RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.

PURPOSE: This phase II trial is studying how well cyclophosphamide plus filgrastim followed by autologous peripheral stem cell transplantation works in treating patients with chronic phase or accelerated phase chronic myelogenous leukemia.

Condition	Treatment or Intervention	Phase
chronic phase chronic myelogenous leukemia accelerated phase chronic myelogenous leukemia Philadelphia chromosome positive chronic myelogenous leukemia childhood chronic myelogenous leukemia	Drug: cyclophosphamide  Drug: filgrastim  Drug: interferon alfa  Procedure: biological response modifier therapy  Procedure: bone marrow ablation with stem cell support  Procedure: chemotherapy  Procedure: colony-stimulating factor therapy  Procedure: cytokine therapy  Procedure: interferon therapy  Procedure: peripheral blood stem cell transplantation  Procedure: radiation therapy	Phase II

Further Study Details: 

OBJECTIVES:

• Assess the clinical outcomes, survival, and morbidity of patients with chronic or accelerated phase chronic myelogenous leukemia when treated with cyclophosphamide and filgrastim (G-CSF) followed by autologous peripheral blood stem cell transplantation.
• Determine whether priming with cyclophosphamide and filgrastim (G-CSF) increases the fraction of benign Philadelphia chromosome negative hematopoietic progenitors in peripheral blood stem cells (PBSC) and reduces the incidence of persistent or recurrent leukemia after autologous transplantation with mobilized PBSC in these patients.

OUTLINE: Patients receive priming therapy consisting of cyclophosphamide IV over 2 hours on day 1 and filgrastim (G-CSF) daily subcutaneously (SQ) starting on day 5 and continuing until completion of leukapheresis. Peripheral blood stem cells (PBSC) are collected between days 14-21.

Patients then receive preparative therapy for transplant consisting of cyclophosphamide IV over 2 hours on days -7 and -6 and total body irradiation twice a day on days -4 through -1. Patients receive the PBSC transplantation on day 0. Patients also receive G-CSF IV starting on day 0 and continuing until blood counts recover. Patients then receive interferon alfa SQ daily in the absence of unacceptable toxicity or disease progression.

Patients are followed at 3 weeks; then at 3, 6, 9, 12, and 18 months; and then annually for 5 years.

PROJECTED ACCRUAL: Not specified

Ages Eligible for Study:  up to  70 Years,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed chronic or accelerated phase chronic myelogenous leukemia (CML)
• Philadelphia chromosome positive OR
• BCR/ABL rearrangement
• No blast crisis or post blast crisis
• No severe fibrosis defined by bilateral trephine biopsies
• No splenomegaly (below umbilicus) that does not respond to chemotherapy and/or radiotherapy
• Ineligible or refused to participate in ongoing allogeneic marrow donor transplant protocols

PATIENT CHARACTERISTICS: Age:

• 70 and under

Performance status:

• Age 65-70 years:
• Karnofsky 80-100%
• Under 65 years:
• Karnofsky 90-100%

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Age 65-70 years:
• Creatinine clearance greater than 60 mL/min (if creatinine at least 1.5 mg/dL)
• Under 65 years:
• Not specified

Cardiovascular:

• Age 65-70 years:
• LVEF at least 45%

Pulmonary:

• Age 65-70 years:
• If history of smoking or respiratory symptoms, spirometry and DLCO must be greater then 50% of predicted

Other:

• Normal organ function (excluding bone marrow)

PRIOR CONCURRENT THERAPY: Biologic therapy:

• Not specified

Chemotherapy:

• See Disease Characteristics

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics

Surgery:

• Not specified

Minnesota
      University of Minnesota Cancer Center, Minneapolis,  Minnesota,  55455,  United States; Recruiting

Study chairs or principal investigators

Catherine M. Verfaillie, MD,  Study Chair,  University of Minnesota Cancer Center   

Study ID Numbers:  CDR0000067972; UMN-MT-9611; UMN-MT-1996-11; NCT00005984
Record last reviewed:  May 2001
Last Updated:  March 3, 2005
Record first received:  July 5, 2000
ClinicalTrials.gov Identifier:  NCT00005984
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08