Chemotherapy Followed by Peripheral Stem Cell Transplantation Plus Biological Therapy in Treating Women With Stage IV Breast Cancer

This study has been terminated.
(Lack of funding to continue study.)
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Lawrence Lum, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier:
NCT00020722
First received: July 11, 2001
Last updated: February 15, 2016
Last verified: February 2016
Results First Received: February 9, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Biological: therapeutic autologous lymphocytes
Drug: Ifosfamide, carboplatin, and etoposide (ICE) regimen
Drug: Cyclophosphamide, Thiotepa, Carboplatin (CTC) or STAMP V (CTC)
Procedure: Leukapheresis
Procedure: peripheral blood stem cell transplantation (PBSCT)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Therapeutic Autologous Lymphocytes

therapeutic autologous lymphocytes: Immediately after pheresis.,The time for ATC infusions will vary from patient to patient, but the infusion rate will be approximately 10 × 109 ATC will be based on the rate calculated from the endotoxin level in the cell product. All patients will be observed for at least 1 hr after an infusion.

Ifosfamide, carboplatin, and etoposide (ICE) regimen: Ifosfamide 2,500 mg/m2 given IV daily on day -8, -7, -6, -5, -4, and -3 prior to PBSCT. Ifosfamide 2,500 mg/m2 infused IV over 1 hour (hour 0-1) on days -8 to -3 for a total dose of 15,000 mg/m2.

Mesna will be administered per BMT Standard of Care Guideline at a dose of 25% of the total Ifosfamide dose 30 minutes prior to and then 3, 6, and 9 hours after ifosfamide daily on days -8, -7, -6, -5, -4, and -3 prior to PBSCT for a total dose of 2500 m


Participant Flow:   Overall Study
    Therapeutic Autologous Lymphocytes  
STARTED     7  
COMPLETED     7  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Therapeutic Autologous Lymphocytes

therapeutic autologous lymphocytes: Immediately after pheresis, the lymphocytes will be activated with soluble monoclonal anti-CD3 antibody (OKT3) which cross-links the CD3 receptors on T cells and activates T cells.

The time for ATC infusions will vary from patient to patient, but the infusion rate will be approximately 10 × 109 ATC will be based on the rate calculated from the endotoxin level in the cell product. All patients will be observed for at least 1 hr after an infusion.

Ifosfamide, carboplatin, and etoposide (ICE) regimen: Ifosfamide 2,500 mg/m2 given IV daily on day -8, -7, -6, -5, -4, and -3 prior to PBSCT. Ifosfamide 2,500 mg/m2 infused IV over 1 hour (hour 0-1) on days -8 to -3 for a total dose of 15,000 mg/m2.

Mesna administered per BMT Standard of Care Guideline at a dose of 25% of the total Ifosfamide dose 30 mins. prior to and then 3, 6, and 9 hrs after ifosfamide daily on days -8, -7, -6, -5, -4, and -3 prior to PBSCT for a total dose of 2500 m


Baseline Measures
    Therapeutic Autologous Lymphocytes  
Number of Participants  
[units: participants]
  7  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     7  
>=65 years     0  
Gender  
[units: participants]
 
Female     7  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     7  



  Outcome Measures
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1.  Primary:   Disease-free Survival   [ Time Frame: Length of time from day of transplant until recurrence or relapse. ]

2.  Secondary:   Overall Survival   [ Time Frame: Length of time from day of transplant until death. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Not enough funding to finish study, cost of immunotherapy infusions for the stem cell transplant portion & of infusions for targeted T cell therapy were limited due to lack of funding, trial was converted into a proof-of-principle or concept trial.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Lawrence G. Lum, M.D., D.Sc
Organization: Barbara Ann Karmanos Cancer Institute
phone: (313) 576-8326
e-mail: luml@karmanos.org



Responsible Party: Lawrence Lum, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT00020722     History of Changes
Other Study ID Numbers: CDR0000068707
P30CA022453 ( US NIH Grant/Contract Award Number )
WSU-2007-033 ( Other Identifier: MI172 )
RWMC-0634246 ( Other Identifier: MI172 )
Study First Received: July 11, 2001
Results First Received: February 9, 2015
Last Updated: February 15, 2016
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration