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| Sponsors and Collaborators: |
Jonsson Comprehensive Cancer Center National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00004114 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill cancer cells.
PURPOSE: Phase I trial to study the effectiveness of chemotherapy plus peripheral stem cell transplantation in treating patients who have advanced hematologic cancer.
| Condition | Intervention | Phase |
|
Leukemia Lymphoma Myelodysplastic Syndromes |
Drug: cyclophosphamide Drug: cytarabine Drug: filgrastim Drug: fludarabine phosphate Procedure: peripheral blood stem cell transplantation |
Phase I |
| MedlinePlus related topics: | Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Lymphoma |
| ChemIDplus related topics: | Cyclophosphamide Filgrastim Cytarabine Cytarabine hydrochloride Fludarabine Fludarabine monophosphate |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Non-Myeloablative Chemotherapy Followed by Unrelated Allogeneic Stem Cell Transplantation in Patients With Advanced Hematologic Malignancies: A Pilot Study |
| Study Start Date: | January 2000 |
OBJECTIVES: I. Determine the feasibility of allogeneic engraftment after unrelated matched allogeneic peripheral blood stem cell transplantation preceded by a nonmyeloablative, fludarabine based conditioning regimen in patients with advanced hematologic malignancies. II. Determine the toxicities of this regimen, especially graft versus host disease, in these patients.
OUTLINE: Patients receive fludarabine IV over 30-60 minutes on days -7 to -4, cyclophosphamide IV over 30 minutes on days -7 to -5, and cytarabine IV over 2 hours on days -4 and -3. Allogeneic peripheral blood stem cells are infused on day 0. Filgrastim (G-CSF) is administered IV over 1 hour or subcutaneously beginning on day 1 and continuing until blood counts recover. Patients are followed weekly until day 60 and then monthly for 10 months.
PROJECTED ACCRUAL: A total of 6 patients will be accrued for this study.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically proven advanced hematologic malignancy unsuitable for standard allogeneic bone marrow transplantation One of the following types: Refractory or relapsed acute myelogenous or lymphocytic leukemia Over 55 years Chronic myelogenous leukemia and failed interferon treatment Over 55 years Lymphoma, chronic lymphocytic leukemia, Hodgkin's disease, or multiple myeloma: Refractory OR More than 2 relapses OR Relapse after autologous peripheral blood stem cell transplantation Myelodysplastic syndrome other than refractory anemia Severe aplastic anemia Under 55 years and either organ dysfunction or not eligible for standard allogeneic bone marrow transplant due to one or more of the following: Chronic hepatitis LVEF less than 50% Karnofsky less than 70% Unrelated matched donor available
PATIENT CHARACTERISTICS: Age: See Disease Characteristics Adult Performance status: See Disease Characteristics Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: See Disease Characteristics SGOT/SGPT no greater than 4 times upper limit of normal Renal: Creatinine no greater than 2 mg/dL Cardiovascular: See Disease Characteristics Pulmonary: DLCO at least 50% predicted Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified
Contacts and Locations| United States, California | |||||
| Jonsson Comprehensive Cancer Center, UCLA | |||||
| Los Angeles, California, United States, 90095-1781 | |||||
| Jonsson Comprehensive Cancer Center |
| National Cancer Institute (NCI) |
| Study Chair: | Christos E. Emmanouilides, MD | Jonsson Comprehensive Cancer Center |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
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| Study ID Numbers: | CDR0000067340, UCLA-9902026, NCI-G99-1603 |
| First Received: | December 10, 1999 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00004114 |
| Health Authority: | United States: Federal Government |
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