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Combination Chemotherapy and Peripheral Blood Stem Cell Transplant Followed By Aldesleukin and Sargramostim in Treating Patients With Inflammatory Stage IIIB or Metastatic Stage IV Breast Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00003199
First Posted: January 27, 2003
Last Update Posted: July 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Leona Holmberg, Fred Hutchinson Cancer Research Center
Results First Submitted: April 10, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Estrogen Receptor-negative Breast Cancer
Estrogen Receptor-positive Breast Cancer
Inflammatory Breast Cancer
Male Breast Cancer
Progesterone Receptor-negative Breast Cancer
Progesterone Receptor-positive Breast Cancer
Stage IIIB Breast Cancer
Stage IV Breast Cancer
Interventions: Drug: tamoxifen citrate
Drug: busulfan
Drug: thiotepa
Drug: melphalan
Biological: aldesleukin
Biological: sargramostim
Procedure: peripheral blood stem cell transplantation
Radiation: radiation therapy

  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
TX/Maintenance Therapy for Stage IIIB/IV Breast Cancer

See Detailed Description.

tamoxifen citrate: Given orally

busulfan: Given orally

thiotepa: Given IV

melphalan: Given IV

aldesleukin: Given SC

sargramostim: Given SC

peripheral blood stem cell transplantation: Undergo autologous peripheral blood stem cell infusion

radiation therapy: May undergo radiotherapy after completion of IL-2/GM-CSF


Participant Flow:   Overall Study
    TX/Maintenance Therapy for Stage IIIB/IV Breast Cancer
STARTED   50 
COMPLETED   28 
NOT COMPLETED   22 
Refused Post-Transplant Immunotherapy                5 
Lack of insurance clearance                2 
Screen fail                15 



  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
TX/Maintenance Therapy for Stage IIIB/IV Breast Cancer

See Detailed Description.

tamoxifen citrate: Given orally

busulfan: Given orally

thiotepa: Given IV

melphalan: Given IV

aldesleukin: Given SC

sargramostim: Given SC

peripheral blood stem cell transplantation: Undergo autologous peripheral blood stem cell infusion

radiation therapy: May undergo radiotherapy after completion of IL-2/GM-CSF


Baseline Measures
   TX/Maintenance Therapy for Stage IIIB/IV Breast Cancer 
Overall Participants Analyzed 
[Units: Participants]
 50 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      50 100.0% 
>=65 years      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      50 100.0% 
Male      0   0.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      0   0.0% 
Not Hispanic or Latino      0   0.0% 
Unknown or Not Reported      50 100.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      1   2.0% 
Asian      7  14.0% 
Native Hawaiian or Other Pacific Islander      4   8.0% 
Black or African American      1   2.0% 
White      37  74.0% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   50 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Event-free Survival   [ Time Frame: 11 years ]

2.  Secondary:   Overall Survival   [ Time Frame: 11 years ]

3.  Secondary:   Number of Participants With Toxicity of a Combination of Low-dose IL-2 and GM-CSF   [ Time Frame: 16 Weeks ]


  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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Leona A. Holmberg
Organization: Fred Hutchinson Cancer Research Center
phone: 206-667-6447
e-mail: lholmber@fredhutch.org



Responsible Party: Leona Holmberg, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT00003199     History of Changes
Other Study ID Numbers: PSOC 1605
NCI-2010-00728 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: November 1, 1999
First Posted: January 27, 2003
Results First Submitted: April 10, 2017
Results First Posted: May 17, 2017
Last Update Posted: July 12, 2017