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| Tracking Information | |||||
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| First Received Date ICMJE | July 11, 2001 | ||||
| Last Updated Date | March 31, 2009 | ||||
| Start Date ICMJE | January 2000 | ||||
| Estimated Primary Completion Date | July 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Disease-free survival [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00020722 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Overall survival [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
Overall survival | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Chemotherapy Followed by Peripheral Stem Cell Transplantation Plus Biological Therapy in Treating Women With Stage IV Breast Cancer | ||||
| Official Title ICMJE | Treatment of Stage IV Breast Cancer With Activated T Cells After Peripheral Blood Stem Cell Transplant (Pilot Phase II) | ||||
| Brief Summary | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation plus biological therapy may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: This phase II trial is studying how well chemotherapy followed by peripheral stem cell transplantation plus biological therapy works in treating women with stage IV breast cancer. |
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| Detailed Description | OBJECTIVES:
OUTLINE: Patients are stratified according to tumor classification (chemosensitive vs chemoresistant). Patients receive filgrastim (G-CSF) subcutaneously (SC) daily for 4 days followed by peripheral blood mononuclear cell (PBMC) collection for PBSCT and generation of activated T cells (ATC). The PBMC are treated ex vivo with monoclonal antibody OKT3 to form ATC. The ATC are expanded for 12-14 days in interleukin-2 (IL-2). Patients then receive high-dose chemotherapy. Patients with chemosensitive disease receive cyclophosphamide IV over 1 hour, thiotepa IV over 1 hour, and carboplatin IV over 1 hour on days -4, -3, and -2. Patients with chemoresistant disease receive ifosfamide IV over 1 hour, etoposide IV twice daily, and carboplatin IV over 1 hour on days -8 to -3. Patients undergo autologous PBSC transplantation on day 0 or on both day 0 and day 1. Patients then receive ATC IV over 15-20 minutes three times per week starting approximately on day +1 for three weeks and then once weekly for at least 6 doses. After completion of study therapy, patients are followed periodically for up to 2 years after PBSC. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Open Label | ||||
| Condition ICMJE | Breast Cancer | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 32 | ||||
| Completion Date | |||||
| Estimated Primary Completion Date | July 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Gender | Female | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | |||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00020722 | ||||
| Responsible Party | Lawrence G. Lum, Barbara Ann Karmanos Cancer Institute | ||||
| Study ID Numbers ICMJE | CDR0000068707, WSU-2007-033, RWMC-0634246 | ||||
| Study Sponsor ICMJE | Barbara Ann Karmanos Cancer Institute | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | March 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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