Combination Chemotherapy in Treating Patients With Acute B-Lymphoblastic Leukemia or Non-Hodgkin's Lymphoma
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Lymphoma |
Drug: asparaginase Drug: cyclophosphamide Drug: cytarabine Drug: daunorubicin hydrochloride Drug: dexamethasone Drug: etoposide Drug: leucovorin calcium Drug: methotrexate Drug: methylprednisolone Drug: therapeutic hydrocortisone Drug: thiotepa Drug: vincristine sulfate |
Phase 2 |
| Study Type: | Interventional |
| 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.
Eligibility| Ages Eligible for Study: | Child, Adult, Senior |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Newly diagnosed undifferentiated nonlymphoblastic non-Hodgkin's lymphoma (Burkitt's or non-Burkitt's) Newly diagnosed large cell lymphoma with CNS involvement Recurrent non-Hodgkin's lymphoma L-3 and B-cell leukemia included At least 1 of the following required: LDH at least 500 IU/liter (old method) or 2,000 IU/liter (new method) Bone marrow involvement (greater than 5% lymphoblasts) CNS involvement (lymphoblasts on CSF cytospin or intracranial mass on CT or MRI scan)
PATIENT CHARACTERISTICS: Age: Any age Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified
PRIOR CONCURRENT THERAPY: Prior therapy allowed for non-Hodgkin's lymphoma No prior therapy for all other diseases
Contacts and LocationsPlease 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 |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00002471 History of Changes |
| Other Study ID Numbers: | 90-013 CDR0000076672 NYU-97-9 NCI-V90-0104 |
| Study First Received: | November 1, 1999 |
| Last Updated: | June 19, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Memorial Sloan Kettering Cancer Center:
|
childhood Burkitt lymphoma L3 childhood acute lymphoblastic leukemia B-cell childhood acute lymphoblastic leukemia L3 adult acute lymphoblastic leukemia B-cell adult acute lymphoblastic leukemia recurrent adult non-Hodgkin lymphoma stage III adult diffuse large cell lymphoma stage III adult immunoblastic large cell lymphoma stage III adult Burkitt lymphoma stage IV grade 3 follicular lymphoma stage IV adult diffuse large cell lymphoma |
stage IV adult immunoblastic large cell lymphoma stage IV adult Burkitt lymphoma recurrent grade 3 follicular lymphoma recurrent adult diffuse large cell lymphoma recurrent adult immunoblastic large cell lymphoma recurrent adult Burkitt lymphoma stage III childhood small noncleaved cell lymphoma stage IV childhood small noncleaved cell lymphoma stage IV childhood large cell lymphoma recurrent childhood small noncleaved cell lymphoma recurrent childhood large cell lymphoma |
Additional relevant MeSH terms:
|
Lymphoma Leukemia Lymphoma, Non-Hodgkin Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Prednisolone acetate Methylprednisolone acetate Hydrocortisone 17-butyrate 21-propionate Cortisol succinate |
Hydrocortisone acetate Dexamethasone Methylprednisolone Methylprednisolone Hemisuccinate Prednisolone Hydrocortisone Prednisolone hemisuccinate Prednisolone phosphate Cyclophosphamide Methotrexate Etoposide Cytarabine Vincristine Thiotepa Daunorubicin |
ClinicalTrials.gov processed this record on September 23, 2016