolerate and what the side effects are and how bad the side effects are.
Stage or Phase 2 studies are done on 10-50 cancer patients which have the certain type of cancer the drug is indicated and the appropriate stage 1 thru 4, for e.g., GBM, lymphoma, lung cancer etc with the typical stage classification. Again the clinical trial primarily looks for the safety of the drug and the side effects. Sometimes these patients may be helped by getting remissions but this is ONLY secondary, the first goal is demonstration of safety for the drug and treatment.
Phase or Stage 3 clinical trials, these are usually two or more treatment “arms". Classically, one arm is the standard treatment of the cancer (for GBM - radiation + standard-dose of temodar in a cycle) and the experimental arm which could be radiation + higher dose temodar for fewer days in a cycle as above +immuno-modulator or other unapproved drugs (not in Richard’s case). Each patient may "cross-over" and do both arms but always one at a time. Cancer Ethics indicate that the least treatment for cancer must be the medically standard treatment, but in some cases this may be palliative care. In a typical experimental drug arm, each patient is enrolled and may not know which arm they are in. And drugs will be given in such a way as to mask for the doctor and the patient if they are the real or placebo drug. The masking of placebo versus real drug is an art and a science. We use placebo tablets and active tablets that look identical, or if there are two different tablets – put tablets inside opaque capsule shells, or we may use aluminum over IV bags.
There are also Phase 4 clinical studies. These are only done in the United States on drugs which have been approved on limited data and the FDA requires further information on the drug to look for smaller amounts of side-effects which may be good or bad.
As always in the U.S. for drugs (not medical devices), each clinical trial is free to the patient (it is ILLEGAL to charge a patient for the medication) including all visits to the doctor and study center!! So this is one way to get good care and drugs without insurance.:( Sometimes, you may also be compensated in money for your time it takes to do these clinical trials. At any time, you can drop out of the clinical trial for any reason.
After the clinical trial, your name will disappear but the data on you (encoded like - white male, 50 yrs old, name "AA") during the clinical trial will remain, the data will usually be published and may also be used to justify marketing a new drug or making dosing changes to an existing one, to help save countless others. Your data also is used to justify if the treatment works better or not.
OVERSIGHT….
The principle investigator (doctor in charge of the entire thing) must have a plan for clinical trial protocol and how the data is used prior to the start of the trial ( for example, see http://clinicaltrials.gov In order to do any clinical trial in the United States on a U.S. citizen, there must be sufficient documentation submitted to the U.S. Food and Drug Administration in Silver Spring, Maryland. The FDA will review and decide if the treatment and drug is safe to proceed given the animal testing, dosage, etc. For Cancer – it is always a risk-based analysis. Also, if the clinical trial uses a hospital, its own institutional review board (IRB) also must give permission to do the trial there as well. Sometimes IRBs may decide that the protocol is not sufficient although the FDA finds it ok.
First line – is the first try at beating the disease. Second line is the second try after the first remission etc. As more remissions end, the chances for beating the disease decrease, and usually fewer treatment or clinical trial options are out there. So one must think very carefully what treatments you choose first, second and third...
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