FOR ALL ON CLINICAL TRIALS (edited name)

[dlhs0324]

Hi Dianne, This is Brenda (Darrell's sister). Darrell asked I post for him the results of his scan and progress. To answer your question about the phase1 Mpdl3280a clinical trial...Darrell heard about this trial through his oncologist @Tennessee Oncology in Nashville, Tn. He talked with one of his doc friends at SCRI handling this trial, and got him in to see him the same day. Darrell's oncologist has really helped him and we are very grateful to him. This is the 2nd trial Darrell has been on, and this one seems to be the best for him. I am new to this club, so if you don't mind, please tell me if I need to post this somewhere else. Darrell is so excited about this trial, we just wanted to share this with others. Please review......

12-20-2012 - Darrell had 1st treatment of phase 1 drug mpdl3280a at SCRI. Treatment time was 4 1/2 hrs. The side effects of this drug according to Darrell is hardly anything compared to the other chemo he has taken. He was not sick at all.....he did feel a little tired, and had 2 knots the size of grapes on each side of his neck. He was able to work and do his normal activities.

1-10-13 - 2nd treatment - cea level was 53.3 - oncologist checked knots on neck and indicated this could be side effect of medicine. The treatment time was 1 hr. Darrell was not sick after treatment, but did feel tired.

1-29-13 - Did a ct/brain/head scan and all was negative....nothing was found. He also had a ct of chest, abdomen/pelvis and conclusion was all was stable in lungs, pelvic area and liver.


1-31-13 - 3rd treatment - cea level down to 34 - Darrell saw oncologist and he indicated his scans were good and he appears to be responding to treatment and all is stable - no new growth. He also checked the knots on each side of Darrell's neck and he could hardly feel them. This treatment only took 30 min's and so far as of 2-4-13, he has had no side effects from this drug....only feels a little tired. Darrell is very happy with the results he has had so far and thinks this drug is helping him. We pray he will continue to have good response and we will keep you all posted of any progress.

[dianne052506]

Hi Brenda,
Darrell gets congratulations on a lot of fronts - having an oncologist who helped him find a trrial, getting a slot in the MPDL3280A single-agent trial, (apparently) being positive for the protein required for the trial, having a stable scan, and a decreasing CEA. Major WOW!
One member posted that she had been told only about 6% of CRC patients are positive for the protein. Darrell does sound very fortunate indeed. Plus he has a caring sister. Lucky guy!
There aren't a lot of rules to the Colon Club, except the big one - Play Nice! You are welcome to start a post, or add your thoughts to an on-going one. There are a couple of other trials with separate threads, but we are also trying to have a continued thread here, not only about our progress on trials, but about the "trials and tribulations" of finding a clinical trial to begin with.
Best wishes to Darrell and to you,
Dianne

[crazymotherof8]

Brenda,
Can you tell us if Darrell had his tumor tested for a protein before being admitted into the trial?
That is such wonderful news for him!!
Niki

[skypup]

Hi all,

I had a CT scan yesterday. I'll get the results and talk with head of research center next Monday. I'll find out all I can about both trials for mCRC happening there. Plus, I'll find out if I have had any success so far and if I'll stay on the trial drug. Fingers crossed...

Theresa

[Maia]

Every crossable body part is crossed for you, Theresa!!

[consdrs]

YOU HAVE TO WAIT A WHOLE WEEK!!!! AAAAAAAAAAAHHHHHHHHHHHHH

I would go clinically insane.

Good luck to you!
Hugs
Connie

[skypup]

Every crossable body part is crossed for you, Theresa!!

What a great visual I have!

[skypup]

YOU HAVE TO WAIT A WHOLE WEEK!!!! AAAAAAAAAAAHHHHHHHHHHHHH

I would go clinically insane.

Good luck to you!
Hugs
Connie

Thanks for the empathy,Connie! I would have gone nuts waiting until I started this trial. Now I figure I am going to do what I am doing now regardless, so why worry... Or that may simply be Denial talking!

[gep]

Thanks everyone for the updates and I'm crossing a few body parts for everyone, too.
My husband is in Nashville and will be at Sarah Cannon for an appointment with Dr. B tomorrow. I told him to ask about the testing for the PDL for colon folks again and about slots in the trial. He has completed 3 weeks of the drugs for his trial and has a week off. No scans or anything like that yet which is making me anxious. I am not there with him. If I had known he would have an appointment with her tomorrow I'd have tried to go with him. At NW they print out appointments for you that say what's happening so when you have a dr appointment it says. Somehow we haven't been asking the right questions regarding what happens each time apart from blood work. Oh well. Anyway, he has some fatigue but with an afternoon nap it's manageable. He does have diarrhea about 5 hours after he takes the intermittent drug. It can last a while and he's been taking immodium and lomotil. It goes away after a day, just like that.
That's all the news.
Gloria

[skypup]

Gloria, I don't know if it's just you and me, or if this is true in general for research centers as opposed to clinical practices, but I don't feel well informed of what will be happening either. I have decided it is because the major business of the place running clinical trials is to do just that -- run trials -- as opposed to treat individual patients. I'm pretty sure they make their real money from the pharmaceutical companies paying them to run the trial, not from billing us for medical care. Just an extra layer of complexity in managing our own care... I've seen an MD exactly once in two months, and that was when he was pitching the trials I am eligible for. Since then it's been nurses or a NP only. I guess it's okay, especially since the NP is great, but it sure feels guinea pig-like.

