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Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous Leukemia

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
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
Drug: cytarabine
Drug: etoposide
Drug: filgrastim
Drug: hydroxyurea
Drug: mitoxantrone hydrochloride
Procedure: peripheral blood stem cell transplantation
Phase II

MedlinePlus related topics:   Cancer    Leukemia, Adult Acute    Leukemia, Adult Chronic    Leukemia, Childhood   

ChemIDplus related topics:   Filgrastim    Cytarabine    Cytarabine hydrochloride    Etoposide    Mitoxantrone hydrochloride    Mitoxantrone    Hydroxyurea    Granulocyte colony-stimulating factor    Etoposide phosphate   

U.S. FDA Resources

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

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:   30
Study Start Date:   October 1994

Detailed Description:

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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002674

Locations
United States, Washington
Fred Hutchinson Cancer Research Center    
      Seattle, Washington, United States, 98109

Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)

Investigators
Study Chair:     Leona A. Holmberg, MD, PhD     Fred Hutchinson Cancer Research Center    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000064310, FHCRC-928.00, NCI-H95-0705
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00002674
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
relapsing chronic myelogenous leukemia  
chronic phase chronic myelogenous leukemia  
accelerated phase chronic myelogenous leukemia  
Philadelphia chromosome positive chronic myelogenous leukemia  

Study placed in the following topic categories:
Philadelphia Chromosome
Chronic myelogenous leukemia
Hydroxyurea
Hematologic Diseases
Myeloproliferative Disorders
Leukemia, Myeloid
Leukemia, Myeloid, Chronic-Phase
Etoposide phosphate
Leukemia
Leukemia, Myeloid, Accelerated Phase
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Mitoxantrone
Bone Marrow Diseases
Etoposide
Cytarabine

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Antisickling Agents
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Hematologic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Sensory System Agents
Therapeutic Uses
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Antineoplastic Agents, Phytogenic
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 19, 2008




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