TNBC Vaccine Trial?
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I will be having the last of the 6 monthly shots the end of this month. I also notice that I'm scheduled to go in again for labs and to see the dr. 4 weeks later, in Feb. I am wondering if anyone knows how often you will see the dr. Or have labs during the 6 mo period before the next injections. I will ask when I go back the end of this month but thought maybe someone's knew
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Hi Connie,
I had my sixth shot in May 2017, then four weeks later went back for labs only and to see the doc as you mentioned. There have been no other visits needed and I only went back for my first booster last month. They told me to come back in June for booster #2. That's it!
Good luck everyone!
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Thanks Angtee15. I was hoping I wouldn't have to go back every month. Since it's a 2 1/2 hr drive without any traffic issues in Orlando (which would be a miracle in itself), I can't say that I'll miss that drive and I know my husband won't. I have enjoyed seeing the Tampa/St. Pete area on the months when we spend the night there due to appt. times
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I had my fourth injection on Wednesday and had the same reaction--just a slight, pinkish puffiness near the injection which went away after two hours. However, in the middle of the night, appr 12 hours after the shot, when I got up for the bathroom, I noticed that the site had gotten pinkish again with a little thickening under the skin and itchiness. The area is about 1 1/2" in diameter. It's 6:15pm Thursday and it's the same, though I assume it will fade away.
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Hi SuprSurvivr, I am receiving my treatment University of Kansas, in Kansas City, Kansas. Can you tell me more about the trial that you are in for the vaccine? I just started my first cycle of Xeloda, on Monday. But I am interested in whatever would help keep any reoccurrence from happening
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after 6 injections, I am out of the trial because I have a malignant nodule in my lung.....
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Connie1230, I’m SO sorry to hear about your recent diagnosis. Keep up the fight and try to find peace and joy in each day. I’ll keep you in my prayers. ✨🙏🏻✨
Pkville, Unfortunately, this particular immunotherapy vaccine clinical trial is closed. But, the KU Cancer Center is a great place to get info about other available trials. Be sure to let your oncologist know you are interested. My dr at KUCC is Dr Anne O’Dea, and she’s awesome.
As for Xeloda, pull up my profile and see the links to various Xeloda for triple negative blogs on this site. Be sure to get some good lotion to slather on your feet. Drink lots of water and have a good breakfast with your morning dose. Feel free to directly ask me any questions. Prayers for you too! ✨🙏🏻✨
I go up for monthly vaccine #5 this Thursday. So far the side effects have been minimal. My ANA blood work still shows some occasional high numbers, so I was referred to a rheumatologist. He says without other symptoms, the results are likely false positives. The urine tests they do before each vaccine to verify I’m not pregnant are showing some blood in my urine. So they have referred me to a urologist, who I’ll see after this upcoming apt
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Oh, Connie, I'm so sorry to hear of the lung nodule.
Lyn
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Here is another Vaccine trial for TNBC NCT03012100 and here is the description:
Brief Summary:
This randomized phase II trial studies how well multi-epitope folate receptor alpha peptide vaccine, sargramostim, and cyclophosphamide work in treating patients with triple negative breast cancer. Vaccines made from a person's white blood cells mixed with tumor proteins may help the body build an effective immune response to kill tumor cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving multi-epitope folate receptor alpha peptide vaccine, sargramostim, and cyclophosphamide may work better in treating patients with triple negative breast cancer.
Below are contact info and locations.
Does anyone know anything about this trial? I haven't heard buzz about it. I am not a great match for the Keytruda trial and wondering if this would be better for me.
