Combination Chemotherapy, Bone Marrow Transplantation, and Radiation Therapy in Treating Infants With Acute Lymphoblastic Leukemia

NCT00002785 | Completed Phase 2 DMC

• 3 other identifiers: 1953CCG-1953CDR0000064841
• Study Type: interventional
• Target: N/A
• Locations: 3 countries
• Sites: 33

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. Bone marrow transplantation may allow the doctor to give higher doses of chemotherapy and kill more cancer cells. Radiation therapy uses high-energy x-rays to damage cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, bone marrow transplantation, and radiation therapy in treating infants with acute lymphoblastic leukemia.

Conditions

Leukemia

Keywords

untreated childhood acute lymphoblastic leukemia

Outcome Measures

Primary Outcomes (1)

• Event Free Survival

Interventions

filgrastim BIOLOGICAL

asparaginase DRUG

cyclophosphamide DRUG

cyclosporine DRUG

cytarabine DRUG

daunorubicin hydrochloride DRUG

dexamethasone DRUG

etoposide DRUG

leucovorin calcium DRUG

mercaptopurine DRUG

mesna DRUG

methotrexate DRUG

methylprednisolone DRUG

pegaspargase DRUG

prednisone DRUG

therapeutic hydrocortisone DRUG

vincristine sulfate DRUG

allogeneic bone marrow transplantation PROCEDURE

low-LET cobalt-60 gamma ray therapy RADIATION

low-LET photon therapy RADIATION

Eligibility Criteria

• Age: Up to 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

DISEASE CHARACTERISTICS: Histologically confirmed acute lymphoblastic leukemia (ALL) in infants under 12 months of age at diagnosis Adequate bone marrow and/or peripheral blood specimens with blasts available No prior treatment for ALL except emergency therapy for the following: Blast cell crisis Superior vena cava syndrome Renal failure due to leukemic infiltration of the kidneys PATIENT CHARACTERISTICS: See General Eligibility Criteria

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 (33)

Long Beach Memorial Medical Center

Long Beach, California, 90806, United States

Location

Children's Hospital Los Angeles

Los Angeles, California, 90027-0700, United States

Location

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

Children's Hospital of Orange County

Orange, California, 92668, United States

Location

UCSF Cancer Center and Cancer Research Institute

San Francisco, California, 94115-0128, United States

Location

Children's Hospital of Denver

Denver, Colorado, 80218, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010-2970, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637, United States

Location

Indiana University Cancer Center

Indianapolis, Indiana, 46202-5265, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0752, United States

Location

University of Minnesota Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

Children's Mercy Hospital - Kansas City

Kansas City, Missouri, 64108, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198-3330, United States

Location

Kaplan Cancer Center

New York, New York, 10016, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Herbert Irving Comprehensive Cancer Center

New York, New York, 10032, United States

Location

Lineberger Comprehensive Cancer Center, UNC

Chapel Hill, North Carolina, 27599-7295, United States

Location

Children's Hospital Medical Center - Cincinnati

Cincinnati, Ohio, 45229-3039, United States

Location

Ireland Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

Children's Hospital of Columbus

Columbus, Ohio, 43205-2696, United States

Location

Doernbecher Children's Hospital

Portland, Oregon, 97201-3098, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Vanderbilt Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84132, United States

Location

Children's Hospital and Regional Medical Center - Seattle

Seattle, Washington, 98105, United States

Location

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792, United States

Location

Princess Margaret Hospital for Children

Perth, Western Australia, 6001, Australia

Location

British Columbia Children's Hospital

Vancouver, British Columbia, V6H 3V4, Canada

Location

IWK Grace Health Centre

Halifax, Nova Scotia, B3J 3G9, Canada

Location

Related Publications (5)

• Dreyer ZE, Dinndorf PA, Camitta B, Sather H, La MK, Devidas M, Hilden JM, Heerema NA, Sanders JE, McGlennen R, Willman CL, Carroll AJ, Behm F, Smith FO, Woods WG, Godder K, Reaman GH. Analysis of the role of hematopoietic stem-cell transplantation in infants with acute lymphoblastic leukemia in first remission and MLL gene rearrangements: a report from the Children's Oncology Group. J Clin Oncol. 2011 Jan 10;29(2):214-22. doi: 10.1200/JCO.2009.26.8938. Epub 2010 Dec 6.

  PMID: 21135279 BACKGROUND

• Nguyen K, Devidas M, Cheng SC, La M, Raetz EA, Carroll WL, Winick NJ, Hunger SP, Gaynon PS, Loh ML; Children's Oncology Group. Factors influencing survival after relapse from acute lymphoblastic leukemia: a Children's Oncology Group study. Leukemia. 2008 Dec;22(12):2142-50. doi: 10.1038/leu.2008.251. Epub 2008 Sep 25.

  PMID: 18818707 BACKGROUND

• Salzer W, Dinndorf P, Dreyer Z, Hilden J, Reaman GH. Analysis of infectious complications in infants with acute lymphoblastic leukemia treated on the Children's Cancer Group Protocol 1953: a report from the Children's Oncology Group. J Pediatr Hematol Oncol. 2009 Jun;31(6):398-405. doi: 10.1097/MPH.0b013e3181a6dec0.

  PMID: 19648788 RESULT

• Robinson BW, Cao K, Hilden JM, et al.: Age is the strongest determinant of leukemia blast cell gene expression in MLL-rearranged infant ALL and MLL-AF4 directs a distinct gene expression profile related to CNS disease. [Abstract] Blood 112 (11): A-1200, 2008.

  RESULT

• Hilden JM, Dinndorf PA, Meerbaum SO, Sather H, Villaluna D, Heerema NA, McGlennen R, Smith FO, Woods WG, Salzer WL, Johnstone HS, Dreyer Z, Reaman GH; Children's Oncology Group. Analysis of prognostic factors of acute lymphoblastic leukemia in infants: report on CCG 1953 from the Children's Oncology Group. Blood. 2006 Jul 15;108(2):441-51. doi: 10.1182/blood-2005-07-3011. Epub 2006 Mar 23.

  PMID: 16556894 RESULT

MeSH Terms

Conditions

Leukemia

Interventions

Filgrastim; Asparaginase; Cyclophosphamide; Cyclosporine; Cytarabine; Daunorubicin; Dexamethasone; Etoposide; Leucovorin; Mercaptopurine; Mesna; Methotrexate; Methylprednisolone; pegaspargase; Prednisone; Hydrocortisone; Vincristine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; 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; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic 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; Aminoglycosides; Glycosides; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Sulfhydryl Compounds; Sulfur Compounds; Purines; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Sulfonic Acids; Sulfur Acids; Aminopterin; Prednisolone; Pregnadienediols; Pregnenediones; Pregnenes; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines

Study Officials

• Patricia A. Dinndorf, MD

  Children's National Research Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: June 16, 2004
• Study Start: July 1, 1996
• Primary Completion: August 1, 2000
• Study Completion: March 1, 2007
• Last Updated: July 24, 2014

Record last verified: 2014-07

Locations

CA (2); US (30); AU (1)