GIST Support WikiThis page is for information related to Perifosine and Gleevec, one of the combination drug trials under Clinical Trial Drugs. Feel free to add your own experiences with the trial in the comments section or any other links to useful resources.
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[edit] Basic Information
Manufacturer: Perifosine is under development by KERYX Biopharmaceuticals. Imatinib (Gleevec) is an approved drug manufactured by Novartis.
Molecular Targets: AKT pathway for perifosine (KIT and PDGFRA for Gleevec)
Trial: Phase II trial of this drug combination is currently underway at MD Anderson Cancer Center - follow this link
GIST Support International website page: link here
[edit] Comments from Trial Participants
[edit] Betty A
5 Mar 2007
Re: Phase ll Study of Perifosine/Gleevec
I am not sure if this trial is anywhere else besides MDA. I have questioned Dr. X about others success rates and etc. He doesn't really give me a straight answer. Says something on the order of, we haven't got the results in yet.
I didn't want to use Sutent yet. Save it. I really would like embolization done if this trial doesn't work, while I am still on Gleevec 800mg. I talked with Dr. X about this and he says he will have to check scans and etc to see if this is possible. I am not comfortable coming off Gleevec.
I could not pass this trial up because, what if it works on wild type. I e-mailed Dr. Y for his opinion on this also. Of course he is the chair of this trial and he thought I should try it. I will be reporting in with everything to try to help others.
24 Apr 2007
Subject: Re: Stable scan report
My first Ct scan since beginning the Perifosine/Gleevec 800mg trial was STABLE. I have been on the trial for 8 weeks with lots of side effects. I have now started cycle 3 of the trial. I thank and praise God for this STABLE report. Thanks to all of you for your prayers and support for me. I love and appreciate all of you.
25 May 2007
Subject: Re: Good news for John B., Vince and Peter G.
Congratulations to John B., Vince and Peter G for great reports. It was wonderful to get to meet John B and his wife Bonnie at MDA last week. John and I are on the same trial at MDA and had alot to talk about.
Today is my dosing day and I don't look forward to it. Take Care all and God Bless You.
11 Dec 2007
Subject: Re: perifosine/gleevec trial - shrinkage
I have good news to report!
I had shrinkage on my tumor in my left upper quadrant and the tumor on my left lobe of my liver on my recent CT scan. I am on the perifosine/gleevec trial at MDA.
I am now beginning cycle 11 and in Feb 2008 I will have been on this trial for 1 year. I have been receiving stable reports until the last 2 CT scans when the shrinkage began.
The side effects are hard on me at times, diarrhea, nausea, vomiting and etc. My blood work is still good except for my HGB which is usually around 10.
I decided to try this trial first instead of going on to Sutent.
What a great Christmas present I have received!!!
Merry Christmas and Happy New Year to All!!!
God Bless You, Betty A. -Corsicana, Texas
12 Dec 2007
Subject: Re: perifosine/gleevec trial
The Onc. gave me the choice of starting this trial or going on to sutent. I had this feeling that I needed to go with the trial and save sutent for later. I would prefer to call it discernment from the Lord.
At the time, I thought if I passed up the clinical trial I would not have another chance to get into this trial. But, Kath was on sutent for 1 year and now she is on the perifosine/gleevec clinical trial.
I will be praying for you to make the right decision concerning your care.
14 Dec 2007
I am wild type. I can deal with any side effects for shrinkage.
[edit] Patient 2
6 Mar 2007
Subject: I am also on perfisone and gleevec
I am going into my third week on this trial, side affects started out with severe vomiting ,3-5 times per time. I WAS taking a gleevec in the morn and a gleevec with 100 mgs of perfisone with my evening meal, I have since taken a gleevec in the morn and a gleevec in the afternoon and I take the perfisone with a meal right before I go to sleep. I also take a zofran with another nausea pill 45 min to an hour before my evening meal. Will update all with any info that I have.
[edit] John B
24 Apr 2007
Great news Betty. I have my scan from the first 2 cycles May 16th. Hopefully I will have good news also. I was able to make it through dosing day without diarrhea this last time so maybe it will get better for you as we move along in the trial. We can only hope. Tomorrow is dosing day for me, wish me luck and plenty of Lomotil.
