vaccine trial

[valleygirl]

Went up to Baltimore to Union Medstar hospital and was bled to see if I was a candidate for the Walter Reed vaccine trial. They called today and I'm (I think what she said)HAL2 positive, so I'm not able to join the trial. Are there any others?

Thanks Valleygirl

[Jackie07]

Valleygirl,

Not HAL2 positive? Did you mean Her2?

['lizbeth]

This seems interesting. I was in the GP2 arm of the Walter Reed and I was HLA2 positive. sandraGA was negative and received AE37.

my understanding is Phase III is only enrolling lower expressors of HER2, the former 3Ns (Triple Negs) who test HER2+ and HER2++

when was your last infusion of Herceptin?

[valleygirl]

Hi lizbeth,

My last Herceptin was June 25th. I was really excited about this, what a disappointment.

[europa]

I started the vaccine trial here at Sibley about 4 months ago...maybe 6 months ago. I was tested for HLA + or -. I was told that they are only enrolling HLA + patients because they have concluded that HER2+ patients that are HLA - don't benefit from the vaccine. this is what I was told. If you are HER2- and HLA- they put you in the AE37 arm. If you are positive and either HER2+ or - they put you in the GP2 arm.

[Sandra in GA]

HLA A2- folks do not have a strong response to cancer, organs from others, or stings and bites. The vaccine, AE37 in designed to "more vigoriously" stimulate our bodies to produce antibodies to fight in these situations. The GP2 vaccine, which is also a peptid vaccine, does a good job for HLA A2+ folks, but not for neg ones.

I could not get into a trial at Mayo because they were only looking at the GP2 vaccines with two different additives to increase effectivity. Then I found the Walter Reed study which had both vaccines. That was one of the best days of my life. I traveled 525 miles each way to do the trial and I would do it again in a heart beat.

Please do your best to get into one of these trials. You will never regret it. When I entered the trial you only had a 30 day window from your last Herceptin treatment. They want you to be disease free.

Sandra

[valleygirl]

Hi Sandra in Ga
Can you tell me who your contact is at Walter Reed. I went up to Baltimore on Wednesday and was bled, Friday they called and said I wasn't a candidate because I was HLA positive. I had such high hopes for this vaccine.

Thanks Denise

[Sandra in GA]

Denise,
I am not sure if the study I am in is still recruiting. I did not go to Walter Reed. There were several locations nationwide with one being in Winston-Salem NC at Wake Forest Medical Center. However, I had a wonderful study nurse and I am certain she will talk with you. Her name is Robin Petro and her number is 336-713-4788. If I were you, I would give her a call and she should be able to share valuable information with you. (Tell her I gave you her name and number.)

Here is the trial info and it looks to me like they are still active. http://clinicaltrials.gov/ct2/show/NCT00524277?intr=%22AE37+peptide%2FGM-CSF+vaccine%22&rank=1
I do know they have been approved for phase III and are tageting a wider population this time. I do not know the details of this.

I am keeping my fingers crossed for you!!!! Do not give up. Keep looking until you find one that fits your needs. That is the secret.

Sandra

['lizbeth]

6/12/2013 Generex Announces Interview of MD Anderson's Dr. Elizabeth Mittendorf, Principal Investigator on Company's AE37 Phase IIb Breast Cancer Efficacy Trial

Unique abilities of AE37 to activate immune system highlighted

WORCESTER, Mass. and TORONTO, June 12, 2013 /PRNewswire/ -- Generex Biotechnology Corporation (www.generex.com (http://www.generex.com)) (GNBT) today announced an interview given by Dr. Elizabeth Mittendorf, M.D., Ph.D. Dr. Mittendorf is the Principal Investigator of the Company's AE37 clinical trial to test the ability of the novel immunotherapeutic agent to prevent relapse in patients who have had HER2-expressing breast cancer, the largest Phase IIb peptide clinical trial conducted to date. AE37 is being developed by the Company's wholly-owned subsidiary, Antigen Express, Inc. (www.antigenexpress.com (http://www.antigenexpress.com)). The interview was conducted by Oncology TV at this year's Annual Meeting of the American Society of Clinical Oncology (ASCO), held in Chicago from May 31 to June 4. The interview can be viewed online at:

