GIST Support WikiThis page is for information related to OSI-930, one of the Clinical Trial Drugs. Feel free to add your own experiences with the drug in the comments section or any other links to useful resources.
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[edit] Basic Information
Manufacturer: OSI Pharmaceuticals
For information from the manufacturer link here.
Molecular targets: KIT, PDGFR beta, VEGF receptors (also known as KDRs)
Trial: Phase I trial at Dana Farber Cancer Center
GIST Support International website page : link here
[edit] Comments from Trial Participants
[edit] Brenda
Brenda's history: I don't know which type of mutation I have (there wasn't enough tissue to do exon mutation testing). All I do know is that it is slow growing, that Gleevec held it at stable, and that I had a better response to Sutent (tumors became more cystic). I've never really had any shrinkage. Most doctors I have seen believe I have had GIST since I was an early teen. I certainly had symptoms back then. I have no known primary, just tons of liver mets. And a couple of years ago (at the end of my Gleevec run) I developed a tumor on the outside of my liver in my lower left quadrant.
8 Mar 2007
Hi, everyone. I went to Dana Farber Monday, 3/5, for an early morning start to the OSI-930 trial. I had a 7:00 AM appointment. My friend Tracy came with me. I was nervous and excited and all around stressed with the new trial beginning. I had my morning labs drawn, and it was a short while later the news came . . . my white count was too low to meet trial protocol (neutrophils need to be 1500, they were 1100) and they couldn't dose me to start the trial. I have a cold/throat/sinus infection, and they think that may be why my wbc was low. It was 1500 last Wednesday for my screening appointment. Oh, and my hemoglobin was 8.0, so they gave me two units of blood.
So, Dr. D decided that as long as I was here, we should get a PET scan as a baseline before the OSI trial. So they scheduled that for tomorrow. It is a good thing, really, since my scans are so hard to read (my tumor load is huge). But not being able to start the trial today really did make me sad. I am on an antibiotic now, and had the PET Tuesday, and will have labs drawn at home on Friday to try to be sure my levels are high enough to meet protocol on Monday. But it is another three day, two night trip next week. Please pray I will be able to start the trial then.
Tracy keeps telling me that everything happens for a reason, so I am believing her for now. I'll keep you all posted, you all keep praying! Blessings, Brenda
22 Mar 2007 Subject: OSI-930 trial - day 4
Well, after a few bumps in the road (of course), I finally started the OSI trial on Monday. My sister was in Boston with me. My white counts were good (2150 neutrophils) and I met all other trial protocols. I even passed my EKG.
The pills are white capsules, and large - kinda like the orange Gleevec capsules. I hate capsules, because they float in my mouth when I try to take them and gag me. Yes, I know, I am a little weird. Anyway, so far, I haven't noticed a single side effect. Of course it is only day 4. It will be a few weeks before we get a new PET or CT scan to see if there is any noticeable effect on the tumors. I am still hoping for a waist out of all of this! :)
I will be going to Boston every Monday for a few weeks. I have to get my schedule settled and I can start seeking partners to accompany me on the trips. Thanks to all of you who continue to pray for me and for this drug to be the next miracle drug for GISTers. I'll keep everyone posted!
27 Mar 2007
Well, yesterday, (Cycle 1, Day 8) went really well. My blood work shows that my white counts are still rising, as are my red counts. Unfortunately, my triglycerides are shooting up, but my guess is that has more to do with my fried chicken diet than anything. The medical profs say it isn't drug related.
I never did get over that upper respiratory thing I had that seemed to delay the start of the trial for me. So yesterday I asked if I could get another antibiotic to kick the rest of it out of my system. I don't think my body is up to kicking those germs out and fighting the GIST (oh, and having enough energy for my every days). So I am hopeful that I will soon be sore throat and cough free, and will FINALLY get my voice back. I can't sing a note at all -- and I really miss singing. I know it sounds silly, since I don't sing for a living or anything. But I love to sing -- in the car, during worship at church, to my boys. I've never beent the biggest fan of my singing voice, but I never realized how much I would miss it if I lost it.
I feel pretty good most of the time. The sweating I have from the tumor activities has all but stopped, and I have no pain in my liver/tumors. I do get pretty tired by the end of the day, but I am hoping that has more to do with the cold than anything else. I still hate the big capsules, but with practice, I am gagging less taking them.
