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	Treatment or Intervention	Phase
accelerated phase chronic myelogenous leukemia Philadelphia chromosome positive chronic myelogenous leukemia chronic phase chronic myelogenous leukemia refractory chronic myelogenous leukemia	Drug: cytarabine  Drug: etoposide  Drug: filgrastim  Drug: hydroxyurea  Drug: mitoxantrone	Phase II

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  17 Years   -   65 Years

Criteria

PROTOCOL ENTRY 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

--Prior/Concurrent Therapy--

• At least 1 month since interferon

--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

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

Study chairs or principal investigators

Leona Holmberg,  Study Chair,  Fred Hutchinson Cancer Research Center   

Study ID Numbers:  CDR0000064310; FHCRC-928.00; NCI-H95-0705
Record last reviewed:  August 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002674
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08