http://www.oncology.tv/Videos/TabId/79/VideoId/474/ASCO-2013-Elizabeth-A-Mittendorf-MD-PhD-HER2-Peptide-Vaccine.aspx (http://www.oncology.tv/Videos/TabId/79/VideoId/474/ASCO-2013-Elizabeth-A-Mittendorf-MD-PhD-HER2-Peptide-Vaccine.aspx)

The interview of Dr. Mittendorf, Assistant Professor, Department of Surgical Oncology, Division of Surgery, The University of Texas MD Anderson Cancer Center, gave an overview of this year's ASCO presentations on AE37, as well as where the breast cancer vaccine fits into the field of cancer immunotherapy. She noted that cancer immunotherapy in general was much more in the limelight at this year's conference. She described the two distinguishing features of AE37 that set it apart from other types of cancer vaccines. Firstly, the vaccine is designed to stimulate CD4+ T helper cells, which are key in generating a more robust anti-tumor immune response. Secondly, the vaccine includes a proprietary modification that increases its potency. The studies that were part of this year's ASCO meeting confirm these unique properties. Dr. Mittendorf was also noted that this vaccine addresses patients with any level of HER2 expression, unlike other HER2-targeted therapies. Currently, patients with low HER2 expression represent a patient population of significant unmet need (representing 50% of all breast cancers).

The updates this year built upon interim results of the Company's controlled, randomized Phase IIb clinical trial of AE37 presented at last year's ASCO meeting. Those presentations demonstrated a clear trend toward reduced relapse in breast cancer patients who had received AE37. One of the studies this year showed that while some patients developed a hypersensitivity reaction (urticarial response), they appeared to have a stronger all-around immune response to the AE37 vaccine. Interestingly, no relapses have been observed in this population of patients. A second presentation demonstrated that repeated AE37 boosters could be safely given to patients to further augment and extend the initial anti-tumor immune response observed with AE37.

The primary efficacy analysis of Phase IIb data from the Antigen Express breast cancer study is expected prior to the end of 2013. Mark Fletcher, Generex President & Chief Executive Officer, commented: "Based on the outstanding interim results announced at ASCO 2012, we are looking forward to qualitatively similar results with greater statistical robustness when data is evaluated later this year, which will leave Antigen Express well-positioned to secure a partnership for a Phase III trial." Antigen Express has been encouraged by the US Food and Drug Administration to submit a protocol for the Phase III trial, which the Company is in the process of preparing under the auspices of a Special Protocol Assessment (SPA), whereby the FDA declares the design, clinical endpoints, and statistical analyses acceptable for FDA approval.

Finally, Dr. Mittendorf pointed to the possible real benefit of combining AE37 with other agents, such as immune checkpoint inhibitors. In particular, inhibitors of PD-1 (programmed cell death protein 1) or CTLA-4 (Cytotoxic T-Lymphocyte Antigen 4) have been shown to essentially take the brakes off the immune system, allowing it to more effectively combat tumor cells in a general way. As AE37 activates the immune system to specifically attack tumor cells, essentially "stepping on the gas", it is an exciting hypothesis to try combining them. It should be noted, however, that patients treated with AE37 alone also appear to have "taken the brakes off" the immune system to an extent.

http://www.antigenexpress.com/news_release.asp?NewsID=194

[valleygirl]

Anyone know about the vaccine trial at the University of Pennsylvania with Dr. Czerniecki?

Denise

['lizbeth]

Note the Phase IIb says there is a clear trend of effectiveness with AE37, and in the robust responders there have been NO recurrences.

I don't know abou twhat works for your nurse SandraGA, but not having a recurrence works for me!

