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SCOT Trial


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#1 TJ903

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Posted 11 April 2008 - 06:28 AM

I want to thank all of you who answered my recent post, but during the back and forth I must have been unclear. I did not get into the SCOT trial. My husband had made arrangements for me to be seen anyway by Dr. Brown at MUSC. They started me on cyclophosphamide, and will see me again in two months. I was so disappointed but those two words 'experimental and investigational' should be removed from the dictionary. In fact- I wish all negative words could be removed!

What really bites is that during my wait for the doctors and the letters of support and the whole appeal process, my lungs got too bad to be in the trial. All of my tears and sleepless nights were for 'naught. I feel so sad it's hard to describe. Has anyone been on the oral cyclophosphamide and had bad side-effects? Should I shop for a wig?

Once again thanks to all of you who responded - your words are like bright sparkly diamonds - each one unique but each one so bright and full of love!

Thanks again - TJ



#2 tintin

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Posted 11 April 2008 - 10:33 AM

That is so depressing, I can not think what to say. I have however heard good things about cyclophosphamide, so take heart there are other routs to keeping this disease at bay.


keep on smiling

crawler

#3 bmw

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Posted 11 April 2008 - 11:17 AM

TJ, I don't think you'll need a wig. I had 12 IV infusions of cyclophosphamide and only lost the three hairs that I had on my chest. Good luck, Birdman



#4 peanut

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Posted 11 April 2008 - 12:44 PM

TJ,
Is there a reason they are choosing oral cyclophosphamide vs. IV cyclophosphamide?
I've read that IV is safer and more effective.

I've had 13 IV cyclophosphamide treatments and still have hair, it's thin though...

peanut



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my HMO makes me wear a helmet...

#5 Gidget

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Posted 11 April 2008 - 12:50 PM

TJ,
I am so sorry to hear your bad news. Yes, I was also denied the stem cell by BCBS and Yes, I appealed and appealed. And Yes, I contacted my state's Attorney General's office only to learn that the state insurance laws allow a loophole for self insured companies - of which 90% of all companies are self insured and as such the state insurance laws cannot force them to provide coverage even if a medical necessity is proven.

So, like you, I went on cyclophosphamide -- only you need to make sure that you do the IV and NOT the oral. If you take the oral pills you are at great risk of developing bladder failure. So, you must take the cyclophosphamide by IV and the dosage should be by "meter squared", meaning that it will be based on your body weight. Again, do not take the oral -- request the IV. If you take the oral you will need to drink literally a gallon of water a day to offset some of the risk of bladder failure and even then the biggest risk is in the evening when you are sleeping and cannot empty your bladder. With the IV, they will hydrate you before they give you the IVcyclophosphamide, then you need to drink about 6-8 glasses of water for the next 2 weeks in order to flush the drug out of your system. This is key -- flushing the drug from your system.

So what you do is schedule the cyclophosphamide IV for a Friday and plan to do absolutely nothing for Friday/Saturday/Sunday. Take this time for yourself, drink lots of water and you will be just fine. I found I had minimal to no problems with the cyclophosphamide as long as I took the 3 days to take it easy and drink the water. Around the 14th -17th day, you will feel tired so plan to take it easy those 2-3 days too.

In my case, the IV cyclophosphamide stabilized my lungs and while on it my skin became slightly softer. Now that I am off it, I have tried to convince the doctors for quarterly dosages with no luck but that is another story.

As far as hair loss, your hair will thin and maybe after 6 months you will see a little bald spot. I did get a wig but never wore it. Also, you won't have to shave your legs that much which is one positive point. I also was very careful with my hair in that I used gentle shampoos and extra conditioners.

You'll do fine on the cyclophosphamide -- just get the IV. The first doctor I went to RX the oral and I told her I wanted the IV -- well she didn't like that much and refused. So, I got a new doctor. No need for doctor egos when it comes to my life. And be sure to get a second opinion or a third opinion until you are sure you know all your options.

Also, keep in mind that any usage of oral cyclophosphamide disqualifies you from the SCOT trial but not the Assist at Northwestern. Also more than 3 doses of IV cyclophosphamide disqualifies you from the SCOT trial but not the Assist at Northwestern. You say that SCOT will not take you 'cause your lungs are so bad, perhaps you should see Dr. Burt at Northwestern. The SCOT study wants younger and healthier people for their trial as their initial study results before the XRAY shields for the stem cell showed a 30% mortality rate if I remember right. Now, they have reduced it to 10% or less but only after recruiting stronger patients. As such, you may want to check out Northwestern which does not have as many exclusion criteria. This is where I had planned to go -- Northwestern. You can also try Dr. Anne Traynor at Maine General in Augusta, ME as she is also running a clinical trial for stem cells. Dr. Traynor trained for 10+ years with Dr. Burt. She also may not have as many exclusion criteria as SCOT. I looked into Maine as I thought it could be less expensive then Chicago if I had to pay out of pocket.

