Combination Chemotherapy in Treating Children With Newly Diagnosed Acute Lymphocytic Leukemia

NCT00003671 | Completed Phase 2 DMC

• 3 other identifiers: 9705POG-9705CDR0000066768
• Study Type: interventional
• Target: 59
• Locations: 5 countries
• Sites: 57

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating children who have newly diagnosed acute lymphocytic leukemia.

Conditions

Leukemia

Keywords

untreated childhood acute lymphoblastic leukemia; B-cell childhood acute lymphoblastic leukemia

Outcome Measures

Primary Outcomes (1)

• Event-free survival

  7 years

Study Arms (1)

Chemotherapy Treatment

EXPERIMENTAL

See detailed description.

Drug: asparaginase; Drug: cyclophosphamide; Drug: cytarabine; Drug: daunorubicin hydrochloride; Drug: dexamethasone; Drug: leucovorin calcium; Drug: mercaptopurine; Drug: methotrexate; Drug: thioguanine; Drug: vincristine sulfate

Interventions

asparaginase DRUG

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

Chemotherapy Treatment

cyclophosphamide DRUG

Also known as: CTX, Cytoxan, NSC #026271, IND #7089

Chemotherapy Treatment

cytarabine DRUG

Also known as: cytosine arabinoside, Ara-C, Cytosar, NSC #063878

Chemotherapy Treatment

daunorubicin hydrochloride DRUG

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

Chemotherapy Treatment

dexamethasone DRUG

Also known as: Decadron, NSC #034521

Chemotherapy Treatment

leucovorin calcium DRUG

Also known as: LCV, Wellcovorin, citrovorum factor, folinic acid, NSC #003590

Chemotherapy Treatment

mercaptopurine DRUG

Also known as: 6-MP, Purinethol, NSC #000755

Chemotherapy Treatment

methotrexate DRUG

Also known as: MTX, amethopterin, NSC #000740, IND #4291

Chemotherapy Treatment

thioguanine DRUG

Also known as: 6-thioguanine, 6-TG, NSC #752

Chemotherapy Treatment

vincristine sulfate DRUG

Also known as: VCR, Oncovin, NSC #067574, IND #7161

Chemotherapy Treatment

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically newly diagnosed early B-cell or B-precursor or B-progenitor acute lymphocytic leukemia Prior registration on POG-9400, stratum 6 for induction therapy Average prognosis (neither very good nor very poor) PATIENT CHARACTERISTICS: Age: Children Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: No prior therapy other than on POG-9400

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 (57)

Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

Lucile Packard Children's Hospital at Stanford

Palo Alto, California, 94304, United States

Location

Sutter Cancer Center

Sacramento, California, 95816, United States

Location

Kaiser Permanente-Southern California Permanente Medical Group

San Diego, California, 92120, United States

Location

Naval Medical Center - San Diego

San Diego, California, 92134-3202, United States

Location

Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California, 95051-5386, United States

Location

Nemours Children's Clinic

Jacksonville, Florida, 32207, United States

Location

Sylvester Cancer Center, University of Miami

Miami, Florida, 33136, United States

Location

Baptist Hospital of Miami

Miami, Florida, 33176-2197, United States

Location

Walt Disney Memorial Cancer Institute

Orlando, Florida, 32803, United States

Location

St. Mary's Hospital

West Palm Beach, Florida, 33407, United States

Location

Emory University Hospital - Atlanta

Atlanta, Georgia, 30322, United States

Location

Tripler Army Medical Center

Honolulu, Hawaii, 96859-5000, United States

Location

Rush-Presbyterian-St. Luke's Medical Center

Chicago, Illinois, 60612, United States

Location

Children's Memorial Hospital, Chicago

Chicago, Illinois, 60614, United States

Location

Christ Hospital

Oak Lawn, Illinois, 60453, United States

Location

Saint Jude Midwest Affiliate

Peoria, Illinois, 61602, United States

Location

Via Christi Regional Medical Center-Saint Francis Campus

Wichita, Kansas, 67214, United States

Location

Tulane University School of Medicine

New Orleans, Louisiana, 70112, United States

Location

Eastern Maine Medical Center

Bangor, Maine, 04401, United States

Location

Maine Children's Cancer Program

Portland, Maine, 04101, United States

Location

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

St. John's Hospital and Medical Center

Detroit, Michigan, 48236, United States

Location

Hurley Medical Center

Flint, Michigan, 48503, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216-4505, United States

Location

Keesler Medical Center - Keesler AFB

Keesler Air Force Base, Mississippi, 39534-2576, United States

Location

University of Missouri-Columbia Hospital and Clinics

Columbia, Missouri, 65212, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Norris Cotton Cancer Center

Lebanon, New Hampshire, 03756, United States

Location

University of New Mexico School of Medicine

Albuquerque, New Mexico, 87131, United States

Location

State University of New York Health Sciences Center - Stony Brook

Stony Brook, New York, 11790-9832, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

Oklahoma Memorial Hospital

Oklahoma City, Oklahoma, 73126-0307, United States

Location

Natalie Warren Bryant Cancer Center

Tulsa, Oklahoma, 74136, United States

Location

James H. Quillen College of Medicine

Johnson City, Tennessee, 37614-0622, United States

Location

Medical City Dallas Hospital

Dallas, Texas, 75230, 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

University of Texas Medical Branch

Galveston, Texas, 77555-1329, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

San Antonio Military Pediatric Cancer and Blood Disorders Center

Lackland Air Force Base, Texas, 78236-5300, United States

Location

Scott and White Clinic

Temple, Texas, 76508, United States

Location

Vermont Cancer Center

Burlington, Vermont, 05401-3498, United States

Location

Inova Fairfax Hospital

Falls Church, Virginia, 22046, United States

Location

Carilion Roanoke Memorial Hospital

Roanoke, Virginia, 24029, United States

Location

Madigan Army Medical Center

Tacoma, Washington, 98431-5000, United States

Location

West Virginia University Medical School, Charleston Division

Charleston, West Virginia, 25304, United States

Location

West Virginia University Hospitals

Morgantown, West Virginia, 26506-9162, United States

Location

St. Vincent Hospital

Green Bay, Wisconsin, 54307-3508, United States

Location

Midwest Children's Cancer Center

Milwaukee, Wisconsin, 53226, United States

Location

Alberta Children's Hospital

Calgary, Alberta, T2T 5C7, Canada

Location

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

Montreal Children's Hospital

Montreal, Quebec, H3H 1P3, Canada

Location

Centre Hospitalier de L'Universite Laval

Sainte-Foy, Quebec, GIV 4G2, Canada

Location

Academisch Ziekenhuis Groningen

Groningen, 9713 EZ, Netherlands

Location

San Jorge Childrens Hospital

Santurce, 00912, Puerto Rico

Location

Clinique de Pediatrie

Geneva, 1211, Switzerland

Location

MeSH Terms

Conditions

Leukemia

Interventions

Asparaginase; Cyclophosphamide; Cytarabine; Daunorubicin; Dexamethasone; Calcium Dobesilate; Leucovorin; Mercaptopurine; Methotrexate; Thioguanine; Vincristine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Amidohydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; 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; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Sulfhydryl Compounds; Purines; Aminopterin; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines

Study Officials

• Naomi J. Winick, MD

  Simmons Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: September 13, 2004
• Study Start: December 1, 1998
• Primary Completion: November 1, 2002
• Study Completion: February 1, 2009
• Last Updated: July 25, 2014

Record last verified: 2014-07

Locations

CH (1); NL (1); CA (4); PR (1); US (50)