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Sponsors and Collaborators: |
Roswell Park Cancer Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00053131 |
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim and sargramostim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. It is not yet known whether combination chemotherapy is more effective followed by filgrastim or sargramostim in treating leukemia.
PURPOSE: Randomized phase II trial to compare the effectiveness of combination chemotherapy followed by filgrastim with that of combination chemotherapy followed by sargramostim in treating patients who have relapsed or refractory acute myeloid leukemia or acute lymphoblastic leukemia.
Condition | Intervention | Phase |
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Leukemia |
Drug: cytarabine Drug: filgrastim Drug: mitoxantrone hydrochloride Drug: sargramostim |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | High Dose Cytarabine And Mitoxantrone Therapy For Relapsed And Refractory Acute Myeloid And Lymphocytic Leukemia: Effects Of GM-CSF Versus G-CSF On Dendritic Cells And Leukemia Associated Antigen-Specific T-Lymphocytes |
Study Start Date: | December 1999 |
OBJECTIVES:
OUTLINE: This is a randomized study.
All patients receive high-dose cytarabine IV over 1 hour twice daily on days 1-6 and mitoxantrone IV over 30 minutes on days 2-4. On day 6, patients are randomized to 1 of 2 treatment arms.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 6 years.
Ages Eligible for Study: | 15 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
United States, New York | |
Roswell Park Cancer Institute | |
Buffalo, New York, United States, 14263-0001 |
Study Chair: | Maria R. Baer, MD | Roswell Park Cancer Institute |
Study ID Numbers: | CDR0000269285, RPCI-RPC-9902 |
Study First Received: | January 27, 2003 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00053131 |
Health Authority: | United States: Federal Government |
recurrent adult acute myeloid leukemia recurrent childhood acute myeloid leukemia recurrent adult acute lymphoblastic leukemia recurrent childhood acute lymphoblastic leukemia |
Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Acute myelogenous leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Recurrence Acute lymphoblastic leukemia, adult |
Leukemia Lymphatic Diseases Mitoxantrone Acute myeloid leukemia, adult Lymphoproliferative Disorders Lymphoma Acute myelocytic leukemia Cytarabine |
Antimetabolites Anti-Infective Agents Neoplasms by Histologic Type Antimetabolites, Antineoplastic Immune System Diseases Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs |
Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Sensory System Agents Therapeutic Uses Peripheral Nervous System Agents Analgesics Central Nervous System Agents |