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
|Phase III||Treatment||Closed||under 22||NCI||POG-8719|
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.
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)
Biologic therapy: No prior therapy Chemotherapy: No prior therapy Endocrine therapy: No prior therapy Radiotherapy: No prior therapy Surgery: No prior therapy
Age: No more than 21 at diagnosis Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified
183 patients will be entered over 5 years.
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.
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.
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
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.