I see on the M.D. Anderson website that there is a clinical trial that I might qualify for. It concerns surveillance for post-treatment OHC SCC patients. They will do CT's and brochoscopies as part of their study to determine the effectiveness of surveillance on detecting recurrences or lung involvement. A person must have completed their "definitive" treatment in the past year and must be either a current (surely not!) or a former smoker.

A person would either take Celebrex or take nothing. The Celebrex-takers would return to Houston monthly for the first year. The non-Celebrex users would return every three months for scans and bronchoscopy, including some biopsies.

I would love to have this sort of good surveillance, and I could go to Houston every three months without too much difficulty. I can not take Celebrex (allergic to sulfa drugs) but I could participate in the non-drug "arm" of the study.

Does this sound like something I should look into? Thanks for your advice.

Hi Colleen,

I just wrote a really long post and it didn't work - so now, I have to re-type.

I am also screening for a trial at Anderson in March. They have you come in for 5 to 7 days and do the whole workup as a new patient and see what you qualify for. At least that is how mine is being handled - even though my doctor has recommended one trial in particular. I think they do that so that if you don't qualify for one - you might qualify for another and they wouldn't have to waste time with more tests etc... I've not screening for the trial you mentioned though as I have never been a smoker.

They also will want your insurance info - to make sure they are an In-Network provider or if you need to apply to have them added to your network. In addition, you will have to have all of your records, slides and other things forwarded to them before the appointment. (Again, this is how my case is being handled)

I have a few things that I'd like to add regarding your post from above. I work in clinical trials and so this is where the info that I am writing is coming from.

In your post - you mentioned that you cannot take celebrex due to your allergy to sulfa drugs. Usually this will prohibit you from entering the trial if celebrex is the study medication. The reasoning is that most trials are single blinded (meaning you the patient, do not know if you are taking study medication or placebo) or double blinded (both you nor the doctor know which arm you belong to). Only in an open label trial, will you know exactly what you are taking (and there is no placebo in open label trials). From the sound of this - it sounds to me like you might have a placebo arm (the one you would qualify for). In cases like this, you generally would not be permitted to enter this trial, b/c it would be dangerous for you to receive the study medication (celebrex) and since you are not supposed to know what you are taking - or which arm you are in, this would not work and would be quite dangerous and risky to enter into. Also, if this is the case, the FDA would not allow it.

However, I wouldn't let that discourage you from screening at Anderson as they have other trials that you might qualify for that would also give you the added surveillance you are seeking. The trial I am looking into involves a green tea extract and is a prevention trial as well.

Also, you might find the www.fda.gov website helpful. On the right hand side of the page, you'll find a link for consumers link for clinical trials. This will give you some great information regarding how trials work and are set up. Also, how your safety is maintained.

The FDA governs all Phase I through III human clinical trials. They approve the protocols and make sure that subjects (patients) are not going to be harmed unnecessarily during a trial (although that is always a risk of an unproven drug or therapy).

In general, You'll definitely want to know what Phase of trial you are entering and make sure you ask lots of questions before entering. Also, remember that if you ever get uncomfortable or are having reactions to the drugs / or are just not comfortable with the treatments, that it is your call, and you can discontinue the trial at any time.

Here are some basics on the phases:

Phase I: These are usually the first trials in humans. These trials are usually done only in young, healthy men (wouldn't want to risk a birth defect in a woman with an unproven drug), and are testing the safety and tolerability of the drug in the human body. This is the phase where they usually also determine the maximum tolerated dose the body can handle. In some trials, they will escalate the dose until the patient shows signs of toxicity. For Cancer and AIDS trials, however, they do not generally use healthy men as it would be unethical to subject healthy people to some of these drugs, so generally (but not always) they will be people who have tried everything else and nothing is working. These people are out of options in many cases and this might be a last hope.

Phase II trials: These are where the efficacy trials start. Does the drug work for the condition it is intended? Are there obvious side effects?

