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



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

For Condition: Philadelphia chromosome positive chronic myelogenous leukemia,chronic phase chronic myelogenous leukemia,accelerated phase chronic myelogenous leukemia
Status: Suspended
Sponsor(s): University of Minnesota Cancer Center ,
Synopsis: 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. Colony-stimulating factors such as filgrastim 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. PURPOSE: Phase II trial to study the effectiveness of chemotherapy and filgrastim followed by peripheral stem cell transplantation in treating patients who have chronic myelogenous leukemia.
Details: OBJECTIVES: I. Assess clinical outcomes, survival, and morbidity of transplantation therapy in patients with chronic myelogenous leukemia when treated with high dose chemotherapy and filgrastim (G-CSF) followed by autologous retrovirally transduced peripheral blood stem cell (PBSC) transplantation. II. Determine whether this priming treatment can increase the fraction of benign Philadelphia chromosome (Ph) negative hematopoietic progenitors in PBSC and reduce the incidence of persistent or recurrent leukemia after autologous transplantation with mobilized PBSC in these patients. III. Assess whether retroviral transduction of mobilized PBSC progenitors determines the contribution of malignant Ph positive progenitors contaminating the graft to relapse after transplantation in these patients. IV. Determine whether this priming treatment can expand the benign progenitor population in the PBSC collections from these patients. PROTOCOL OUTLINE: In the priming phase, patients receive cyclophosphamide IV over 2 hours on day 1 and filgrastim (G-CSF) subcutaneously (SQ) daily beginning on day 4 and continuing until the completion of leukapheresis. Peripheral blood stem cells (PBSC) are harvested 4-7 times between days 10 and 21 beginning when blood counts recover (CD34+ cells are selected from 2 of these PBSC collections and transduced with the LN NEO virus prior to cryopreservation). In the transplant phase, patients who have not received prior radiotherapy receive cyclophosphamide IV over 2 hours daily on days -7 and -6 and total body irradiation on days -4 through -1. Autologous PBSC and LN NEO transduced CD34+ cells are reinfused on day 0. Patients also receive G-CSF IV daily beginning on day 0 and continuing until blood counts recover. Patients who have received prior radiotherapy receive oral busulfan every 6 hours on days -10 through -7 and cyclophosphamide IV daily on days -6 through -3. Autologous PBSC and LN NEO transduced CD34+ cells are reinfused on day 0. Patients also receive G-CSF IV daily beginning on day 0 and continuing until blood counts recover. All patients then receive interferon alfa SQ daily until disease progression or unacceptable toxicity. Patients are followed at 3 weeks; at 3, 6, 9, 12, 18, and 24 months; and then annually thereafter. PROJECTED ACCRUAL: A total of 4-26 patients will be accrued for this study.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/65 Years
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed chronic or accelerated phase chronic myelogenous leukemia; Philadelphia chromosome positive OR BCR/ABL rearrangement - No blast crisis or post blast crisis - No moderate to severe fibrosis defined by bilateral trephine biopsies - Not eligible for or refused to participate in allogeneic marrow transplant protocols - No splenomegaly (below umbilicus) that does not respond to chemotherapy and/or radiotherapy --Prior/Concurrent Therapy-- - Biologic therapy: Prior interferon alfa allowed - Chemotherapy: Prior hydroxyurea allowed; At least 2 months since prior busulfan (at time of PBSC harvest) - Endocrine therapy: Not specified - Radiotherapy: Not specified - Surgery: Not specified --Patient Characteristics-- - Age: 18 to 65 - Performance status: Karnofsky 90-100% - Life expectancy: Not specified - Hematopoietic: Not specified - Hepatic: Not specified - Renal: Not specified - Other: Normal organ function (except bone marrow)
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
CatherineVerfaillie,  Study Chair,  University of Minnesota Cancer Center

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


Additional Information:
Study ID Numbers:  CDR0000067974;  UMN-MT-9507
Study Start Date: June 2001
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005986

Other Chronic Phase Chronic Myelogenous Leukemia Studies:
1. Imatinib Mesylate and Decitabine in Treating Patients With Chronic Myelogenous Leukemia

2. Imatinib Mesylate and 17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Chronic Myelogenous Leukemia

3. Chemotherapy and Filgrastim Followed by Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous Leukemia

4. Cyclophosphamide and Filgrastim Followed By Peripheral Stem Cell Transplantation in Treating Patients With Chronic or Accelerated Phase Myelogenous Leukemia

5. Chemotherapy in Treating Patients With Newly Diagnosed Acute or Chronic Myelogenous Leukemia or Myelodysplastic Syndrome

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