Combination Chemotherapy Followed by Melphalan and Peripheral Stem Cell Transplantation in Treating Children With Newly Diagnosed Acute Myeloid Leukemia

NCT00004056 | Completed Phase 1 DMC

• 3 other identifiers: 9822POG-9822CDR0000067253
• Study Type: interventional
• Target: 35
• Locations: 2 countries
• Sites: 20

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.

Conditions

Leukemia

Keywords

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)

Outcome Measures

Primary Outcomes (2)

• Feasibility and toxicity of an intensive regimen that uses timed-sequential therapy

  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.

  Length of study

• Feasibility and toxicity of a single high dose of melphalan with peripheral stem cell rescue

  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.

  Length of study

Secondary Outcomes (1)

• Make observations regarding PCR evidence of Minimal Residual Disease

  Length of study

Study Arms (1)

Chemo + STEM cell

EXPERIMENTAL

See detailed description.

Biological: filgrastim; Drug: asparaginase; Drug: cytarabine; Drug: daunorubicin hydrochloride; Drug: melphalan; Drug: thioguanine; Procedure: peripheral blood stem cell transplantation

Interventions

filgrastim BIOLOGICAL

Also known as: Granulocyte Colony-Stimulating Factor, r-metHuG-CSF, GCSF, Neupogen®, NSC #614629

Chemo + STEM cell

asparaginase DRUG

Also known as: E. coli, Elspar, NSC #109229

Chemo + STEM cell

cytarabine DRUG

Also known as: cytosine arabinoside, AraC, Cytosar, NSC #063878

Chemo + STEM cell

daunorubicin hydrochloride DRUG

Also known as: daunomycin, DNR, Cerubidine, NSC #82151

Chemo + STEM cell

melphalan DRUG

Also known as: L-phenylalanine mustard, L-PAM, L-sarcolysin, Alkeran, NSC #008806

Chemo + STEM cell

thioguanine DRUG

Also known as: 6-thioguanine, 6-TG, NSC #000752

Chemo + STEM cell

peripheral blood stem cell transplantation PROCEDURE

Chemo + STEM cell

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Children's Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (20)

University of Alabama Comprehensive Cancer Center

Birmingham, Alabama, 35294, United States

Location

Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Lucile Packard Children's Hospital at Stanford

Palo Alto, California, 94304, United States

Location

Children's Hospital and Health Center

San Diego, California, 92123-4282, United States

Location

Nemours Children's Clinic

Jacksonville, Florida, 32207, United States

Location

Emory University Hospital - Atlanta

Atlanta, Georgia, 30322, United States

Location

Children's Memorial Hospital, Chicago

Chicago, Illinois, 60614, United States

Location

Maine Children's Cancer Program

Scarborough, Maine, 04074, United States

Location

Johns Hopkins Oncology Center

Baltimore, Maryland, 21231, United States

Location

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

Children's Hospital of Michigan

Detroit, Michigan, 48201, United States

Location

Cardinal Glennon Children's Hospital

St Louis, Missouri, 63104, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Tomorrows Children's Institute

Hackensack, New Jersey, 07601, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Simmons Cancer Center - Dallas

Dallas, Texas, 75235-9154, United States

Location

Cook Children's Medical Center - Fort Worth

Fort Worth, Texas, 76104, United States

Location

Midwest Children's Cancer Center

Milwaukee, Wisconsin, 53226, United States

Location

Montreal Children's Hospital

Montreal, Quebec, H3H 1P3, Canada

Location

Related Publications (1)

• Hurwitz CA, Chang M, Graham M, et al.: Timed-sequential remission induction and intensification followed by stem cell rescue for childhood AML -a POG pilot study. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-1553, 2002.

  RESULT

MeSH Terms

Conditions

Leukemia; Leukemia, Monocytic, Acute

Interventions

Filgrastim; Granulocyte Colony-Stimulating Factor; Asparaginase; Cytarabine; Daunorubicin; Melphalan; Thioguanine; Peripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid, Acute; Leukemia, Myeloid

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Amidohydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• Craig A. Hurwitz, MD

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 1999
• First Posted: May 20, 2004
• Study Start: October 1, 1999
• Primary Completion: October 1, 2002
• Study Completion: March 1, 2007
• Last Updated: July 28, 2014

Record last verified: 2014-07

Locations

US (19); CA (1)