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'lizbeth · 08-13-2013, 08:57 AM

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.

08-13-2013, 08:57 AM	#22
'lizbeth Senior Member Join Date: Apr 2008 Location: Sunny San Diego Posts: 2,214	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.