Combination Chemotherapy in Treating Pediatric Patients With Advanced-Stage Large Cell Lymphoma

NCT00002618 | Completed Phase 3 DMC

• 3 other identifiers: 9315POG-9315CDR0000063955
• Study Type: interventional
• Target: 242
• Locations: 3 countries
• Sites: 10

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Giving the drugs in different doses may kill more cancer cells. PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy with various combinations of drugs in treating pediatric patients with advanced-stage large cell lymphoma.

Conditions

Lymphoma

Keywords

childhood diffuse large cell lymphoma; childhood immunoblastic large cell lymphoma; AIDS-related peripheral/systemic lymphoma; AIDS-related diffuse large cell lymphoma; AIDS-related immunoblastic large cell lymphoma; AIDS-related diffuse mixed cell lymphoma; stage III childhood large cell lymphoma; stage IV childhood large cell lymphoma

Outcome Measures

Primary Outcomes (1)

• Event free survival

  To study whether intermediate-dose methotrexate/high-dose Ara-C (ID MTX/HDAra-C), administered during the maintenance phase can improve the event free survival (EFS) of patients with advanced-stage large cell lymphoma (LCL).

  Length of study

Study Arms (2)

Regimen A

ACTIVE COMPARATOR

Patients begin radiotherapy (5 days a week for 4.5 weeks) to residual tumor on day 1 of maintenance.

Biological: filgrastim; Drug: cytarabine; Drug: doxorubicin hydrochloride; Drug: leucovorin calcium; Drug: mercaptopurine; Drug: methotrexate; Drug: prednisone; Drug: vincristine sulfate; Radiation: low-LET cobalt-60 gamma ray therapy; Radiation: low-LET electron therapy; Radiation: low-LET photon therapy

Regimen B

ACTIVE COMPARATOR

Patients receive whole brain irradiation (5 days a week for 3.1 weeks) beginning on day 1 of maintenance. Patients are followed monthly for 6 months, every 3 months for 18 months, every 6 months for 3 years, and annually thereafter.

Biological: filgrastim; Drug: cytarabine; Drug: doxorubicin hydrochloride; Drug: leucovorin calcium; Drug: mercaptopurine; Drug: methotrexate; Drug: prednisone; Drug: vincristine sulfate; Radiation: low-LET cobalt-60 gamma ray therapy; Radiation: low-LET electron therapy; Radiation: low-LET photon therapy

Interventions

filgrastim BIOLOGICAL

Also known as: rmetHuG-CSF, G-CSF, Neupogen, NSC #614629

Regimen A; Regimen B

cytarabine DRUG

Also known as: CYTOSINE ARABINOSIDE, Ara-C, Cytosar, NSC #63878

Regimen A; Regimen B

doxorubicin hydrochloride DRUG

Also known as: Adriamycin, NSC #123127

Regimen A; Regimen B

leucovorin calcium DRUG

Also known as: LCV, Wellcovorin, citrovorum factor, folinic acid, NSC #3590

Regimen A; Regimen B

mercaptopurine DRUG

Also known as: 6-MP, Purinethol, NSC #755

Regimen A; Regimen B

methotrexate DRUG

Also known as: amethopterin, NSC #740

Regimen A; Regimen B

prednisone DRUG

Also known as: Deltasone, Meticorten, Liquid Pred, NSC #10023

Regimen A; Regimen B

vincristine sulfate DRUG

Also known as: VCR, Oncovin, NSC #67574

Regimen A; Regimen B

low-LET cobalt-60 gamma ray therapy RADIATION

Regimen A; Regimen B

low-LET electron therapy RADIATION

Regimen A; Regimen B

low-LET photon therapy RADIATION

Regimen A; Regimen B

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Previously untreated large cell lymphoma, including the following histologic designations: Rappaport classification Diffuse histiocytic Mixed lymphocytic-histiocytic Working Formulation classification Diffuse large cell, cleaved and/or noncleaved Immunoblastic Diffuse, mixed small and large cell Lukes-Collins classification Diffuse large cleaved Diffuse large noncleaved Immunoblastic T or B cell True histiocytic Updated Kiel classification Cytocentric large cell Centroblastic-centrocytic T-zone Lymphoepithelioid cell (Lennert's) Immunoblastic T or B cell Large cell anaplastic Pleomorphic Centroblastic-centrocytic, diffuse Malignant histiocytosis Murphy stage III/IV HIV-associated lymphoma eligible Any degree of bone marrow involvement eligible CNS disease eligible (such patients not randomized) PATIENT CHARACTERISTICS: Age: Under 22 Performance status: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant or nursing Adequate contraception required of fertile patients 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 (10)

