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Clinical Trials (PDQ®)

  • Last Modified: 4/9/2007

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Clinical Trials (PDQ®)

Phase III Trial of CHOP (CTX/ADR/VCR/PRED) in Children with Localized non-Hodgkin's Lymphoma

Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Related Publications
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentCompleted21 and underNCIPOG-8314

Objectives

I.  Determine whether involved field radiotherapy (discontinued per May 1987 
notice) improves remission induction, local control, disease-free survival, 
and survival in children with localized non-Hodgkin's lymphoma in favorable 
sites (Murphy Stages I and II).

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Previously untreated patients not 
over the age of 21 years at the time of diagnosis who have histologically 
proven diffuse non-Hodgkin's lymphoma.  Eligible histologies by the Rappaport 
classification include:  diffuse lymphoblastic (convoluted or nonconvoluted), 
diffuse histiocytic, and diffuse undifferentiated Burkitt's and non-Burkitt's 
type; those by the Lukes-Collins classification are lymphocytic (convoluted or 
undefined), immunoblastic sarcoma, histiocytic lymphoma, and follicular center 
cell (large cleaved and noncleaved, and small noncleaved).  Patients with 
greater than 5 percent blasts in a bone marrow aspirate and those with CNS 
involvement are not eligible; those with primary non-Hodgkin's lymphoma of 
skin localized to a single site or single site plus regional nodes are 
eligible.  Patients with localized non-Hodgkin's lymphoma of bone will be 
registered and treated on protocol with radiotherapy plus chemotherapy (no 
randomization) and analyzed separately.

Expected Enrollment

126 patients will be entered over about 4.2 years.

Outline

Randomized study.  All patients will receive Chemotherapy and all except those 
with a primary lymphoma of the bone will be randomized to receive or not to 
receive Radiotherapy.  All patients with bone lymphoma (including those with 
primary lymphomas of soft tissue with extension into bone or evidence of bony 
erosion) will receive Radiotherapy.  Per May 1987 notice, patients are no 
longer treated on the Radiotherapy plus Chemotherapy regimen, as sufficient 
patients have been accrued to that treatment combination.  Only patients with 
head and neck primaries will receive CNS Prophylaxis.
Induction:  4-Drug Combination Chemotherapy.  CHOP:  Cyclophosphamide, CTX, 
NSC-26271; Adriamycin, ADR, NSC-123127; Vincristine, VCR, NSC-67574; 
Prednisone, PRED, NSC-10023.
Consolidation:  4-Drug Combination Chemotherapy.  CHOP.
Maintenance:  2-Drug Combination Chemotherapy.  6-Mercaptopurine, 6-MP, 
NSC-755; Methotrexate, MTX, NSC-740.
CNS Prophylaxis:  Single-agent Intrathecal Chemotherapy.  MTX.
Radiotherapy (treatment discontinued per May 1987 notice):  Irradiation of 
areas of disease with Co60 or 4-6 MeV accelerators, with electron beam 
equipment for anterior boosts in the head and neck.

Published Results

Link MP, Shuster JJ, Donaldson SS, et al.: Treatment of children and young adults with early-stage non-Hodgkin's lymphoma. N Engl J Med 337 (18): 1259-66, 1997.[PUBMED Abstract]

Link MP, Donaldson SS, Berard CW, et al.: Results of treatment of childhood localized non-Hodgkin's lymphoma with combination chemotherapy with or without radiotherapy. N Engl J Med 322 (17): 1169-74, 1990.[PUBMED Abstract]

Link MP, Donaldson SS, Berard CW, et al.: High cure rate with reduced therapy in localized non-Hodgkin's lymphoma (NHL) of childhood. [Abstract] Proceedings of the American Society of Clinical Oncology 6: A-749, 190, 1987.

Related Publications

Hutchison RE, Murphy SB, Fairclough DL, et al.: Diffuse small noncleaved cell lymphoma in children, Burkitt's versus non-Burkitt's types. Results from the Pediatric Oncology Group and St. Jude Children's Research Hospital. Cancer 64 (1): 23-8, 1989.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Pediatric Oncology Group

Michael Link, MD, Protocol chair
Ph: 650-723-5535
Email: mlink@stanford.edu

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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