Valleygirl,

Here is my nurses' email for the Walter Reed AE37 & GP2 trial. You can email her and double check the status:

sherri.thomas.ctr@amedd.army.mil

['lizbeth]

6/5/2013 Generex Announces ASCO Presentations of AE37 Vaccine Data; Potential Leading Immunotherapy Option for Breast Cancer Patients

Treatment Regimen Targets All HER2 Expressing Patients, including those 50% of patients for whom no therapies are available

WORCESTER, Mass. and TORONTO, June 5, 2013 /PRNewswire/ -- Generex Biotechnology Corporation (www.generex.com) (GNBT) today announced two presentations showing the strengths of AE37 as a viable and promising treatment option for patients who have had breast cancer. The compound is being developed by its wholly-owned subsidiary, Antigen Express, Inc. (www.antigenexpress.com). The two presentations were made at the 2013 Annual Meeting of the American Society of Clinical Oncology (ASCO) held in Chicago from May 31 to June 4.

The two presentations focused on the safety and long-term immunity that can be achieved with AE37 treatment. The first presentation, "Risk factors for development of delayed urticarial reactions in the phase II trial of HER2 peptide vaccines plus GM-CSF versus GM-CSF alone in high-risk breast cancer patients to prevent recurrence", by Alfred Trappey et al, reports on cumulative safety data from the ongoing Phase II efficacy study. The maximum toxicities observed (allergic reactions) occur very infrequently, are easily managed, and have no long-term consequences. In addition, they were observed both in the control arm of the study as well as in the peptide arm, indicating that they were associated with the GM-CSF adjuvant rather than the peptide. The demonstrated safety of AE37 in this larger Phase II patient population confirms prior observations from earlier previous Phase I studies.

"I am very pleased with the progress Antigen Express has made over the years, particularly with the AE37 vaccine program," stated Richard Purcell, Chief Operating Officer of Antigen Express. "The AE37 data continues to track positively, as shown by the immunological and safety results presented in Chicago this week. Given the buzz, excitement, and significant focus on immunotherapy at ASCO this year, a big pharma partnership is a realistic expectation for the Company in the near future."

The second presentation extended results from a published 2013 ASCO abstract, ("Effect of immunization with Ii-Key modified HER2 (776-790) peptide vaccine (AE37) on immunologic responses in prostate cancer patients", by Sonia Perez et al) showing that AE37 induced immunological responses for longer time periods than have been observed with any other peptide vaccines used for breast cancer. In particular, the recent presentation "Booster inoculations of the AE37 peptide vaccine enhance immunological responses in a phase II study", by Eleftheria Anastasopoulou et al, showed that administration of AE37 as a booster for up to two years after the initial therapy further increased the level of specific anti-tumor immunity that could be observed in patients. Not only can the specific immune response be maintained but is even augmented by subsequent dosing.

The strong safety profile and superior immunogenicity set AE37 apart, both from other types of immunotherapy as well as other peptide immunotherapies targeting breast cancer. Combined with highly encouraging interim results, showing a reduction of relapse in patients treated with AE37 in a controlled, randomized Phase II efficacy trial, these latest studies support ongoing plans the Company has for a pivotal Phase III registration trial.

"Several distinct products are being developed with the Antigen Express Ii-Key technology and are at various stages of development," said Joe Moscato of Company consultant Seahawk Capital Partners, Inc. "Our attendance at ASCO 2013 gave Antigen Express the opportunity to initiate and continue discussions with multiple interested prospective big pharma partners and collaborators. The different products have applicability in diseases such as breast cancer, prostate cancer, ovarian cancer, influenza, and HIV. Interim data from October of 2011 suggested efficacy in our AE37 breast cancer vaccine, enhanced with our proprietary Ii-Key/HER2 antigen hybrid, has helped to validate Antigen Express' Ii-Key technology overall." Mr. Moscato went on to say: "The Ii-Key hybrid technology allows tumor-associated or foreign antigens, like viral antigens, to potently enhance the immune system's ability to recognize and destroy cancerous or virus-infected cells bearing any of the targeted antigens, as well as generate immunological memory. We are committed to finding alliances and partners to work together on the best clinical trial programs for each distinct product and, as the end of this year approaches, and new data is unveiled in our late-stage Phase IIb breast cancer trial, we are looking to have sufficient positive data to attract and finalize key partnerships and collaborations."

