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......

Colleen,
We've actually had many discussions about scan safety and radiation exposure from them

Go to this link and click on "Radiation Exposure Levels" http://www.oralcancerfoundation.org/facts/radiation.htm

CT is definitely radiographic and has the highest exposure of any diagnostic scanning modality.

I wonder what would be the different exposure with a PET/CT? This wasn't mentioned in the above article. I just had my second PET/CT in 10 months at MDACC Houston. A good 30 minutes on the table with this scan. 18 minutes on the chest and pelvis. Then he came back in, repositioned me, and the remaining time was head and neck. I've had 2 CT scans there also during this past year, they were much quicker scans I think maybe because they were just head and neck. Thats a lot of radiation I think in a 10 month period. They told me last week that they were going to back off on the scans for awhile (hope so!) and just wanted to see me in the clinic for routine exam. Nothing is showing up on the scans which of course is always great news.

MDACC also called me and sent me a packet about the Celebrex trial. The Bronchoscopy sounded extremely gruesome. As was explained to me on the telephone, they would want to go in and take small pieces of lung tissue for study....as per trial protocol... YIKES!!! I can only assume that they would put me under for this particular procedure. The young lady on the telephone suggested that I read everything over and then call with any questions or concerns. I think maybe I need more details....

Did they send you a document called the Informed Consent? If so, it should outline all the study procedures that you will endure and should also specify if you will need to be under general anethesia or not for that trial.

Did they send you a document called the Informed Consent? If so, it should outline all the study procedures that you will endure and should also specify if you will need to be under general anethesia or not for that trial.

I spoke with the research nurse/project administrator today.....Cindy Duron....She indicated that I would be a perfect candidate for the study, exc. that my "definitive treatment" was completed over one year ago. She thinks that they will be required to stay within those guidelines, but she is going to check and see if I can be admitted to the study, based on the fact that I had a PET/CT in December, before the one-year mark.

I, too, will have to find out more about the bronchoscopy and biopsy......and the repeated exposure to the radiation from the scans.

I would love to have such a thorough surveillance program, however.

I doubt that I will have the option anyway. I'll keep you posted. In the meantime, please post anything you find out about it...and about the bronchial biopsy procedure.

I have read about a new bronchoscope that can be used in a doctor's office. Maybe they use that one. It's supposed to be quite benign.

I suppose that a biopsy site would heal quickly and not cause permanent damage to the bronchial tissues.

...much food for thought.

Russell...I see that you are in Houston. I live in central Louisiana, so I could participate without too much trouble. You would have no trouble at all, if you're interested. I hope that you'll continue to post your findings and your decisions about this. Thanks.

I can not take Celebrex, but in this study, it is a voluntary part of the study, so I can opt to be in the other "arm" of the study.

Russell.....When was your treatment? Are you tempted by the trial? Does your doctor feel that it would be a good thing to do? Was your treatment done at MDA?

I recently asked my ENT to view my vocal cords, which have not been normal since my neck dissection. (I think that the nerve was insulted. They have slowly improved.) After puffing some numbing spray into my nostrils, and then some other numbing stuff into my throat, he passed a very thin, flexible fiberoptic scope through one nostril, down as far as my vocal cords. There was absolutely NOTHING to this. I suppose that the bronchoscopy is more involved, but it must be similar. I imagine that the scope will be somewhat larger, if it is going to be able to take a biopsy. Surely for this clinical trial, they will use this flexible scope, and not the old-fashioned rigid scope!

Yes, Informed Consent was included in the documents that were sent. When I reached the part about lung tissue samples being taken, I began to have second thoughts, not to mention cold feet...I never realized the trial would be this involved. Lots more reading to do and questions to ask before I can decide.

