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| Descriptive Information Fields | |||||
| Brief Title † | Peripheral Stem Cell Transplantation in Treating Patients With Breast Cancer or Hematologic Cancer | ||||
| Official Title † | Ex Vivo Expanded Megakaryocytes for Supportive Care of Breast Cancer Patients: A Phase I/II Study | ||||
| Brief Summary | RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy. PURPOSE: Randomized phase I/II trial to study the effectiveness of peripheral stem cell transplantation in treating patients who have breast cancer or hematologic cancer. |
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| Detailed Description | OBJECTIVES:
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 durations of CD34+ culture times (6 days vs 9 days). After an initial harvest of filgrastim (G-CSF)-mobilized autologous peripheral blood stem cells (PBSC) for transplantation, patients receive one additional dose of G-CSF and undergo one additional apheresis. The CD34+ cells are cultured in the presence of recombinant human thrombopoietin, interleukin-3, and flt3 ligand to expand megakaryocytes. Patients then undergo treatment with high-dose chemotherapy (and, in some cases, total body irradiation) followed by reinfusion of the conventional PBSC harvest and the ex vivo expanded megakaryocytes. Patients are followed until blood counts recover. PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study. |
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| Study Phase | Phase I, Phase II | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Active Control | ||||
| Primary Outcome Measure † | |||||
| Secondary Outcome Measure † | |||||
| Condition † | Breast Cancer Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic/Myeloproliferative Diseases |
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| Intervention † | Drug: filgrastim Drug: recombinant flt3 ligand Drug: recombinant human thrombopoietin Drug: recombinant interleukin-3 Procedure: in vitro-treated peripheral blood stem cell transplantation |
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| MEDLINE PMIDs | |||||
| Links | Clinical trial summary from the National Cancer Institute's PDQ® database ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Active, not recruiting | ||||
| Enrollment † | |||||
| Start Date † | November 1999 | ||||
| Completion Date | |||||
| Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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| Gender | Both | ||||
| Ages | 18 Years to 60 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00006225 | ||||
| Organization ID | CDR0000068145 | ||||
| Secondary IDs †† | NU-97B2, NCI-V00-1611 | ||||
| Study Sponsor † | Robert H. Lurie Cancer Center | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | October 2003 | ||||
| First Received Date † | September 11, 2000 | ||||
| Last Updated Date | November 16, 2008 | ||||