['lizbeth]

http://www.clinicaltrials.gov/ct2/results?term=breast+cancer+vaccines+her2&recr=Open&no_unk=Y

I see about 14 vaccine trials on clinicaltrials.gov

The PRESENT trial has only a 30 day window, and is only for lower expressors. That is trial #10 on the list. Perhaps a Phase II is still open at some locations. E75 is showing about a 43% reduction in recurrence rates.

I'm only familiar with AE37, E75, and GP2 (personal experience) vaccines. I see several new vaccines in a Phase I at one location. So if they are close, or you are willing to travel they could be possibilities.

If you are HLA-A2+ you should be eligible for the GP2, and according to clinicaltrials.gov - it is still in PhaseII and open.

I don't know about the Pennsylvania location vaccine, but would be eager to learn more about it. It might have come up before, but I don't recall.

There must be an opportunity for a vaccine trial for you. Totally worth it with the lowered recurrence rates.

[valleygirl]

Thanks lizbrth for all the info! penniesinaction.org this is the website where I found the info but can't find on the clinical trial pages.

['lizbeth]

http://www.ncbi.nlm.nih.gov/pubmed/22252842

Oh the pennies in action has been discussed before. I've forgotten the details but here is a journal article in pub med.

[Catia]

hi.
I am also in the GP2 arm of the trial due to having tested HLA2-positive,. I am enrolled at MD Anderson in Houston and as far as I know they are still looking for participants for it.

['lizbeth]

I asked the San Antonio Med Ctr nurses for the latest status of the clinical trials and here is my understanding of what is open for Her2 3+ (which is us, the Her2+++).

Walter Reed Vaccine trial:

"If a patient is HER2 3+ and HLA A2+ then she would qualify for the study. If she is Her2 3+ and HLA A2-she would NOT qualify for the study. Don't forget there are several other inclusion/exclusion criteria that she may have not met. Also, there are only 3 sites open to enrollment at this time due to the trial being almost fully enrolled and Walter Reed is not one of them. It is us at SAMMC, MD Anderson in Houston and I can't remember the 3rd at this time, but I will ask and let you know.

At this time you can still enroll for AE37 at MD Anderson. They are looking to close the trial to enrollment by the end of the year." (this is the Phase II HER2 3+ HLA A2- group).

So it appears that the "not qualifying" is based on full enrollment at specific sites.

[Sandra in GA]

Hey, 'lizbeth! No recurrance is what I am all about!!!

When I had my scare in Dec. with a couple of spots on my right lung, I called my study nurse and she emphatically stated she was sure they were nothing ~ and she was right!

Sandra

['lizbeth]

Sandra you've been quiet lately. Is it flower season?

[valleygirl]

anyone doing these....NCT00195091 or NCT00393783

['lizbeth]

Were you diagnosed as Stage III or Stage IV?

NCT00393783: Xenogeneic HER2/Neu DNA Immunization for Patients With Metastatic and High Risk Breast Cancer: A Phase I Study to Assess Safety and Immunogenicity

Eligibility Criteria
Breast cancer patients with AJCC Stage III or metastatic (AJCC Stage IV) disease that over-express HER2 will potentially be eligible for this trial. Patients may have measurable disease, evaluable disease or be without evidence of disease. They may be receiving hormonal therapy and they may have already received trastuzumab (Herceptin) or be receiving trastuzumab during this study.
Inclusion Criteria:
Patients must have ALL of the features listed below:


AJCC Stage IV breast cancer (histologically confirmed) with no evidence of disease or stable disease. Patients may be either off therapy or on hormone therapy and/or trastuzumab.

OR AJCC Stage III breast cancer < or = to 36 months post completion of adjuvant therapy.


Pathology slides must be reviewed by the Department of Pathology at MSKCC.



