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Sponsors and Collaborators: |
Robert H. Lurie Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005787 |
RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill cancer cells. Treating the peripheral stem cells in the laboratory may improve the effectiveness of the transplant.
PURPOSE: Phase I trial to study the effectiveness of peripheral stem cell transplantation in patients who have relapsed or refractory non-Hodgkin's lymphoma and who will be treated with high-dose chemotherapy.
Condition | Intervention | Phase |
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Cancer-Related Problem/Condition Lymphoma |
Drug: epoetin alfa Drug: filgrastim Drug: recombinant flt3 ligand Drug: recombinant interleukin-3 Drug: sargramostim Procedure: in vitro-treated peripheral blood stem cell transplantation |
Phase I |
Study Type: | Interventional |
Study Design: | Supportive Care |
Official Title: | Ex Vivo Expanded Peripheral Blood Mononuclear Cells for the Elimination of Neutropenia Associated With High Dose Chemotherapy |
Study Start Date: | February 2000 |
OBJECTIVES:
OUTLINE: Autologous peripheral blood mononuclear cells (PBMNC) are harvested. Unselected PBMNC are cultured and expanded ex vivo in flt3 ligand, interleukin-3, filgrastim (G-CSF), sargramostim (GM-CSF), and epoetin alfa for 13 days. Expanded PBMNC are reinfused on day 0.
Patients are followed monthly for 1 year.
PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.
Ages Eligible for Study: | 17 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United States, Illinois | |
Robert H. Lurie Comprehensive Cancer Center, Northwestern University | |
Chicago, Illinois, United States, 60611-3013 |
Study Chair: | Jane N. Winter, MD | Robert H. Lurie Cancer Center |
Study ID Numbers: | CDR0000067725, NU-99Z1, NCI-G00-1734 |
Study First Received: | June 2, 2000 |
Last Updated: | October 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00005787 |
Health Authority: | United States: Federal Government |
neutropenia recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse large cell lymphoma recurrent adult immunoblastic large cell lymphoma |
recurrent adult lymphoblastic lymphoma recurrent adult Burkitt lymphoma recurrent mantle cell lymphoma recurrent marginal zone lymphoma recurrent small lymphocytic lymphoma extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue nodal marginal zone B-cell lymphoma splenic marginal zone lymphoma |
Flt3 ligand protein Epoetin Alfa Lymphoma, Mantle-Cell Lymphoma, Follicular Lymphoma, small cleaved-cell, diffuse Lymphoma, B-Cell, Marginal Zone Leukocyte Disorders Granulocytopenia Lymphoma, large-cell, immunoblastic Lymphoma, large-cell Lymphoma, B-Cell Burkitt's lymphoma Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, Large-Cell, Immunoblastic Lymphoma |
Chronic lymphocytic leukemia Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Hematologic Diseases Leukemia, B-cell, chronic Agranulocytosis Lymphoblastic lymphoma Mantle cell lymphoma Recurrence Neutropenia Lymphatic Diseases Burkitt Lymphoma B-cell lymphomas Lymphoproliferative Disorders Lymphoma, Non-Hodgkin |
Radiation-Protective Agents Neoplasms Neoplasms by Histologic Type Immunologic Factors Immune System Diseases Hematinics |
Therapeutic Uses Physiological Effects of Drugs Hematologic Agents Adjuvants, Immunologic Protective Agents Pharmacologic Actions |