Lymphoma Clinical Trial
Official title:
Phase II Trial of Intensive, Short-Course Combination Chemotherapy in the Treatment of Newly Diagnosed Patients With Poor-Risk Nonlymphoblastic Lymphoma and Acute B-Lymphoblastic Leukemia and in Patients With Recurrent Non-Hodgkin's Lymphoma
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die. Combining more than one drug may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating
patients who have acute B-lymphoblastic leukemia or recurrent non-Hodgkin's lymphoma.
OBJECTIVES: I. Improve the survival of children and adolescents with poor-risk
nonlymphoblastic lymphoma and acute B-lymphoblastic leukemia using an intensive,
short-course regimen of combination chemotherapy. II. Assess the toxicity of the regimen.
OUTLINE: Nonrandomized study. Induction: 7-Drug Combination Chemotherapy with Leucovorin
Rescue plus Triple Intrathecal Therapy (TIT). Cyclophosphamide, CTX, NSC-26271; Thiotepa,
TSPA, NSC-6396; Vincristine, VCR, NSC-67574; Daunorubicin, DNR, NSC-82151; Dexamethasone,
DM, NSC-34521; Etoposide, VP-16, NSC-141540; Methotrexate, MTX, NSC-740; with Leucovorin
calcium, Citrovorum Factor, CF, NSC-3590; plus TIT: IT MTX; IT Cytarabine, IT ARA-C,
NSC-63878; IT Hydrocortisone, IT HC, NSC-10483. Consolidation: 6-Drug Combination
Chemotherapy with Leucovorin Rescue plus TIT. ARA-C; VP-16; Asparaginase (E. coli), ASP,
NSC-109229; MTX; VCR; Methylprednisolone, MePRDL, NSC-19987; with CF; plus TIT. Reinduction:
7-Drug Combination Chemotherapy with Leucovorin Rescue plus TIT. CTX; TSPA; VCR; DNR; DM;
VP-16; MTX; with CF; plus TIT.
PROJECTED ACCRUAL: A maximum of 30 patients, accrued from 4 institutions, will be entered.
If at any time more than 3 patients are not "event free", the trial will be terminated
early, with patients considered event free if they enter remission, do not die as a result
of treatment toxicity, and do not experience progression within 1 year from the start of
therapy.
;
Primary Purpose: Treatment
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