Re: vaccine trial
 

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

Re: vaccine trial
 

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.

Re: vaccine trial
 

NCT00195091

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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.

Re: vaccine trial
 

'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

Re: vaccine trial
 

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.

Re: vaccine trial
 

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

Re: vaccine trial
 

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

Re: vaccine trial
 

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

Re: vaccine trial
 

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

Re: vaccine trial
 

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