Combination Chemotherapy Followed by Melphalan and Peripheral Stem Cell Transplantation in Treating Children With Newly Diagnosed Acute Myeloid Leukemia
- Conditions
- Leukemia
- Interventions
- Biological: filgrastimProcedure: peripheral blood stem cell transplantation
- Registration Number
- NCT00004056
- Lead Sponsor
- Children's Oncology Group
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy drugs and kill more cancer cells.
PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy followed by melphalan and peripheral stem cell transplantation in treating children who have newly diagnosed acute myeloid leukemia that has not been treated previously.
- Detailed Description
OBJECTIVES: I. Determine the feasibility and toxicity of timed sequential remission induction and consolidation in children with newly diagnosed acute myeloid leukemia. II. Determine the feasibility and toxicity of a single high dose of melphalan with peripheral blood stem cell rescue following an intense timed sequential induction and consolidation in these children.
OUTLINE: This is a multicenter study. Remission induction: Patients receive daunorubicin IV over 15 minutes on days 1-3, cytarabine IV continuously on days 1-7, oral thioguanine daily on days 1-7, and cytarabine intrathecally (IT) on day 1. Cytarabine IV over 3 hours is administered every 12 hours on days 10-12. Filgrastim (G-CSF) is administered IV or subcutaneously (SQ) beginning on day 13 and continuing until blood counts recover. On approximately day 28, patients undergo a bone marrow aspirate and biopsy to assess response. Patients who have attained an M1 or M2a status proceed to consolidation or, if a 5/5 or 6/6 HLA matched sibling donor is available, proceed to allogeneic bone marrow transplantation. Patients with greater than 25% blasts go off study. Consolidation 1: Patients receive daunorubicin IV over 15 minutes on days 1 and 2, cytarabine IV over 3 hours every 12 hours on days 1, 2, 8, and 9, and asparaginase on days 2 and 9. G-CSF IV or SQ begins on day 10 and continues until blood counts recover. Consolidation 2: Patients receive cytarabine IV over 3 hours every 12 hours on days 1, 3, and 5. G-CSF IV or SQ begins on day 6 and continues until blood counts recover. Peripheral blood stem cells (PBSC) are collected after the second course of consolidation. Consolidation 3: Treatment is repeated as in consolidation 1. Patients who remain in morphologic remission after consolidation 3 proceed with therapy. Patients receive melphalan IV over 30 minutes on day -2, then PBSC are reinfused on day 0. G-CSF IV or SQ begins on day 1 and continues until blood counts recover. Patients are followed every 6 months for 4 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 20-30 patients will be accrued for this study within 8 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Chemo + STEM cell filgrastim See detailed description. Chemo + STEM cell daunorubicin hydrochloride See detailed description. Chemo + STEM cell peripheral blood stem cell transplantation See detailed description. Chemo + STEM cell thioguanine See detailed description. Chemo + STEM cell asparaginase See detailed description. Chemo + STEM cell cytarabine See detailed description. Chemo + STEM cell melphalan See detailed description.
- Primary Outcome Measures
Name Time Method Feasibility and toxicity of an intensive regimen that uses timed-sequential therapy Length of study To determine the feasibility and toxicity of an intensive regimen that uses timed-sequential therapy as a strategy for both remission induction and consolidation of newly diagnosed children with AML.
Feasibility and toxicity of a single high dose of melphalan with peripheral stem cell rescue Length of study To test the feasibility and toxicity of a single high dose of melphalan with peripheral stem cell rescue following an intense timed-sequential induction and consolidation.
- Secondary Outcome Measures
Name Time Method Make observations regarding PCR evidence of Minimal Residual Disease Length of study To make observations regarding PCR evidence of Minimal Residual Disease in patients with relevant specific translocations who obtain a clinical remission.
Trial Locations
- Locations (20)
University of Alabama Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
Arizona Cancer Center
🇺🇸Tucson, Arizona, United States
Nemours Children's Clinic
🇺🇸Jacksonville, Florida, United States
Children's Hospital and Health Center
🇺🇸San Diego, California, United States
Emory University Hospital - Atlanta
🇺🇸Atlanta, Georgia, United States
Maine Children's Cancer Program
🇺🇸Scarborough, Maine, United States
Children's Memorial Hospital, Chicago
🇺🇸Chicago, Illinois, United States
Massachusetts General Hospital Cancer Center
🇺🇸Boston, Massachusetts, United States
Lucile Packard Children's Hospital at Stanford
🇺🇸Palo Alto, California, United States
Johns Hopkins Oncology Center
🇺🇸Baltimore, Maryland, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Cardinal Glennon Children's Hospital
🇺🇸Saint Louis, Missouri, United States
Midwest Children's Cancer Center
🇺🇸Milwaukee, Wisconsin, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Tomorrows Children's Institute
🇺🇸Hackensack, New Jersey, United States
Simmons Cancer Center - Dallas
🇺🇸Dallas, Texas, United States
Cook Children's Medical Center - Fort Worth
🇺🇸Fort Worth, Texas, United States
Mount Sinai School of Medicine
🇺🇸New York, New York, United States
Montreal Children's Hospital
🇨🇦Montreal, Quebec, Canada
Children's Hospital of Michigan
🇺🇸Detroit, Michigan, United States