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Old 12-01-2014, 12:21 AM   #1
Lani
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Thumbs up new bc vaccine from Washington Univ (not UNIV OF WASHINGTON) PROMISING

BASED ON DIRECTING IMMUNE SYSTEM AGAINST MAMMOGLOBIN A , WHICH VAST MAJORITY OF BCs have (in contrast to her2, which a small --but very important-- minority have amplified)

1-Dec-2014
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Contact: Diane Duke Williams
williamsdia@wustl.edu
314-286-0111
Washington University School of Medicine
@WUSTLmed
Breast cancer vaccine shows promise in small clinical trial





IMAGE: A breast cancer vaccine designed by researchers at Washington University School of Medicine in St. Louis is safe in patients with metastatic breast cancer. Preliminary evidence from the small clinical...
Click here for more information.



A breast cancer vaccine developed at Washington University School of Medicine in St. Louis is safe in patients with metastatic breast cancer, results of an early clinical trial indicate. Preliminary evidence also suggests that the vaccine primed the patients' immune systems to attack tumor cells and helped slow the cancer's progression.

The study appears Dec. 1 in Clinical Cancer Research.

The new vaccine causes the body's immune system to home in on a protein called mammaglobin-A, found almost exclusively in breast tissue. The protein's role in healthy tissue is unclear, but breast tumors express it at abnormally high levels, past research has shown.

"Being able to target mammaglobin is exciting because it is expressed broadly in up to 80 percent of breast cancers, but not at meaningful levels in other tissues," said breast cancer surgeon and senior author William E. Gillanders, MD, professor of surgery. "In theory, this means we could treat a large number of breast cancer patients with potentially fewer side effects.

"It's also exciting to see this work progress from identifying the importance of mammaglobin-A, to designing a therapeutic agent, manufacturing it and giving it to patients, all by investigators at Washington University," he added.

The vaccine primes a type of white blood cell, part of the body's adaptive immune system, to seek out and destroy cells with the mammaglobin-A protein. In the smaller proportion of breast cancer patients whose tumors do not produce mammaglobin-A, this vaccine would not be effective.

In the new study, 14 patients with metastatic breast cancer that expressed mammaglobin-A were vaccinated. The Phase 1 trial was designed mainly to assess the vaccine's safety. According to the authors, patients experienced few side effects, reporting eight events classified as mild or moderate, including rash, tenderness at the vaccination site and mild flu-like symptoms. No severe or life-threatening side effects occurred.

Although the trial was designed to test vaccine safety, preliminary evidence indicated the vaccine slowed the cancer's progression, even in patients who tend to have less potent immune systems because of their advanced disease and exposure to chemotherapy.

"Despite the weakened immune systems in these patients, we did observe a biologic response to the vaccine while analyzing immune cells in their blood samples," said Gillanders, who treats patients at Siteman Cancer Center at Barnes-Jewish Hospital and Washington University. "That's very encouraging. We also saw preliminary evidence of improved outcome, with modestly longer progression-free survival."

Of the 14 patients who received the vaccine, about half showed no progression of their cancer one year after receiving the vaccine. In a similar control group of 12 patients who were not vaccinated, about one-fifth showed no cancer progression at the one-year follow-up. Despite the small sample size, this difference is statistically significant.

Based on results of this study, Gillanders and his colleagues are planning a larger clinical trial to test the vaccine in newly diagnosed breast cancer patients, who, in theory, should have more robust immune systems than patients who already have undergone extensive cancer therapy.

"If we give the vaccine to patients at the beginning of treatment, the immune systems should not be compromised like in patients with metastatic disease," Gillanders said. "We also will be able to do more informative immune monitoring than we did in this preliminary trial. Now that we have good evidence that the vaccine is safe, we think testing it in newly diagnosed patients will give us a better idea of the effectiveness of the therapy."

###

This work was supported by the Breast Cancer Research Program (BCRP) of the Department of Defense Congressionally Directed Medical Research Programs (DOD/CDMRP), grant number W81XWH-61-0677; Gateway for Cancer Research, P-06-016; The Foundation for Barnes-Jewish Hospital; the National Cancer Institute (NCI) of the National Institutes of Health (NIH), T32 CA009621; the NCI Cancer Center Support Grant, P30 CA91842; and George and Diana Holway.

Tiriveedhi V, Tucker N, Herndon J, Li L, Sturmoski M, Ellis M, Ma C, Naughton M, Lockhart AC, Gao F, Fleming T, Goedegebuure P, Mohanakumar T, Gillanders WE. Safety and preliminary evidence of biological efficacy of a mammaglobin-A DNA vaccine in patients with stable metastatic breast cancer. Clinical Cancer Research. Dec. 1, 2014.

Washington University School of Medicine's 2,100 employed and volunteer faculty physicians also are the medical staff of Barnes-Jewish and St. Louis Children's hospitals. The School of Medicine is one of the leading medical research, teaching and patient-care institutions in the nation, currently ranked sixth in the nation by U.S. News & World Report. Through its affiliations with Barnes-Jewish and St. Louis Children's hospitals, the School of Medicine is linked to BJC HealthCare.