[dianne052506]

When I was at the research clinic and signed all the consents and agreed on a start day, they handed me a printed calendar that went out 4 months with all my appointments, and noted which ones were just blood draws, and which were other. I didn't quite put it all together at the time, but it plays out like this: I have infusions every 3 weeks. For the first 6 weeks, I had blood draws every week, then it dropped to draws just the day of the infusion. During that first 6 weeks, I think I saw the doctor 4 times when I was there. After that, the schedule has me seeing the PA and nurse on the even-numbered rounds, and the doctor each odd-numbered round. Since I get a CT before each odd-numbered round, that means I get to hear the news directly from Dr. P. Even though I'm not scheduled to see the doc every round, I've still met with him, particularly since I keep having proteinuria.
I wonder if the "lost" feeling we have dealing with a research clinic is similar to what we felt as newbies starting off with FOLFOX. The procedures, routines, and the language were all Greek back then. I want to last long enough to understand it all.

[skypup]

I wonder if the "lost" feeling we have dealing with a research clinic is similar to what we felt as newbies starting off with FOLFOX. The procedures, routines, and the language were all Greek back then. I want to last long enough to understand it all.

Great point, Dianne. We have been at this so long, and I had forgotten how lost I felt at the beginning until you just reminded me. I got a calendar with the technical details, too, yet it is still weird that no doc is getting to know me at the research center. Sounds like you are on a good schedule there. Can you tell me about proteinuria? I've seen it listed as a possible side effect, but don't know anything about it. How are you feeling in general?

[dianne052506]

I've been on Avastin a loooong time, easily more than 100 doses. I started having trouble with the protein more than 4 years ago. They're supposed to do a urinalysis before Avastin each time to check for protein. I recall hearing the chemo nurses refer to readings as 1+, 2+ 3+. I'm assuming that refers to ppm. If I'm at 2+, they still check with the doc, but I still end up getting Avastin. At 3+, they have also ordered a 24-hour urine analysis, but so far, that has come back with no problem. Before the trial, when I was at 3+, an interim onc I was seeing ordered the Avastin left off for several months (I was on XELIRI/Avastin), and my CEA started climbing. When I got back to my original onc, he cut the Avastin, but kept it in the cocktail. Don't know what will happen if the protein number keeps climbing, but I expect they will get permission from the trial sponsor to leave Avastin off for one round. So far, my kidneys have recovered nicely each time. Without chemo or Avastin from April to August last year, I started the trial with basically zero protein in the analysis.
Avastin does the same thing to my BP. Last April, before my onc took me off everything to get ready for the trial, I was having episodes of 180/100 or more. In addition to the amoldipine I was already on (courtesy of Avastin), my doc added Micardis. Three months of no Avastin, and my BP was so low, I had to drop the Micardis. I was 120/68 most of the time when I started the trial, now BP is running more 135/75. Enough Avastin and I may have to adjust BP meds again.

other than a general tiredness, I feel pretty good. I feel like I was deprived of food for so man years of chemo, that I can't stop eating everything in sight! Warmer weather will mean exercise for this kid!
dge

[dlhs0324]

Hi Brenda,
Darrell gets congratulations on a lot of fronts - having an oncologist who helped him find a trrial, getting a slot in the MPDL3280A single-agent trial, (apparently) being positive for the protein required for the trial, having a stable scan, and a decreasing CEA. Major WOW!
One member posted that she had been told only about 6% of CRC patients are positive for the protein. Darrell does sound very fortunate indeed. Plus he has a caring sister. Lucky guy!
There aren't a lot of rules to the Colon Club, except the big one - Play Nice! You are welcome to start a post, or add your thoughts to an on-going one. There are a couple of other trials with separate threads, but we are also trying to have a continued thread here, not only about our progress on trials, but about the "trials and tribulations" of finding a clinical trial to begin with.
Best wishes to Darrell and to you,
Dianne

Thank you Dianne, We are praying for everybody and Darrell has been blessed so far. Darrell's tumor tissue was tested before he was enrolled in the study and he has been very lucky so far. He went through all pre-screening procedures prior to being approved. Thank you for your kind words and you are an inspiration to us.

[dlhs0324]

Brenda,
Can you tell us if Darrell had his tumor tested for a protein before being admitted into the trial?
That is such wonderful news for him!!
Niki

Hi Niki,
Yes, Darrell had his tumor tissue sample tested before he was enrolled in the study and he has been very lucky so far. He went through all pre-screening procedures prior to being approved. Darrell has a great oncologist and he is up to date on a lot of on-going trials. Thank you for your kind words and everybody here on this forum is an inspiration to Darrell.