R
United States, Arizona Mayo Clinic in Arizona Recruiting Scottsdale, Arizona, United States, 85259 Contact: Clinical Trials Referral Office 855-776-0015 Principal Investigator: Donald W. Northfelt United States, District of Columbia MedStar Georgetown University Hospital Withdrawn Washington, District of Columbia, United States, 20007 United States, Florida Mayo Clinic in Florida Recruiting Jacksonville, Florida, United States, 32224-9980 Contact: Clinical Trials Referral Office 855-776-0015 Principal Investigator: Alvaro Moreno-Aspitia University of Miami Miller School of Medicine-Sylvester Cancer Center Recruiting Miami, Florida, United States, 33136 Contact: Onaidy T Torress 305-243-3379 OTorres@med.miami.edu Principal Investigator: Carmen J. Calfa United States, Illinois University of Chicago Comprehensive Cancer Center Not yet recruiting Chicago, Illinois, United States, 60637 Contact: Simona Olberkyte 773-702-4848 solberkyte@medicine.bsd.uchicago.edu Principal Investigator: Rita Nanda Carle Cancer Center NCI Community Oncology Research Program Recruiting Urbana, Illinois, United States, 61801 Contact: Christine M. Canfield 217-326-1881 christine.canfield@carle.com Principal Investigator: Kendrith M. Rowland United States, Louisiana Ochsner Medical Center Jefferson Recruiting New Orleans, Louisiana, United States, 70121 Contact: Socea A. May 504-842-2373 Socea.may@ochsner.org Principal Investigator: John T. Cole United States, Massachusetts Dana-Farber Cancer Institute Not yet recruiting Boston, Massachusetts, United States, 02215 Contact: Rachel Hepp 617-724-0878 etripp@mgh.harvard.edu Principal Investigator: Steven J. Isakoff United States, Minnesota Mayo Clinic Recruiting Rochester, Minnesota, United States, 55905 Contact: Clinical Trials Referrals Office 855-776-0015 Principal Investigator: Kathryn J. Ruddy United States, Virginia Inova Fairfax Hospital Recruiting Falls Church, Virginia, United States, 22042 Contact: Parisa Saifollahi 703-720-5210 Parisa.Saifollahi@inova.org Principal Investigator: Mary J. Wilkinson United States, Wisconsin Marshfield Clinic Recruiting Marshfield, Wisconsin, United States, 54449 Contact: Brenda Maronde 715-389-7542 maronde.brenda@marshfieldresearch.org Principal Investigator: Arlene A. Gayle Sponsors and Collaborators
Academic and Community Cancer Research United
National Cancer Institute (NCI)
Investigators
Principal Investigator: Kathryn Ruddy Academic and Community Cancer Research United 0 -
Oh so sorry, the contact info and locations got all jumbled... Well, you can look it up on Clinicaltrials.gov if you are interested in it. ;-)
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I was in the trial, at Texas Presbyterian Oncology.
Unfortunately I had a recurrence of TNBC. I was in the Low-dose arm.
I hope you all have better results.
Jojo
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I am so sorry to hear of your recurrence! I’ll keep you in my prayers. ✨🙏🏻
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I'm really ignorant about these trials, but I have a question. Do they not also give the person the old school chemos? Like A/C and a Taxol or Taxotere? Do they only get the vaccine and another unusual chemo?
I do want to know if vaccines work but I worry about the ladies not getting what we know works for so many people.
It sounded like the chemo/vaccine was given before surgery. Once they realize that there is still cancer in the tumor/lymph nodes....is there no chance to go and get more established chemo? Is the person in the trail just expected to sit back and wait?
Sorry if I am really misunderstanding how these trails work.
Worried about all my sister.
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Meggy, All the trials I have seen you also get traditional chemo. I don't remember the details of this particular trial but if I think you get neo-adjuvant chemo and then you get the vaccine after.
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Rdeesides, thanks for the information. It sounds like a win win if someone gets into those trials. I'm crossing my fingers that this leads to vaccines for all of us.
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I'm in the Tapimmune Folate Receptor trial and I had the first booster injection last Wednesday (Hallowee, Oct 31st). This time they gave me the injection in the right arm, 3" below my right shoulder. During the active part of the trial all 6 injections were midway up my right forearm. I have no idea what the switch was about. The only other change was that they didn't take a urine sample to check protein levels which they did last winter/spring. Again, I have no idea why there was this small change. The clinical trial coordinator said there has been no news about preliminary results. I thought the next phase was already in the works and I would think that'd they'd need to have some results from our phase first since our phase was intended to determine the dosing protocol. Anyway, the process was simple. I had a very slight reaction at the injection site--a little raised and pinkish and later a little itchy but by the next day the itchiness was gone and the raised area never got bigger than a dime; receded completely after 5 days.
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Below are excerpts from a news release made by the company sponsoring the Tapimmune trial:
"Marker Therapeutics also reported initial findings from its interim analysis of its dose-finding study (Study FRV-002) in patients with triple negative breast cancer, using TPIV200 as a maintenance therapy for patients in remission following first-line therapy. The four-arm study included low and high dose TPIV200 with or without cyclophosphamide.
Of 27 patients evaluated to date for immunogenicity, 26 showed significant immune response to the vaccine treatment. Of 80 patients treated at 11 clinical sites, 11 have shown disease progression to date following treatment with TPIV200."
Finally, our clinical sites have been very supportive of our Phase II vaccine studies in ovarian and breast cancer, and their rapid enrollment is a credit to our Principal Investigators and clinical investigative sites, as well as our clinical operations team. We are pleased with the progress in building our clinical development infrastructure and believe we can leverage that experience to drive our upcoming MultiTAA T cell studies efficiently."
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a terry I am interested in the vaccine trial. I just received news that my cancer has spread to my mediastinal nodes. That may be consider stage 4. Will the vaccine trial accept Local reoccurrence or stage 4 tnbc? This is my first post so I am hoping I am doing this correctly
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Deedi, I'm so sorry I didn't see your post. I don't visit the forum as often as I did when I was under active treatment. Have you gotten information that has been helpful?