In any event, good luck. You will do fine on cyclophosphamide. Don't worry. Maybe, it will be just the kick your body needs to stabilize your lungs. And don't get me started about the insurance industry.Been there. Now, if we could just all figure out how to get the insurance industry to allow experimental when it is a medical necessity, we will be ahead as treatment for all severe immune disorders is considered experimental. REgards, Gidget



#6 janet905

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Posted 11 April 2008 - 01:25 PM

Hi tj, I'm so sorry about your worsening symptoms. that must be so hard . gidget is right about the cyclophosphamide. Persons who take the oral form are at much greater risk of developing bladder cancer down the road. you should discuss the possibility of using the iv route with your doctor. I hope it helps you a lot. hang in there!!



#7 janey

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Posted 11 April 2008 - 04:37 PM

TJ,
I'm so sorry that you weren't accepted into the SCOT trial, but more so for your decreasing lung function. I agree with the others that you should look into the trials at Northwestern ASAP. Here's a link to a couple of Northwestern clinical trials for scleroderma.

It seems that most people are given IV cyclophosphamide. I love Peanut's question on why oral and not IV since IV has been proven to be safer. When I was prescribed oral cyclophosphamide, my rheumatologist referred to a large study that show the effectiveness of one year of oral cyclophosphamide on scleroderma lung disease. Here's a link to studies using oral and studies using IV cyclophosphamide. Oral cyclophosphamide has had a trial with 158 patients. All the IV cyclophosphamide trials were 50 or less. It does appear that all trials showed positive results. It must be the larger trial with oral cyclophosphamide that sends rheumies in that direction.

As already mentioned, with oral cyclophosphamide you need to drink LOTS of water. My rheumatologist said that if you're not getting up in the middle of the night to pee, then you're not drinking enough water. That's the part I really hated because I never had to pee during the night until I took cyclophosphamide. Of course I didn't experience it very long. After 3 weeks of oral cyclophosphamide I got quite sick and had to come off it. I'm now on cellcept and my lungs have stabilized.

Please make sure you understand all of the possible side effects of cyclophosphamide (oral and IV), of course that goes for any drug you take. I hope that whatever treatment you get, that you'll see results soon. Just please stay on top of how you feel and make sure you inform you doctor of any problems.

Big Hugs to you,


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#8 LisaBulman

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Posted 12 April 2008 - 01:40 AM

Hi Tj,
I am so sorry that your have been getting worse and now you're only option is cytoxan. I was on the IV form, which is a bit safer for your bladder. Everyone is different and has different side effects. Now I am super sensitive to meds of all kinds. Two weeks after my first IV cytoxan treatment my hair was coming out by the handful. So, I went and cut it super short and got two wigs just in case. I never lost all of my hair but it did get really thin.

Good luck with the treatments!

Hugs,
Lisa
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#9 Annie N

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Posted 12 April 2008 - 04:42 AM

Hi TJ
Sooooo sorry about you're not getting into the trial. I took oral cyclophosphamide - I wasn't on this forum then, so I didn't know about anything else and I felt okay, almost better as my lungs seem to be stabilize . I drank all the water they told me too and after the beginning it wasn't too bad to do. I just drank a certain amount at regular intervals all during the day.
I was on the cyclophosphamide for 9 months and now am on cellcept.
I had thin hair but I have that normally due to anemia - but didn't get anywhere needing to needing a wig.
I'm glad you're getting to do this as the studies seem to show it really helps, and I did feel okay, even more energized.
I hope this stabilizes things for you and stops any further damage. With all the new studies coming out, something's got to come out for us!!!

Annie N.



#10 debonair susie

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Posted 12 April 2008 - 07:16 AM

Hi TJ,

It broke my heart... to read that you are so down-hearted, due to thins whole thing. I sure wish we could all just board a plane and be there with you, right now!

You are getting great feedback form all of those who know about cyclophosphamide... I'm sorry I can't offer any information, but they have you covered.

Please keep your hubby close... hold each other... I am so glad you are in this together!

I will continue to keep you in my thoughts through this.

Huge, soft hugs for you, TJ.

Susie


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#11 TJ903

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Posted 13 April 2008 - 09:06 AM

How do I get the doctors to put me on IV? Dr. Brown at MUSC says 'oral' and my rheumatologist won't change the treatment. I wanted IV for the reasons that everyone is talking about and had the port put in. It got infected, but that's because it wasn't being used and they did not flush it correctly and had to be removed. Guess I'll have to try and convince them to put another port in and get the IV. It always seems to be an uphill battle for me and all this fighting with insurance and doctors is so-o-o-o-o-o draining.

Can I ask you guys - what is the regular IV course of treatment? As I've got absolutely no veins - that seems to be the logical path.

Thanks guys for everything!!!

#12 Gidget

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Posted 13 April 2008 - 01:04 PM

TJ,
I cannot tell you what would be your logical IV treatment but Hopkins put me on 750 mg Meter Squared of IV cytoxan which is not just 750 mg but can be more as it is based on your weight. I tolerated the 750mg meter squared with no problems. After 3 months of this, my local rheumatologist bumped the dosage to 950 mg Meter Squared based on the assumption that this would be the only time I would get cyclophosphamide and he really wanted to lower my white count down as low as he could get it.

If I remember correctly, the normal white count ranged between 4.0 and 10.0. When I started the cyclophosphamide I was at 14.0 or well above normal. On the 750 mg meter squared, my white count was just getting below the 10 after 3 months. On the higher dosage, my white count came down to slightly below 4 by the last dose. The cyclophosphamide was administered by the oncologist office. The oncologist's office took my blood count weekly along with my blood pressure. While the cyclophosphamide was administer by IV, I was given a sedative with the hydration which was fantastic. In fact, I could tell the minute the sedative wore off 'cause everything hurt again. But anyway, in speaking with the oncologist, it is the neutraphil count that will show how prone to infection you are and not your white blood count. Throughout the entire cyclophosphamide period, my neutraphils stayed within the normal range. And yes, I did have it administered through my port-a-cath. The surgeon refused to put it in until he had a date directly from the oncologist as to when the first cyclophosphamide dose was scheduled to be administered. It was his way of saying he wouldn't put it in until he was sure it would be used.

For me the IVcyclophosphamide was great -- it stablized my lungs and softened my skin. Now about 6 months later, my skin has started to tighten again and my white count is back up to the 10 range but my lungs are still stable.

I don't know what to tell you if your doctor will not give you IV cyclophosphamide. Like I said one of the first doctors I had refused to give me the IV over the oral -- so I got a new doctor--but then I am a "shopper" for great medical care. Perhaps you can find out from the resident if there is another rheumatologist out of the medical center that is using IV cyclophosphamide. In my case, the doctor only prescribing oral -- her resident did tell me of another associate that was using the IV cyclophosphamide, however, I wasn't all that happy with the general level of service and decided to move on.

As you need immediate treatment, I would contact your Dr. Brown and find out why he will not prescribe the IV cyclophosphamide. It may be something as simple as his office cannot administer the drug by IV and he doesn't have the relationship with oncology or hematology to have it administered. For example, even though I go to Johns Hopkins a world renown facility, they CANNOT draw blood from the port-a-cath as the oncology dept at JH refuses to work with Rheumatology with regards to this because I am not a patient of oncology. So JH has to write the RX for blood counts and I have it currently drawn at the Mayo Clinic where Rheumatology and Oncology/Hematology work well together. I then either fax or bring my blood counts with me to my JH appointment. It seems crazy and I am lucky that the Mayo Clinic is so supportive. So maybe your medical center has some medical administration problems similar to JH and that is the reason for the push for the oral.

For the IV cyclophosphamide, JH wrote the orders and it was administered to me in CT. Sorry for the long response. Good Luck gidget



#13 TJ903

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Posted 15 April 2008 - 08:56 AM

Thanks for all the info Gidget. Just came back from my rheumatologist and he's pretty adamant about the Oral Cytoxan. He did say that he'll call Dr. Brown and check with him, but since Brown is the expert in Sclero treatments, he'll advise whatever he says. Talk about bull headedness. I tried to explain about my trouble taking pills and drinkng so much, 'cause then I don't eat. I had my 2nd dialation in less than a year and this one didn't work as well as the first. So, taking pills is becoming a problem again.

There isn't another Rhuematologist in my HMO that is taking new patients so I'm out of luck. I would say that it doesn't take a brain surgeon to figure out that a once a month IV is far better than a daily dose but I'm not the 'expert'. And I asked him why are they doing the SCOT trial with IV instead of oral if oral is better. My rheumatologist said 'blah blah yadda yadda medical words more blah blah' and I never did get an answer. Oh and he told me that people on these forums are biased to the success of their own treatments and that those who have had bad experiences with IV, wouldn't talk about it. Therefore, we don't really know anythng, especially about our own bodies (my interpretation). All I know is that if I drink a gallon of water a day, I'm not eating. So which is better?

I'm just so confused. Maybe I should just flip a coin. Thanks again for the info and support. You helped alot! -TJ

#14 Gidget

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Posted 15 April 2008 - 01:25 PM

TJ,
Sorry to be a pest, but can you call Dr. Brown and find out why he has decided on oral. I mean as a SCOT doctor, he knows that any usage of oral cyclophosphamide disqualifies you from the SCOT trial. So even if your lungs came back up to the level needed for the SCOT trial, you would not be able to participate. Maybe, he thinks that the oral will be easier for you or that is what you want or something. I can see your rheumatologist not wanting to go against Dr. Brown's doctors orders as he is really just the facilitator and it sounds like Dr. Brown is your treating doctor. I would give Dr. Brown a call as maybe he thinks you want the oral and doesn't know that you want the IV. As a side note, under the SCOT you can have 3 IV doses of cyclophosphamide (I think it is 1000 mg each not adjusted for body weight). The reason they allow the 3 doses is so that if your lungs are below the standard, the hope is that the 3 doses will be enough to raise your lung function to qualify for the SCOT trial. Anyway, I would push to speak with Dr. Brown as he is your treating sclero doctor based on your posting. If you have the opportunity to change local rheumatologist's and cannot find one that specializes in sclero, then choose a local rheumatologist that is a Lupus expert. Many of the sclero treatments are following the Lupus treatments ie. IV cyclophosphamide, stem cells, etc.. Good Luck. Gidget.