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| Sponsors and Collaborators: |
Robert H. Lurie Cancer Center National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00005787 |
Purpose
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 |
|
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 |
| MedlinePlus related topics: | Cancer Lymphoma |
| Drug Information available for: | Filgrastim Epoetin alfa Erythropoietin Sargramostim Granulocyte-macrophage colony-stimulating factor |
| 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.
Eligibility
| 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:
Contacts and Locations| United States, Illinois | |||||
| Robert H. Lurie Comprehensive Cancer Center, Northwestern University | |||||
| Chicago, Illinois, United States, 60611-3013 | |||||
| Robert H. Lurie Cancer Center |
| National Cancer Institute (NCI) |
| Study Chair: | Jane N. Winter, MD | Robert H. Lurie Cancer Center |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000067725, NU-99Z1, NCI-G00-1734 |
| First Received: | June 2, 2000 |
| Last Updated: | October 18, 2008 |
| ClinicalTrials.gov Identifier: | NCT00005787 |
| Health Authority: | United States: Federal Government |
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