New Posts New Posts RSS Feed - Copper depletion trial - phase II results
  FAQ FAQ  Forum Search   Events   Register Register  Login Login

Copper depletion trial - phase II results

 Post Reply Post Reply Page  <1 456
Author
123Donna View Drop Down
Senior Member
Senior Member
Avatar

Joined: Aug 24 2009
Location: St. Louis, MO
Status: Offline
Points: 13509
Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Jul 21 2015 at 7:40am
Sharon,

This is the criteria for the current study:

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

http://clinicaltrials.gov/ct2/show/NCT00195091
Criteria

Inclusion Criteria:

  1. 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).
  2. 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.
  3. Six weeks must elapse from last chemotherapy or radiation therapy.
  4. The patient must have had definitive surgical therapy for their breast cancer. This includes lumpectomy and axillary dissection or mastectomy.
  5. 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)
  6. 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.
  7. ECOG performance status < 1
  8. Life expectancy of greater than 3 months.
  9. 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
  10. Erythropoietin alpha is allowed, as indicated.
  11. Bisphosphonates may be administered if they were started prior to starting this therapy.
  12. Patients must be on stable medical therapy for at least 2 weeks if they are being treated medically for their peripheral neuropathy.
  13. Concurrent herceptin is not allowed.
  14. 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.
  15. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  1. Patients who have had chemotherapy or radiotherapy within 6 weeks prior to entering the study.
  2. Objective evidence of breast cancer.
  3. Carcinomatous meningitis or history of neoplastic parenchymal brain disease.
  4. Serum creatinine >1.5 x normal.
  5. History of allergic reactions attributed to compounds of similar chemical or biologic composition to TM.
  6. Pregnant women are excluded from this study because TM has the potential to have teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with TM, breastfeeding should be discontinued if the mother is treated with TM.
  7. Because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with TM.



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

Back to Top
math666 View Drop Down
Senior Member
Senior Member


Joined: Dec 13 2014
Location: Houston,TX,USA
Status: Offline
Points: 105
Post Options Post Options   Thanks (0) Thanks(0)   Quote math666 Quote  Post ReplyReply Direct Link To This Post Posted: Jul 21 2015 at 3:44pm
Hope Trial Phase III will begin as soon as possible !!!
Back to Top
NICINS View Drop Down
Newbie
Newbie


Joined: Jul 23 2015
Location: WI
Status: Offline
Points: 1
Post Options Post Options   Thanks (0) Thanks(0)   Quote NICINS Quote  Post ReplyReply Direct Link To This Post Posted: Jul 23 2015 at 1:39pm
I am new to this so I apologize if I am out of place. Has one gone through any previous trials yet, if so did anyone have a copper IUD inserted during the trial? 

The reason I ask is because I am currently going through chemotherapy so I can't use hormone birth controls so one of my Drs told me to use the copper IUD... and then I see studies about copper depletion. Makes me hesitant about getting it put in me. 
Back to Top
jesshemee View Drop Down
Newbie
Newbie


Joined: Sep 03 2015
Location: Texas
Status: Offline
Points: 1
Post Options Post Options   Thanks (0) Thanks(0)   Quote jesshemee Quote  Post ReplyReply Direct Link To This Post Posted: Sep 03 2015 at 9:37pm
I had your same hesitation. My oncologist told me to find a non hormonal birth control, so I asked my gynecologist who suggested paragard (copper IUD). I asked my oncologist about it, and at first she said it was fine. I then pushed her further, mentioning the clinical trial, and she agreed that it might be best not to chance it... 

So now we are tracking ovulation... So far so good, but I've only had my period back for a few months since chemo ended.
Back to Top
praying2016 View Drop Down
Newbie
Newbie
Avatar

Joined: Apr 24 2016
Location: PARIS
Status: Offline
Points: 7
Post Options Post Options   Thanks (0) Thanks(0)   Quote praying2016 Quote  Post ReplyReply Direct Link To This Post Posted: Apr 24 2016 at 4:15pm
i would like to start taing TM before my cancer comes back.. any one with info if iy realy works (depleting cooper) and as a European can doctors in the US treating me with this if trial 3 isnt recuiting yet?
Dx 39
2 daughters 3 & 6
Ki67 70%
PCr
Dx 12/5/2015, IDC, Left, 4cm, Stage IIIA, Grade 3, 3/14 nodes, ER-/PR-, HER2-
Chemotherapy 12/13/2015
Surgery 3/15/2016 Lumpectomy
Radiation Therapy 5/15/2016
Back to Top
caregiver20 View Drop Down
Newbie
Newbie


Joined: May 10 2016
Status: Offline
Points: 32
Post Options Post Options   Thanks (1) Thanks(1)   Quote caregiver20 Quote  Post ReplyReply Direct Link To This Post Posted: May 10 2016 at 6:06pm
My wife has been on TM through an independent oncologist for about six months now. It took a while for her copper levels to decline (she as an avid vegetarian, and may have been taking in too much copper for the treatment to have an impact), but the numbers have since dropped. As of yet it's difficult to tell if it's had an impact - she has seen something of a progression since she went on it, but it may have slowed down the cancer's movement (difficult to say). 

This of course doesn't mean it won't work for others - my wife's TNBC is a beast, and seemingly nothing has yet worked for it. I'm hopeful that others will see better results, as research seems to show that it's promising. 

I'd also put in a plug for just purchasing the treatment on your own - my wife gets it through the Prescription Center, as someone else mentioned in this thread. It's not that expensive, and you don't need to wait for admittance to the trial. 
Back to Top
gordon15 View Drop Down
Senior Member
Senior Member


Joined: Jun 22 2015
Location: San Diego CA
Status: Offline
Points: 788
Post Options Post Options   Thanks (0) Thanks(0)   Quote gordon15 Quote  Post ReplyReply Direct Link To This Post Posted: May 10 2016 at 6:27pm
Caregiver: thanks for your imput and ideas, it means a lot, to me and others, I'm sure...
wife: IDC/Lobular Stage2B 2008 lumpectomy/TAC+rads
TNBC Stage 3A/w/metaplastic/squamous Nov2015 Carboplatin-Gemzar chemo/masectomy Taxolchemo+rads 4-16
PET scan stable 9-2016/ 1-2017
Back to Top
123Donna View Drop Down
Senior Member
Senior Member
Avatar

Joined: Aug 24 2009
Location: St. Louis, MO
Status: Offline
Points: 13509
Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: May 10 2016 at 11:28pm
Caregiver,

Thank you for sharing your wife's experience.  

Donna
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

Back to Top
caregiver20 View Drop Down
Newbie
Newbie


Joined: May 10 2016
Status: Offline
Points: 32
Post Options Post Options   Thanks (0) Thanks(0)   Quote caregiver20 Quote  Post ReplyReply Direct Link To This Post Posted: May 11 2016 at 3:01pm
You're welcome, Gordon and Donna. Our experience has run the gamut through clinical trials, chemos, alternative medicines, and eventually off-label medicines, so I have like I've learned a fair bit in the process. While as of yet we haven't figured out really how to stop her disease, hopefully some of the knowledge will help others!
Back to Top
 Post Reply Post Reply Page  <1 456
  Share Topic   

Forum Jump Forum Permissions View Drop Down

Forum Software by Web Wiz Forums® version 12.01
Copyright ©2001-2018 Web Wiz Ltd.