Combination Chemotherapy in Treating Pediatric Patients With Advanced-Stage Large Cell Lymphoma
NCT ID: NCT00002618
Last Updated: 2014-07-24
Study Results
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Basic Information
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COMPLETED
PHASE3
242 participants
INTERVENTIONAL
1994-12-31
2006-09-30
Brief Summary
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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.
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Detailed Description
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OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms, except for those with CNS disease. These patients are assigned to arm II and receive whole brain irradiation on Regimen B. Arm I: Induction (Modified APO): Patients receive vincristine IV on days 1, 8, 15, 22, and 29, doxorubicin IV over 15 minutes on days 1 and 22, prednisone three times a day on days 1-28, and methotrexate intrathecally (IT) on days 1, 8, and 22. Patients in complete remission on day 43 proceed to maintenance, those in partial remission undergo biopsy then proceed to maintenance, and those with residual disease receive radiotherapy on regimen A concurrently with maintenance. Maintenance (day 1 is day 43 of Induction): Courses of intermediate dose methotrexate/leucovorin calcium and high dose cytarabine (ID MTX/CF/HD ARA-C) and modified APO alternate every 3 weeks. Patients receive a total of 15 courses (8 of ID MTX/CF/HD ARA-C and 7 of Modified APO). ID MTX/CF/HD ARA-C: Patients receive methotrexate IV over 24 hours on day 1, leucovorin calcium IV or orally every 6 hours on days 2 and 3, cytarabine IV over 48 hours on days 2 to 4, and methotrexate IT on day 1 of courses 1, 3, and 5. Filgrastim (G-CSF) is administered beginning on day 5 and continuing until blood counts recover. Modified APO: Patients receive vincristine IV on day 1, oral mercaptopurine on days 1-5, doxorubicin IV over 15 minutes on day 1, and oral prednisone three times a day on days 1-5. Arm II: Induction: Patients receive treatment as in arm I except that patients with CNS disease also receive methotrexate IT on days 15, 29, and 36. Maintenance (day 1 is day 43 of Induction): Modified APO: as in Arm I, with methotrexate administered on day 1 of courses 1, 3, and 5 (days 1-5 for patients with CNS disease). Courses repeat every 21 days for a total of 15 courses. Patients with CNS disease begin radiotherapy on Regimen B on week 2 of maintenance. Regimen A: Patients begin radiotherapy (5 days a week for 4.5 weeks) to residual tumor on day 1 of maintenance. Regimen B: 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.
PROJECTED ACCRUAL: A total of 242 patients will be accrued for this study over approximately 5.4 years.
Conditions
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Study Design
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RANDOMIZED
TREATMENT
Study Groups
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Regimen A
Patients begin radiotherapy (5 days a week for 4.5 weeks) to residual tumor on day 1 of maintenance.
filgrastim
cytarabine
doxorubicin hydrochloride
leucovorin calcium
mercaptopurine
methotrexate
prednisone
vincristine sulfate
low-LET cobalt-60 gamma ray therapy
low-LET electron therapy
low-LET photon therapy
Regimen B
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.
filgrastim
cytarabine
doxorubicin hydrochloride
leucovorin calcium
mercaptopurine
methotrexate
prednisone
vincristine sulfate
low-LET cobalt-60 gamma ray therapy
low-LET electron therapy
low-LET photon therapy
Interventions
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filgrastim
cytarabine
doxorubicin hydrochloride
leucovorin calcium
mercaptopurine
methotrexate
prednisone
vincristine sulfate
low-LET cobalt-60 gamma ray therapy
low-LET electron therapy
low-LET photon therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
PRIOR CONCURRENT THERAPY: No prior therapy
21 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Children's Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Joseph H. Laver, MD
Role: STUDY_CHAIR
Medical University of South Carolina
Locations
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Via Christi Regional Medical Center-Saint Francis Campus
Wichita, Kansas, United States
MBCCOP - LSU Medical Center
New Orleans, Louisiana, United States
Memorial Mission Hospital
Asheville, North Carolina, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Medical City Dallas Hospital
Dallas, Texas, United States
San Antonio Military Pediatric Cancer and Blood Disorders Center
Lackland Air Force Base, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Cancer Center, University of Virginia HSC
Charlottesville, Virginia, United States
University of Puerto Rico School of Medicine Medical Sciences Campus
San Juan, , Puerto Rico
Clinique de Pediatrie
Geneva, , Switzerland
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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POG-9315
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000063955
Identifier Type: OTHER
Identifier Source: secondary_id
9315
Identifier Type: -
Identifier Source: org_study_id
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