 |
03-03-2013, 04:07 PM
|
#1
|
|
Senior Member
Join Date: Aug 2011
Posts: 271
|
Seeking advice from Vaccine trial participants
I am considering one of 2 vaccine trials.
University of Washington, Arm 5, Her2 peptide vaccine plus 2000mcg Ampligen
and the Mayo Clinic MC1136, Phase 1 trial Multi-epitope Her-2/neu Peptide Vaccine with GM-CSF. I have read all the paperwork on both.
Here is what scares me. Both say if you participate and there are problems with your health caused by the trial, your insurance might not cover these problems. Wondering how you other ladies that participated in Vaccine trials feel about this? Did you contact your insurance company and tell them you were participating in a trial?
For the Mayo Clinic trial, the Vaccine includes, GM-CSF. They conduct echo's since this can effect the heart, and also they list as rare side effects Leukemia. I talked to MD Anderson and many of the trials that use GM-CSF only accept patients that have been done with Herceptin in 6 months for less. I do not qualify for any of those. Has anyone been part of a trial that used GM-CSF? If so what was your experience. I live in Illinois so Mayo is close to my home, although I have the resources to participate in the Seattle trial as well.
As you can see from my signature...I was Stage IIIc and I am 2 years and 4 months out. I really would like to be part of the advance of vaccines for all the women in my life that I love...but reading the fine print on a trial is scary. I have great overall health and a strong heart.
Can someone shed some light on your decision making process to partipate in a trial.
__________________
DX November 2010
Brain MRI, CT of lung, liver, bone, all clear
Double Mastectomy w/expanders December 1, 2010
ER- PR- Her2+++, grade 3, 12 positive nodes out of 15
Stage IIIc
Started TCH/Chemo December 31, 2010
6 rounds TCH
Herceptin every 3 weeks for a year
33 rounds of TomoTube radiation, to chest wall, neck, skin and lymph area
September, 2011, MRI to lower spine, hips, DX bulging disk, L4 & L5, pain not from cancer
Expanders removed, implants in Dec 1, 2011
Finished Herceptin, December 21, 2011
August 2012, CT of chest and abdomen, all ok
Enrolled in MC1136 Phase I Peptide Vaccine Trial at Mayo Clinic, Rochester, Minnesota
March 2013, First Vaccine
April 2013, 2nd Vaccine
May 2013, 3rd Vaccine
June 2013, 4th Vaccine
July 2013, 5th Vaccine
August 2013, 6th Vaccine Done!
September 2013, Mayo visit, Echo results 68, vaccine did not effect my heart! Blood work normal.
January 31, 2013, Mayo visit, Echo normal
February 23, 2014, Numb lips on right side, Brain MRI, normal!
June, 2015, Finished the trial at Mayo Clinic. Feels good!
|
|
|
|
03-03-2013, 05:09 PM
|
#2
|
|
Senior Member
Join Date: Jan 2012
Posts: 362
|
Re: Seeking advice from Vaccine trial participants
Hi there,
I'm about to get the GP2 + GM-CSF vaccine from Walter Reed. I have been waiting for this moment since I got diagnosed. The vaccine I'm getting has been given to hundreds of women and they are nearing the end of Phase 2 and will be entering Phase 3 soon. So I am not too concerned about the side effects. Actually, tomorrow I have to go in for them to test the vaccine on my thigh to see if I get a reaction. And the on Wednesday I have to stay at the hospital for 2 hours after getting the full vaccine so they can check me every 15 minutes for a reaction. From what I have read, there are a lot of vaccines that have some GM-CSF as part of their formula. So the risk of the bad effects you mention, I believe, are low. I think that the benefits outweigh the risks. Just my thought on it.
__________________
DX 10/2011
PET Scan + MRI 10/2011
Lumpectomy 11/11/11
Stage 2B +++ ER+(10%), PR+(5%), HER2+++(1 positive node, 1 micromets to second node)
AC started 12/2011 ended 1/2012
Taxol + Herceptin weekly for 12 weeks ended 4/2012
30 zaps of radiation done 6/2012
Tamoxifen 6/2012
every 3 weeks of Herceptin for another year.
Metformin Trial 8/12
10/12 MRI- CLEAR
01/13 BRAIN MRI- CLEAR!
01/13 Neck MRI- CLEAR!
FINISHED HERCEPTIN 1/9/2013...Woot Woot
Starting Walter Reed Vaccine Trial 2/13
CT Scans + ultrasound of abdomen CLEAR-5/13
02/2015 through 11/2015 emergency D&Cs for Tamoxifen induced uterine polyps which caused uncontrollable hemorrhaging
12/2015 blood clot to left leg caused by Tamoxifen. No longer taking it. On Xarelto, a blood thinner
12/2015 Ablation to prevent hemorrhaging from potential issues with Tamoxifen residue in my system
1/2016 continuing journey without hormonal therapy. Reevaluating the option of a hysterectomy and oopherectomy.