Phase III trials: Here they are fine tuning the drug, testing in a larger number of people (there might be a side effect that only 1 in 1,000 people or less experience and you might not see it in a small scale trial) and FDA applications for drug approval usually follow several Phase III trials for each drug (If studies show that it was effective and safe).

Phase IV trials: These are after market trials. The drug is already FDA approved, but they might be researching a new indication (for instance, I recently saw a trial for the reduction of leukoplakia lesions and the drug was Actos (a diabetic drug), I think this was a phase IV - but I can't remember for certain). Also, sometimes, they are just gathering more information on different populations. Maybe the original trials didn't have enough of a certain race or age group as drug can act differently in different ages and races.

I hope this information helps. My history is like yours, surgery only.....and I know that the added surveillance is welcome, so I'd definitely encourage you to explore this option.

Also, check into your insurance. I have United HealthCare and I just found out that I have a wonderful rider policy which gives me access to all of the CCCs in the nation at the In Network Rates and Copays and also includes a travel allowance that will allow me to go to Houston and they will reimburse some of the costs. In addition - this particular rider also covers clinical cancer trials - if there are costs associated with them. Not all insurances have this option as my plan during my initial diagnosis did not have anything close to this benefit.

If you have any questions related to trials - feel free to ask and I'll answer if I know. Also, let me know if you decide to screen - we might be there at the same time and could meet for dinner or lunch or something.

Amy M.

WOW!!! Amy, thanks so much for the good info! and to think that you had to write this twice. eek!

I DO have some questions.....I can't form them all right now, so you'll hear more from me.

How did you decide to submit to the trials? Did your doctor suggest that you would get additional excellent attention this way?

The trial that I saw described was one for which they seemed to assign people to one arm or the other.....to the Celebrex or the non-Celebrex arm. The non-C. people would come monthly, and the non-C people would come every three months, so you would have to know which you were in.

You are right, in that I couldn't take a chance on being in the Celebrex arm.

I have Blue Cross Insur., and i have NO idea whether it covers expenses for trials or not. I never thought I would need it...of course!

I live within driving distance of Houston (4-4 1/2 hrs.,) and at the current time, I have a son who lives there. He will be moving soon, however.

I would love to receive the advanced surveillance that they offer through this trial.

One question that I have is that they speak of routine bronchial biopsies.....eek. I wonder if this is a simple thing, or something that I would rather not submit to. I may have to ask this question in a separate post.

So.back to you.....Why, exactly, did your dr. suggest that you would benefit from participating in a trial, especially at a center so far from you home? Just curious....

If trials are desirable.....beyond the altruistic aspect of helping to promote the science....then I think that I will probably qualify for this one, and since it doesn't involve anything beyond having some extra surveillance at one of the best CCC's, I might go for it.

I'll come up with some different questions later. Thanks soso much for your help.

I

Amy.....Our timing is very similar. My surgery was Jan. 4, 2006. The trial I am interested in wants patients who are less than one year away from their final definitive treatment. They may or may not allow me to participate, since I am slightly beyond that 1-year window. I have written them an inquiry.

I presume that if I participate, my personal dr. will have to recommend me, though I have all of my records.

See...the questions are starting to come now, one at a time.....

If I am interested in participating in a trial at MDA, can I simply express that interest personally? or should I express that interest to my surgeon and have him refer me? (He will probably say, "Why?")

Many clinical trials pay the test subjects or, at least, pay for the studies, exams, scans, scopes, drugs, etc.

Amy,
Nice job of explaining the phases and how a double blind study really works.

Gary,

You are absolutely correct - most studies do pay the subjects and never charge your insurance. That is why you get so many participants in trials. However, from what I am gathering, I think that MD Anderson puts you in as a new patient first - b/f screening you for the trials and thus - they bill your insurance. They were quite clear about having to be in network. I kept questioning this too - b/c I was like "But, I'm SCREENING for a trial." I think b/c cancer trials are so involved and they do scans and everything to make sure you don't have active cancer for these particular trials we are speaking of, that might be why they don't pay for the screening per say.