Prefacing this by reminding everyone that this is only the subjective report of ONE GIST patient, not trial data or the like -- The most exciting thing from yesterday is this . . . . . .
I had thought my belly shrank already in the first week. But I was afraid it was wishful thinking. So, I asked Carrie (my dear, sweet, wonderful sister in Christ and friend), who said she really thought so, too. (Mind you, no waist yet). Then, when we got to DFCI, the woman who almost always does my vitals at the Dana Clinic stopped in to say hello (they are doing my vitals at the Clinical Research Center now so I don't see her as much). She took one look at my belly and commented that it was smaller!!! She made my day! It definitely feels less "tight" and I can move the "tumor mass" with my abdominal muscles now (definitely could not do that last week). The only bad part is that I can now feel the fat on my belly because it isn't stretched so tight. Reminds me that I cannot blame all my weight on these tumors!! :)
So, all in all, it looks very promising. I was just wishing there were lots more slots in this trial for GISTers. I have no idea how it is working in other cancers or in any other GIST patients on the trial. And I do have that weird, slow growing kind of GIST, remember. But my prayer is that this will be another awesome wonder drug for GISTers like me -- much like Gleevec was.
So, God, in His infinite wisdom, has once again led me along the journey on which I am supposed to be. I was sad when I missed out on the AMN-107 trial, but the OSI trial looks like the trial I should be on. God's fingerprints are once again evident all over my life. He truly never lets me down. I will keep you all posted on the progress, as I work toward tiny tumors and a waist!! Love and blessings to all, Brenda
11 Apr 2007
Just a quick update (I am late for work!)
For those who don't know, I am on the OSI-930 trial at DFCI -- 400 mg. in the morning and 400 mg. in the evening. They are big, white capsules (much like the Gleevec capsules).
So far, OSI seems to be working well. My belly definitely shrank, my blood counts are rising, and I feel great. No side effects so far. I am three weeks into this OSI journey.
My PET was stable, and had previously been increasing in activity (or "hotness"). So stable is good. My first CT on OSI is April 30 (my next DFCI visit). I'll keep you all posted.
30 April 2007
Well, my blood counts continue to rise. They are nearly normal! And my scan is, "very stable." There may be overall shrinkage in the liver/tumor mass, but the CT doesn't measure that well as it takes pictures in slices "horizontally" through the body rather than measuring how big the entire mass is. But my local oncologist believes there is some shrinkage, as he can now feel the bottom edge of my tumor mass on the right side, which he had previously noted as "well into the pelvic bone." Dr. George believes that there is "more room" in my belly. And I can breathe better and deeper, definitely feeling the "more room." They also seem a bit softer, "less firm" by Dr. George's description. No side effects from the OSI thus far. And the best news (to me at least), is that there is no other GIST patient on this (I guess the London GISTer was a hoax?!), so I am now officially the Original OSI-930 GIST Guinea Pig Pioneer (OOGGPP). :)
It's not shrinkage, and it isn't a cure, but it's something. And no side effects seems like a great thing to me. So let's hope there continues to be good news for me and my very hard to read scans.
Blessings to all of you!! Love, Brenda
6 Jul 2007
Subject: Brenda Bannon's OSI trial update
Hi, everyone. Life has been busy for me lately, since I spent at least a year feeling really poorly on Sutent. The last year on Sutent my blood counts (red and white) were really low, and I did get a couple of transfusions toward the end. I don't know if the Sutent stopped working because the tumors morphed, or just because my body got so weak I couldn't fight any longer. I did not realize how awful I really felt until I started feeling better on the OSI.
I started the OSI in March. There was rather immediate, noticable shrinkage in my belly, which normally looks like I am at least 9 months pregnant due to the huge mass of tumor and liver that fills my abdominal cavity. A lot of people commented on my belly appearing smaller. The bad part about that is that as my belly shrinks, and becomes softer, I can feel the pads of fat that cushion my belly! :)
I don't know if the overall mass in my belly continues to shrink, but I believe that it is. It seems less and less bulky as time goes by, and I am more and more comfortable (able to move and breathe more. I can even tie my own shoes now). The best news is that I don't seem to have any side effects at all (except that the drug does a number on my stomach when I take it without a meal - even if I take it with a little food, it's still pretty caustic. And taking it with boneless hot wings? DEFINITELY NOT GOOD!).