Via Christi Regional Medical Center-Saint Francis Campus

Wichita, Kansas, 67214, United States

Location

MBCCOP - LSU Medical Center

New Orleans, Louisiana, 70112, United States

Location

Memorial Mission Hospital

Asheville, North Carolina, 28801, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425-0721, United States

Location

Medical City Dallas Hospital

Dallas, Texas, 75230, United States

Location

San Antonio Military Pediatric Cancer and Blood Disorders Center

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

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78284, United States

Location

Cancer Center, University of Virginia HSC

Charlottesville, Virginia, 22908, United States

Location

University of Puerto Rico School of Medicine Medical Sciences Campus

San Juan, 00936-5067, Puerto Rico

Location

Clinique de Pediatrie

Geneva, 1211, Switzerland

Location

Related Publications (4)

• Hutchison RE, Laver JH, Chang M, Muzzafar T, Desai S, Murphy S, Schwenn M, Shuster J, Link MP; Children's Oncology Group. Non-anaplastic peripheral t-cell lymphoma in childhood and adolescence: a Children's Oncology Group study. Pediatr Blood Cancer. 2008 Jul;51(1):29-33. doi: 10.1002/pbc.21543.

  PMID: 18300314 BACKGROUND

• Hutchison RE, Finch C, Kepner J, Fuller C, Bowman P, Link M, Schwenn M, Laver J, Desai S, Barrett D, Murphy SB. Burkitt lymphoma is immunophenotypically different from Burkitt-like lymphoma in young persons. Ann Oncol. 2000;11 Suppl 1:35-8.

  PMID: 10707776 BACKGROUND

• Nasr MR, Laver JH, Chang M, Hutchison RE. Expression of anaplastic lymphoma kinase, tyrosine-phosphorylated STAT3, and associated factors in pediatric anaplastic large cell lymphoma: A report from the children's oncology group. Am J Clin Pathol. 2007 May;127(5):770-8. doi: 10.1309/FNY8Y4H6PK1V2MGE.

  PMID: 17439836 RESULT

• Laver JH, Kraveka JM, Hutchison RE, Chang M, Kepner J, Schwenn M, Tarbell N, Desai S, Weitzman S, Weinstein HJ, Murphy SB. Advanced-stage large-cell lymphoma in children and adolescents: results of a randomized trial incorporating intermediate-dose methotrexate and high-dose cytarabine in the maintenance phase of the APO regimen: a Pediatric Oncology Group phase III trial. J Clin Oncol. 2005 Jan 20;23(3):541-7. doi: 10.1200/JCO.2005.11.075.

  PMID: 15659500 RESULT

MeSH Terms

Conditions

Lymphoma; Lymphoma, Large B-Cell, Diffuse; Dendritic Cell Sarcoma, Interdigitating

Interventions

Filgrastim; pegfilgrastim; Granulocyte Colony-Stimulating Factor; Cytarabine; Doxorubicin; Leucovorin; Mercaptopurine; Methotrexate; Prednisone; Vincristine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Histiocytic Disorders, Malignant; Histiocytosis

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; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Sulfhydryl Compounds; Sulfur Compounds; Purines; Aminopterin; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines

Study Officials

• Joseph H. Laver, MD

  Medical University of South Carolina

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: July 29, 2004
• Study Start: December 1, 1994
• Primary Completion: September 1, 2000
• Study Completion: September 1, 2006
• Last Updated: July 24, 2014

Record last verified: 2014-07

Locations

US (8); PR (1); CH (1)