Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Acute Myeloid Leukemia in Second Remission
Condition: Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 2

Summary: 
      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: Phase II trial to study the effectiveness of peripheral stem cell transplantation
      following chemotherapy in treating patients with acute myeloid leukemia in second remission.
    

Detailed description: 
      OBJECTIVES: I. Determine the ability of mobilization using cytarabine, etoposide, and
      filgrastim (G-CSF), conditioning using busulfan and etoposide, and autologous peripheral
      blood stem cell transplantation to generate a 2-year disease-free survival rate in at least
      30% of patients with acute myeloid leukemia (AML) in second complete remission. II. Determine
      whether the treatment-related mortality can be limited to less than 20% in patients treated
      with this regimen. III. Determine whether adequate numbers of PBSC can be collected in these
      patients. IV. Determine the engraftment kinetics of primed PBSC obtained from these patients.

      OUTLINE: Mobilization/harvest: Patients receive cytarabine IV over 2 hours every 12 hours and
      etoposide IV continuously on days 1-4. Filgrastim (G-CSF) is administered subcutaneously (SC)
      beginning on day 14 and continuing until peripheral blood stem cells (PBSC) are harvested.
      When blood counts recover, PBSC are harvested and selected for CD34+ cells. Conditioning:
      Beginning at least 4 weeks after hospital discharge for mobilization and harvest and when
      blood counts recover, patients receive oral busulfan every 6 hours on days -7 to -4 and
      etoposide IV over 4 hours on day -3. PBSC are reinfused on day 0. G-CSF is administered SC
      beginning on day 0 and continuing until blood counts recover. Patients with documented CNS
      disease at first relapse receive methotrexate intrathecally at intervals of 1 week or greater
      before and/or after PBSC transplantation for a total of 6 doses. Patients are followed every
      3 months for 2 years and then every 6 months for 3 years.

      PROJECTED ACCRUAL: A total of 26-48 patients will be accrued within 2 years.
    

Intervention name(s): filgrastim; busulfan; cytarabine; etoposide; methotrexate; peripheral blood stem cell transplantation
Intervention type(s): Biological; Drug; Drug; Drug; Drug; Procedure
Intervention description(s): 10 microgram/kg body wt subcutaneously daily beginning on d 14 and con't until peripheral blood collection is completed; 1 mg/kg PO q 6 hrs for 16 doses on days -7 thru -4.; 2000 mg/ sq meter IV over 2 hours q 12 hrs x 8 doses on days 1-4; 40 mg/kg (total dose) IV cont infusion over 96 hrs on days 1-4 of consolidation therapy and 60 mg/kg IV over 4 hrs on day -3 of transplant; For patients with documented CNS disease at first relapse, 12 mg intrathecal for a total of 6 doses given before and/or after transplantation; Infusion on Day 0
Other intervention name(s): G-CSF; Ara-C
Intervention MeSH terms: Cytarabine; Methotrexate; Etoposide; Busulfan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adult acute myeloid leukemia in remission; adult acute erythroid leukemia (M6); adult acute myeloblastic leukemia without maturation (M1); adult acute myeloblastic leukemia with maturation (M2); adult acute promyelocytic leukemia (M3); adult acute myelomonocytic leukemia (M4); adult acute monoblastic leukemia (M5a); adult acute megakaryoblastic leukemia (M7); adult acute monocytic leukemia (M5b); adult acute minimally differentiated myeloid leukemia (M0)