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Scot Trial Vs. Assist Trial


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#1 GocartMoz

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Posted 07 November 2006 - 03:58 AM

In speaking with the folks at Northwestern, who are engaged in The ASSIST Clinical trial, involving Cytoxan v. Stem Cell Transplant, for the treatment of Scleroderma, I was informed that the similar SCOT study, offered to patients at various other facilities, use total body irradiation, which is why Northwestern apparently pulled out of the SCOT study. Does anybody have any thoughts on this? Also, for those folks interested in Stem Cell Transplants, I am told that The ASSIST trial, unlike the SCOT study, has a crossover option. In the SCOT study, if you are chosen for the Cytoxan arm of the study, you do not have an option of receiving a stem cell transplant. In the ASSIST study, if you are chosen for the Cytoxan arm of the study and the treatment fails, but you are still qualified for a Stem Cell transplant, you can crossover and receive the transplant. These 2 differences seem to me to be major considerations in deciding upon a course of treatment. Has anyone else looked into this? I am visiting with the Duke people, who are involved with the SCOT study, after Thanksgiving. Thereafter, it is decision time. Sometimes I feel like I am over analyzing this, but for something this aggressive, I want to weigh all options and get as many expert opinions as I can.

Dave



#2 janey

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Posted 07 November 2006 - 10:09 AM

Dave,
You can never over analyze a big decision like this! I hope those links that were put into your message provides you with more information about both trials. In last week's newsroom we ran this Update on the ASTIS Trial that you might want to review. Apparently the results are looking pretty good. "No treatment-related mortality (TRM) nor unexpected toxicities have yet been observed in either arm with a median follow-up of 18 months" (Sorry I miss read it before).

I, too didn't like the aspect of the SCOT Trail that you didn't have a choice as to which treatment you received. I don't know if the same is true for ASTIS. My pulmonary doctor has been pushing the SCOT Trail so I emailed them recently to see if I would even be considered due to my pacemaker. I figured it might be an automatic stopping point - sure enough - I was right. Automatic ineligibility! Oh well - the person that responded did provide the name of a sclero specialist at the Mayo Clinic in Scotsdale, so I might just go get an opinion from a specialist as to how my local doctors are doing in my treatment. I know they have slowed the progress of the disease, but it's still moving.

Good luck in your decision. Please keep us updated on journey.
Big Hugs,


Janey Willis
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#3 GocartMoz

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Posted 07 November 2006 - 10:36 AM

Janey,

Thanks for your reply. The Astis trial is actually a different clinical trial than Astis. The Northwestern clinical trial is called The Assist trial. I believe only Northwestern is doing this study, though I am not 100% sure of this. The Assist trial is referenced in the following article:

Stem Cell Transplantation for Scleroderma, authored by Ann E. Traynor, MD.
The study is detailed at:
Scleroderma Clinical Trials: Current Studies, Open Enrollments: Allogeneic Hematopoietic Stem Cell Transplantation (NST) for Patients With Systemic Sclerosis

Thanks for your input

Dave



#4 GocartMoz

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Posted 07 November 2006 - 10:38 AM

I am having trouble keeping this all straight. I meant the Assist trial is different than the Astis trial. Sorry,

Dave

#5 Shelley Ensz

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Posted 07 November 2006 - 11:01 AM

Dave, I apologize as I had assumed (we know what that means!) that you mean ASTIS instead of ASSIST, and had edited and linked your message accordingly.

I have now added the Allogenic trial to our current clinical trials page, and included that link (hopefully correct now?) in your previous message. I hope this sorts it out, but if not, let me know and I will gladly make more revisions until we get it all straight.
Warm Hugs,

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#6 Gidget

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Posted 07 November 2006 - 12:15 PM

Hi Dave,
I also feel as if I am being pushed in the direction of the Scot Trial by my doctor. Is the trial you are refering to the "Cyclophosamide and rATG with Hematopoietic Stem Cell Support in Systemic Scleroderma." clinical trial number NCT00278525? I have just been in contact with them and have asked for more information. These are scary decisions. Let me know if this is the same trial. Regards Gidget

#7 janey

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Posted 07 November 2006 - 04:33 PM

Dave,
Thanks for bringing up the ASSIST study at Notherwestern. Yes, it is confusing with such a close acronyn to ASTIS. I went to the link you provided. It looks like it's just one procedure rather than two like in the SCOT trial. The procedure described is very interesting.

Gidget the number of the trial that Dave is talking about is NCT00282425. Now I need to go look at the one you have brought up. Man - these stem cell trials are coming out of the woodwork. That's a good thing! Kinda indicates that things are going right.

Both of you - please get us updated on the process and information.

Big Hugs,
Janey Willis
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#8 GocartMoz

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Posted 07 November 2006 - 05:34 PM

Well, if this was not confusing enough, I think I am about to make it more confusing. The study I spoke to the folks at Northwestern about was not NCT00282425. The mistake was mine. I thought I had provided the correct link, but in looking at it closer, it was not the link for the ASSIST study. NCT00282425 is another stem cell transplant study being done at Northwestern, but it involves donor stem cells from a brother or sister. The study I was referring to is an autologous study, meaning the patients own stem cells are used. This is the study referred to in Dr. Ann Traynor's article, but is apparently not the NCT00282425 study. I believe the number Gidget gave is actually the correct study, but I cannot be sure about it as the ASSIST acronym does not appear in the page outlining the program. I apologize for all the confusion.

Dave

#9 mimi

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Posted 07 November 2006 - 05:50 PM

I have gone thru all of the screening phases for the SCOT trial and am just waiting to be randomized. I am already scheduled to start the stem-cell part Dec.

18th--should I get that arm.

I am going to Disney next week with my kids as a last hurrah!

Anyway, I saw the stem cell doctor and he assured me that if I wind up with the cytoxan arm and it doesn't work, I can have a stem cell transplant. It would not be under the cover of the study, but I could pursue it on my own. I was also assured that all parts of the body that need to be protected during the full-body radiation will be----the lungs and kidneys.

I have gone back and forth and back and forth and so on. I wish I knew the answer. At this point, I am almost glad that the study will make the decision for me. If it were up to me, I would change my mind every two minutes.

I really trust my doctors. I have seen a doctor at Northwestern and am trying to get his opinion. I am worried about both procedures. I am worried to not do anything. I am worried about the time it would take to go thru the screening process for another study and the dammage I would incur.

I will keep you guys posted.

I do know that they want 244 patients for this study and so far there are only about 6 people who have qualified. I am lucky to have one of the transplant centers AND a participating MD (my rheumatologist) 20 minutes away.

Mimi



#10 LisaBulman

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Posted 08 November 2006 - 03:15 AM

Hi everyone,

I don't envy either one of you! I would not want to be in a position to make this decision. You have done your research and in the end be confident with your decision. Dave please let us know what you decide.

Mimi, have fun in Disney! I was just there last month and we had so much fun. Let us know where you end up in the study!

Hugs,

Lisa


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#11 Gidget

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Posted 08 November 2006 - 10:49 AM

Dave,
Not sure how it works -- but I sent you a message. Thanks Gidget

#12 GocartMoz

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Posted 08 November 2006 - 01:32 PM

Gidget,

I sent you an e-mail. Let me know if you don't get it.

Dave