Clinical trial at MD Anderson for cushings

[da89165]

I was looking at the adrenal clinic website at MD Anderson and found they are printing a Pituitary Program Newsletter. I looked all over and could not find a date on the Newsletter. Here's the link to the page with the newsletter. It was newsletter #1.

 

MD Anderson Endo page

 

 

New Clinical Trial

 

The Pituitary Tumor Program at M. D. Anderson Cancer Center will soon be opening a new multi-center Phase III clinical trial sponsored by Novartis: "A randomized, double-blind study to assess the safety and efficacy of different dose levels of Pasireotide (SOM230) over a 6 month treatment period in patients with de novo, persistent or recurrent Cushing?s disease."

 

Pasireotide is a novel somatostatin analogue that exhibits a high binding affinity for four of the five known human somatostatin receptors, whereas expression of somatostatin receptors 1, 3 and 5 has been demonstrated in ACTH-secreting pituitary tumors. Pasireotide inhibits the release of ACTH from the tumor and thereby controls hypercortisolemia. The effect on tumor volume remains to be determined. The outcome of the clinical trial may allow pasireotide to become available for medical treatment for patients with Cushing?s disease.

 

Eligibility criteria include:

 

? Patients (18 years or older) with persistent or recurrent Cushing?s disease secondary to an ACTH-secreting pituitary tumor after surgical resection are eligible to participate.

 

? Patients with de novo Cushing?s disease may be included only if they are not considered surgical candidates.

 

? Patients must not have received radiation therapy to the pituitary within the last ten years or have a pituitary tumor compressing the optic chiasm.

 

? Patients who are currently treated with adrenal blocking medications are eligible after a brief wash-out period.

 

? Additional criteria for participation in the study apply.

 

Study participants will need to self-administer pasireotide subcutaneously twice daily and participate in 18 study visits at MD Anderson over the course of 14 months. Participants will not be charged for any costs related to the study drug or visits. Patients will have the option to continue to receive therapy with pasireotide after study completion as long as they do not meet any of the criteria for discontinuation of the study or until pasireotide is commercially available or the pasireotide development program is discontinued. Please contact Mary Jean Klein, Manager, Clinical Protocol Administration, at 713-792-2840 for further information.

 

[Kathryn G]

That sounds very interesting, Gina. Good to know.

Kate G

[casperslove]

I was offered that drug thru Dr. L. He's running that protocol as well. Got the whole run down on it. Just didn't think it was for me at this time, but I hope I don't regret that. It's not FDA approved just yet and it won't CURE cushings, just stop the tumor from secreting. If you stop the drug, the tumor will start up again. Not sure of the long term side effects on it yet either. If someone wants to avoid surgery though, this might be something to try. But, anyway, if anyone has questions on it, I can try to answer them. Dr. L tried to talk me into it for almost an HOUR. I just can't get to Seattle once a month, even if the pharmaceutical company picked up the tabs. They won't pay for my hubby to take time off of work or to pay a babysitter etc. Anyway, I could go on. . .

[da89165]

Kay,

 

Did he explain how this differs from the Keto drug?

[MCF]

The keto drug inhibits steroidogenesis in the adrenals, IIRC. It's worrisome that they don't know what effect the drug will have on tumor size, characteristics. Kay, I think you made the right decision.

[chanceofrain]

The drug is promising but from what I've seen thus far there is no documented evidence of tumor shrinkage and there may be issues with the drug working for a while but then after a while the tumor is no longer responsive to the drug. I think it is going in the right direction but I wonder if it will be a long term or short term solution like keto.

[casperslove]

It's long term. You'd have to be on the drug life long. I have no idea if it matters the size of the tumor. There's no tumor shrinkage at all on the drug tho. That's not what it does. All I know is that it's supposed to stop the tumor from secreting. That's all. And it's a pit based drug vs the adrenal one like Susan said.

 

And the fact that the tumor COULD become unresponsive to it after long term use is unknown at this time. So it's definitely all a big question mark. *I* think it's for people that either can't go through surgery or just don't want to. Or maybe instead of BLA, this is another option?? Dr. L was all for it but I know the drug companies pay the docs the big bucks for getting their drug off the ground and keeping people on it. More money in their pockets. I'm just not convinced.

[cat lady]

Certainly good to see that options for people who are looking at no options are being explored. I'd have to think long and hard about the choice between a BLA and a medication that could potentially suppress hormone production if those were the only 2 options I was facing.

[ikho1967]

I did hear good things about it from an Oregon patient who was in the initial study and have heard that another high profile neuro endo finds it promising too. But like everyone says, the long term effects are unknown. But maybe if this one isn't it, it could hold someone over until the "real deal" comes along??? Difficult choices.

 

Also, I don't know if this still holds true, but in the last pass made cyclics could not be on it... maybe that has changed?

 

Best, Lisa E.

[chanceofrain]

I know it is supposed to be long term, but from the results i know of i think this is questionable at this time. I know it is also very hard for a cyclical patient to be in the study unless he/she can have two consecutive 2x elevated UFC's at the time of screening. Hopefully down the road this will be a good option for all cushing's patients.

[Kristy]

Sign me up! I've been on keto for over a year now... and if it can stop that little bugger from secreting too much acth...I'm with it.

 

I wish anyways... sigh...

 

 

k

[casperslove]

Lisa - Dr. L thinks I am cyclical, but thought I'd be a good candidate. I did have high UFC's tho, so not sure if that makes a difference. Maybe like chanceofrain said, if you have a harder time getting the 2 high UFC's, you have a harder time getting approved to even be IN the study....

[da89165]

Sign me up! I've been on keto for over a year now... and if it can stop that little bugger from secreting too much acth...I'm with it.

 

I wish anyways... sigh...

 

 

k

 

Hey Kristy!!

 

I was thinking about you when I read this. Glad you saw the post! How are you doing?

[Jo MacRaild]

Hi all, Corries been back on octreotide, AKA sandostatin since January...& she had it briefly last year too. Its similar as in it targets growth hormone analogues.. if any one wants any info just shout. Overall, in her, I'd say its not stopping the cortisol, but its doing a very good job on the side effects. Hard to say really, they wont test it....

 

it has cut insulin hyperproduction. & thats ''what'' were using it for..

 

but its also, cut the optic nerve compression, eye droop, headaches , totally initially but back to cyclical now, & body tanning, sweating & full body flushes. HR & BP are more normal, blood volume is improved , fluid gain is normal..& she feels a lot happier..

 

 

it's documented to work on extra pituitary & ectopic ACTH, as well as food stimulated cushings , & naughty adrenal nodules expressing angiotensin 11, that really kick off in the heart function & affect the BP badly, as well as the intended acromegaly & carcinoid syndrome. but not how long for..did wonder if it had a use in Nelsons too ..

 

 

http://www.us.sandostatin.com/index.jsp

 

Heres the octreotide website, if anyones interested, you can tick the box, as a med prof, & get the latest study & usage info..

[amanda w.]

SOM230 Has it's posatives and negatives. I was approvd for the study and particpated in phase 1 and 2. I then stopped the drug and discontinued the trail. The principal investaigator was Dr. Ludlam and that is how I started seeing him and learning more about cushings. There are side effects to this drug that me and some otheres had, however, they mild and able to be easily treated. The first thing I noticed about the SOM230 (side effect) when I first began the drug, is it makes you really cold. I had the heat up as far as it could go, which was past 90 and tons of blankets on and still could not get warm. THis side effect lasted for a couple hours everytime I took the drug. However, the coldness went away after about a week of being on the med. It was weird, and then I did not have this problem anymore.

 

It is true that you have to have 2 UFC's 2x's the limit straight in a row. For some people this may be hard. It was for me at first. There was one time I think I go one that was only like 5 points away and had to start all over. There was another time that the lab ended up using both urines as one sample and then I had to start over again.

 

I think this may be a promising drug. If anyone wants to know more about you can email me at adw7133@yahoo.com. I would be will to tell you more about my experiance in this trail.

