FOR ALL ON CLINICAL TRIALS (edited name)

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fcancerIsay
Posts: 37
Joined: Tue May 08, 2012 6:56 pm

Re: FOR ALL ON CLINICAL TRIALS (edited name)

Postby fcancerIsay » Wed May 08, 2013 7:49 pm

Just wanted to post a quick update -- I am currently enrolled in the Phase I Clinical Trial using Designer T-cells at Roger Williams Hospital in Rhode Island. Had my first t-cell infusion last Monday, coupled with an Interleukin-2 pump. The procedure went well, except I had problems with nausea/vomiting the first 24 hours -- could be the anesthesia. Will definitely have Zofran next time around. Am pretty exhausted and came down with a fever of 102 on days 5 and 6. They are still not exactly sure what caused that, but no fever on days 8 and 9. Too early to tell what exactly is transpiring, but CEA has gone down slightly in each blood test following the first infusion. I am told that it is not unusual for the CEA level to go down and then to possibly go up again and that it is just too early to draw any conclusions. Although I feel as if I have been knocked for a loop, I pray my army of "designer" white blood cells are forcing my immune system to kick in and destroy the cancer that is trying to destroy my liver. I am still very happy to be enrolled in this trial. Second of three infusions is next Monday, May 13. Fingers crossed!!
Diag. 6/11 Stage IV CC, Mult. Mets to liver, Nodes
Full Hysterectomy due to CC 8/12
Chemo 6/11 - 2/13
Clinical T Cell Trial 3/13
Onc says "Chemo for Life", but I say "NED One Day" :)
F Cancer I Say!

dianne052506
Posts: 1651
Joined: Sun Nov 02, 2008 11:57 pm
Location: North Carolina

Re: FOR ALL ON CLINICAL TRIALS (edited name)

Postby dianne052506 » Thu May 09, 2013 7:11 am

fcancerIsay,
Thanks for the update. Congratulations on getting enrolled in such an interesting trial. How often are they running CEA? Have they already had experience with it going down and then back up? There are so few colon cancer patients enrolled on the trial I am on, I haven't been able to get an answer on others' experience with CEA. Mine started down, and then has been creeping up slightly every 6 weeks when it is run. They pulled blood for it Monday, but I haven't called yet to find out the results.

If you only get 3 infusions of the drug, what happens after that?

Sorry the first treatment knocked you for such a loop. I haven't had trouble with nausea on this trial, just every time when I drink contrast for a CT scan. If you like Zofran, but are so nauseous that you are having trouble getting liquids down, you might ask about the dissolvable film form of the medicine, Zuplenz. Looks like a piece of paper less than a half inch square, and dissolves instantly on your tongue. Plus it seems to leave a nice, almost wintergreen, aftertaste in my mouth. It has really helped me with contrast.
Best wishes,
Dianne
May 06 Stage IV CC: liver,ovarian mets
Oct 07 inoperable lung mets
Feb 08 - Apr'12 chemo
allergic to oxaliplatin, irinotecan
Aug '12-Feb'14 Genentech PD-L1/Avastin trial
Mar '14 -radiation to largest lung nodule
still recovering; looking at trials again

crazymotherof8
Posts: 392
Joined: Wed Jun 29, 2011 3:30 pm
Location: SE Arizona

Re: FOR ALL ON CLINICAL TRIALS (edited name)

Postby crazymotherof8 » Thu May 09, 2013 3:18 pm

Hi my dear friends in the fight. I just posted on the main site at viewtopic.php?f=1&t=42069, but wanted to thank you all so much for all of the wonderful information that you have all shared throughout this thread. It has given us all so many more options then we thought were possible. Matt has chosen to go on hospice and I have to respect his decision. He is just tired of being tired. I did however get some new information on the trial for the Xilinox. That is the trial for colon cancer patients who are losing weight. I did a lot of research on it and it sounds like it could really extend life for someone like my husband but unfortunately it has not begun in AZ yet. It has a target date to start in Tuscon in June but the nurse said those target dates usually don't happen when they are supposed to. The trial is now up and running in San Diego and several other sites. The contact person for the study is wonderful and extremely helpful. I know that the links to the study are back a few pages on this thread as well as a thread posted by Maia. It is a phase 3 trial and the leading side effect they saw of the drug in previous trials was a good one, it was that the quality of life improved dramatically for ALL patients. Because the drug helps to stop the loss of body mass it slows down what the oncologist calls the "wasting away" process of late stage cancer patients.
Love to you all and prayers that you all will continue with the least amount of side effects and the best quality of life!
Niki
DH Matt - 49 - father to 8
Dx Mar11 w/Mets to liver, lungs Folfox + Avastin Mar 11 - Jul 11
Sept11 Spleen remvd bc low platelets
Oct12 Folfox+Avastin
Mar12 Folfiri+Avastin
Aug12 bone mets; irinotecan+Erbitux
Dec12 chemo failed - trial
passed June 17, 2013

