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| Sponsor: | Northwestern University |
|---|---|
| Information provided by: | Northwestern University |
| ClinicalTrials.gov Identifier: | NCT00006225 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic-Myeloproliferative Diseases |
Biological: filgrastim Biological: recombinant flt3 ligand Biological: recombinant human thrombopoietin Biological: recombinant interleukin-3 Procedure: in vitro-treated peripheral blood stem cell transplantation |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | Ex Vivo Expanded Megakaryocytes for Supportive Care of Breast Cancer Patients: A Phase I/II Study |
| Study Start Date: | November 1999 |
| Study Completion Date: | January 2004 |
| Primary Completion Date: | January 2004 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Hormone receptor status:
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:
Contacts and Locations| United States, Illinois | |
| Robert H. Lurie Comprehensive Cancer Center, Northwestern University | |
| Chicago, Illinois, United States, 60611 | |
| Study Chair: | Jane N. Winter, MD | Robert H. Lurie Cancer Center |
More Information
| Responsible Party: | Jane Winter, MD, Northwestern University |
| ClinicalTrials.gov Identifier: | NCT00006225 History of Changes |
| Other Study ID Numbers: | NU 97B2, NU-97B2, NCI-V00-1611 |
| Study First Received: | September 11, 2000 |
| Last Updated: | February 18, 2011 |
| Health Authority: | United States: Federal Government |
|
stage IV adult Hodgkin lymphoma stage IV breast cancer stage IIIA breast cancer recurrent breast cancer stage IIIB breast cancer stage IIIC breast cancer recurrent adult Hodgkin lymphoma stage II cutaneous T-cell non-Hodgkin lymphoma stage III cutaneous T-cell non-Hodgkin lymphoma stage IV cutaneous T-cell non-Hodgkin lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma isolated plasmacytoma of bone extramedullary plasmacytoma refractory multiple myeloma Waldenstrom macroglobulinemia |
stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma stage II chronic lymphocytic leukemia stage IV chronic lymphocytic leukemia recurrent adult acute lymphoblastic leukemia adult acute myeloid leukemia in remission adult acute lymphoblastic leukemia in remission T-cell large granular lymphocyte leukemia acute undifferentiated leukemia stage III grade 1 follicular lymphoma stage III grade 2 follicular lymphoma stage III grade 3 follicular lymphoma stage III adult diffuse small cleaved cell lymphoma stage III adult diffuse mixed cell lymphoma |
|
Breast Neoplasms Neoplasms Leukemia Lymphoma Lymphoma, Non-Hodgkin Multiple Myeloma Neoplasms, Plasma Cell Plasmacytoma Myeloproliferative Disorders Lymphoma, Large-Cell, Immunoblastic Myelodysplastic-Myeloproliferative Diseases Neoplasms by Site Breast Diseases Skin Diseases Neoplasms by Histologic Type |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Bone Marrow Diseases Lenograstim Flt3 ligand protein Adjuvants, Immunologic |