Colleen, I think I was picked randomly for this trial...that is to say....my doctor has never mentioned the trial to me. I received a phone call from MDA and then they sent me all the info. I have had surgery to the throat above the voice box with laser at MD Anderson. I am fast approaching the one year mark this April, so time may be a factor also for the trial. To be honest, this trial is much more involved or invasive than I had originally thought. I'm really undecided at this time. Also, I still have to go in every two months for follow up with the surgeon on the treatment that I have had at MDA. Anyway, should I decide to go any further with the trial, I will be sure and let you know.

Russell....Who is listed as the sponsor for this study? On the internet, it said that the U.S. Department of Defense is the sponsor. Is this correct (and why??)

How are the studies paid for? by the U.S.gov't., or by your insurance. My ins. is BC/BS, and they will pay for clinical trials.

I am beginning to waffle some on the idea of having so many biopsies taken....but i will wait and see if they even offer me a chance to enroll. I doubt that they will. That might affect their scientific results.

Also.....did you hear that Congress has cut funding for cancer research, most specifically clinical trials, including those for oral cancer.

Just wondering if either of you have made your appointments yet to screen for these studies? Mine is for third week of March.

Amy...I have made contact with the research nurse. I am actually outside the time restrictions (one year post-treatment) so she felt that they probably could not admit me to the study, but she was going to look into it. I have learned a bit more from Russell, and I am beginning to feel a little leary about the repeated bronchial biopsies. The nurse has called me back and left a message for me to call her. I will do that tomorrow, but I doubt that I will have to worry about being accepted. I'll let you know.

I went back and re-read this thread with interest today. I have also been asked to participate in a clinical trial at MDA. They spoke to me about it on my last F/U visit 2 weeks ago. It's the "EPOC" trial - Erlotinib Prevention of Oral Cancer. Erlotinib (Tarceva) is a drug that blocks the activity of an enzyme found on the surface of many tumor cells that may control tumor growth and survival. It is already approved for tx of non-small cell lung ca.

Here's the interesting thing - the main screening test involves testing the tumor tissue they removed during my surgery for certain genetic markers that indicate a higher risk of recurrence. Apparently this screening is fairly new. Since my Dr at MDA has always told me I have a very low risk of recurrence (he says he thinks 5%) I figured I would not qualify, but at least would know. Well here's the bad news - they called me yesterday and told me that I do qualify - which means I have those genetic markers present, indicating a 65% chance of recurrence in the next 3 years.

Is anyone else in this trial? I am going to go ahead with the next steps, which involve additional exam and screening. I figure it can't hurt to have the extra surveillance even if I end up with the placebo. It's kind of a downer, though, knowing that I have those genetic markers...

Keep us posted please, I think this is very interesting. I've necer heard of screening for genetic markers as far as recurrence was concerned.

Tim

Ginny,

I am in Houston now - I don't qualify for the Green Tea Extract trial that my doctor referred me for - but they are screening me for the EPOC trial. To be honest though, I don't know that I'll do it even if I qualify.

The way they explained it to me - was that it wasn't necessarily a hereditary genetic marker - but more of a mutation of sorts where two genes get deleted and cause you to be high risk for recurrence. That is my understanding - however, I could be off base on that.

I just agreed to screening on Monday - and they have to obtain additional slides from my last biopsy as they didn't send enough to do the testing. Like you, I figure I'll wait and see what the results are and at least I'll have that info. However, the side effects of Tarceva don't sound too pleasant. From what I read - most everyone gets the rash and most people get the diarrhea and a lot have nausea....plus there is a multitude of additional side effects that are much less common. HOwever, you'll probably know quite quickly if you are on placebo by a lack of side effects.

For me, expense comes into the picture as well. Since this is a National Cancer Institute sponsored trial - there is no reimbursement to participate and since I'd be traveling from Cincinnati, that would be a pretty big expense, as I'd have to come back for another screening visit, and then at months 1, 2, 3, 6, 9, 12 and every 6 months after for 2 years. I don't know that I want to go to that expense for a trial. Now, if it were a proven treatment - that would be a different issue all together.