Maia_as_guest

Re: FOR ALL ON CLINICAL TRIALS (edited name)

Postby Maia_as_guest » Thu May 09, 2013 5:04 pm

Sending you, Nikki, and Matt lots lots and lots of love and wishes of peace and pain free moments
((((hugs)))

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fcancerIsay
Posts: 37
Joined: Tue May 08, 2012 6:56 pm

Re: FOR ALL ON CLINICAL TRIALS (edited name)

Postby fcancerIsay » Thu May 09, 2013 7:27 pm

Hi Dianne:
To answer your question, they did blood tests on days 2, 3 and 5 after the first infusion and checked CEA each time. Then they checked it again on day 7. They mentioned it could down, then go up again, then down again and seemed to indicate that based on past experience on this trial. So, I am guessing it matters what the level is when the infusions are over. I am not exactly sure what will happen after the 3rd infusion and have not pushed that issue because it is probably a question they can only answer when they see the results some time after the last infusion. My goal at this point is to take one infusion at a time. I am trying very hard not to worry too much about the overall picture, since it can get so overwhelming at times and all that happens is that I lose a lot of precious sleep worrying. Thank you so much for your suggestion of Zulpenz to help with the darn nausea -- I was unaware of its existence, which is why I am so thankful for this forum! So much to learn and this is the best place to get answers when you most need them!
Diag. 6/11 Stage IV CC, Mult. Mets to liver, Nodes
Full Hysterectomy due to CC 8/12
Chemo 6/11 - 2/13
Clinical T Cell Trial 3/13
Onc says "Chemo for Life", but I say "NED One Day" :)
F Cancer I Say!

skypup
Posts: 2598
Joined: Mon Dec 17, 2012 12:12 pm

Re: FOR ALL ON CLINICAL TRIALS (edited name)

Postby skypup » Thu May 09, 2013 7:36 pm

crazymotherof8 wrote:Hi my dear friends in the fight. I just posted on the main site at viewtopic.php?f=1&t=42069, but wanted to thank you all so much for all of the wonderful information that you have all shared throughout this thread. It has given us all so many more options then we thought were possible. Matt has chosen to go on hospice and I have to respect his decision. He is just tired of being tired. I did however get some new information on the trial for the Xilinox. That is the trial for colon cancer patients who are losing weight. I did a lot of research on it and it sounds like it could really extend life for someone like my husband but unfortunately it has not begun in AZ yet. It has a target date to start in Tuscon in June but the nurse said those target dates usually don't happen when they are supposed to. The trial is now up and running in San Diego and several other sites. The contact person for the study is wonderful and extremely helpful. I know that the links to the study are back a few pages on this thread as well as a thread posted by Maia. It is a phase 3 trial and the leading side effect they saw of the drug in previous trials was a good one, it was that the quality of life improved dramatically for ALL patients. Because the drug helps to stop the loss of body mass it slows down what the oncologist calls the "wasting away" process of late stage cancer patients.
Love to you all and prayers that you all will continue with the least amount of side effects and the best quality of life!
Niki

I wrote on the other thread, but here in this little group where we are pushing the limits as best we can and working together to do so, this news hits me hard in the gut. My heart breaks for you, my best thoughts wrap around Matt.

dianne052506
Posts: 1651
Joined: Sun Nov 02, 2008 11:57 pm
Location: North Carolina

Re: FOR ALL ON CLINICAL TRIALS (edited name)

Postby dianne052506 » Tue May 28, 2013 10:21 pm

To all,
My apologies for being absent for so long. In all honesty, I just haven't known what to say. I told Dr. P. today that every time I think of friends here - going on hospice, or still struggling to find a drug regimen that is both tolerable and effective - I get downright angry. I'm not angry at God, I am angry at the medical profession, and the whole way that clinical trials are handled. There is still such an overall lack of communication that makes it difficult for people to find a trial that fits, in a time window that is appropriate for the trial cohort and the patient's medical need.

After I finally calmed down some, this is (more or less) my understanding:
The results for the single-drug study of MPDL3280A will be announced next week.
40% of patients either had shrinkage or stability.
At this time, there are no plans for additional studies with the single drug for CRC patients.

The study I am on is still looking for first-line patients for the study arm with MPDL3280A/FOLFOX/Avastin.
AT this time, the MPDL3280A/Avastin arm is not enrolling CRC patients, but Dr. P. says that is subject to change on a monthly basis, and he expects to enroll some by this summer. He stills pushes how important it is for patients to look at trials sooner, rather than later when their symptoms and side effects from other treatments may be too bad. He said that making an appointment and seeing him for a consult or second opinion is the best way to get on his radar and be in line when spots open up on trials. I write all this with a bit of caution, because I feel that when I've written about the trial before, I've offered some false hope, but I'm writing as closely as I can to what the doc said, so I am praying this actually is an option for someone.