URL: https://news.wustl.edu/news/Pages/27732.aspx
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Old 12-01-2014, 07:22 PM   #2
KathyT
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Re: new bc vaccine from Washington Univ (not UNIV OF WASHINGTON) PROMISING

Thanks for sharing!
__________________
Kathy
38 years old!

January 17th 2014-mammo, ultrasound, biopsy
January 20th 2014- diagnosed, ER/PR+, Her2+++, Stage 2A
January 21st 2014-MRI, right breast only plus lymph nodes
January 23rd 2014- Pet scan-2 cm tumor, 3 lymph nodes
February 4th 2014-port insertion
February 12th 2014-first chemo treatment(TCHP x6 cycles)
May 28th 2014-LAST chemo treatment!!
July 10th 2014-double mastectomy
July 29th 2014-start radiation(30)
Sept. 11th 2014last radiation treatment!!!
November 12 2014-started Tamoxifen
January 20 2015-reconstruction begins, lat flap
February 4 2015-last Herceptin treatment!!
April 24, 2015- pet scan-NED!!
June 3 2015- exchange surgery, port removed!!
September 8 2015-hysterectomy/oophorectomy
September 15 2015-Revision of lat flap reconstruction
December 23 2015-nipple reconstruction
May 9th 2016-Mets to pituitary gland, liver and C7 vertebrae
May 10th-port put back in:(
May 17th- biopsy of mass on back
May 19th-started Herceptin/Perjeta
May 20th-5 treatments Cyberknife to pituitary gland tumor
June 9th-Started THP (will have 6 cycles)
August 17th-MRI of brain, significant reduction in tumor
😃, repeat MRI in 3 months. Received first Zometa
infusion.
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Old 12-02-2014, 11:22 AM   #3
'lizbeth
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Re: new bc vaccine from Washington Univ (not UNIV OF WASHINGTON) PROMISING

Oh Lani - that is very encouraging, and for Metastatic Breast Cancer even.

Are they currently enrolling for a Phase II?
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Old 12-02-2014, 11:49 AM   #4
Carol Ann
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Re: new bc vaccine from Washington Univ (not UNIV OF WASHINGTON) PROMISING

I saw a post about Phase II on Facebook, 'Lizbeth ... they are enrolling early stage women who have been just diagnosed; they want to see how women with better immune systems handle it. Unfortunately that leaves out metastatic women. I saw where some were going to call the University to ask more questions as to why they were being cut and to hopefully still be included.

Carol Ann
__________________
July 24, 2013: "Infected" Right Nipple and benign cyst removed, pathology report revealed Paget's, DCIS, and ILC 1.25 cm, ER+/Pro+/HER2 equivocal, Grade 2 under benign cyst, previous diagnostic mammo/ultrasound said I was perfectly healthy in both breasts.

Aug 18, 2013: MRI report says Left breast is perfectly healthy "consistent with previous studies".

Sept 2013: I insist on a bilateral mastectomy anyway. Too nervewracking to let left breast remain with higher risk after 3 cancers in right, nipple in right is already gone anyhow.

Sept 18, 2013: Bilateral mastectomy, 11 right nodes removed, ALL negative BUT -- ER+/PRO+/HER2+ tumor, 1.0 cm, Grade 2 found in a piece of "grossly unremarkable" breast tissue from prophylactic mastectomy of left breast, no nodes removed.

Oct 25, 2013: 13 left side nodes removed, ALL negative, Stage 1 across the board, NO RADS needed, YAAAAY! Port also installed.

Nov 25, 2013 Begin 6 rounds TCH.

March 10, 2014 Just finished 6th and LAST Chemo today, YAAAAAY!

March 24, 2014 Echocardiogram to make sure I'm still good for Herceptin every 3 weeks.

March 31, 2014 Echo results NORMAL, first Herceptin all by itself. Now if only my eyes would stop streaming from the Taxotere ... :)

April 21, 2014 Started Arimidex and therapy for "mild" lymphedema in left hand and arm

May 2014 Therapy completed, I have sleeves and gloves for both arms, a Flexi touch lymph pump to hook up to for an hour every day, and I've become an arm bandaging expert. :)

June 2014 Begin Fosamax to prevent osteoporosis; bone scan revealed osteopenia

Nov 17, 2014 FINAL Herceptin!

Dec 4, 2014 My right thigh muscle has been extra achy for days ... I discover a blister rash cluster on the side of my right thigh while taking a shower. Port appointment cancelled until Dec 17, my doc is working me in tomorrow afternoon to see me and the rash. My muscle at least feels less achy.

Dec 5, 2014 Yep, I have shingles. Boo! I start acyclovir and also have a prescription for a painkiller just in case for over the weekend.

Dec 17, 2014 Port is OUT!

