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Hello and copper depletion

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123Donna View Drop Down
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    Posted: Jan 29 2018 at 7:46am

A phase II study of copper-depletion using tetrathiomolybdate (TM) in patients (pts) with breast cancer (BC) at high risk for recurrence: Updated results.

Background: The tumor microenvironment (TME) plays a critical role in the spread of tumors. Bone marrow derived VEGFR2+endothelial progenitor cells (EPCs) and copper-dependent lysyl oxidase (LOX) are key in tumor progression. We hypothesized TM-associated copper depletion inhibits tumor metastases by reducing the number of EPCs and other copper dependent (CD) processes in the pre-metastatic niche. These results are an update with longer follow-up. Methods:Phase II study of BC pts at high risk for recurrence, defined as node+ triple negative (TNBC), stage 3 and 4 with no evidence of disease (NED) were enrolled on a trial of CD with TM. Ceruloplasmin (Cp) levels were maintained between 8-16 mg/dl for two years with an extension phase or until relapse. The primary endpoint was change in EPCs measured by flow cytometry before and during treatment. Secondary endpoints included tolerability, safety, PFS and LOXL-2 levels. Results: 75 pts received 2650 cycles of TM on primary and extension study. The median age is 51 years (range 29-66). Forty-five pts have stage 2/3 BC and 30 with stage 4 NED. TNBC pts were 48% and 40% of pts are stage 4 NED. Median Cp level decreased from 28 to 16 (p < 0.0001) after one cycle. Copper depletion was most efficient in TNBC where Cp levels dropped from 23.5 to 13 after one cycle. TM was well tolerated with grade 3/4 toxicities including: reversible neutropenia (2.3%), febrile neutropenia (0.04%), fatigue (0.2%). Five-year analysis showed a decrease in EPC’s (p = 0.004) and LOXL-2 (p < 0.001). At a median follow-up of 6.9 years, the EFS for 75 pts is 75.6%. PFS for 36 pts with TNBC is 79.2%. EFS for stage 2/3 TNBC is 90% and for stage IV TNBC is 66.7%. Conclusions: TM is safe, well tolerated and appears to affect multiple components of the TME creating an inhospitable environment for tumor progression especially in high risk patients such as TNBC. Randomized trials are warranted, especially in patients at high risk for relapseClinical trial information: UL1TR000457.


DX IDC TNBC 6/09 age 49, Stage 1,Grade 3, 1.5cm,0/5Nodes,KI-67 48%,BRCA-,6/09bi-mx, recon, T/C X4(9/09)
11/10 Recur IM node, Gem,Carb,Iniparib 12/10,MRI NED 2/11,IMRT Radsx40,CT NED11/13,MRI NED3/15

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123Donna View Drop Down
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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Apr 18 2016 at 10:42pm
There is a Phase II Trial that is ongoing, but currently not recruiting.  The best chance is you can't find a trial to participate is see if your oncologist will prescribe it off-label.  Your onc could contact the principal investigator to find more information about the study.  






DX IDC TNBC 6/09 age 49, Stage 1,Grade 3, 1.5cm,0/5Nodes,KI-67 48%,BRCA-,6/09bi-mx, recon, T/C X4(9/09)
11/10 Recur IM node, Gem,Carb,Iniparib 12/10,MRI NED 2/11,IMRT Radsx40,CT NED11/13,MRI NED3/15

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Post Options Post Options   Thanks (0) Thanks(0)   Quote mommak Quote  Post ReplyReply Direct Link To This Post Posted: Apr 18 2016 at 7:22pm
Hello. I am in Canada and have had a recurrence two weeks ago of my TNBC. Have always wondering about copper depletion trials. What is the best way to get info regarding this?? Am I eligible here in BC Canada? 

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123Donna View Drop Down
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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Apr 09 2015 at 2:42pm
"The most recent results from Phase 2 trials are encouraging. This is for a Phase 2 study of Xtandi (enzalutamide) as a single agent for AR+ triple negative breast cancer, enrolling 42 patients in Stage 1 and 118 in total. With 26 of the 42 enrolled women testing AR+ positive (to any degree), 42% met the primary endpoint of complete or partial response, or 16 week of stable disease. The data is good enough to reject the null hypothesis (that Xtandi is ineffective), and full data should be in before the end of 2015."
DX IDC TNBC 6/09 age 49, Stage 1,Grade 3, 1.5cm,0/5Nodes,KI-67 48%,BRCA-,6/09bi-mx, recon, T/C X4(9/09)
11/10 Recur IM node, Gem,Carb,Iniparib 12/10,MRI NED 2/11,IMRT Radsx40,CT NED11/13,MRI NED3/15

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Post Options Post Options   Thanks (0) Thanks(0)   Quote wwjdJanice Quote  Post ReplyReply Direct Link To This Post Posted: Jan 21 2015 at 8:55pm

I am still in initial TNBC tx (have taken 4 rounds AC & 5 rounds Taxotere) and currently in 3rd of 7 weeks of radiation (no chemo), I had recurrence 3 months after initial double mastectomy while on AC.   I learned of tetrathiomolybdate (TM) from this website and numerous times tried to contact Dr. Linda Vahdat who is running TM trial in New York by phone : 212-821-0644 and email : ltv2001@med.cornell.edu but never got a reply.  Yesterday I got a 2nd opinion from a Breast Oncologist and showed her Dr. Vahdat's clinical study and she called and talked to Dr. Vahdat today (doctors have a way of getting thru to other doctors).  TM is commercially available to treat Wilson's Disease but is in trial as a cancer tx but if your doctor is willing to monitor you closely and willing to prescribe it then you can get it today outside of the trial but cost of drug likely will not be covered by insurance.  My oncologist is willing to prescribe it to me outside the trial and I guess I will pay for the drug out of pocket :) best of luck to you, in my prayers :) Janice

TNBC (ER-/PR-/HER2-), BRCA1&2-, AR- (Androgen Receptor-)
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Jojocat Quote  Post ReplyReply Direct Link To This Post Posted: Jan 08 2015 at 10:00pm
hI Natasha:
       Last summer Dr. v told me that most women stopped taking the medication after certain period of time probably around 2 to 4 years, they are still fine. Only those stage 4 ladies have to keep taking the drug.
        Love
Joanie
    
DX 10/24/2013 Between stage 2b and 3a. 2 big nods 1.8cm a d 1.4 cm. tumor 4.5 cm.   35 years old. 11/15/2013. AC/T
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Post Options Post Options   Thanks (0) Thanks(0)   Quote math666 Quote  Post ReplyReply Direct Link To This Post Posted: Jan 08 2015 at 9:53pm
the idea of copper depletion in starving cancer to let it standstill came out early.


Copper May Play Role In 'Starving' Cancer To Standstill

Date:
February 12, 2004
Source:
Texas A&M University - Agricultural Communications
Summary:
Starving a cancerous tumor of its blood supply might stop its growth while other treatments aim to kill it. "Nutrient depletion" is how Dr. Ed Harris, Texas A and M University biochemist, describes the process in the February issue of Nutrition Reviews.


LLEGE STATION -- Starving a cancerous tumor of its blood supply might stop its growth while other treatments aim to kill it.



"Nutrient depletion" is how Dr. Ed Harris, Texas A&M University biochemist, describes the process in the February issue of Nutrition Reviews. His article traces how independent studies around the world led researchers to consider copper, a trace mineral in the human diet, for its potential in controlling cancerous growth.

"The idea is to deprive a selective nutrient from being active in tumors. In research so far, there is no indication of anyone being cured, but tumors have stopped growing," said Harris, who is an expert on the relation of copper in various human diseases. "Ultimately, nutrient depletion may be used in combination with other treatments."

The role of copper to control cancer traces its beginnings to Dr. Judah Folkman of the Harvard School of Medicine, whose pioneering work in angiogenesis, or the formation of new blood cells, began about 40 years ago but only since the 1980s have been recognized in medical research. Folkman first launched the idea that if a tumor is to grow, it must have its own blood supply, Harris said.

"For one increment of tumor growth, Folkman said, there also must be one increment of capillary or vessel growth," Harris noted. "And that was shocking."

But that astonishing notion led some researchers to explore ways to stop the capillary growth that nourished tumors. About the same time, other researchers were examining the role of copper in forming blood vessels.

To test a theory of whether copper was instrumental in blood vessel formation, scientists needed an organ that had none. They found that in the cornea of rabbit's eyes. Small pellets of copper were implanted into rabbit corneas, and soon vessels formed around them, the biochemist noted.

Then came the idea that if copper was needed to create blood vessels, and if blood vessels were necessary for tumor growth, what would happen if copper were regulated?

"Studies looked at inoperable cancer -- cancer that couldn't be touched as in deep in the brain," Harris said. "There was some impact, but there also was fear that perhaps such treatment would stop the cancer but cause a serious copper-deficient disease."

Yet another study, by George Brewer in Michigan, looked at the use of tetrathiomolybdate, which is normally given to people with a copper overload, Harris said.

Brewer got permission to try the anti-copper drug on terminal cancer patients for six months in an attempt to lower their copper levels and thus stop the blood-vessel growth that was feeding the tumors. "Five of the six people who received the drug showed no further growth in their tumors after one year," Harris noted. "And it was found that cancers of the muscle don't respond to this treatment. But even that is encouraging because it narrows down and gives researchers a place to look to see what is different about cancers of the muscle and blood vessel supplies."

