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Phase II Study of Purging of Circulating Tumor Cells (CTCs) From Metastatic Breast Cancer Patients

Phase 2
18 Years
55 Years
Not Enrolling
Breast Cancer, Metastatic Breast Carcinoma, Invasive Breast Carcinoma

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Trial Information

Phase II Study of Purging of Circulating Tumor Cells (CTCs) From Metastatic Breast Cancer Patients

Cyclophosphamide is designed to interfere with the multiplication of cancer cells, which may
slow or stop their growth and spread throughout the body. This may cause the cancer cells
to die. Carboplatin and thiotepa are designed to interfere with the growth of cancer cells
by stopping cell division, which may cause the cells to die. Mesna is designed to prevent
toxicities from cyclophosphamide. Granulocyte colony-stimulating factor (G-CSF or GCSF) is
designed to help your white blood count recover after transplant.

If you are found to be eligible to take part in this study, you will be given G-CSF twice a
day through a needle under the skin (subcutaneous injection), on Days 1-5. On Day 5, stem
cell collection will begin. You will have a catheter placed into a vein in your chest. A
central venous catheter is a sterile flexible tube that will be placed into a large vein
while you are under local anesthesia. Your physician will explain this procedure to you in
more detail, and you will be required to sign a separate consent form for this procedure.

If further shrinkage of tumor is needed, the doctor may use chemotherapy combined with G-CSF
described above. Your doctor will explain this procedure to you in more detail, and you will
be asked to sign a separate consent form for this procedure.

Blood will be removed from your body through the catheter and passed through a machine that
separates the stem cells from the other cells. The stem cells will be frozen for storage,
and the blood will be returned to your body. This 3-hour process is called apheresis. The
process will be done once a day for 1-6 days until enough stem cells are collected. Blood (
about 4 teaspoons) will be collected at the first Apheresis to have as a comparison sample
to check for any breast cancer leftover in the blood.

The collected blood cells will go through a filter to select out the blood stem cells and
the CTCs will be left behind.

Blood (about 2 tablespoons) will be drawn daily during peripheral blood stem cell

On Days 6, 5, 4, and 3 before the transplant, you will receive cyclophosphamide, mesna,
thiotepa, and carboplatin through a needle in your vein. Blood (about 2 teaspoons) will be
drawn for routine tests.

On Day 0, your stem cells will be transplanted. Stem cells will go through a device to
remove the breast cancer cells. If the bone marrow is collected because there was not enough
stem cells, researchers will not treat the bone marrow to remove breast cancer cells.
Collected breast cancer cells will be studied to understand the biological role of these
cancer cells.

After the transplant, G-CSF will be given through a needle under your skin until the white
blood cell count is normal for 3 days in a row.

Blood (about 2 tablespoons) will be drawn daily after the transplant while you are still in
the hospital. You are expected to remain in the hospital for 3 weeks. Once you are released
from the hospital, you will have blood (about 2 tablespoons) drawn for routine tests every
week until your cell counts recover.

Five (5) weeks after your transplant, if your doctor thinks it is needed, you will have
radiation therapy, hormonal therapy, or receive trastuzumab.

At Months 1, 3, 6, 9, 12, 16, 20, and 24 after the transplant, your complete medical history
will be recorded, and you will have a physical exam. You will have a chest X-ray and bone
scan. If your doctor thinks it is needed, you will have an x-ray of hot spots which are
areas that show positive on the bone scan. If your doctor thinks it is needed, you may have
a CT scan of the head, a mammogram, or a breast ultrasound performed. At Months 1 and 3
after the transplant, you will have a PET/CT scan. At Months 6, 9, 12, 16, 20, and 24 after
the transplant, you will have a CT scan of the chest and abdomen then as needed to check
the status of the disease. Blood (about 2 teaspoons) will be drawn to measure cancer markers
and CTCs.

While on study you must notify the doctor of any new drugs you are taking.

This is an investigational study. The transplant is not FDA approved. The drugs G-CSF,
cyclophosphamide, carboplatin, and thiotepa are all approved by the FDA and commercially
available. The CliniMACS device is not commercially available or FDA approved. The
CliniMACS device is being used in research only and will be provided free of charge. Up to
70 patients will take part in this study. All will be enrolled at M. D. Anderson.

Inclusion Criteria:

1. 18 to 55 years old

2. Metastatic breast carcinoma.

3. Histological confirmation of invasive breast carcinoma

4. Complete or partial response to pre-transplant standard-dose chemotherapy, or
hormonal therapy. For bone disease, stable disease (SD) is allowed.

5. Patient must have tumor assessed for estrogen-receptor (ER) and progesterone-receptor

6. Persistent detectable or non-detectable CTCs by Veridex Technology after completion
of standard therapy.

7. Zubrod performance status 0 or 1.

8. Patients must have adequate hematological parameters (White Blood Count/WBC >=
3,000/mm3; platelet count >= 100,000/mm3)

9. Adequate renal function (serum creatinine <= 1.5mg/dl)

10. Adequate liver function (total bilirubin, serum glutamate pyruvate transaminase
(SGPT) <= 2 times normal).

11. Adequate cardiac function (Left ventricular ejection fraction (LVEF)>= 50%).

12. Adequate pulmonary function (Carbon Monoxide Diffusing Capacity (DLCO)>= 50% of
predicted value).

13. Females of childbearing (women who are post-menopausal < 1 year, not surgically
sterilized, or not abstinent) potential must use adequate contraception.

14. Patients must sign an informed consent.

Exclusion Criteria:

1. Prior HDCT with Autologous hematopoietic stem cell transplantation (AHST) in adjuvant

2. History or presence of brain/leptomeningeal metastasis.

3. History of other malignancies except cured non-melanoma skin cancer or cured cervical
carcinoma in situ.

4. Presence of other severe medical illnesses or conditions. Severe heart disease,
(myocardial ischemia, myocardial infarction, etc.) Pulmonary disease (COPD,
asthma,etc). Renal failure and hepatic failure.

5. Clinically significant active infections (patient requiring IV antibiotics,
uncontrolled infections, or hospitalized due to infections).

6. HIV infection.

7. Pregnant or lactating women.

8. Medical, social or psychologic factors which would prevent the patient from receiving
or cooperating with the full course of therapy or understanding the informed consent

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants With Reduction in CTCs Following High-dose Chemotherapy With Purged Autologous Stem Cell Products

Outcome Description:

Number of circulating tumor cells (CTCs) measured at one month post autologous hematopoietic stem cell transplantation (AHST), considered both as longitudinal values and compared to the baseline number of CTCs.

Outcome Time Frame:

Baseline to 1 month post AHST

Safety Issue:


Principal Investigator

Naoto Ueno, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

June 2007

Completion Date:

February 2012

Related Keywords:

  • Breast Cancer
  • Metastatic Breast Carcinoma
  • Invasive Breast Carcinoma
  • Breast Cancer
  • breast carcinoma
  • Carboplatin
  • Paraplatin
  • Cyclophosphamide
  • Neosar
  • Cytoxan
  • Thiotepa
  • Purged Autologous Stem Cells
  • Circulating Tumor Cells
  • CTCs
  • Breast Neoplasms
  • Carcinoma
  • Neoplastic Cells, Circulating



UT MD Anderson Cancer Center Houston, Texas  77030