 

The one thing I did not like at all about the SOM230 was the SOM230 is not a pill. It is an injection. You have to give yourself 2 shots a day. You arms legs or wherever you give yourself the shot begins to get sore. Also, while giving the injections they have to be ontime for the med to work. You give yourself injections every 12 hours which was a big problem for me. Because I was having to give my seld injections at 9p pacific time and i live in the Eastern time zone. So I would have to get up at midnight to give myself injections. It is like birth control in a way as far as how it works time wise. If you do not take exactly on time it's effects are not as good.

 

I also found that as my cortisol levels dropped at I also started going into a sever depression. During this study though, it was really hard for them to monitor my progress because at first my levels dropped and then they went back up. This is why they though i was cycled. It also made me really tired, as soon as I would take it I would have to take a nap.

 

The good thing about the med, was I had to go off all my BP meds. I had more energy and was able to go up and down stairs a lot better. I was also starting to loose some weight.

 

SO if anyone wants to ask me questions go ahead. If I do not get right back with you just email my personal account adw7133@yahoo.com

 

Depsite the negatives about the SOM230 if and when it is approved if I am still where I am now, i will quit testing and take the med. It would be much easier. You do not have to prove what type of cushing you have you only have to prove you have high levels of cortisol. That is our problem the cortisol not the tumor. In recnet studies it tells us millions of people have pit tumors, but on a few of choses ones (LOL) actually have the symptoms, which is cushings.

 

If you join the study though, one thing that most people on the board are used to are UFC's. So ....get ready to pee in jugs. LOL

 

Amanda

[Kristy]

I'm doing good Gina. I've had a plateful here lately and have been MIA on the patient boards. I started a new job last December. My daugher graduates college this summer, is marrying, and is moving away! My eldest son is also moving to college this fall. Soon it will be just me and my hubby and my youngest son.

 

I hope the SOM230 ends up being a viable option. In the interim, for me, the keto is doing its job. I am cycling still, but the cycles that bust through the blockade happen every now and again - like I am fine for a month, then a few days of restless sleep and the works, then back to normal. If I don't take my keto (I take 200 3x per day), on time, the same time everyday, my body complains. First I get the facial flushing, then my cheeks feel hot, then I start sweating. Even my youngest notices when "Mommy needs her meds." The drug is helping me and is a good alternative for me at this time.

 

I started seeing Dr. Devin a few months ago. I like her team. I like her. Dr. McCutcheon referred me to her about 4 months ago. My insurance had changed, and the tests I normally would run that were ordered by Dr. Petak couldn't all be done at the new lab that was on my insurance. I was really nervous about seeing her. I was so afraid that all of the problems I had during diagnosis would resurface. On her request, I ordered the medical records post surgery from Dr. Petak and the records from Dr. Ludlam. She reviewed them, didn't make mention of them at all, and was and has been very professional. I think she is one who thinks for herself. I admire that in people. I also notice her staff and her fellow both have good attitudes.

 

I really am doing alot to try to be healthy in the midst of this. My vitamin D tends to drop off into the gutter if I am not careful. I do take vitamins, (specially b-complex) and I try to get some outside sunlight, but it really helped when Dr. Devin suggest I add yogurt into my diet 2x per day. I know... I know... yougurt... blech... but I do like it with a handful of granola, and I do like it with real peaches added, and I do like it with real blueberries added. I also like to slice up bannana real thin and freeze it on a cookie sheet, (after they are frozen, they go well into a ziploc) then add the ice-bananna to it. Anyways, between these changes and 6 weeks of medical therapy, my vitamin D was actually excellent this time! Actually, all of my labs were excellent this time! A few are still outstanding, but I don't expect anything to be an issue.

 

I know that someday, we will have to talk about next steps, but I am hoping to hold the disease steady until I finish up my new construction project. I think as long as I am doing well on the medical therapy and my tumor regrowth remains in control, and my overall health holds, there isn't a problem. I think between both Dr. Devin and Dr. Petak, they will keep a good objective eye on me.

 

I miss everyone and think of you often!

 

Kristy