I had my second booster injection as part of the Tapimmune Folate Receptor trial. This time the injection was in the thigh. They move the injection site around--I have no idea why. I'm in the low dose arm of the trial. Some patients get 3 injections. At the injection site I have slight thickening in a pinkish circle which grew to about 2" in diameter and has now (3rd day) reduced to 1" and is almost faded. There was slight itching. Other than that there are no side effects.
Tapimmune was purchased by Marker Pharmaceuticals. I don't know whether anyone is posting under that title--guess I should do a search ;-)
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Here's an update from Marker Therapeutics* on the Folate Receptor vaccine trial:
"The Company reported initial findings from its dose-finding, four-arm Phase 2 clinical trial in triple negative breast cancer, including low- and high-dose TPIV200 with or without cyclophosphamide. Of 27 patients evaluated for immunogenicity, 26 showed significant immune response to the vaccine treatment. Of 80 patients treated at 11 clinical sites, 14 have shown disease progression, as of April 30, 2019, following treatment with TPIV200."
*Tapimmune was purchased by Marker
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Thanks for the updates! My last two boosters have been in my upper arm vs the lower forearm for the earlier shots. I’ve had very little reaction - just some inject site itchiness for a few days.
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I just noticed in My Chart that a test result was posted for something called ANTI-TSH AUTOANTIBODY. I don't think I ever had that test before, or if I had it, as part of all the tubes of blood they take, I didn't get the results. So in this case the result was "negative" which is the normal reading. I have no idea what a TSH antibody is, if that's what we're talking about. SuprSurvivr, did you get that test as part of your blood work?
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Aterry - I haven’t had the that test. When Iwent back to check older test results - I do have some TSH results about every two months during the monthly shot phase. My results have a number assigned and just say “TSH” with an “Mcu/ml” with a range of 0.35 to 5.0. Mine have generally fallen in the 1.5 range. Last time the test was run was 5-18.
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Aterry - just did a google search on that test - https://www.ncbi.nlm.nih.gov/m/pubmed/10874533/
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This was reported by Marker Therapeutics, yesterday:. (TapImmune was purchased--I guess--by Marker.)
- "Based on a preliminary analysis of 34 patients enrolled in the triple negative breast cancer trial, 31 patients showed meaningful immune response to vaccine treatment;
- Of 80 patients treated at 11 clinical sites, 14 have shown disease progression, as of September 30, 2019, following treatment with TPIV200."
This seems to be good newsbecause there are no further progressions since the last report which was in May, although the ratio of patients showing meaningful immune response is a little lower.I had another injection, yesterday. This was in my upper arm. I have the same very minimal reactions as the other times. Slightly pink, slight swelling, slight itching. They only took 2 tubes of blood this time.
Thanks for posting that link, SuprSurvivr.
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Somehow I missed posting when I had my most recent immunotherapy injection. This was clear back in May. Gosh. The visit was very routine (except for the Covid protocols). There was mild reaction. The bump grew to about 3" diameter and then began to recede; by day 5 it was gone. Slight itching.
I have one more to go; November. Then I'll be eager to see when results get published. I was among the last to be signed up so if I'm almost finished this whole round should be almost finished. I don't know if they do any blood tests later to see if the T cell count holds.
I haven't posted for awhile so I also want to send belated best wishes to everyone who is confronted with treatments in the middle of the pandemic. I wish you the best in every way; best care; best results, best peace of mind.
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Aterry,
Thank you so much for the updates on the vaccine. It has been really helpful. Hopefully, others who were in the trial will also continue posting. It gives me hope to see so many doing well0 -
Hi, Aterry! Good to hear all went well. Your experiences pretty much mirror mine as for the reaction and how long they last. I entered the trial about the same time you did. I thought there were more vaccine sessions, so I checked with my trial coordinator. Here is what she said, “You will only have one more vaccine! So Booster #5 will be at your November visit and that is the last vaccine. There will be one more study follow-up visit 6 months after your November visit, but they just do labs and provider visit for that last one.”
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Hi, NorCalS! I was looking at your treatments and saw you did the Xeloda too after radiation. Was that standard of care for you? When I did it a couple years ago it was kind of a new thing.
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Sam0623
I am starting a research study at Mayo Jax in November 2020, for TRP- breast cancer. Study number is NCT03012100, Multi-epitope Folate Receptor Alpha Peptide Vaccine, GM-CSF, and Cyclophosphamide in treating patient with triple negative breast cancer. I will be taking cytoxan twice a day for a week, skipping a week and then starting injections but i was wondering if anyone had side effects for the cytoxan PO, 50 mg dose?
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