I am however, slightly annoyed that they insisted that I stay in HOuston for 5 to 7 business days for the screening and it really only required 3 days (which would have been one day if one of the doctors had not taken a vacation day at the last minute). They tried to reschedule me for the other doctor on next Monday, but I wasn't staying for that long with nothing to do and no testing that was being done and so they worked me in today (Wednesday).

Good luck and let me know if you enter the trial. I'll be a couple of weeks behind you if I decide to do it.

Amy - I sent you an email to your own email address. I was very interested to hear that they were also talking to you about this trial - I knew you were considering the Green Tea trial and I actually asked the reseach nurse about that one...she said it was about full.

I will keep everyone posted as to what I learn about this. I am tentatively going back in 2 weeks and will have an opportunity then to talk with the principal investigator, and plan to ask a lot of questions about this new test. They will do additonal screening then, and if I pass, I will start the trial. I am lucky in that I am already being followed at MDA so it's only a few extra trips, and I travel for business so have lots of frequent flyer miles.

The side effects do worry me but so does the knowledge that my recurrence rate just jumped to 65% - so in weighing all things I believe the extra surveillance I will get as part of this trial can only be a good thing... and even if I am on the placebo, I will hopefully help further the research into ways to prevent recurrences...I read about everyone who is going through those recurrences and my heart just goes out to them - and everyone here who is facing this disease, whether patient or caregiver...

Here is the link to the trial synopsis on the FDA website for those who are interested. They do not have it posted on the MD Anderson website currently.

http://www.clinicaltrials.gov/ct/show/NCT00402779?order=2

Hmm I have re-read Amy's and Ginny's entries about this trial. I have also sent an email to the researchers, but I doubt that I will qualify, since it has been over a year since my diagnosis.

NOTE: If anyone thinks that they might be interested in a clinical trial, most of the ones I have seen have required enrolling within that one-year window.

I am not sure that I want to know if I have the increased recurrence marker......will have to think about that.

And the drug sounds more than a little un-pleasant, unless they have some reasonable expectation that it will be effective against recurrence.

I doubt that I will have a decision to make anyway. I'll keep you posted.

How can I contact the research nurse about the green tea study? I know that you said that it is nearly full, but you never know. Maybe they need one more Southern girl in their study.

Colleen - here's a link to the info regarding the green tea extract trial on MDA's website. If you look, there is another link on this page where you can contact someone about your interest. http://utm-ext01a.mdacc.tmc.edu/dept/prot/clinicaltrialswp.nsf/Index/ID01-155

Hi Colleen,

I just sent you a private message with some info for both of these trials since I am hear now and just talked to them regarding both trials on Monday.

Amy

Since we are on the subject, where would I look to find the who,what,and wheres about a clinical study?

Brian has posted some good links on this website which can give you a good choice of trials. (At least I think they are still there).

You can also go to the FDA website (http://www.clinicaltrials.gov/) and look them up - but not every trial is listed there. In addition, you can visit a specific CCC's website that you are interested in and see if they have a trial that you might be interested in, but they do not always post all of the trials. There is no good comprehensive database that I currently know of where you can find every trial available.

The other thing you can try is to call the universities that are close to you and see if they have any trials you would qualify for and could learn more information on. Of course - you'd only be looking at universities with medical schools. You're probably limited to universities with regard to cancer trials - as they usually don't do cancer trials in regular research facilities that are stand alone. However, if you are interested in trials for other things than cancer - you can call each center to see what they offer - however, with a cancer diagnosis, you are going to be limited in trials that will allow you to participate. Any cancer diagnosis is almost automatic exclusion from most trials.

Hope this helps.

http://www.oralcancerfoundation.org/search.htm to the search engine. Enter clinical trials. You will find the resource page links to clinical trial search engines.

Remember for the most part clinical trials are hard to qualify for, let alone find one that you want to be part of near you. It is all about exluding people that do not meet the matching criteria of the trial. Most trials are very limited in the parameters of the participating patients.