I don't seem to be experiencing any tumor/disease symptoms either. That seems pretty indicative that the drug is doing something good. All in all, it still looks like a good medication, at least for my GIST. I can't wait until more GISTers are on the drug to see what others experience is.
Everyone says how much better I look. Apparently I was looking mighty peaked at the end of my Sutent stint. I feel good. And I have lots more energy. I can see how being out of commission for a while definitely got me behind, so I am catching up these days. But how wonderful it is to have the energy and to be here to catch up.
Glad to share good news with all of you! I'll keep you all posted. Blessings, Brenda
29 Aug 2007
Subject: OSI-930 update
Hi, everyone. Sorry I haven't posted recently. I am so busy with life (three boys, single mom, full-time job) that I barely have time to stop and breathe lately. Soon the boys will go back to school, and hopefully things will be a little less hectic.
Anyway, OSI-930 continues to keep my tumor symptoms at bay with no noticable side effects. My bone marrow has bounced back nicely after being beaten up by Sutent, and my counts were normal yesterday at my local oncologist visit (hemoglobin 12!!). That is after discontinuing the Aronesp shots about two months ago. At least I know the damage from the Sutent was not permanent. I was a bit fearful that might be the case. I was not looking forward to stingy Aronesp shots forever.
The only bad news is that my shrinking tumors have made the layers and piles of fat on my belly much more noticable!! So I guess I finally need to start thinking about exercising and eating better. I'll let you know if I ever get from the "thinking about it" stage to doing anything about it! :)
So far it looks like I am still the only GISTer on OSI. I wish there was other data to see if it works for anyone else. I don't know how long it will work for me, but for now, it is wonderful. I love being too busy to get to my emails. It's nice to feel good and not be completely exhausted. After about 8 months of needing transfusions every so often to keep my blood counts up, and pneumonia last December, my life is needing a lot of attention. It's been a long year. August 5 marked one year since I left my husband, and I still have boxes that haven't been unpacked.
Anyway, please know that despite the fact I am not able to keep up on the lists like I used to, I am here, fighting the GIST war in my corner of the world. And if there's anything anyone needs to know from me about Sutent, or OSI-930, or Dana Farber that the other GISTers on the list cannot answer for some reason, or if you just want to check in and say hi, you are welcome to email me privately. I read my private emails more often, because I do research for individuals newly diagnosed with any cancer, and I communicate with the world by email! I have all my GIST list emails filtered, and don't read them daily. I skim them about once a week to see if there's anything urgent I need to respond to.
Anyway, OSI is good. Life is good. Hope you all are well.
Much love and blessings, Brenda OOGGPP OSI-930 since 3/07
17 Oct 2007 Subject: My update
Hi, all! I am so sad that I could not make the walk this year. It's been a long year, and I kind of fell off the lists during this time. I tried to keep up, but couldn't do much more than skim through the subjects of the emails. I look at the lists now and hardly recognize anyone. There are so many new names, it just convinces me we still have a long way to go to win this war. Of course, I still plan on being there when we finally defeat the dragon!!
I still don't know if any other GIST patients have started OSI-930, but I can tell you that I have never felt this good on any GIST treatment. My blood counts have all returned to normal limits. My chemistries are all slowly creeping back toward normal. I have no side effects that I have noticed. I have no tumor/disease symptoms that I notice. My only complaint is that the capsules are big and float in my mouth and gag me twice a day as I take them!! :) I'll take it!! For those of you who I know, a big cyber hug and hello! You are never far from my heart or my prayers. For those of you whom I have never "e-met," welcome to the one of the best groups of people with whom I have ever been associated or had the incredible priviledge to know. Nobody that gets drafted into this war is happy to be drafted, but you have been dr= afted into an army that will fight along side you like family. We WILL win this war. There have been many casualties, however, and we will have more before the war is over. But I don't plan to be one of them. I plan to celebrate that victory with many, many of you! That day, there will be a worldwide "YAHOO" from GISTers everywhere. I cannot wait to hear it! Anyway, I am still here, floating in cyberspace. Still fighting. Still the original OSI-930 GIST Guinea Pig Pioneer (OOGGPP for short!). Much love and many blessings to you all, Brenda
Misdiagnosed with neuroendocrine cancer March 2002 with local doctors. Sought specialty care for neuroendocrine cancer at MSKCC. Correctly diagnosed with GIST cancer July 2002 (Stage IV, inoperable, innumerable liver tumors, no known primary) - Requested transfer to GIST specialist at MSKCC, denied. Sought second opinion consult at DFCI, hired Dr. Suzanne George & DFCI team as primary oncologists. Gleevec 800 mg. August 2002 - December 2004 -Sutent (various dosages and schedules) February 2005 - February 2007 - OSI-930 trial (800 mg.) March 2007 to present.
18 Oct 2007
Subject: Re: My update-OSI930
My scans are really difficult to read. Because my liver is full of so many tumors of various sizes and shapes, and they "overlap" so to speak, on the scan, it is difficult to know if they are changing size. I think I have one tumor on the outside of my liver in my lower left pelvic area, but I don't know how easily it is visualized on scan. Since scans "slice through" my body rather than do a length and width measurement of the whole liver/tumor mass, we don't really have a good measure. However, Dr. George said on Monday that my scans look "fabulous." Six weeks ago they were "extremely stable." On palpation, the docs can now put their fingers in between the edge of the tumor mass and my pelvic/right hip bone (and the mass was well into the hip prior to OSI-930). Given all the experiential/subjective data, it appears that there has been some shrinkage, and the tumors are MUCH more soft. Additionally, people noticed my belly getting smaller and commented during the first several weeks of OSI. People still think it is shrinking (or I am shrinking), and the sides of my waist now exist again. (People don't even realize it is me from the back sometimes!) The mass had increased enough that it was pushing out on my sides of my waist. I can see and feel the fat on my belly now (the mass was so big and my belly so tight, there was no "jiggle" to the fat at all). Who would have thought that a jiggly fat belly would be such a welcome blessing?!! LOL! Anyway, it all looks good as far as we can tell. Another GISTer with more distinct and individualized tumors to measure would really help support the data. I am anxiously awaiting the OSI GIST Guinea Pig Pioneer #2!! I hope I will be able to communicate with him/her, no matter where they are. Much love and many blessings, Brenda
18 Oct 2007
I'm sorry, I don't know my mutational status. However, there is a theory that mutational testing can be done via the blood, and I may participate in that study/trial/testing. If so, we may be able to determine mine. Otherwise, I think we need to do mutational testing for the trial, and it may mean another biopsy. I would like to avoid that, given the vascularity of the liver and the tendency of GIST tumor bleeding to seed other tumors. Also, even the smallest wound puts an extra load on my body/immune system, and I really like to try to be as healthy as possible to continue to use all my resources to fight the dragon. I will let you know as soon as I know my exon mutation. I have been very curious all these years as well.
November 2007
Hi, Mike. Yes, I am doing well. PET report said "no significant change" but to my unknowing and untrained eye did look a bit "cooler" with some darker spots on my liver. Still no side effects, still keeping cancer stable. All my chems and cbc counts are moving toward normal. It is all good news from this OSI Guinea Pig. Hope all is well with others. Blessings, Brenda
18 Nov 2007
Subject: Re: "Battle Fatigue" - it's LONG - FYI
An insightful post, for sure. In many respects, I would agree with your post. This is not like a boxing match in which I will knock out my opponent in 10 rounds or so. However, I do see it as a battle . . . quite frankly, I see it as a war.
My metaphorical use of "war" is more like this:
In March of 2002 my docs found "innumerable" and "inoperable" nodules/tumors in my liver. In April, they were diagnosed as malignant neuroendocrine tumors with no known primary. A local oncologist told me I would slowly get worse, she would treat my symptoms as best she could (to keep me comfortable), and I would die. She didn't believe I would see 40 (I was 36 at the time with 7, 4, and 1 year old boys). I immediately fired this oncologist because her attitude and prognosis were COMPLETELY unacceptable.
I knew I had been drafted into a war, with my own personal battle being a small part of it. The war itself was on cancer, and the "enemy" I had been drafted to battle was GIST. The good thing was that I was drafted into the war as the General in my battle, and I realized I needed to find the best "2ND in Command" or "right hand man" to advise me.
