Purged Circulating Tumor Cells (CTCs) From Metastatic Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00429182
First received: January 29, 2007
Last updated: February 28, 2013
Last verified: February 2013
  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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Number of Participants With Reduction in CTCs Following High-dose Chemotherapy With Purged Autologous Stem Cell Products [ Time Frame: Baseline to 1 month post AHST ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Median Progression Free Survival (PFS) [ Time Frame: Overall study (baseline to disease progression) ] [ Designated as safety issue: No ]
    Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression. PFS time measured in months.


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 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.
Other Name: Paraplatin
Drug: Cyclophosphamide
1.5 gm/m^2 by vein days -6, -5, -4, -3 prior to stem cell infusion.
Other Names:
  • Cytoxan
  • Neosar
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:
  • SCT
  • Autologous hematopoietic stem cell transplantation
  • AHST

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 (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 (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 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. 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 procedure.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Naoto Ueno, MD, PhD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

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
Results First Received: February 28, 2013
Last Updated: February 28, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on July 20, 2014