A Phase 2 interventional study of Carboplatin and Cyclophosphamide in Breast Cancer, Metastatic Breast Carcinoma and Invasive Breast Carcinoma, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2013-04-10.
Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Treatment
The goal of this clinical research study is to learn the relationship of high-dose chemotherapy (HDCT) and circulating tumor cells (CTCs) in controlling metastatic breast cancer. The study also will investigate the role of CTCs in breast cancer.
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 collection.
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.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 32 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.
Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Carboplatin + Cyclophosphamide + Thiotepa
Drug: Carboplatin · Drug: Cyclophosphamide · Drug: Thiotepa · Procedure: Stem Cell Transplant
Target Area Under the Curve (AUC) of 20, then divided into 4 doses given by vein (IV) days -6, -5, -4, -3 prior to stem cell infusion.
Also known as: Paraplatin
1.5 gm/m\^2 by vein days -6, -5, -4, -3 prior to stem cell infusion.
Also known as: Cytoxan, Neosar
120 mg/m\^2 by vein days -6, -5, -4, -3 prior to stem cell infusion.
Stem Cell Transplant on Day 0.
Also known as: SCT, Autologous hematopoietic stem cell transplantation, AHST
Number of Participants With Reduction in CTCs Following High-dose Chemotherapy With Purged Autologous Stem Cell Products
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.
Time frame: Baseline to 1 month post AHST
Median Progression Free Survival (PFS)
Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression. PFS time measured in months.
Time frame: Overall study (baseline to disease progression)
Recruitment Period: February 27, 2007 to July 25, 2011. All Recruitment done at The University of Texas (UT) MD Anderson Cancer Center.
| Milestone | High-dose Chemotherapy |
|---|---|
| Started | 32 |
| Completed | 25 |
| Not completed | 7 |
| Withdrew: Not evaluable, disease progression | 2 |
| Withdrew: Not eligible | 5 |
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.
| participants | High-dose Chemotherapy |
|---|---|
| Number of Participants With Reduction in CTCs Following High-dose Chemotherapy With Purged Autologous Stem Cell Products | 9 |
Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression. PFS time measured in months.
| months | High-dose Chemotherapy |
|---|---|
| Median Progression Free Survival (PFS) | 10.6 (1 to 16.4) |
Collected over 4 years and 5 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| High-dose Chemotherapy | — | 2/32 (6.3%) | 32/32 (100%) |
| Event | High-dose Chemotherapy |
|---|---|
| ThrombocytopeniaBlood and lymphatic system disorders | 1/32 |
| DeathGeneral disorders | 1/32 |
| Event | High-dose Chemotherapy |
|---|---|
| NauseaGastrointestinal disorders | 27/32 |
| DiarrheaGastrointestinal disorders | 20/32 |
| Age Continuous(years) | High-dose Chemotherapy |
|---|---|
| Median | 44 (29 to 59) |
| Sex: Female, Male(Participants) | High-dose Chemotherapy |
|---|---|
| Female | 22 |
| Male | 10 |
| Region of Enrollment(participants) | High-dose Chemotherapy |
|---|---|
| United States | 32 |
This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.
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M.D. Anderson Cancer Center