4/1/2018 2mm stroke. Yes, stroke! No cause ever found but they believe it was a migraine that went bonkers and created a tiny clot. No deficits. I was back to normal with 24hrs. Now on baby aspirin for life.
7/27/2018 hysterectomy and oopherectomy
01/07/2019 Mastectomy and expanders put in
3/22/2019 Vtach, almost died. Cause unknown.
7/22/2019 New perky boobs put in
7/21/2020 Off of all drugs but a baby aspirin because of the stroke in 2018.
www.mychemobag.org
www.facebook.com/mychemobag
8 YEARS NED
|
|
|
|
|
03-03-2013, 08:11 PM
|
#3
|
|
Senior Member
Join Date: Nov 2004
Location: Misty woods of WA State
Posts: 4,128
|
Re: Seeking advice from Vaccine trial participants
Hi Jill -
I am one those here who participated in the U of W Tumor Group peptide/ampligen trial.
A small arm is being launched with a higher dose of ampligen than anyone had in the phase 1 (4 different doses) trial.
I got the highest dose of ampligen and had NO side effects whatsoever. Actually felt a little less fatigued/more energy.
Good luck. If you end up coming to Seattle, let's try to meet, OK.
__________________
"When I hear music, I fear no danger. I am invulnerable. I see no foe. I am related to the earliest times, and to the latest." H.D. Thoreau
Live in the moment.
MY STORY SO FAR ~~~~
Found suspicious lump 9/2000
Lumpectomy, then node dissection and port placement
Stage IIB, 8 pos nodes of 18, Grade 3, ER & PR -
Adriamycin 12 weekly, taxotere 4 rounds
36 rads - very little burning
3 mos after rads liver full of tumors, Stage IV Jan 2002, one spot on sternum
Weekly Taxol, Navelbine, Herceptin for 27 rounds to NED!
2003 & 2004 no active disease - 3 weekly Herceptin + Zometa
Jan 2005 two mets to brain - Gamma Knife on Jan 18
All clear until treated cerebellum spot showing activity on Jan 2006 brain MRI & brain PET
Brain surgery on Feb 9, 2006 - no cancer, 100% radiation necrosis - tumor was still dying
Continue as NED while on Herceptin & quarterly Zometa
Fall-2006 - off Zometa - watching one small brain spot (scar?)
2007 - spot/scar in brain stable - finished anticoagulation therapy for clot along my port-a-catheter - 3 angioplasties to unblock vena cava
2008 - Brain and body still NED! Port removed and scans in Dec.
Dec 2008 - stop Herceptin - Vaccine Trial at U of W begun in Oct. of 2011
STILL NED everywhere in Feb 2014 - on wing & prayer
7/14 - Started twice yearly Zometa for my bones
Jan. 2015 checkup still shows NED
2015 Neuropathy in feet - otherwise all OK - still NED.
Same news for 2016 and all of 2017.
Nov of 2017 - had small skin cancer removed from my face. Will have Zometa end of Jan. 2018.
|
|
|
|
|
03-04-2013, 05:55 PM
|
#4
|
|
Senior Member
Join Date: Sep 2005
Location: Stockton, NJ
Posts: 4,179
|
Re: Seeking advice from Vaccine trial participants
GM-CSF is also known by its brand name, Leukine. Go on www.leukine.com
Leukine (only the first dose) can give extreme fatigue side effects and even a hive at the injection site. I took Leukine instead of Neulasta (or Neupogen) as my white blood cell booster because it boosts the dendrites (as well as the other white blood cell components such as monocytes, lympocytes and the important neutrophils). The dendritic effect is what makes vaccines work and I was using it alone to try to self vaccinate during chemo. I had such extreme fatigue (only with the first dose) that I could not even move. This is extreme and at least they are making you stay 2 hrs just in case. You can read about Leukine online and you should so you know what to expect. I did not do a vaccine trial but I did do 87 doses of Leukine.
__________________
Kind regards
Becky
Found lump via BSE
Diagnosed 8/04 at age 45
1.9cm tumor, ER+PR-, Her2 3+(rt side)
2 micromets to sentinel node
Stage 2A
left 3mm DCIS - low grade ER+PR+Her2 neg
lumpectomies 9/7/04
4DD AC followed by 4 DD taxol
Used Leukine instead of Neulasta
35 rads on right side only
4/05 started Tamoxifen
Started Herceptin 4 months after last Taxol due to
trial results and 2005 ASCO meeting & recommendations
Oophorectomy 8/05
Started Arimidex 9/05
Finished Herceptin (16 months) 9/06
Arimidex Only
Prolia every 6 months for osteopenia
NED 18 years!
