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| Sponsors and Collaborators: |
Fred Hutchinson Cancer Research Center National Cancer Institute (NCI) |
|---|---|
| Information provided by: | Fred Hutchinson Cancer Research Center |
| ClinicalTrials.gov Identifier: | NCT00002674 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by G-CSF and peripheral stem cell transplantation in treating patients with chronic myelogenous leukemia.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia |
Biological: filgrastim Drug: cytarabine Drug: etoposide Drug: hydroxyurea Drug: mitoxantrone hydrochloride Procedure: peripheral blood stem cell transplantation |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | CYTOREDUCTIVE CHEMOTHERAPY WITH MITOXANTRONE, CYTOSINE ARABINOSIDE AND ETOPOSIDE FOLLOWED BY RECOMBINANT HUMAN G-CSF FOR MOBILIZATION OF PERIPHERAL BLOOD STEM CELLS IN PATIENTS WITH CHRONIC MYELOID LEUKEMIA |
| Estimated Enrollment: | 30 |
| Study Start Date: | October 1994 |
| Study Completion Date: | March 2000 |
OBJECTIVES: I. Evaluate the efficacy of MCE (mitoxantrone/cytarabine/etoposide) followed by granulocyte colony-stimulating factor to mobilize peripheral blood stem cells (PBSC) in patients with chronic myeloid leukemia (CML). II. Evaluate the toxicity of this regimen. III. Evaluate the cytoreductive effects of this regimen in CML as determined by the ability to mobilize Philadelphia chromosome-negative PBSC. IV. Assess the time of peak CD34+ and CD34+/CD38- cell concentrations in the peripheral blood of patients treated with this regimen.
OUTLINE: The following acronyms are used: ARA-C Cytarabine, NSC-63878 DHAD Mitoxantrone, NSC-301739 G-CSF Granulocyte Colony-Stimulating Factor (source not specified) HU Hydroxyurea, NSC-32065 MCE DHAD/ARA-C/VP-16 VP-16 Etoposide, NSC-141540 Single-Agent Cytoreduction followed by 3-Drug Combination Chemotherapy/Stem Cell Mobilization. HU; followed by MCE; G-CSF.
PROJECTED ACCRUAL: 30 patients will be entered over 3 years.
Eligibility| Ages Eligible for Study: | 17 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Philadelphia chromosome-positive chronic myeloid leukemia (CML) in chronic or accelerated phase Ineligible for allograft protocols or no available HLA-matched sibling marrow donor No patients under age 55 who have consented to unrelated donor search unless: Search unsuccessful for 6 months and unlikely a donor will be found Transplant from an unrelated donor declined No history of CML blast crisis No grade III/IV myelofibrosis
PATIENT CHARACTERISTICS: Age: Over 17 to under 66 Performance status: Not specified Life expectancy: No limitations from disease other than leukemia Other: No hepatic, renal, pulmonary, or cardiac dysfunction that would preclude transplant preparative regimen No HIV antibody No active infection
PRIOR CONCURRENT THERAPY: At least 1 month since interferon
Contacts and Locations| United States, Washington | |
| Fred Hutchinson Cancer Research Center | |
| Seattle, Washington, United States, 98109 | |
| Study Chair: | Leona A. Holmberg, MD, PhD | Fred Hutchinson Cancer Research Center |
More Information
| Study ID Numbers: | CDR0000064310, FHCRC-928.00, NCI-H95-0705 |
| Study First Received: | November 1, 1999 |
| Last Updated: | June 17, 2009 |
| ClinicalTrials.gov Identifier: | NCT00002674 History of Changes |
| Health Authority: | United States: Federal Government |
|
relapsing chronic myelogenous leukemia chronic phase chronic myelogenous leukemia accelerated phase chronic myelogenous leukemia Philadelphia chromosome positive chronic myelogenous leukemia |
|
Antimetabolites Philadelphia Chromosome Anti-Infective Agents Immunologic Factors Hydroxyurea Hematologic Diseases Myeloproliferative Disorders Leukemia, Myeloid Leukemia, Myeloid, Chronic-Phase Immunosuppressive Agents Antiviral Agents Etoposide phosphate |
Leukemia Leukemia, Myeloid, Accelerated Phase Leukemia, Myelogenous, Chronic, BCR-ABL Positive Peripheral Nervous System Agents Analgesics Mitoxantrone Chronic Myelogenous Leukemia Bone Marrow Diseases Antineoplastic Agents, Phytogenic Etoposide Cytarabine |
|
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Hydroxyurea Antineoplastic Agents Hematologic Agents Physiological Effects of Drugs Leukemia Sensory System Agents Therapeutic Uses Analgesics Etoposide Nucleic Acid Synthesis Inhibitors |
Cytarabine Neoplasms by Histologic Type Antisickling Agents Hematologic Diseases Myeloproliferative Disorders Enzyme Inhibitors Leukemia, Myeloid Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Leukemia, Myelogenous, Chronic, BCR-ABL Positive Peripheral Nervous System Agents Mitoxantrone Bone Marrow Diseases |
