Combination Chemotherapy in Treating Children With Very High Risk Acute Lymphocytic Leukemia

NCT00003783 | Completed Phase 2 DMC

• 3 other identifiers: 9806POG-9806CDR0000066915
• Study Type: interventional
• Target: 36
• Locations: 5 countries
• Sites: 58

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 and combining drugs in different ways may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of chemotherapy in treating children who have very high risk acute lymphocytic leukemia.

Conditions

Leukemia

Keywords

untreated childhood acute lymphoblastic leukemia; L1 childhood acute lymphoblastic leukemia; L2 childhood acute lymphoblastic leukemia; B-cell childhood acute lymphoblastic leukemia

Outcome Measures

Primary Outcomes (1)

• Assess the feasibility of delivering a new combination of agents during a 20 week post-induction consolidation phase

  20 weeks

Study Arms (2)

Complete Response and no CNS 3

EXPERIMENTAL

See detailed description.

Biological: filgrastim; Drug: asparaginase; Drug: cyclophosphamide; Drug: cytarabine; Drug: daunorubicin hydrochloride; Drug: dexamethasone; Drug: etoposide; Drug: idarubicin; Drug: leucovorin calcium; Drug: mercaptopurine; Drug: methotrexate; Drug: prednisone; Drug: vincristine sulfate; Radiation: radiation therapy

Complete Response and CNS 3

EXPERIMENTAL

See detailed description.

Biological: filgrastim; Drug: asparaginase; Drug: cyclophosphamide; Drug: cytarabine; Drug: daunorubicin hydrochloride; Drug: dexamethasone; Drug: etoposide; Drug: idarubicin; Drug: leucovorin calcium; Drug: mercaptopurine; Drug: methotrexate; Drug: prednisone; Drug: vincristine sulfate; Radiation: radiation therapy

Interventions

filgrastim BIOLOGICAL

Also known as: G-CSF

Complete Response and CNS 3; Complete Response and no CNS 3

asparaginase DRUG

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

Complete Response and CNS 3; Complete Response and no CNS 3

cyclophosphamide DRUG

Also known as: CTX, Cytoxan, NSC #026271

Complete Response and CNS 3; Complete Response and no CNS 3

cytarabine DRUG

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

Complete Response and CNS 3; Complete Response and no CNS 3

daunorubicin hydrochloride DRUG

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

Complete Response and CNS 3; Complete Response and no CNS 3

dexamethasone DRUG

Also known as: Decadron, NSC #034521

Complete Response and CNS 3; Complete Response and no CNS 3

etoposide DRUG

Also known as: VP-16, VePesid, NSC #141540

Complete Response and CNS 3; Complete Response and no CNS 3

idarubicin DRUG

Also known as: 4-demethoxydaunorubicin, Idamycin, NSC #256439

Complete Response and CNS 3; Complete Response and no CNS 3

leucovorin calcium DRUG

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

Complete Response and CNS 3; Complete Response and no CNS 3

mercaptopurine DRUG

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

Complete Response and CNS 3; Complete Response and no CNS 3

methotrexate DRUG

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

Complete Response and CNS 3; Complete Response and no CNS 3

prednisone DRUG

Also known as: Deltasone, Meticorten, Liquid Pred, NSC #010023

Complete Response and CNS 3; Complete Response and no CNS 3

vincristine sulfate DRUG

Also known as: VCR, Oncovin, NSC #067574

Complete Response and CNS 3; Complete Response and no CNS 3

radiation therapy RADIATION

Complete Response and CNS 3; Complete Response and no CNS 3

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Newly diagnosed B-cell precursor acute lymphocytic leukemia No L3 morphology Very poor prognosis CNS 3 (blasts and WBC greater than 5 microliters) OR Must meet all of the following criteria: No simultaneous trisomy 4 and 10 DNA index no greater than 1.16 (if FISH 4 and 10 unsatisfactory) No TEL-AML1 \[t(12;21)\] Meets at least 1 of the following: Has MLL (11q23) and/or BCR-ABL \[t(9;22)\] WBC greater than 100,000/mm3 Age over 12 (boys) or 16 (girls) OR Boys Girls WBC 8 12 greater than 80,000/mm3 9 13 greater than 60,000/mm3 10 14 greater than 40,000/mm3 11 15 greater than 20,000/mm3 Concurrent registration on stratum 6 of POG-9400 before 11/15/1999 OR Concurrent registration on stratum 4 of POG-9900 after 11/15/1999 Concurrent registration on POG-9201, POG-9705, or POG-9806 unless ineligible PATIENT CHARACTERISTICS: Age: Children Performance status: Not specified Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Not specified Renal: Not specified PRIOR CONCURRENT THERAPY: See Disease Characteristics

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 (58)

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

Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida, 33140, 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

Hope Children's Hospital

Oak Lawn, Illinois, 60453, United States

Location

Saint Jude Midwest Affiliate

Peoria, Illinois, 61602, United States

Location

Via Christi Regional Medical Center

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, 11790-7775, 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, 77555-0209, 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 Community 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; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Filgrastim; Granulocyte Colony-Stimulating Factor; Asparaginase; Cyclophosphamide; Cytarabine; Daunorubicin; Dexamethasone; Calcium Dobesilate; Etoposide; Idarubicin; Leucovorin; Mercaptopurine; Methotrexate; Prednisone; Vincristine; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

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; 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; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Sulfhydryl Compounds; Purines; Aminopterin; Pregnadienediols; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines; Therapeutics

Study Officials

• William P. Bowman, MD

  Cook Children's Medical Center - Fort Worth

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: April 27, 2004
• Study Start: March 1, 1999
• Primary Completion: November 1, 2002
• Study Completion: March 1, 2007
• Last Updated: July 28, 2014

Record last verified: 2014-07

Locations

US (51); PR (1); CH (1); CA (4); NL (1)