HER2 over-expression by FISH or by staining 3+ on immunohistochemistry in either the primary or metastatic tumor.



Karnofsky performance status > or = to 80%.



Patients must have recovered from the toxicity of any prior therapy, and not received major surgery, radiation therapy, or chemotherapy for at least 4 weeks prior to entry into the trial. (Ongoing hormonal therapy and/or trastuzumab administration is permitted.)



Age > 18 years

['lizbeth]

NCT00195091
Phase II Study of Tetrathiomolybdate (TM) in Patients With Breast Cancer


Eligibility

Ages Eligible for Study: 18 Years and older Genders Eligible for Study: Female Accepts Healthy Volunteers: No Criteria
Inclusion Criteria:


Patients must have histologically confirmed breast malignancy that is:


High risk stage II breast cancer (≥4 positive lymph nodes),
Stage III breast cancer, including inflammatory breast cancer
Stage IV breast cancer in a complete remission (bone only not allowed unless the bone scan is normal).


The patient must have had what is considered standard adjuvant systemic therapy that may include chemotherapy, hormonal therapy and radiation therapy. They may have undergone high dose chemotherapy with stem cell support as part of their therapy in the adjuvant or metastatic setting. The patient is allowed to continue to take adjuvant hormonal therapy (for high risk adjuvant patients) and may be allowed to be on hormonal consolidation post transplant if they are without evidence of disease after a transplant for metastatic breast cancer. The patient cannot be actively receiving chemotherapy or any biologic agent to treat their breast cancer.
Six weeks must elapse from last chemotherapy or radiation therapy.
The patient must have had definitive surgical therapy for their breast cancer. This includes lumpectomy and axillary dissection or mastectomy.
No clinical or radiologic evidence of disease after surgery and/or systemic treatment (by CT scan of chest, abdomen and pelvis and bone scan or PET scan prior to enrollment)
Because no dosing or adverse event data are currently available on the use of TM in patients < 18 years of age, children are excluded from this study.
ECOG performance status < 1
Life expectancy of greater than 3 months.
Patients must have normal organ and marrow function as defined below:


hemoglobin >10mg/dL
absolute neutrophil count >1,500/mL
platelets >100,000/mL
total bilirubin < 1.5 x normal institutional limits
AST(SGOT)/ALT(SGPT) <1.5 X institutional upper limit of normal


Erythropoietin alpha is allowed, as indicated.
Bisphosphonates may be administered if they were started prior to starting this therapy.
Patients must be on stable medical therapy for at least 2 weeks if they are being treated medically for their peripheral neuropathy.
Concurrent herceptin is not allowed.
The effects of TM on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Ability to understand and the willingness to sign a written informed consent document.

['lizbeth]

NCT00195091

http://www.annieappleseedproject.org/oldsite/ep.yimg.com/ca/I/annieappleseedproject_2206_8547904.gif

Email from Advocate Amy B. October 2008:

I would like to share this clinical trial with the advocate community and make sure that everyone who is eligible knows about the trial.

Dr. Vahdat is my oncologist and I would encourage anyone interested to get in touch with her directly. I am including the general description of the trial and I am sure she will answer any specific questions. This is a general and very basic overview.

A Phase II study of Tetrathiomolybdate (TM) in women with breast cancer at moderate to high risk of relapse.

Linda Vahdat, MD

NCI.gov clinical trials #:NCT00195091

Eligible patients: Patients with Stage 3 breast cancer or Stage 4 breast cancer with no evidence of disease who have completed what is considered standard therapy for their cancer. Hormonal treatments are allowed. Concurrent trastuzumab is not allowed.

Trial: The goal of this clinical trial is to try to keep breast cancer cells in a dormant state by depleting copper, an essential component to helping them come out of dormancy.

Background information: The observation that has always puzzled researchers is why a patient can relapse with cancer after many years of being cancer-free.

Similarly, in patients whose cancer has spread, why can a treatment that removes all visible traces of breast cancer recur again? Multiple lines of evidence point to the fact that cancer cells lie dormant awaiting for a "signal" to start growing. It is believed that a crucial part of this "signal" is the ability to recruit blood vessels to the dormant tumor cell so that it can lay down blood vessels to feed itself and spread.

