Combination Chemotherapy Followed by Melphalan and Peripheral Stem Cell Transplantation in Treating Children With Newly Diagnosed Acute Myeloid Leukemia
Information source: Children's Oncology Group
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Leukemia
Intervention: filgrastim (Biological); asparaginase (Drug); cytarabine (Drug); daunorubicin hydrochloride (Drug); melphalan (Drug); thioguanine (Drug); peripheral blood stem cell transplantation (Procedure)
Phase: Phase 1
Status: Completed
Sponsored by: Children's Oncology Group Official(s) and/or principal investigator(s): Craig A. Hurwitz, MD, Study Chair, Affiliation: Maine Children's Cancer Program at Barbara Bush Children's Hospital
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.
Clinical Details
Official title: 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
Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Feasibility and toxicity of an intensive regimen that uses timed-sequential therapyFeasibility and toxicity of a single high dose of melphalan with peripheral stem cell rescue
Secondary outcome: Make observations regarding PCR evidence of Minimal Residual Disease
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.
Eligibility
Minimum age: N/A.
Maximum age: 21 Years.
Gender(s): Both.
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
Locations and Contacts
University of Alabama Comprehensive Cancer Center, Birmingham, Alabama 35294, United States
Arizona Cancer Center, Tucson, Arizona 85724, United States
University of Arkansas for Medical Sciences, Little Rock, Arkansas 72205, United States
Lucile Packard Children's Hospital at Stanford, Palo Alto, California 94304, United States
Children's Hospital and Health Center, San Diego, California 92123-4282, United States
Nemours Children's Clinic, Jacksonville, Florida 32207, United States
Emory University Hospital - Atlanta, Atlanta, Georgia 30322, United States
Children's Memorial Hospital, Chicago, Chicago, Illinois 60614, United States
Maine Children's Cancer Program, Scarborough, Maine 04074, United States
Johns Hopkins Oncology Center, Baltimore, Maryland 21231, United States
Massachusetts General Hospital Cancer Center, Boston, Massachusetts 02114, United States
Children's Hospital of Michigan, Detroit, Michigan 48201, United States
Cardinal Glennon Children's Hospital, Saint Louis, Missouri 63104, United States
Hackensack University Medical Center, Hackensack, New Jersey 07601, United States
Tomorrows Children's Institute, Hackensack, New Jersey 07601, United States
Mount Sinai School of Medicine, New York, New York 10029, United States
Montreal Children's Hospital, Montreal, Quebec H3H 1P3, Canada
Simmons Cancer Center - Dallas, Dallas, Texas 75235-9154, United States
Cook Children's Medical Center - Fort Worth, Fort Worth, Texas 76104, United States
Midwest Children's Cancer Center, Milwaukee, Wisconsin 53226, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: October 1999
Last updated: July 24, 2014
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