FOR ALL ON CLINICAL TRIALS (edited name)

[skypup]

Hello all,
I posted this as a sep post but thought may be more beneficial here

This is the trial I will, hopefully be starting in the very near future:

Open-Label Phase 2 Efficacy Trial of Cancer Macrobeads in Patients With Treatment-Resistant Pancreatic or Colorectal Cancer
http://ClinicalTrials.gov/show/NCT01053013

The success rate for this trial, in my humble opinion, is far more promising than any other so it was sort of a no brainer to go with it. It seems right for me for many reasons: it's close to me, there is no chemo involved, I can be home most of the time, the process is relatively simple, they have been doing this in humans for 7 years and there has not been any negative long term effects so far. When I asked about the protocol and its success, this is what he said:

For colorectal cancer, our data to date indicate that 70% of the patients (now 43 patients) with Stage IV disease and a failure to respond to available therapies do show a response to our cancer macrobeads. To date there is a median survival of more than 12 months, with the longest survivals being up to 4 -5 years. We are still learning and need to do much more before we can say more definitively, but we are encouraged. On the safety side, the macrobeads have proven to be very safe. Our experience with safety now spans seven years of use.

I will be crossing every limb in hopes of success for you guys!!
Thanks
Michelle

Hi Michelle, I posted on your other thread with some articles that give results from the animal and phase 1 trials, just in case you hadn't tracked those down yet. It looks like a promising and novel approach, and don't you love that there is no chemo involved!!! Good for you!

[sandrichelle]

Thanks Sky...yes I do and if you don't mind me asking, are you in a trial currently? If so, which one and how is it going?

[skypup]

I'm on an phase 1 immunotherapy trial that targets a protein that is aberrant and overexpressed by some cancer cells, including most CRC cells. The jury is still out, but I should know a lot more in about two months. So far I seem to have had a small amount of regression, but my last scan showed very small liver hypodensities that are too small to characterize. Will keep everyone posted.

[sandrichelle]

Hi Sky,

Which protein is it? Just curious. Thanks
Michelle

[dianne052506]

Had round 16 yesterday to complete the phase 1b trial. http://clinicaltrials.gov/ct2/show/NCT01633970 The study lasted 48 weeks, and I have been stable through that whole time (with maybe the slightest bit of shrinkage, but probably just margin of error in the measurements). I have now been off chemo for 17 months, and for me, stability through this time has been nothing short of miraculous. Through most of the trial, I had a CT scan every 6 weeks, but has I got to the last part of the trial, the frequency dropped, so I have not had a scan in 3 months now. The protocol is for a CT scan and follow-up apt 30 days from round 16, and after that scans every 3 months.

Originally, I was told that if I progressed after finishing the trial, that I could go back on for another 16 rounds. Yesterday, Dr. P. told me that even if I have no progression at the 30 scan, that Genentech was offering me the option of staying on the study drug + Avastin, or just Avastin as maintenance. Apparently, I am one of the first persons, if not the first person, to complete this arm of the study. I am pretty sure I am the first CRC person. I do not know if I am positive for the protein that seems to indicate better response with this drug.

Interesting dilemma. Although the side effects of the study drug have been minimal (especially compared to the misery of oxaliplatin and irinotecan), they have been increasing with the last few treatments. The fatigue is getting worse; I have more sinus issues, some GI problems, and now a rash that is slowly spreading. It was limited to my neck and forearms, and, at first, we thought it might be a photosensitivity to HCTZ. However, I am 6 weeks off of HCTZ, and everyday the rash seems to be a little worse. There is actually a possibility that I have had reactions to both the study drug and HCTZ. Although the rash and itching are almost driving me nuts, Dr. P. is excited and says that the rash is a sign my immune system is responding to the drug.

In the big picture, I can live with the rash. From reading other posts, others live with far worse on Erbitux. However, I'm leaning towards dropping both drugs if the 30-day scan is good, just to give my body a chance to recover. I'm trying to convince myself that I am not basing that decision on the rash. I wish I understood enough about immunotherapy to understand whether dropping the drug and going back on it if/when there is progression.

I would appreciate any thoughts or comments.
Dianne

[1YEAR]

Dianne
Which facility did you use to participate in this study? I see a Durham option listed on the net? Just curious as we are in North Carolina too and I thought it might be an option for my husband to consider?
Thanks and I am happy for you that it has kept your disease stable

[dianne052506]

I travel to Huntersville, to Carolina BioOncology, about a 30 mile, 45 minute drive from my house. Durham (I assume Duke) is a recent addition to the trial. When I started, Huntersville was the only thing in the Southeast.

[1YEAR]

Thanks Dianne I will ask my husbands oncologist about it. The zip was listed as Durham 27705 and "big duke" as people tend to call the hospital is 27710 zip so that confused me.

