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Treatment of Newly Diagnosed Childhood AML Using a Timed-Sequential Remission Induction and Consolidation Followed by Single Dose Melphalan With Peripheral Stem Cell Rescue: A POG Pilot Study


Phase 1
N/A
21 Years
Open (Enrolling)
Both
Leukemia

Thank you

Trial Information

Treatment of Newly Diagnosed Childhood AML Using a Timed-Sequential Remission Induction and Consolidation Followed by Single Dose Melphalan With Peripheral Stem Cell Rescue: A POG Pilot Study


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.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically proven, previously untreated primary acute myeloid
leukemia (AML) Isolated granulocytic sarcoma (myeloblastoma) allowed Patients with
cytopenias and bone marrow blasts greater than 5% but less than 30% eligible only if there
is karyotypic abnormality characteristic of de novo AML (t(8;21), inv16, t(9;11), etc.) OR
unequivocal presence of megakaryoblasts No acute promyelocytic leukemia (M3) No Down
syndrome

PATIENT CHARACTERISTICS: Age: 21 and under Performance status: Not specified Life
expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than
3 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL Uric acid no
greater than 8.0 mg/dL Cardiovascular: Cardiac function normal by echocardiogram
Pulmonary: No uncontrolled, life threatening pneumonia Other: No uncontrolled, life
threatening sepsis or meningitis Not pregnant Fertile patients must use effective
contraception

PRIOR CONCURRENT THERAPY: No prior therapy

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Craig A. Hurwitz, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Maine Children's Cancer Program at Barbara Bush Children's Hospital

Authority:

United States: Federal Government

Study ID:

CDR0000067253

NCT ID:

NCT00004056

Start Date:

October 1999

Completion Date:

Related Keywords:

  • Leukemia
  • untreated childhood acute myeloid leukemia and other myeloid malignancies
  • childhood acute monoblastic leukemia and acute monocytic leukemia (M5)
  • childhood acute myeloblastic leukemia without maturation (M1)
  • childhood acute myeloblastic leukemia with maturation (M2)
  • childhood acute myelomonocytic leukemia (M4)
  • childhood acute erythroleukemia (M6)
  • childhood acute megakaryocytic leukemia (M7)
  • childhood acute minimally differentiated myeloid leukemia (M0)
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location

Arizona Cancer CenterTucson, Arizona  85724
University of Alabama Comprehensive Cancer CenterBirmingham, Alabama  35294
Emory University Hospital - AtlantaAtlanta, Georgia  30322
Johns Hopkins Oncology CenterBaltimore, Maryland  21287
Simmons Cancer Center - DallasDallas, Texas  75235-9154
Children's Hospital of MichiganDetroit, Michigan  48201
Tomorrows Children's InstituteHackensack, New Jersey  07601
Mount Sinai School of MedicineNew York, New York  10029
Midwest Children's Cancer CenterMilwaukee, Wisconsin  53226
Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Hackensack University Medical CenterHackensack, New Jersey  07601
Nemours Children's ClinicJacksonville, Florida  32207
Maine Children's Cancer ProgramScarborough, Maine  04074-9308
Cardinal Glennon Children's HospitalSaint Louis, Missouri  63104
Cook Children's Medical Center - Fort WorthFort Worth, Texas  76104
Lucile Packard Children's Hospital at StanfordPalo Alto, California  94304
Children's Hospital and Health CenterSan Diego, California  92123-4282
Children's Memorial Hospital, ChicagoChicago, Illinois  60614