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May 17, 2013 at 12:38 pm #60448
I signed a tree’s worth of paper consent forms @ DF on Tuesday for the BMS Phase 2 Nivolumab Given Sequentially With Ipilimumab trial (I think that I will just call this the N&Y (Nivolumab & Yervoy) Combo Trial) Tissue biopsies of some abdominal mets was Wednesday. Now, I have to redo all my scans on the 23rd as they are just older than the 28 day trial requirement, and first treatment is tentatively scheduled for the 28th. Feeling a bit better emotionally at this particular moment now that treatment & schedule is concrete.May 17, 2013 at 1:27 pm #60449 It is always good to have a plan! And some patients have a few back-ups too. I hope this goes well for you, seems to be getting a lot of good press. Let us know what the side effects are like if any. And of course let us know if you need our support.May 17, 2013 at 3:38 pm #60450Shirley ZParticipant Hi Stan,
You must feel relief just having a plan in place now.The stress involved with the decision making is never easy.
I’ll be praying for great results. GO STAN!
Shirley ZMay 17, 2013 at 9:22 pm #60451AnonymousGuest
Good move Stan!! Keep us posted.
JeffMay 18, 2013 at 2:12 am #60452kylezParticipant
Good luck and mojo between now and the 28th, Stan!
Nice that the arms differ only in the sequence of which one goes first. You’d almost think the insurance companies would be recruiting people into this one. Sounds like those DF folks are earning their keep.May 25, 2013 at 2:21 am #60453
Well, I had a great big curveball thrown my way late today. I had all of my scans redone yesterday but I was just informed that yesterdays redo of my brain MRI showed a new 6mm met that was not there 45 days ago. Looks like the BMS Phase 2 trial will not be starting for me on Tuesday. I am still in shock and will not really know what the new plan might be until next week. New Doctor appointments & Probably SRS. And then who knows? I am finding out the hard way that it is best to always have a backup plan here.May 25, 2013 at 12:01 pm #60454 Hi Stan,
So sorry to get this news. I am sure it is a shock to you as many experience no symptoms and then they find a brain met. The good news is that SRS/gamma knife seems to readily take care of these nasty mets and kills them! So as soon as that takes place you can enter a trial. We’re here to support you and help you through this.May 30, 2013 at 11:03 pm #60455
I met with the BWH/DF radiology team today and my SRS treatment is now scheduled for next Thursday. Mask was made today and measurements taken. All of these health professionals at Dana Farber & Brigham & Womens Hospital certainly make me feel that I am very lucky to be located in Boston area.June 7, 2013 at 7:28 pm #60456 My SRS treatment was postponed from yesterday to today. I was in to DF/BWH @ 7:30 and home by 10 am. Completely invasive. Slept for about 4 hours and taking it easy now. The worst for me has been the Kepra over the past several days as it makes me tired and a bit irritable. Today was first day of dexamethasone and that is low dose for a few more days. A+ so far to my radiology team. New MRI in 6 weeks+-July 19, 2013 at 7:32 pm #60457 I had my 6 week post-SRS Brain MRI this morning at DF and the good news is that nothing new has shown up – just the normal post-surgical changes.
Based on this good news, I had assumed that I would just be immediately rescheduled for updated CT Scan etc. necessary to be able to start my postponed BMS Phase 2 Nivolumab/Ipilimumab trial, but I will have to wait for Dr. Hodi’s office to call me on Monday as they need to check on some screening criteria regarding how long I have to be off radiation prior to starting the trial. After all of this time, with this good news and all, waiting another weekend should not be too difficult. And, of course, the other good news of the day is that my jury duty for Monday was cancelled.
Does anybody have any experience with a BMS study and how long must one generally be removed from brain radiation before being able to join study?July 20, 2013 at 6:51 pm #60458
I’ve reached out to find this out, but I believe it is 30 days. I can’t find it in the protocols either. Have you looked in the materials they gave you?July 20, 2013 at 8:21 pm #60459LynnLucParticipant I did Nivolumab at Moffitt and my trial set criteria as
• At least 4 weeks since prior systemic radiotherapy
o At least 2 weeks since prior focal radiotherapy
o At least 8 weeks since prior radiopharmaceuticals (strontium, samarium)
• At least 4 weeks since prior surgery that required general anesthesia (72 hours for surgery requiring local/epidural anesthesia) and recovered
• At least 2 weeks since prior immunosuppressive doses of systemic medications, such as steroids or absorbed topical steroids (doses > 10 mg/day prednisone or equivalent)
• No concurrent participation in another clinical study involving treatment with medications, radiotherapy or surgery, or prior participation in this study
• No concurrent use of any of the following:
o Other anticancer agents
o Immunosuppressive agentsJuly 21, 2013 at 1:29 pm #60460
Thx Catherine & LynnLuc
Thx for your responses to my query. My paperwork is all typical consent forms that describe the research study & plans and all side effects, but fails to describe this type of criteria. My own research shows 30 days to be the norm. I hope to receive the answer from the clinical study coordinator nurse tomorrow.July 21, 2013 at 5:23 pm #60461
I have an answer for you from an expert on the trial: “Brains mets need to be treated and with no evidence of progression at least 8 weeks from the end of treatment.” But do double check with the study nurse..July 25, 2013 at 12:26 am #60462 So, on Friday I was in the clear, but when the final report came in by Monday, one new brain met was then discovered. Second round of SRS now scheduled for a week from tomorrow and then a visit to onc to figure where to go from there. I guess I am looking for a backup plan for my former backup plan.
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