This signal has been termed the "angiogenic switch". There are many compounds being tested that might affect the turning on of this "angiogenic switch". These are called anti-angiogenesis agents. It is well known that copper plays an essential role in the angiogenic process. People who have breast cancer tend to have higher copper levels than those who do not.

We will be studying controlled copper depletion, a process where you lower the copper level in the body to the level where normal cellular processes can take place but tumor angiogenesis cannot. This process has been tried with patients with advanced cancer and the preliminary results support the hypothesis of this clinical trial.

Practical information: This trial is being conducted at

Weill Medical College of Cornell University by the Breast Cancer Research group.

This trial consists of taking TM pills ( an anti-copper agent) for two years. For the first 6 weeks, one must visit our office once every 2 weeks for 3 visits. This is to make sure that the copper levels do not go too low. After that, a once a month visit is required.

If you would like more information please contact:

The office number until November 1: 212-746-7332 then 212-821-0644

Diana Donovan, ANP: donovdi@med.cornell.edu

Marta Cobham, RN (research nurse): mac2034@med.cornell.edu

Linda Vahdat, MD: ltv2001@med.cornell.edu



This trial is supported by the Susan B Komen for the Cure, Breast Cancer Alliance of Greenwich and the NY Community Trust.

Remember we are NOT Doctors and have NO medical training.

[Sandra in GA]

'lizbeth you know me too well! Even though it is still summer, we (ha, that should read I) have already started gibbing weekly to get blooms for the October and November shows. We have already been invited to judge four shows and they expect blooms from us.

You know these vaccine trials are near and dear to my heart. If anything can get my attention, these can. I do go down to Mayo the 22nd for my next check up with scans etc. If I get a clean bill, it will be FIVE years. That is really hard to believe. I will let everyone know if I reach that mark!

Lots of love,
Sandra

['lizbeth]

I know nothing about gibbing.

Can you believe 5 years? I'm hitting 6 years at Thanksgiving.

That annoys me that a nurse would state something in an ongoing clinical trial is "not effective". That is seriously defeating the purpose of a blinded study.

I love the one vaccine trial said that robust responders have experienced a zero recurrence rate. I had a huge local response. So am hoping the zero recurrence rate is a long term trend in all the vaccine trials.

Stay well, and happy gibbing.

[NEDenise]

Denise -
Dr. C was my surgeon at Penn. His study was only for early stage BC so I didn't qualify. I'm not sure if they're still enrolling or not.

Denise

[valleygirl]

Denise,

I was talking to a women from Pennies for action and she was thinking I would qualify, I'm 3C.
I was wonder why it wasn't sponsored by the NIH. I'm so hoping I'm a canidate for this one since I wasn't able to join the vaccine trial at Walter Reed. I'm only about 2 hours from Philly. Looks like I might qualify for the one in New York but it's phase 1 and 5 1/2 hours away, not sure how I could work that around my work schedule.
Hope your doing well Denise, I always read your posts and keep you in my prayers.
Kind regards,
Denise

[NEDenise]

Hi
Dr C is the one who told me I didn't qualify as a 3c lady myself. If you find out that things have changed... would you please let me know. A vaccine trial... that close to home... would be a dream come true!
Be well, name twin! And, thanks so much for the prayers!
:) Denise

[valleygirl]

Denise,
You may want to look into NCT00393783. It's in phase 1 and for stage III & IV. It's in New York. I have an appointment on Sept. 18th and plan to take the train in to the city. It makes me a little nervous that it is only in phase 1, but it looks promising. After talking with them it looks like I only have to go on weeks 1, 4,7 and 13, so I should be able to do schedule this around work.

Denise

[NEDenise]

Hey!
Thanks for the heads-up! I read over the criteria, and it seems that until I'm off steroids, Avastin, and Lapatnib... I can't do this one.

But I hope it works out for you!
Denise