January 2016 Shingles again and this time it started where my left breast (where the hidden HER2+++ tumor was!) used to be. My onc nurse got me a same day appointment to see my doc when I called and told her I had a rash on the site. The antiviral meds are working once again, though, so that is good news. :)
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Old 12-02-2014, 12:04 PM   #5
'lizbeth
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Re: new bc vaccine from Washington Univ (not UNIV OF WASHINGTON) PROMISING

Early stage? Yes, I understand the disappointment. I felt the same way when many vaccines were switching from studying high HER2 expressors to lower expressors.

Asking is good, and keep asking. I will look for the study information. I believe they can study both early and advanced. It is just a matter of bringing all the right people together.
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Old 12-02-2014, 12:10 PM   #6
'lizbeth
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Re: new bc vaccine from Washington Univ (not UNIV OF WASHINGTON) PROMISING

NCT02204098 and it is a Phase 1B trial, not Phase II.

Interesting study. Did you see the exclusions? Not yet enrolling. This is an interesting one to watch. If you notice that it starts enrolling please post the information.
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Old 12-02-2014, 12:19 PM   #7
Carol Ann
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Re: new bc vaccine from Washington Univ (not UNIV OF WASHINGTON) PROMISING

Will do!

CA
__________________
July 24, 2013: "Infected" Right Nipple and benign cyst removed, pathology report revealed Paget's, DCIS, and ILC 1.25 cm, ER+/Pro+/HER2 equivocal, Grade 2 under benign cyst, previous diagnostic mammo/ultrasound said I was perfectly healthy in both breasts.

Aug 18, 2013: MRI report says Left breast is perfectly healthy "consistent with previous studies".

Sept 2013: I insist on a bilateral mastectomy anyway. Too nervewracking to let left breast remain with higher risk after 3 cancers in right, nipple in right is already gone anyhow.

Sept 18, 2013: Bilateral mastectomy, 11 right nodes removed, ALL negative BUT -- ER+/PRO+/HER2+ tumor, 1.0 cm, Grade 2 found in a piece of "grossly unremarkable" breast tissue from prophylactic mastectomy of left breast, no nodes removed.

Oct 25, 2013: 13 left side nodes removed, ALL negative, Stage 1 across the board, NO RADS needed, YAAAAY! Port also installed.

Nov 25, 2013 Begin 6 rounds TCH.

March 10, 2014 Just finished 6th and LAST Chemo today, YAAAAAY!

March 24, 2014 Echocardiogram to make sure I'm still good for Herceptin every 3 weeks.

March 31, 2014 Echo results NORMAL, first Herceptin all by itself. Now if only my eyes would stop streaming from the Taxotere ... :)

April 21, 2014 Started Arimidex and therapy for "mild" lymphedema in left hand and arm

May 2014 Therapy completed, I have sleeves and gloves for both arms, a Flexi touch lymph pump to hook up to for an hour every day, and I've become an arm bandaging expert. :)

June 2014 Begin Fosamax to prevent osteoporosis; bone scan revealed osteopenia

Nov 17, 2014 FINAL Herceptin!

Dec 4, 2014 My right thigh muscle has been extra achy for days ... I discover a blister rash cluster on the side of my right thigh while taking a shower. Port appointment cancelled until Dec 17, my doc is working me in tomorrow afternoon to see me and the rash. My muscle at least feels less achy.

Dec 5, 2014 Yep, I have shingles. Boo! I start acyclovir and also have a prescription for a painkiller just in case for over the weekend.

Dec 17, 2014 Port is OUT!

January 2016 Shingles again and this time it started where my left breast (where the hidden HER2+++ tumor was!) used to be. My onc nurse got me a same day appointment to see my doc when I called and told her I had a rash on the site. The antiviral meds are working once again, though, so that is good news. :)
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Old 12-02-2014, 08:43 PM   #8
Rolepaul
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Re: new bc vaccine from Washington Univ (not UNIV OF WASHINGTON) PROMISING

It will be interesting to see how the next phase of the study works out. I am working on getting more info and will post what is not proprietary.
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Old 12-03-2014, 12:23 PM   #9
'lizbeth
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Re: new bc vaccine from Washington Univ (not UNIV OF WASHINGTON) PROMISING

Rolepaul, they are dramatically changing cancer management if they can get patients to treat with vaccines before surgery.

This seems to have such a huge perception obstacle. Patients are so convinced they will die because they have been diagnosed with cancer. Convincing them to do a treatment before surgery or neoadjuvant treatment could be a challenge. Educating the public on the survivability of a cancer diagnosis for the vast majority of people is key. Too many patients get sucked into the current system and are pushed into standard of care with fear tactics. Changing the system will be critical over the next 2 decades. I hope you are up to the challenge!


I've been thinking of you and Prop 303 in AZ. Can you follow up in a separate post. What has been the change created by this proposition? Have patients gained more access to lifesaving treatments yet?

Last edited by 'lizbeth; 12-03-2014 at 12:24 PM.. Reason: extra letter deleted
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