Harris said every drug ever made has been tested against cancer, but nutritional intervention may lead to a different approach in combination with other medical treatments.

Story Source:

The above story is based on materials provided by Texas A&M University - Agricultural CommunicationsNote: Materials may be edited for content and leng

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rosewater View Drop Down
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Post Options Post Options   Thanks (0) Thanks(0)   Quote rosewater Quote  Post ReplyReply Direct Link To This Post Posted: Jan 05 2015 at 10:46pm
Thanks for the information Jojocat ! Did the Dr. mention how long she recommends doing the copper treatment?
Very interested,
Natasha
DX IDC TNBC 03/14 age 40, Stage 1, Grade 3, 2cm, 0/4Nodes, lumpectomy 04/14, DD A/C x4, Taxol x12, Carboplatin x2, BMX 10/14, rads x28 Finished Jan 14/15, Oopherectomy Jan 29/15 BRCA 2+
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Jojocat Quote  Post ReplyReply Direct Link To This Post Posted: Jan 05 2015 at 10:36pm
Hi all:
      I just sent math666 a private message about the clinical trial. I haven't been posting recently because I wrap my life back a little bit and try to pretend not having cancer in my mind. Yes, I am still taking TM. The drug protects my mind and keep me up. I try not to have fear. Life is wonderful everyday.
      I can't answer the question about the trial because paper works might take forever.
      Dr. v told me that the survival rate was 100 percent, if the cancer does not come back in one year of the copper depletion treatment. The average following was 7 years. Isn't it amazing?
      I was comparing entering the trial and paying out of our own pocket. I found that the cost is almost the same. I visited the doctor through Skype and did not have to travel and take a day off. Of course, it is better to be in the trial but timing is very important. No treatment is 100 percent working. Copper deletion does not kill, cancer kills.   Timing is very important.
      Love you all
      Joanie.
DX 10/24/2013 Between stage 2b and 3a. 2 big nods 1.8cm a d 1.4 cm. tumor 4.5 cm.   35 years old. 11/15/2013. AC/T
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Sharon E Quote  Post ReplyReply Direct Link To This Post Posted: Dec 30 2014 at 9:56pm
I have been taking prenatals ever since I was first diagnosed.  I just checked the bottle and it does not list copper at all. Does that guarantee it is not in there?  I don't need to make my odds worse:)
3/12 Stg2b TNBC, IDC, Grade 3, age 49, 3 nodes, BRCA-,4/12-8/12 AC/T, 9/12 MBX no rads
10/14 Recur chest, BM, biopsy removed tumors, Gem/Carb 4,1/15, NED 1/15, Rads, 7/15 BM, Gem/Carb 4
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Post Options Post Options   Thanks (0) Thanks(0)   Quote math666 Quote  Post ReplyReply Direct Link To This Post Posted: Dec 30 2014 at 9:42pm
Thanks a lot, Dona!

I will study the clinical trials website.

math666
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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Dec 29 2014 at 11:16pm
Math666,

So far there is no Phase III study listed on the clinical trials website.  



At the Weill Cornell website, it says the Phase II study is closed to enrollment, but no mention of Phase III.




DX IDC TNBC 6/09 age 49, Stage 1,Grade 3, 1.5cm,0/5Nodes,KI-67 48%,BRCA-,6/09bi-mx, recon, T/C X4(9/09)
11/10 Recur IM node, Gem,Carb,Iniparib 12/10,MRI NED 2/11,IMRT Radsx40,CT NED11/13,MRI NED3/15

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Post Options Post Options   Thanks (0) Thanks(0)   Quote math666 Quote  Post ReplyReply Direct Link To This Post Posted: Dec 29 2014 at 10:46pm
Could someone please update the phase III status of Copper Depletion Therapy clinical trial ?

If the phase III has been approved by FDA, that means a lot .

Thanks very much !

math666

-------------------------------------

Jojocat Posted: 04 May 2014 at 11:09am

I just spoke to Dr Vahdat who is in charge of the clinical trial. The trial is curently closed for phase 2. Phase 3 is approved by FDA already. It is coming soon maybe this fall of next year. If you call them they will take your information and let you on later. The trial is free absolutely. 

http://forum.tnbcfoundation.org/copper-depletion-trial-phase-ii-results_topic11974_post121207.html?KW=#121207


CBK Posted:18 Sep 2014 at 10:04am

By the way, I was at Cornell yesterday and was told that the new study has not been approved yet and there's no waiting list yet. They're hopeful that it may begin in the spring, but don't know.

http://forum.tnbcfoundation.org/hello-and-copper-depletion_topic12196_post122920.html?KW=#122920

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Post Options Post Options   Thanks (0) Thanks(0)   Quote TriplePositiveGirl Quote  Post ReplyReply Direct Link To This Post Posted: Sep 18 2014 at 12:16pm
Hi CBK -

I know what you mean! I was never a big supplement taker until "cancer" came into my life. I now take curcumin (anti-inflammatory), fish oils, Vit D3, Bitter Melon, Bee Propolis, B12 and Mushroom Supplements fairly regularly. I stopped taking multi-vitamins a while back even though the brand I was taking had no copper in it. 

I have learned a lot about nutrition and supplementation since having cancer. At least something good came from something bad.

I would be very interested to hear about your copper deletion experience as time goes on. I find this study very fascinating - and I hope it continues to benefit those involved in the study.

Best Wishes,
Lisa
Diagnosed Jan 2010; Stage IIa, grade 2, 3.2cm in rt. breast, no nodes and BRCA-. 4 cycles Carbo/Gemzar 3/10; Lump 6/10; 2 cycles carbo/gem after surgery 8/10; 35 Rads finished 12/1/10. NED.
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Post Options Post Options   Thanks (0) Thanks(0)   Quote CBK Quote  Post ReplyReply Direct Link To This Post Posted: Sep 18 2014 at 10:04am
Jojocat, all I know is that my copper level hovers around 15 naturally and most people are at 28-45. (I'm not sure whether we're talking about the same units but that's the extent of my knowledge.) Yes, why.

By the way, I was at Cornell yesterday and was told that the new study has not been approved yet and there's no waiting list yet. They're hopeful that it may begin in the spring, but don't know.

There is a doctor in NYC who is not part of the study who administers copper pills; Cornell refers people to him but they didn't give me his name for this purpose because they said they don't want him to be inundated.  So I guess you could email Cornell and nicely ask for the referral?

TriplePositiveGirl - you are right. We are advised NOT to take multivitamins. Instead, I take what I jokingly call A through F every day: aspirin, B-12, C, D, E, and fish oil. And the copper pills. I was so anti-supplements before cancer that I never even took pre-natal vitamins, reasoning that I eat well and get every nutrient I need naturally. Now I swallow a whole batch at once. Funny how life changes.

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Post Options Post Options   Thanks (0) Thanks(0)   Quote Jojocat Quote  Post ReplyReply Direct Link To This Post Posted: Sep 17 2014 at 10:45pm
CBK:
   How low was your cooper level? I was 22mg/ul. I had the same question you had that why did I get cancer if I was already low. I am getting 40 mg per day too. But dr. Vahdat told me that I can take 100 mg. why do you only take 40?

Rebecca:
    Thank you for sharing the new info with me. I am going to call them to get a back up.   I am not too happy with dr . Chang.
    Joanie.
DX 10/24/2013 Between stage 2b and 3a. 2 big nods 1.8cm a d 1.4 cm. tumor 4.5 cm.   35 years old. 11/15/2013. AC/T
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Post Options Post Options   Thanks (1) Thanks(1)   Quote TriplePositiveGirl Quote  Post ReplyReply Direct Link To This Post Posted: Sep 17 2014 at 7:06pm
One thing to be aware of if any of you take multi-vitamins: make sure to read the labels because copper can be an ingredient found in several brands of multi-vitamins. Life Extension makes a safe multi vitamin without copper. 

Lisa
Diagnosed Jan 2010; Stage IIa, grade 2, 3.2cm in rt. breast, no nodes and BRCA-. 4 cycles Carbo/Gemzar 3/10; Lump 6/10; 2 cycles carbo/gem after surgery 8/10; 35 Rads finished 12/1/10. NED.
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Post Options Post Options   Thanks (0) Thanks(0)   Quote 8malik Quote  Post ReplyReply Direct Link To This Post Posted: Sep 17 2014 at 6:26pm
CBK Thanks for the information
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Post Options Post Options   Thanks (0) Thanks(0)   Quote CBK Quote  Post ReplyReply Direct Link To This Post Posted: Sep 16 2014 at 10:50pm
8malik, see the post above yours by 123Donna. She provides links to information about the trial I'm in at Cornell Medical Center with Dr. Linda Vahdat.

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Post Options Post Options   Thanks (0) Thanks(0)   Quote 8malik Quote  Post ReplyReply Direct Link To This Post Posted: Sep 16 2014 at 8:21pm
CBK I haven't heard of a clinical trial with copper depletion?  Mine is a drug that boosts your immune system to attack the cancer.
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