Colleen, It sounds like you are right - it may not be a blinded study. You may be eligible if they are allowed to let you participate. The Inclusion / exclusion criteria (in this case the length of time from treatment for you) are approved by the FDA and some research centers will not deviate from these - as they are set up to protect the safety of the subjects. Generally these are cut and dry. For instance they would never allow a diabetic to participate if that wawas listed as exclusion. However, with time frames, I've seen them be more leniant at times - it really depends on the facility. Sometimes deviation from the I/E criteria will trigger audits from various places (including the FDA) and no site wants to get an audit and have the possibility of getting issued a citation due to deviation from I/E criteria. They are ultimately set up for the safety of the patient and that is why the FDA doesn't like deviations from them.

In my case, my Head and Neck Surgeon found the trial and recommended me to participate. He sent my inforrmation (with my approval of course) and then we waited. They hadn't called me after a few weeks - so I just called and followed up with them and got the process rolling. I think they get lots of inquiries - so you may have to start it for yourself as well.

You can always refer yourself. In many trials - we advertise to attract patients (inform patients) that the studies exist and many times we have strictly research centers that do nothing but research trials and patients self refer all of the time. Other times, their personal doctor will refer them.

Keep in mind that a doctor is always overseeing a trial even though you may see a non-doctor coordinator or nurse during most of your visits (not sure about these trials we are speaking of in particular though) and that the FDA and another institution called an IRB oversees all trials to ensure your safety. MD Anderson's website also has a great explanation in plain english to explain trials and IRBs and other things that you might hear along the way.


I dont' know what the bronchial biopsy involves. I've had the scopes -but I've been asleep for all of them. I have only had tongue biopsies as that is all of the suspicious places that I have had.

One reason my doc recommended me to participate in a trial so far away: I travel every week with my job from Los Angeles to Boise to Miami. So, the travel isn't a big deal to me. I have lots of sky miles and hotel points and just found out that my insruance will actually pay travel expenses due to a cancer diagnosis/ treatment and even the participation in a cancer trial. ($10,000 lifetime benefit) And, another girl in my office has a Houston site for another trial and I might swithc a location I have with her for this location in which I'd be going to Houston every 4 weeks anyway and I could coordinate the visits so that I didn't ahve to pay out of pocket to go (Or would only need to pay for one hotel room but wouldn't have to bother with the flights.).

Last question: Why my doc wants me to go: Well, Phase I trials can be risky - in that they are for untested drugs and sometimes are the first tests in human - so neither myself of my doc wants me to participate in those in general. However, the one he wants is a green tea extract. The premise is that asians who drink it all the time have a lot lower incidence in oral cancer and it may either prevent or repair the damage that leads to the cancer. In either case, he feels that it wouldn't hurt as it is only green tea. I'm not so sure I'd go for a drug trial since I dont have active cancer that we know.

Even though is isn't a drug per se - green tea does have some chemical properties like drugs and can also have side effects - so that is the risk that I take if I participate. The general side effects are similar as to that of having a lot of caffeine - nervousness, shakiness, diarrhea etc.....

Amy.....what a generous soul you are to take the time to be so thorough! Thanks soso much!

I am sorry that I didn't see this particular trial sooner, since it is so specific for me. My surgeon ("Dr. Ego," as my forum friend Sue has dubbed him") feels certain that my maxillary/palatal cancer is gone from that site and will not return. It was there for a long time, however--overlooked and then not recognized by my dentist...another story!.....so i am determined to have intensive surveillance done for possible metastasis. My surgeon is so sure that it is gone, that he doesn't have me come in often. I am not to return for 6 months. I don't know if I'll have a scan then or not. I know that I would feel better to know that someone was looking at me carefully more often.

The MDA study would involve scans every three months, I think, and the bronchoscopy. I presume that the routine bronchial biopsies would be perhaps a scraping....? a punch???? I have no idea. I think I'll try to find a phone number today. I'll keep you posted.

I am wondering...and I might have to start a new post for this question: How often is it safe to have a scan? Is CT radiographic? I know that MRI is not, but I think that the CT is. I'm sure that they wouldn't do anything that would damage a person's health......