As for me, I just had round 14 out of 16 today. We had to leave out the Avastin again because of high proteinuria, but Dr. P. tells me that with the half-life of Avastin in the system, I am still getting some benefit out of it. The side effects have been minimal - the usual Avastin sniffles and occasional nosebleed, plus fatigue and dry skin from the study drug. The rash that I've had a little bit off an on for the last few months blossomed over the last few weeks into hives around the back and sides of my neck and slightly on my forearms. It turns out, though, that there is a strong possibility that it is not an immune system reaction to the study drug, but phototoxic dermatitis from the HCTZ I have taken for years for fluid/BP, hence the limitation to just areas of sun exposure. I am so very thankful that I did not go to the pool this weekend, or I would have been in for total misery if the HCTZ theory is right. Have stopped that medicine in the hopes that it will be out of my system in time for a trip to the beach late June.

The scan 3 weeks ago showed that the lung nodules are still stable or perhaps have had some slight shrinkage. For me, 15 months off of chemo, this is nothing short of miraculous. Saturday made seven years on the cancer journey. It has not been easy, but my friends here have been a blessing along the way.
With prayers for all,
Dianne
May 06 Stage IV CC: liver,ovarian mets
Oct 07 inoperable lung mets
Feb 08 - Apr'12 chemo
allergic to oxaliplatin, irinotecan
Aug '12-Feb'14 Genentech PD-L1/Avastin trial
Mar '14 -radiation to largest lung nodule
still recovering; looking at trials again

crazymotherof8
Posts: 392
Joined: Wed Jun 29, 2011 3:30 pm
Location: SE Arizona

Re: FOR ALL ON CLINICAL TRIALS (edited name)

Postby crazymotherof8 » Tue May 28, 2013 11:43 pm

Dear Dianne,
I am so happy for you and so happy that you are able to continue to be off of chemo. Please don't feel bad about us, we were so grateful for the information that you have provided and continue to provide for all who are fighting this battle. I pray for you and all my other friends on this board and am so pleased when I hear a good report.
I am going to post how DH is doing on the main thread and share his experience with intrathecal pain pump.
Love and hugs,
Niki
DH Matt - 49 - father to 8
Dx Mar11 w/Mets to liver, lungs Folfox + Avastin Mar 11 - Jul 11
Sept11 Spleen remvd bc low platelets
Oct12 Folfox+Avastin
Mar12 Folfiri+Avastin
Aug12 bone mets; irinotecan+Erbitux
Dec12 chemo failed - trial
passed June 17, 2013

gep
Posts: 418
Joined: Wed Aug 19, 2009 6:21 pm
Location: Chicago, IL

Re: FOR ALL ON CLINICAL TRIALS (edited name)

Postby gep » Wed May 29, 2013 8:40 am

Been holding off on posting. I don't know what it is about the info on that PDL1 and avastin trial but Georgetown did do testing on Eli's tissue. The first round was his 2007 tissue and they said the slides were stained and they couldn't do the testing. Then it took a bit to get Genentech the 2010 tissue but they got it two plus weeks ago and yesterday we learned that it was not expressing PDL1 so no trial for Eli. In the interim, Sarah Cannon called and told him that they now have this trial with all the arms. It's showing up on the clinical trials.gov website, too, with another location in PA, too, I think. They said if he was positive he could do the trial there, too. So, I know he's got CRC and he was tested for it so I'm surprised, Dianne, to hear that Dr. P says they are not taking any more CRC patients. In any case, it's been about six weeks of waiting while Eli has been off of chemo. He had the sir spheres on April 2nd. Waiting to hear back from the oncologist about what to do next. He's feeling better and eating more again, at least. As for the cachexia trial, I think it's more than just losing weight, it's losing muscle mass. I asked the nurse practitioner about it for Eli and she said he didn't have cachexia??
The waiting part is really hard. Dianne, I am so glad that you have been able to take advantage of this trial without chemo. I think Eli may go on the big R while we try to find something else for him. Stay stable for all of us. Yesterday I learned that one of my work colleagues just entered hospice. He was diagnosed with a gastric (he wouldn't say which but everyone thinks it's pancreatic) cancer two months ago. They tried chemo but it wasn't working. He's 55. Everyone's story is different and their own. We need those good ones to balance off the bad ones.
Gloria
caregiver to Eli
dx 8/07 3B
7/09 - liver & celiac lym node
1/10 Liver Res & Lym nodes out
7/10 Back - Liver & other lym nodes
12/12 hit chemo wall
1/12 Clin Trial - MEK & AKT inhibitors
3/12 Trial failed/ spheres 4/12
7/30/13 Eli died.

andy21
Posts: 376
Joined: Tue Jun 26, 2012 4:07 pm
Location: N California

Re: FOR ALL ON CLINICAL TRIALS (edited name)

Postby andy21 » Wed Jun 12, 2013 9:18 pm

Quick update on my father: Phase I Clinical Trial using Designer T-cells at Roger Williams Hospital at Rhode Island

1st infusion last week. This is Clinical Trial phase with IL2.

Good News: My father whose CEA had climbed to 60+ has come down to 25 within a week. As per doctor, T cell + IL2 is working good.
CEA has been very effective guide to my dad's cancer as proved by scans last year.

Challenge: IL2 is making my father have lot of diarrhea that has made him very weak.

Thanks to wintercrossing and Fcancerisay in being guides to me on this trial, as their experience is priceless.

My personal take on this trial is that although it's not THE answer, it's still easier than Chemo for those who can tolerate IL2.

2 More infusions left and final Scan end of July.
Caregiver: To 67 Yr father
diag. Stage IV, 5/12, liver mets
6 cycles Xelox/Avastin, Start 06/12
Stage 1 of Two Stage Resection Surgery in Dec, 12. 2nd line fails.
T Cell Trial May-Jul, 2013
Becomes a Heavenly Angel in August, 2013

skypup
Posts: 2598
Joined: Mon Dec 17, 2012 12:12 pm

Re: FOR ALL ON CLINICAL TRIALS (edited name)

Postby skypup » Wed Jun 12, 2013 9:31 pm

Ah, I'm so happy for the good turn-around on your father's CEA. Is it a low dose of IL2? Is it expected that it will get easier or harder or stay about the same?

andy21
Posts: 376
Joined: Tue Jun 26, 2012 4:07 pm
Location: N California

Re: FOR ALL ON CLINICAL TRIALS (edited name)

Postby andy21 » Thu Jun 13, 2013 4:52 pm

It's low dose of IL2. The doctor cut it in half so let's see if it makes it better.
Caregiver: To 67 Yr father
diag. Stage IV, 5/12, liver mets
6 cycles Xelox/Avastin, Start 06/12
Stage 1 of Two Stage Resection Surgery in Dec, 12. 2nd line fails.
T Cell Trial May-Jul, 2013
Becomes a Heavenly Angel in August, 2013

concernedrelative
Posts: 322
Joined: Tue May 17, 2011 1:33 pm

Re: FOR ALL ON CLINICAL TRIALS (edited name)

Postby concernedrelative » Fri Jun 14, 2013 7:52 am

Might be of use to someone...

FDA Guidance on codevelopment of 2 or more INDs for use in combo - http://www.fda.gov/downloads/Drugs/Guid ... 236669.pdf
Crgvr to 37 y.o. DW
3/11 Dx IV w mets lungs, xeloxi/avastin
8/12 switch irino/avastin
4/13 2nd line failed
6/13 imprime pgg trial failed
7/13 stivarga started/failed
9/13 folfiri+erb
Lost her valiant and noble fight 022114

wireles99
Posts: 23
Joined: Fri Feb 22, 2013 4:39 pm
Location: Dallas TX

Re: FOR ALL ON CLINICAL TRIALS (edited name)

Postby wireles99 » Thu Jul 04, 2013 12:52 am

Trial that I'm considering, don't have much info on yet, hoping on this board someone would give us better info.
It's a phase 2A trials as follows:

Phase 2A Study of NPC-1C Chimeric Monoclonal Antibody to Treat Pancreatic and Colorectal Cancer

If you are on it or know someone that ... and would like to share the info of good & bad points on, I would certainly would like to do so.

NCT 01040000
DX 09/04 Stage II rectal/Stage I colon
Chemo & Radiation 2005
NED till 2009
recurrence Stage IV colon cancer
FOLFOX & Avastin 2009, and 11/12-01/13
FOLFIRI & Avastin 2010-2012
Erbitux 2012
Several lung mets
04/13 to present on clinical trials

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sandrichelle
Posts: 396
Joined: Tue Feb 21, 2012 10:31 am
Location: Albany, NY

Re: FOR ALL ON CLINICAL TRIALS (edited name)

Postby sandrichelle » Thu Jul 04, 2013 9:13 am

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
Dx Stage IV CC 02/12-56.1 CEA
Resection/Bye Bye Uterus 02/12
Folfox 03/12-08/12
05/01/12 3 TX CEA-6.5
07/23/12 10 TX CEA-5.0
09/18/12 PET shows 3 suspicious spots CEA -15.5
09/25/12 CEA- 23.8
10/23/12 CEA-51.8 1st of 6 FOLOFIRI
http://www.yeswecansir.com


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