This is detailed of what I went through to apply for trial screening. If you're looking for actual trial info, this is not it, this pertains about how to prepare to be approved to start screening. Celine's post here, her blog and the TV special goes into the details of the trial itself.
My Onc's staff did the paperwork then forwarded it to me to forward to NIH/NCI along with uploading copy of last CT scan to PACS and this is when the trouble began. Onc closed over the weekend so I had to do everything myself, paperwork from Onc was not complete. I have a Mac and no Word program. Found that I could buy Word for one month and get a one time free 30 day trial, perfect! Went to install and my laptop is too old for it to install. Returned Word. Found a place that I could use Word online and download my papers, it was a struggle but I finally finished it and forwarded it along with latest blood test results.
The latest CD that I got had copies of scans for 1 PET, 2 CTs and a Xray, much too big to upload even though I zipped them. Left laptop on overnight and line was still in the same spot when I woke. Called the Dosimetrist where I had radiation and he suggested to get a new CD with only the latest CT on it and send only the Dicom file that has the pictures, glad the file department was open late. Yay, uploaded then I get a note from man at the Film Library that the file uploaded but no picts in it. What a wonderful help he was, uploaded and he sent note to RN/OCN and original contact that it uploaded.
Also think about what time zone you are in, I am PST/California and Maryland is East Coast, this was sometimes a problem. Remind them of this and give cell # instead of home # if you go out, they call many times.
I was contacted by someone that screened my application and soon after I heard from a Research Nurse Specialist. Usually this takes one week but was delayed due to my marking my app YES I am currently on active therapy treatment and the answer was no. Once it was corrected, everything moved pretty fast. What an amazing lady this RN/OCN was, she bent over backwards to help. She coordinated all with my Onc and Onc nurse.
Unfortunately my Onc thinks the Folfuri/Avastin is working based on reports of PET and CT scan. Applied for another trial at City of Hope and that Onc said my cancer had progressed, received opinions 2x from each Onc, no change. RN/OCN said I must have progression to get into the TIL, FDA requires it. So we agreed for me to send in the actual CD and reports that I mentioned above with PET and CTs. Sent overnight so she could submit to Board, which meets on Wed and Thurs, to go over and explain the split decision to them. You must have no prior treatment for 30 days once the Board approves.
Now a new problem pops up. My Onc wants me back on chemo, been without for 4 weeks now and don't know how much longer I would have to be off. He also said to think about the toll it would take on me and my husband to fly 6 hours one way the many times we would have to go there and part of process is to stay in hospital for 30 days. Alternative would be to go on chemo, take new CT scan April 30, be off chemo for 30 days. If progression then send CD and I will start where I left off, get approval from Board. Now the problem becomes my age, I was 70 Nov 2016 and that is their limit. Still might not get approved because the time it takes for the trial I will have turned 71. Chance it or not? RN/OCN also told me that they screened 33 applicants and out of those 33 only 3 were approved to start the trial. Pretty crappy odds I think for me, so I decided to withdraw for now.
Started chemo the 21st, have been approved for immu trial at City of Hope and only need to be off chemo for 14 days before screening. Also appt set up to see Thoracic Surgeon to get an evaluation.
This same TIL NCT02757391 has started? at MD Anderson in Houston, Texas 3 hours away and there are plans to start in San Diego, under 2 hour drive and neither have an age limit. Have a call into MDA and/or will wait for San Diego.
I sure hope this helps others out to prepare for the screening, for me it was not a piece of cake!
70yo Fem DX: 1/21/2016 RC Stage IV-Nodules lungs
MSS-Kras Wild-Lynch Synd Neg-Lung Biopsy 1/27/16-Port 2/19/16
MRI 7/7/16 Endometrial polyp found, watching LAR 7/19/16, No Ileostomy, Stage ypT3 N1
CT 11/7/16: Most mets stable,1 shrunk,1 new??
CEA Tests: 1/21/16=20, 12/22/16=5.3, 1/20/17=4.8, 2/15/17=6.2
9/20/16-1/24/17 Folfuri & Avastin
PET/CT 2/10/16-1/31/17=Some shrunk & growth to 2, Avastin failing ???
2/21/17 Folfuri & Avastin