I immediately began a search for the best neuroendocrine specialist/liver with unknown primary onc I could find and found Leonard Saltz at MSKCC. Saw him, he ordered another biopsy, by June I was diagnosed with GIST. His plan? Wait. Although Gleevec was standard protocol treatment at that time, and Dr. Maki and his team were at MSKCC, Dr. Saltz said that he would wait, because my cancer grows so slowly, and start Gleevec later when we really "needed" to. I didn't like his plan. I called MSKCC to see if I could switch oncs and get one of Dr. Maki's team members to head up my treatment and see me. At this point, I was searching to be cancer free. MSKCC told me that it was against their policy to allow patients to switch doctors. Yep, I fired them. Off to Dana Farber for a second opinion and consult.
If I was going to find a 2ND in Command for my Army, so to speak, he or she was going to be the best damned one I could find. So, we saw Dr. Suzanne George, a member of Dr. George Demitri's team at DFCI. First, she confirmed the GIST diagnosis. Her plan? Immediately start Gleevec. Treat my GIST as a chronic disease rather than a terminal one. Hope the research keeps up and I outlive my cancer. LOVED that plan. LOVED her! This General had a 2ND in Command.
Next, I had to find a local onc to help manage my disease and keep me alive. Given the rarity of my cancer, the huge tumor load I carried, and my general distaste for pessimism, I needed to find a local onc who would believe I could live until I was 90, who had enough humility to let someone else be the lead on my care, and whose interpersonal communication skills would allow him or her to communicate well with me, my family, and the rest of my treatment team (aka "Army"). I found that onc in Dr. Joseph Dudek at NYOH in Albany. He's still awesome! My primary care doc was already on board and his thoroughness the reason I found the cancer -- so I had him. Then I had the online support and information groups for GIST I joined, my fellow warriors. Later in my battle I would need a stoke specialist, an neuro-opthalmologist, and a neurologist to join my team for a year or so. They have since retired, ready to be re-called should I need them.
Over the years I have watched other "Generals" in this war die on the battlefield. I have watched them bravely go where no other (or few other) Generals had previously traversed. They brought us Sutent, and continue to bring us new options as more of us progress through Gleevec and Sutent and other options. War is hell, they say. I have cried many, many tears for those Generals who have given their lives for this war.
I'm an old General now, wading through the OSI-930 trial and doing my best to make it to 90. I am 42 and 7 months now, so I have a way to go. But every day I am here, every day I live life to the fullest, every day I see, hear, taste, smell, touch this beautiful world -- is one day closer to winning the war. Winning is curing all cancer. Winning my battle, or killing my "enemy" is finding a cure for GIST. Staying alive and active in the battle until we win is my job now.
None of us ask to be drafted. And, like all wars, some dodge the draft and run away; some begrudgingly obey the draft, but they don't fight; some choose not only to fight their personal battle, but the battle against the bigger enemy -- GIST -- and some choose to fight those battles and the war on cancer. But everyone of us helps give "intelligence information" for this war. Each one of us contributes in some way, and we are all in this together. On the front lines of this war shoulder to shoulder. I know we will eventually win the war on GIST, and I intend to be here to celebrate when we do. I also know we will win the war on cancer. Not so sure I will be here for that, but hope to be. I plan to see my boys through college, marriage, and to hold and spoil my grandbabies for as long as I possibly can. My oldest is only 13, so I definitely need a long-term battle plan. I believe I have one. Together with my faith in my God, the GIST in my belly doesn't stand a chance of winning.
Blessings, Brenda
20 Jan 2008
Subject: OSI-930 - 10 months, an update
Just a quick update to let everyone know that, for me at least, the OSI-930 drug at 800 mg. continues to keep me "healthy" and stable. I am certain I've had shrinkage, and many people continue to comment that I am still "the incredible shrinking woman." My liver full of tumors, as many of you know, fills my abdominal cavity from ribcage to hip bones and across to my pancreas/spleen. I look pregnant - and there have to be people wondering if I am part elephant, having been 8 - 9 months pregnant forever! :)
Anyway, I am not able to get on to the computer as often. Still don't know my exon type, but I am one of those with that weird, slow growing, possibly pediatric GIST's. No surprise there. I am NOT one of the more "normal" human specimens!!