We are on a trial at MDA that combines Perifosine with Gleevec. We are both on the arm that takes the drug once a week. The trial goes for 8 weeks and if tumors increase the trial ends otherwise you stay on the trial. Perifosine is just hard on the GI tract. I just started the second cycle or month of the trial and actually feel ok so far but it is the second and third dose of the day that messes with you.
17 May 2007
Subject: Good news
Just got back from MDA for my first 8 weeks scan on clinical trial of Gleevec & Perifosine. No tumor growth this time and possibly some shrinkage. All good news to me so I enter another 8 week cycle. Not related to my trial but of interest to me, Dr Trent says Nilotinib trial seems to be changing between Novartis and FDA so his trial for Nilonotib has not started yet. I believe he said Fox Chase is the only facility with it at this time . He did estimate that it would be 300- 50 sights world wide. Got to Meet Betty Arnett and her husband Ronnie while at MDA and that was great to put name to face and we got to have several visits as our appts were 30 minutes part. Sure wish Perifosine wasn't so hard on the GI tract. I have this odd side effect from the Perifosine in than I get 6 days in row with more energy than the 800mg of Gleevec takes away. Pretty amazing and hope it continues. Had to share my good news.
I know 3 individuals including myself and we all have stability now on the Perifosine.
30 Nov 2007
Great news, Kath. I have been on that trial but had to get off while I had colon surgery. See Dr Trent the 6th and hopefully get back on as I am not stable now but was while I was on the trial. This time I am going to try tincture of opium to control the diarrhea. Sure hope that works as that was the only issue I had. Great to hear your good news.
John
5 Feb 2008
Subject: Re: Perifosine/gleevec trial scan results
Sorry to hear that Kath. I will await to hear what you try next. Glad I got to meet you last week at MDA. 60 days and I might be in the same boat.
John B
16 Apr 2008
Subject: Sorafanib Side Effects
I started Sorafanib treatment almost 2 weeks ago after failure of the Gleevec & Perifosine trial at MDA. I am having real problems with blisters on my hands and feet. Dr. Trent has lowered dose to 600mg so far and have a call into them now on my response which is pretty much no change. I was just wondering if anyone else had had similar issues.
John
John started the Sorafenib trial - see Sorafenib page
[edit] Kath
October 9, 2007
Today Kath posted:
Hi All, Last week I was at MD Anderson to get ready to enter the perifosine/gleevec trial. I was ramdonized on Arm B which means I take 900mg (6 50mg tabs 3 times) perifosine once a week and gleevec every day. Participants on the Arm A part of the trial, take 100mg perifosine every day. I volunteered to have a biopsy done on Friday, but it turned out I couldn't because the tumor has moved and was sitting in between intestines and, therefore, it would be too risky to do the biopsy. The worst part of the day was that I hadn't been able to eat or drink anything from midnight and by 3:00 p.m. I was no longer hungry but craving my missed cup of morning coffee! Yesterday was my first day of taking meds. I was allowed to pick what day I wanted to take the perifosine and since I wanted my weekends free, I chose Monday. I'm taking 400mg gleevec which is the dose I was taking when I had a recurrence. On Monday I'll also be taking 8mg ondansetron (zofran) and 8mg dexamethasoneorally 30 minutes before my first dose, then every 8 hours as needed. The only side-effect I experienced was a bout of diarrhea after my second dose. I must admit I'm pleasantly surprised at how well I feel. I know others are not this lucky. I return to MDA next week for bloodwork and then again two weeks later, and then once every months. My next scan will be after 8 weeks of treatment. BTW, I don't have the usual puffy eyes yet but since I've just restarted gleevec it may take a few more days.
October 23, 2007 - Kath posted
Last week I went to MDA for bloodwork. My levels were all normal which makes me very happy because I had low WBC with sutent that required a neulasta shot after each cycle.
I took my third dose of perifosine yesterday. Last week my side-effects were hardly noticeable, however, this time, the nausea and diarrhea were worse. I had bad nausea after my first dose and nausea again after the evening dose even though I take two different anti-nausea drugs before taking those doses. I have a theory as to why they are worse than the afternoon dose. I think it's because I take 200mg gleevec along with the 300mg perifosine at those times.
