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Phase III Randomized Comparison of No Maintenance vs Maintenance Chemotherapy with 6-MP/MTX Following Remission Induction in Patients with Stage I/II 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 IIITreatmentClosedunder 22NCIPOG-8719

Objectives

I.  Compare, in a randomized Phase III setting, the relapse-free survival and 
survival of patients with localized non-Hodgkin's lymphoma receiving 24 weeks 
of maintenance chemotherapy with daily 6-mercaptopurine and weekly 
methotrexate vs. no maintenance therapy after remission 
induction/consolidation with 
vincristine/prednisone/adriamycin/cyclophosphamide.

Entry Criteria

Disease Characteristics:


Histologically proven diffuse non-Hodgkin's lymphoma of one
of the following working formulation histologies:
  Lymphoblastic lymphoma
  Small noncleaved cell lymphoma
  Large cell lymphoma

Murphy Stage I or II disease required (localized disease in
favorable sites), i.e.:

  Involvement of one or more nodal areas on the same side of
  the diaphragm

  One or two extranodal tumors with or without regional node
  involvement on the same side of the diaphragm

  Primary GI tumor (grossly completely resected), usually
  ileocecal, with or without associated mesenteric nodes

  Primary non-Hodgkin's lymphoma of the skin localized to a
  single site with or without regional node involvement

  Single bone involvement

  Primary tumor of the head and neck

  Tumor at the base of the skull (provided there is no
  cranial nerve involvement and the brain CT and CSF cytology
  are negative)

The following are excluded:
  Involvement on both sides of the diaphragm
  Primary mediastinal, pleural, or thymic tumors
  Extensive intra-abdominal disease
  Paraspinal or epidural tumors
  More than 5% blasts in the bone marrow aspirate
  CNS involvement
  Cranial nerve palsy (even if the brain CT and CSF cytology
     are both negative)


Prior/Concurrent Therapy:


Biologic therapy:
  No prior therapy

Chemotherapy:
  No prior therapy

Endocrine therapy:
  No prior therapy

Radiotherapy:
  No prior therapy

Surgery:
  No prior therapy


Patient Characteristics:


Age:
  No more than 21 at diagnosis

Performance status:
  Not specified

Hematopoietic:
  Not specified

Hepatic:
  Not specified

Renal:
  Not specified


Expected Enrollment

183 patients will be entered over 5 years.

Outline

Study randomized for Maintenance only.
Induction:  4-Drug Combination Systemic Chemotherapy plus (for patients with 
head and neck primaries only) 3-Drug Intrathecal Chemotherapy.  Vincristine, 
VCR, NSC-67574; Prednisone, PRED, NSC-10023; Adriamycin, ADR, NSC-123127; 
Cyclophosphamide, CTX, NSC-26271; plus Triple Intrathecal Therapy (TIT):  
Methotrexate, MTX, NSC-740; Hydrocortisone, HC, NSC-10483; Cytosine 
arabinoside, ARA-C, NSC-63878.
Consolidation:  4-Drug Combination Systemic Chemotherapy plus (for patients 
with head and neck primaries only) 3-Drug Intrathecal Chemotherapy.  ADR; CTX; 
VCR; PRED; plus TIT.
Maintenance.
Arm I:  2-Drug Combination Systemic Chemotherapy plus (for patients with head 
and neck primaries only) 3-Drug Intrathecal Chemotherapy.  6-Mercaptopurine, 
6-MP, NSC-755; MTX; plus TIT.
Arm II:  No treatment.

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, Shuster JJ, Berard CW, et al.: Nine weeks of chemotherapy without radiotherapy is sufficient treatment for most children with localized non-Hodgkin's lymphoma (NHL). [Abstract] Proceedings of the American Society of Clinical Oncology 12: A-1309, 384, 1993.

Related Publications

Hutchison RE, Banki K, Shuster JJ, et al.: Use of an anti-ALK antibody in the characterization of anaplastic large-cell lymphoma of childhood. Ann Oncol 8 (Suppl 1): 37-42, 1997.[PUBMED Abstract]

Hutchison RE, Berard CW, Shuster JJ, et al.: B-cell lineage confers a favorable outcome among children and adolescents with large-cell lymphoma: a Pediatric Oncology Group study. J Clin Oncol 13 (8): 2023-32, 1995.[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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