What is the protein you mention that indicates the best response to the study drug? and how would you rate how you feel compared to FOLFOX and FOLFIRI ? I ask this as my husband reports he's wiped from chemo! So I was looking for an easier regime

Thx again

[dianne052506]

The protein is PD-L1 (programmed [cell] death ligand) which the study drug is supposed to target. There was an earlier trial with just MPDL3280A. Like this one, it was open to all solid tumors (as opposed to blood cancers). The sponsor tested all patients, and eventually changed the trial so that it was only open to patients who tested positive for the protein. For my trial, I know they tested the patients for the protein, but they didn't tell us who had it and who didn't. Supposedly, having the Avastin with the study drug improves the effectiveness even if the patient didn't test positive for the protein to begin with.
I had 31 rounds of oxaliplatin, and another 34 rounds of irinotecan (I had Xeloda with them instead of 5-FU and leucovorin, so actually XELOX and XELIRI instead of FOLFOX and FOLFIRI. There is no comparison. If my body wasn't already beaten up from 6+ years of chemo, I probably wouldn't even have much fatigue at all from the study. I dream of the day where something this easy is first line treatment instead of chemo.
My best advice to you and your husband is to immediate contact the clinics where the trial is offered. There are often limited slots available, and you must hit a window with an open slot matching the right point in the patient's treatment. For Carolinas BioOncology, the best thing to do is to call and ask for an appt for a second opinion. They really don't want to discuss trial availability over the phone.
dge

[sandrichelle]

Hi Diane, I can't express how happy it makes me that you have been chemo free for so long. I wish I had an absolute "I would do this" advice for you but I don't. I think that taking a break is for your bodies sake is always a good idea However with that said, is there a chance that IF you we're to progress than you couldn't get the drug? That would be my only concern.
I myself will be starting my trial on Tuesday after a really nice 2 month break from anything. Appears that in he last month my tumors didn't grow all that much, uptake on pet decreases but cea went rally high 414. I also had a first look at my ca 19-9 and the cea 125 which I never had tested before and both of those are normal ( anyone know if that's makes sense).
Anyway, I think that the decision you end up making will be the right decision regardless and we are all here to support you in that!
Hope you get that rash under control and get back some energy!
Michelle

[wireles99]

Wanted to see if anyone knew anything about this trial that I am considering ... NCT01040000
http://clinicaltrials.gov/ct2/show/NCT0 ... 000&rank=1
It's a phase 2 trial ... they do have to test for protein before you are accepted ... but that's basically all I know ...
If anyone has any info it would be greatly appreciated ...

Tried the trial NCT01447732 phase 1 for CEP37250/KHK2804 and unfortuately it did not work or help any ...

Mary

[usopen]

Dianne, you did it.....finished he trial and no progression. I am so happy for you. Sorry about the rash. I know that can be aggravating. Would something like Benadryl help, or an antibiotic? There has to be something.
Wow, I did not know you had that much chemo. I thought I was going to set a record on # of times I had (am having) oxaliplatin.

Don't know what to say about continuing the drug. I trust Dr.P in saying that the rash means showing good immune response. I was wondering what he would do about continuing the drug if it were him.

I'm having a scan friday, not trying to worry or have any tremendous expectations. Just taking day to day. Starting to have some GI discomfort, but taking meds now for that. Have distention in my abdomen.....can hardly stand to see that, or look in the mirror. i hope it's not ascites.

My mail box here is messed up. So I haven't being doing any PM's. I need to fix that.

Joan

[concernedrelative]

Just posting an FYI and of course things can change at any moment. Had a nice conversation with a care coordinator in Albany NY at NY Oncology & Hematology. No slots available for rectal patients for the single agent trial of MPDL3280A. Laying ground work in case scans don't go well tomorrow or just trying to keep myself occupied! Looking into combo therapy with similar; unfortunately none around us.

Amusingly, they are P.I. for the Imprime study we are currently on but wouldn't give up any info and I was too focused on my questions to ask.

Best, V.

[dianne052506]

Joan,
Can you see Dr. P. this week about the swelling? That has to be rough on you, just from a comfort issue. For me, things always tend to go wrong on the weekends, so if you can talk to someone before then, it might be nice, just to be on the safe side.

Benadryl is wonderful, but it puts me to sleep right away. I've got an Rx for hydroxyzine, which doesn't make me quite as sleepy,
I'll be thinking of you Friday.
Dianne

[gep]

Haven't written on here in a while. Eli's been having stomach distention and abdominal issues over the last few weeks. Elevated bilirubin is keeping him from any other treatment.
The last we were told by Sarah Cannon about the trial that Dianne is on is that they sent 9 patient archival CRC tumors and none of them came back positive for the protein. So, they said that they had been talking to Genentech about paying for new biopsy tissue to test thinking that the old tissue isn't showing the protein much. So, there's an issue as to whether the test will be done on archival tissue or new fresh tumor tissue. Something to discuss wherever you go looking for the trial.
Just an FYI. Trying to take it a day at a time.
My best to everyone.
Gloria