Said Christopher Robin to Pooh: "You must remember this: You're braver than you believe and stronger than you seem and smarter than you think"
|
|
|
|
|
03-04-2013, 06:56 PM
|
#5
|
|
Senior Member
Join Date: Aug 2010
Posts: 72
|
Re: Seeking advice from Vaccine trial participants
Hi JillaryJill
Yeah for you to be considering a vaccine!!! 
I did the GP2 with Herceptin trial. I am thrilled that I did. Very little side effects from the GM-CSF which was given in tandem with the GP2. Just a little redness was my experience. I did not notice being tired from the vaccine. Vaccines are consider quite safe and with very few side effects if any, thus why it is such a potentially hopeful and encouraging solution to prevent this rotten cancer.
In regards to insurance, I did let my insurance know that I was participating in that trial. They did not have a problem with my participation but did say that I had something in my policy that made it acceptable. I thought that a bit strange but did not ask any more questions. As long as they gave me the green light, and we were sure about the decision from our end, I went for it. I would be a little leery to not inform them before hand. Reason being, just as you said, if something happened, I would not want to have the worry about an insurance problem on top of everything else. Though again, side effects, I believe, are likely to be very minimal.
Best of luck with your decision. |
|
|
|
|
03-05-2013, 12:08 PM
|
#6
|
|
Senior Member
Join Date: Apr 2011
Posts: 403
|
Re: Seeking advice from Vaccine trial participants
Do you have to be off treatment in order to participate in the washing UC trial? Thanks!
__________________
1/11 age 36 DX
ER/PR-, Her2 +
TCH*6, Herceptin
BMX with immediate recontruction 5/2011 Lattismus Flap- Dx stage 3c 10/23 nodes
9/11 Radiation
3/12 Local recurrence to skin stage IV
Whole body scan CLEAR
4/12 Tykerb & Xeolda Skin mets slowly regressing
8/12 PET & Brain CT Clear
5/13 Skin mets progressing
6/13 PET scan chestwall recurrence in contralateral anxillary,internal mammary and ipsilateral subpectoral nodes
6/13 kadcyla
10/13 whole body scan -clear NED. previously resolved skin rash gone but 3 new lesions. Biopsy confirmed for skin recurrence
11/13 to 02/14 tykerb & herceptin
02/14 add abraxane/gemzar, 2 weeks on 1 week off at reduced dose
05/14 whole body PET clear/ brain CT clear but skin mets are getting worse, ready for new chemo
05/14 navelbine perjeta herceptin
07/14 skin mets progressing red rash worse
08/14 wide local excision with diep flap to close wound. Final path shows 2 positive margins showing inflammatory carcinoma Going back to surgery in 2 weeks
09/01/14 resection- clear margins
3 weeks after 2nd surgery, a new nodular rash found near drain incision with 2 small red spots behind the chest wall biopsy on 10/1. Positive for breast cancer
Radiation 11/2014 with xeloda then weekly cisplatin
11/14 brain MRI clean
12/14 finished 33 radiations burnt and very painful. Bedridden for 1 week
12/14 t current Herceptin and perjeta only
02/15 rash on upper back right side skin mets radiation planned
02/15 staring electron radiation *35
Stopped at 30 due to severe skin burn, resumed 10 days later
05/15 red patches appeared in between previously radiated area, skin mets. Ct and brain Mri clear. Simulation planned, radiation to start after trip to Alaska.
05/24 new spot identified in scar line on previously radiated reconstructed breast- electron on both side chest wall area and scar line
07/15 multiple skin and lung recurrence begin halaven
11/15 cough much better but very tired on halaven and starting to see some new red skin blotches-suspicious
11/15 heading to China for immune therapy
|
|
|
|
|
03-05-2013, 12:36 PM
|
#7
|
|
Senior Member
Join Date: Aug 2011
Posts: 271
|
Re: Seeking advice from Vaccine trial participants
Thank you for all the input. I have one more question if anyone can answer this. I looked at my FISH for HER-2/neu gene and the score was 28.95/2.20 = 13.16 which I assume means I am a high expressor of HER-2. From what I am gathering the vaccines are more effective on the low expressers...but I am not a scientist and might not be factual here.
Any thoughts on this? Again, thank you for your help!
__________________
DX November 2010
Brain MRI, CT of lung, liver, bone, all clear
Double Mastectomy w/expanders December 1, 2010
ER- PR- Her2+++, grade 3, 12 positive nodes out of 15
Stage IIIc
Started TCH/Chemo December 31, 2010
6 rounds TCH
Herceptin every 3 weeks for a year
33 rounds of TomoTube radiation, to chest wall, neck, skin and lymph area
September, 2011, MRI to lower spine, hips, DX bulging disk, L4 & L5, pain not from cancer
Expanders removed, implants in Dec 1, 2011
Finished Herceptin, December 21, 2011
August 2012, CT of chest and abdomen, all ok
Enrolled in MC1136 Phase I Peptide Vaccine Trial at Mayo Clinic, Rochester, Minnesota
March 2013, First Vaccine
April 2013, 2nd Vaccine
May 2013, 3rd Vaccine
June 2013, 4th Vaccine
July 2013, 5th Vaccine
August 2013, 6th Vaccine Done!
