Clinical trial · Interventional

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

NCT00002618CI-TRIAL-00015176completedPhase 3ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Lymphoma	Lymphoma	ONTOLOGY_EXACT	0.90

Interventions

Interventions (11)

Intervention	Type	Mapped drug	Match
cytarabine	Drug	Cytarabine	ALIAS
doxorubicin hydrochloride	Drug	Doxorubicin	ALIAS
filgrastim	Biological	Filgrastim	ALIAS
leucovorin calcium	Drug	Leucovorin	ALIAS
low-LET cobalt-60 gamma ray therapy	Radiation	—	UNRESOLVED
low-LET electron therapy	Radiation	—	UNRESOLVED
low-LET photon therapy	Radiation	—	UNRESOLVED
mercaptopurine	Drug	Mercaptopurine	ALIAS

Design

Arms and outcomes

Arms (2)

type
ACTIVE_COMPARATOR
label
Regimen A
description
Patients begin radiotherapy (5 days a week for 4.5 weeks) to residual tumor on day 1 of maintenance.
interventionNames
1. Biological: filgrastim
2. Drug: cytarabine
3. Drug: doxorubicin hydrochloride
4. Drug: leucovorin calcium
5. Drug: mercaptopurine
6. Drug: methotrexate
7. Drug: prednisone
8. Drug: vincristine sulfate
9. Radiation: low-LET cobalt-60 gamma ray therapy
10. Radiation: low-LET electron therapy
11. Radiation: low-LET photon therapy
type
ACTIVE_COMPARATOR
label
Regimen B
description
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.
interventionNames

Eligibility

Eligibility (as posted)

Sex: All
Maximum age: 21 Years

Show eligibility criteria text

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

References

Publications (4)

BACKGROUNDHutchison 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
BACKGROUNDHutchison 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
RESULTNasr 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
RESULTLaver 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

Registry

Dates and enrollment

Start: Dec 1, 1994
Primary completion: Sep 1, 2000
Completion: Sep 1, 2006
First posted: Jul 29, 2004
Last update posted: Jul 24, 2014
Enrollment: 242 (estimated)
Lead sponsor: Children's Oncology Group NETWORK
Collaborators: National Cancer Institute (NCI)
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

Data updated 22 days agoSource updated Jul 24, 2014source: clinicaltrials

Locations

Locations by country (10)

Country	Sites	Recruiting
United States	8	0
Switzerland	1	0