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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 therapy

Feasibility 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

Page last updated: August 23, 2015

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