Also, of interest is the fact that I'm not having the puffy eyes I had when I took 400mg gleevec all at one time. I'm now taking 200mg in the a.m. and 200mg in the p.m. Of course, I realise it may just be that I've been off gleevec for over a year, but I believe it's breaking up the dose that makes the difference.
I'm returning to MDA next Thursday for bloodwork, chest x-rays, etc. After this visit I'll be doing monthly visits. My next CT scan will be at my first monthly visit towards the end of Nov.
24 Oct 2007
Subject: Perifosine/gleevec trial update - Brad
Kath, I am wondering how you did on sutent and whether you left due to progression or side effects. How did you decide on this particular trial? Do you know your mutation? I hope you see tremendous success with this. Brad
I took sutent for a year until the tumor it was keeping stable began growing and I also had a new tumor develop. In the meantime, I had one of the tumors removed and still have the other. That's another story. My side-effects on sutent were not as severe as what others experience, but I did have high blood pressure that was controlled with meds. I have no known mutation. I had mutational testing done on my primary in Australia and it came back as 'wild' and then I later had the Armed Forces Institute of Pathology test a tumor I had removed last year and it also came back as 'wild'. My tumors have all had high mitotic counts; my primary was 75/50hpf. Whereas, I think, many wild type GISTs are slow growing.
I began seeing Dr Trent at MDA just over a year ago. He picked this trial for me. He does have some others if this one doesn't work out.
Kath
1 Dec 2007
Subject: Perifosine/Gleevec Trial - First CT results
I had my first CT scan since starting the perifosine/gleevec trial 8 weeks ago and I am happy to report that I am STABLE. For me, the main side-effect of the perifosine is diarrhea. I'm on the once a week dose and some weeks I have mild or no side-effects, however, each week the side-effects seem to be less bothersome. The diarrhea problem is reduced/resolved by taking imodium with the perifosine. My blood pressure is normal as is all my blood work. With sutent I had high blood pressure and needed a neulasta shot every six weeks to resolve my neutropenia.
For anyone looking for a trial, I would recommend trying this one. It's at M.D. Anderson and (I think) one other location, but I'm not sure where.
I must admit that psychologically, I feel so much better than I did a few days ago. What a great Christmas present!
Kath
3 Dec 2007
Lee Ann asked: Will they give you any hints as to how others are doing on it? How many are on the trial so far? I've asked the research nurse this very question. The impression I get is that they are having good results so far. I also know of another listmate who has had shrinkage. Hopefully, she'll post with her results.
I'm not sure how many are on the trial. I have my next appt on 12/27 and can find out more then.
Kath
5 Feb 2008
Subject: Perifosine/gleevec trial scan results
On Wednesday night last week, I had my second scan since starting the perifosine/gleevec trial. Dr Choi (at MDA) checked the scan and determined that I had progression so I am no longer in the trial. I'm continuing to take 400mg gleevec and will head back to M.D. Anderson either this week or next to find out what's next for me. Will keep you all updated.
BTW, even though I didn't do well on the perifosine/gleevec, others have had stability or shrinkage.
Kath
4 Feb 2008
From: Marina
I wish the news had been better.
Since you have wild type GIST, what about drugs that target PI3K instead.
PI3K is central hub inside the cell that receives signals from a variety of cell surface receptors besides KIT and PDGFA. So maybe a PI3K inhibitor would "cover the bases" that you don't know what is actually driving your GIST??
XL765 by Exelixis is in trial in San Antonio.
Otherwise, I would ask about a HSP90 inhibitor, for nearly the same reason. It has a broad mechanism of action, and so you don't really have to know where the defect lies in your GIST cells....HSP90 may hit it anyway.
Marina
9 Feb 2008
Subject: Starting Serofenib (Nexavar)
I will be starting serofenib (off label) next week. The side-effects seem to be same as for sutent. A couple of differences are that it is taken on an empty stomach (2 200mg pills twice a day, one hour after food and two hours before food) and no alcohol (there goes my red wine which I swore was the reason I don't have liver mets).
I will have my next CT scan in two months. If at that time it is determined that the drug is not working, I will be facing surgery no. 7. I feel lucky that surgery continues to be an option for me.
Kath
See Kath under Serofenib (Nexavar)