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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Information provided by (Responsible Party): | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00429182 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer Metastatic Breast Carcinoma Invasive Breast Carcinoma |
Drug: Carboplatin Drug: Cyclophosphamide Drug: Thiotepa Procedure: Stem Cell Transplant |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of Purging of Circulating Tumor Cells (CTCs) From Metastatic Breast Cancer Patients |
| Enrollment: | 32 |
| Study Start Date: | June 2007 |
| Study Completion Date: | February 2012 |
| Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: High-dose chemotherapy
Carboplatin + Cyclophosphamide + Thiotepa
|
Drug: Carboplatin
Target AUC of 20, then divided into 4 doses given by vein (IV) days -6, -5, -4, -3 prior to stem cell infusion.
Other Name: Paraplatin
Drug: Cyclophosphamide
1.5 gm/m^2 by vein days -6, -5, -4, -3 prior to stem cell infusion.
Other Names:
Drug: Thiotepa
120 mg/m^2 by vein days -6, -5, -4, -3 prior to stem cell infusion.
Procedure: Stem Cell Transplant
Stem Cell Transplant on Day 0.
Other Names:
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Naoto Ueno, MD, PhD | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00429182 History of Changes |
| Other Study ID Numbers: | 2006-0280 |
| Study First Received: | January 29, 2007 |
| Last Updated: | February 16, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
Breast Cancer breast carcinoma Carboplatin Paraplatin Cyclophosphamide Neosar |
Cytoxan Thiotepa Purged Autologous Stem Cells Circulating Tumor Cells CTCs |
|
Breast Neoplasms Carcinoma Neoplastic Cells, Circulating Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasm Metastasis Neoplastic Processes Pathologic Processes Cyclophosphamide |
Thiotepa Carboplatin Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists |