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Purged Circulating Tumor Cells (CTCs) From Metastatic Breast Cancer

This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, October 2008

Sponsored by: M.D. Anderson Cancer Center
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00429182
  Purpose

Primary Objectives:

  • To determine whether high-dose chemotherapy (HDCT) with purged autologous stem cell products will reduce the presence of circulating tumor cells (CTCs) among metastatic breast cancer (MBC) patients after receiving high-dose chemotherapy autologous hematopoietic stem cell transplantation.
  • To determine whether reduction of CTCs will correlate with prolonged progression-free survival (PFS).

Secondary Objectives:

  • To determine whether reduction of CTCs will correlate with prolonged overall survival (OS).
  • To characterize the biology of CTC.

Condition Intervention Phase
Breast Cancer
Drug: Carboplatin
Drug: Cyclophosphamide
Drug: Thiotepa
Procedure: Stem Cell Transplant
Phase II

Genetics Home Reference related topics:   breast cancer   

MedlinePlus related topics:   Breast Cancer    Cancer   

ChemIDplus related topics:   Cyclophosphamide    Carboplatin    Thiotepa   

U.S. FDA Resources

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

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • To learn if elimination of circulating tumor cells (CTCs) in blood stem cells along with high-dose chemotherapy will help to control metastatic breast cancer. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The study also will investigate the role of CTCs in breast cancer. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

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
1: Experimental
Carboplatin + Cyclophosphamide + Thiotepa
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.

Show detailed description  Show Detailed Description

  Eligibility
Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  1. 18 to 60 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 (PR).
  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 (WBC 3,000/mm3; platelet count 100,000/mm3)
  9. Adequate renal function (serum creatinine 1.5mg/dl)
  10. Adequate liver function (total bilirubin, SGPT 2 x normal).
  11. Adequate cardiac function (LVEF >= 50%).
  12. Adequate pulmonary function (DLCO >= 50% of predicted value).
  13. Patients must sign an informed consent.

Exclusion Criteria:

  1. Prior HDCT with AHST in adjuvant setting.
  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.
  5. Clinically significant active infections.
  6. HIV infection.
  7. Chronic active hepatitis.
  8. Pregnant or lactating women (females of childbearing potential must use adequate contraception).
  9. 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 procedure.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00429182

Contacts
Contact: Naoto Ueno, MD, PhD     713-792-8754    

Locations
United States, Texas
U.T. M.D. Anderson Cancer Center     Recruiting
      Houston, Texas, United States, 77030
      Principal Investigator: Naoto Ueno, MD, PhD            

Sponsors and Collaborators
M.D. Anderson Cancer Center

Investigators
Principal Investigator:     Naoto Ueno, MD, PhD     U.T. M.D. Anderson Cancer Center    
  More Information


UT MD Anderson Cancer Center website  This link exits the ClinicalTrials.gov site
 

Responsible Party:   U.T.M.D. Anderson Cancer Center ( Naoto Ueno, MD, PhD/Associate Professor )
Study ID Numbers:   2006-0280
First Received:   January 29, 2007
Last Updated:   October 1, 2008
ClinicalTrials.gov Identifier:   NCT00429182
Health Authority:   United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Breast Cancer  
Carboplatin  
Cyclophosphamide  
Thiotepa  
Purged Autologous Stem Cells
Circulating Tumor Cells
CTCs

Study placed in the following topic categories:
Skin Diseases
Breast Neoplasms
Carboplatin
Cyclophosphamide
Breast Diseases
Thiotepa

Additional relevant MeSH terms:
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Alkylating Agents

ClinicalTrials.gov processed this record on October 03, 2008




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