September 2013, Mayo visit, Echo results 68, vaccine did not effect my heart! Blood work normal.
January 31, 2013, Mayo visit, Echo normal
February 23, 2014, Numb lips on right side, Brain MRI, normal!
June, 2015, Finished the trial at Mayo Clinic. Feels good!
|
|
|
|
|
03-05-2013, 12:44 PM
|
#8
|
|
Senior Member
Join Date: Oct 2005
Location: Lakeville, Minnesota
Posts: 199
|
Re: Seeking advice from Vaccine trial participants
Yes, to be in the univ of wash trial you have to be Ned and off treatment.
Laurie
__________________
diagnosed stage 2- 3/2005
4.5 cm & 2+ nodes , er/pr- & HER2+
4 AC
12 taxol/Herceptin
Year of Herceptin
liver mets- July-2010
7 taxotere/Herceptin
RFA- Feb.2011
NED
U of Wa vaccine trial-oct 2011-Feb 2012
Herceptin/tykerb
Ned - 2 1/2 years
Herceptin & perjeta
Ned 3 years
Herceptin- reducing treatments , due to s/e, to 5-6 a year
NED- 3 1/2 years
Ned - 4 years
2/15- stopped herceptin - on no treatment
|
|
|
|
|
03-13-2013, 08:26 AM
|
#9
|
|
Senior Member
Join Date: Sep 2005
Location: Madison, Connecticut
Posts: 638
|
Re: Seeking advice from Vaccine trial participants
Hi JillaryJill,
I was one of the early participators in a vaccine trial in Seattle (2005). I am a high Her2 expresser. I also had GM-CSF. I had no side effects and was told 2 years later that i was a "responder".
That said, I appreciate your caution. Judging by your signature, you are NED now. You are appropriately worried about being in the minority that does experience significant side effects. On the other hand, if you can develop a lasting immunity to Her 2, you may prolong your NED for many years and perhaps prevent recurrence. Such an irresistible siren call. If you decide to move ahead; please be assured that at least in Seattle, they do monitor you very closely.
You are wise to give it much thought. i think the experiences of our members has been widely positive. God speed in your decision making.
Love and Hugs,
Kim (from CT)
__________________
2001 - Stage 0, lumpectomy, radiation, tamoxifen
2004 - Stage 4, mets to 4 lobes of lungs and liver, lumpectomy, er/pr -, her2 neu+++, Herceptin and Navelbine then Herceptin only.
2005 - Breast Ca vaccinations with the Tumor Vaccine Group in Seattle
2011 - Still Herceptin only and NED
2011, June - STOPPED Herceptin and kicked up my heels!
2012, February - 1 small tumor came back to haunt me in my lungs - back on Herceptin only, tumor stable.
2015, November - tumor on lungs removed (Segmentectomy), back on Herceptin only
Received U of W vaccine clinical "booster" Vaccine
2022 On Herceptin and NED continues - WOOT WOOT!
|
|
|
|
|
03-21-2013, 03:40 PM
|
#10
|
|
Senior Member
Join Date: Apr 2008
Location: Sunny San Diego
Posts: 2,214
|
Re: Seeking advice from Vaccine trial participants
Yes, the word has been put out that it is more effective on the lower expressors. I'm a bit skeptical, but am hoping to see the data showing this.
The posters and mid trial reports showed a positive difference between the control arm and the vaccine arm for the Her2+++. I suspect the vaccines are also effective for our group but a new, bigger market (lower expressors) has been discovered.
Ummm . . . hello . . . hand up over here! How about us high expressors?
Anyone seen the latest data?
__________________
Diagnosed 2007
Stage IIb Invasive Ductal Carcinoma, Pagets, 3 of 15 positive nodes
Traditional Treatment: Mastectomy and Axillary Node Dissection followed by Taxotere, 6 treatments and 1 year of Herceptin, no radiation
Former Chemo Ninja "Takizi Zukuchiri"
Additional treatments:
GP2 vaccine, San Antonio Med Ctr
Prescriptive Exercise for Cancer Patients
ENERGY Study, UCSD La Jolla
Reconstruction: TRAM flap, partial loss, Revision
The content of my posts are meant for informational purposes only. The medical information is intended for general information only and should not be used in any way to diagnose, treat, cure, or prevent disease
|
|
|
|
Posting Rules
|
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts
HTML code is Off
|
|
|
All times are GMT -7. The time now is 09:46 AM.
|
Linear Mode
