ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00002618
Recruitment Status : Completed
First Posted : July 29, 2004
Last Update Posted : July 24, 2014
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

November 1, 1999
July 29, 2004
July 24, 2014
December 1994
September 2000   (Final data collection date for primary outcome measure)
Event free survival [ Time Frame: Length of study ]
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).
Not Provided
Complete list of historical versions of study NCT00002618 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Combination Chemotherapy in Treating Pediatric Patients With Advanced-Stage Large Cell Lymphoma
A Phase III Study of Large Cell Lymphomas in Children and Adolescents: Comparison of APO vs APO + IDMTX/HDARA-C and Continuous vs Bolus Infusion of Doxorubicin

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.

OBJECTIVES: I. Compare the event free survival of children with advanced stage large cell lymphoma treated with modified APO (doxorubicin/prednisone/vincristine/mercaptopurine) with or without intermediate-dose methotrexate/high dose cytarabine as maintenance therapy following induction therapy with APO. II. Characterize further the immunophenotypic and morphologic correlates of pediatric large cell lymphoma.

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.

Interventional
Phase 3
Allocation: Randomized
Primary Purpose: Treatment
Lymphoma
  • Biological: filgrastim
    Other Names:
    • rmetHuG-CSF
    • G-CSF
    • Neupogen
    • NSC #614629
  • Drug: cytarabine
    Other Names:
    • CYTOSINE ARABINOSIDE
    • Ara-C
    • Cytosar
    • NSC #63878
  • Drug: doxorubicin hydrochloride
    Other Names:
    • Adriamycin
    • NSC #123127
  • Drug: leucovorin calcium
    Other Names:
    • LCV
    • Wellcovorin
    • citrovorum factor
    • folinic acid
    • NSC #3590
  • Drug: mercaptopurine
    Other Names:
    • 6-MP
    • Purinethol
    • NSC #755
  • Drug: methotrexate
    Other Names:
    • amethopterin
    • NSC #740
  • Drug: prednisone
    Other Names:
    • Deltasone
    • Meticorten
    • Liquid Pred
    • NSC #10023
  • Drug: vincristine sulfate
    Other Names:
    • VCR
    • Oncovin
    • NSC #67574
  • Radiation: low-LET cobalt-60 gamma ray therapy
  • Radiation: low-LET electron therapy
  • Radiation: low-LET photon therapy
  • Active Comparator: Regimen A
    Patients begin radiotherapy (5 days a week for 4.5 weeks) to residual tumor on day 1 of maintenance.
    Interventions:
    • 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
  • Active Comparator: 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.
    Interventions:
    • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
242
Not Provided
September 2006
September 2000   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
up to 21 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Puerto Rico,   Switzerland,   United States
 
 
NCT00002618
9315
POG-9315 ( Other Identifier: Pediatric Oncology Group )
CDR0000063955 ( Other Identifier: NCI )
Yes
Not Provided
Not Provided
Children's Oncology Group
Children's Oncology Group
National Cancer Institute (NCI)
Study Chair: Joseph H. Laver, MD Medical University of South Carolina
Children's Oncology Group
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP