Combination Chemotherapy in Treating Patients With Acute B-Lymphoblastic Leukemia or 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.
Drug: daunorubicin hydrochloride
Drug: leucovorin calcium
Drug: therapeutic hydrocortisone
Drug: vincristine sulfate
|Study Design:||Primary Purpose: Treatment|
|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|
|Study Start Date:||February 1990|
|Study Completion Date:||January 2003|
|Primary Completion Date:||January 2003 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002471
|United States, Michigan|
|University of Michigan Comprehensive Cancer Center|
|Ann Arbor, Michigan, United States, 48109-0752|
|United States, New York|
|Kaplan Cancer Center|
|New York, New York, United States, 10016|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|United States, Pennsylvania|
|Children's Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104|
|Study Chair:||Norma Wollner, MD||Memorial Sloan Kettering Cancer Center|