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Sponsored by: |
M.D. Anderson Cancer Center |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00429182 |
Primary Objectives:
Secondary Objectives:
Condition | Intervention | Phase |
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Breast Cancer |
Drug: Carboplatin Drug: Cyclophosphamide Drug: Thiotepa Procedure: Stem Cell Transplant |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase II Study of Purging of Circulating Tumor Cells (CTCs) From Metastatic Breast Cancer Patients |
Estimated Enrollment: | 36 |
Study Start Date: | June 2007 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Carboplatin + Cyclophosphamide + Thiotepa
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Drug: Carboplatin
Target AUC of 20, then divided into 4 doses given IV days -6, -5, -4, -3 prior to stem cell infusion.
Drug: Cyclophosphamide
1.5 gm/m^2 IV days -6, -5, -4, -3 prior to stem cell infusion.
Drug: Thiotepa
120 mg/m^2 IV days -6, -5, -4, -3 prior to stem cell infusion.
Procedure: Stem Cell Transplant
Stem Cell Transplant on Day 0.
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Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Naoto Ueno, MD, PhD | 713-792-8754 |
United States, Texas | |
U.T. M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: Naoto Ueno, MD, PhD |
Principal Investigator: | Naoto Ueno, MD, PhD | U.T. M.D. Anderson Cancer Center |
Responsible Party: | U.T.M.D. Anderson Cancer Center ( Naoto Ueno, MD, PhD/Associate Professor ) |
Study ID Numbers: | 2006-0280 |
Study First Received: | January 29, 2007 |
Last Updated: | October 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00429182 History of Changes |
Health Authority: | United States: Institutional Review Board |
Breast Cancer Carboplatin Cyclophosphamide Thiotepa |
Purged Autologous Stem Cells Circulating Tumor Cells CTCs |
Immunologic Factors Skin Diseases Breast Neoplasms Antineoplastic Agents, Alkylating Carboplatin Cyclophosphamide |
Antirheumatic Agents Alkylating Agents Immunosuppressive Agents Breast Diseases Thiotepa |
Molecular Mechanisms of Pharmacological Action Skin Diseases Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Breast Neoplasms Cyclophosphamide Carboplatin Immunosuppressive Agents Pharmacologic Actions |
Thiotepa Neoplasms Neoplasms by Site Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents Breast Diseases |