Best wishes and blessings to all, Brenda
5 Apr 2008
Hi, all. It's sure been a while since I posted last. I wish I could say that I have kept up with all the posts, but I have not been able to do that. Between single motherhood of three growing boys, a full-time job, 2 dogs, three cats, a bunny and a guinea pig (and the constant battle against getting a ferret for my 11 year old), going to Boston every three weeks for the OSI-930 trial, dealing with the seemingly impossible divorce proceedings, and life in general, getting on the lists to read posts falls below the "urgent need to do" threshold in my life. Additionally, I must admit, that as I watch the posts, I see so many names I do not know, and I remember so many I have known and loved who have fallen on the battlefield before me.
As March brought the six year anniversary since the discovery of my stage IV GIST, I passed the date many memories of my journey thus far. As April brings my 43rd birthday (I was nearly 37 the discovery of my GIST), I am overwhelmed with how blessed I have been in my journey.
Now, those of you who are still around and have known me, you are aware of my goal of living until I am 90. I still plan to make it there, sliding in to my 90th birthday all "lived out" and ready to go home. I have lots to do between now and then, including getting my boys through school and college and into careers. Finding appropriate wives for my incredibly awesome sons, and then holding each of my new baby grandchildren as they arrive. Spoiling those grandbabies (some of whom had better be girls, as I have three boys and never had the opportunity to do the "froofy" thing with them), and watching them grow. Most importantly, I expect to raise three strong men of Christ, Godly men who are men of integrity and passion, who will teach Judeo-Christian history and the love of God and Christ to their children and grandchildren. I know that isn't "politically correct" and I mean no offense to anyone - it is simply my most passionate goal in life.
As the Original OSI-930 GIST Guinea Pig Pioneer, I had such hopes for this drug. But the trial is small, and although the results for me have been very good, they haven't for some others. So I have been saddened to see that others haven't been as successful on it, although we haven't had very many GISTers on this drug. As of my last DFCI visit, I was still stable, and everything looked good. My DFCI team has convinced the trial folks to let me start coming for visits every 6 weeks vs. every 3 (which I have been doing for more than a year), which is a HUGE relief for me! Of course I still get CTs every 6 weeks (YUK), so now my complaining begins about that! :) I'd love to have scans every three months again!!!!
Life is so good, despite how many trials I face with all the other life stuff. Even on my darkest days (like when I have no money to pay my utilities nor get food), I remember how grateful I am that I am still here, still working, still relatively healthy (albeit the 6 gazillion tumors filling my liver, that fills my belly, that makes me look 8 months pregnant all the time - hey, it used to be 9 months! How cool is that?!)
To the relatively "newbie" folks - I've been doing this for 6 years, and there are still a few of us old timers (even older than me, like my dear friend Marina) out there - and we are so much further ahead in the research and treatment arenas than we were when we started out on the GIST battlefield. Imagine where we might be in 2012 when my oldest graduates high school?!!?? How cool would it be if he graduated High School and a cure for GIST was discovered?! :) My point? Stay hopeful, stay positive, keep believing that a cure is coming, and keep living! Enjoy the rain on your face, the wind in your hair (even if it messes up your hairstyle), the sun on your skin, the rustle of the leaves in the breeze, the smell of the roses and the lilacs, the beauty of the sunrise, the hope in tomorrow. LIVE. Fight this beast with all you have, but never stop living in the meanwhile. I figure if I stop living, I might as well not be fighting the beast at all.
So, from this OOGGPP old timer, I wish you all well. I thank you all for being here to support me and one another, and to fight shoulder to shoulder with me in this war. I'm going to head back into the chaotic, stressful, wonderful life that the Lord has blessed me to live -- and I'll be out here fighting every day doing my part to win this war. Be well, live well, and keep up the fight. We will win this thing, and I will be sliding into 90 - lived out and ready to go home. Blessings, Brenda Bannon (dx. 6/2002 with GIST stage IV - Gleevec 800 mg. @ 2 years, Sutent @ 2 years, OSI-930 @ 1 year . . . still breathing!) :)
[edit] Chris
Chris had been on IPI-504 - see IPI-504 page