Combination Chemotherapy in Treating Patients With Acute B-Lymphoblastic Leukemia or Non-Hodgkin's Lymphoma
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| ClinicalTrials.gov Identifier: NCT00002471 |
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Recruitment Status :
Completed
First Posted : August 30, 2004
Last Update Posted : June 20, 2013
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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 or disease | Intervention/treatment | 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 |
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.
| Study Type : | Interventional (Clinical Trial) |
| 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 |
| Actual Primary Completion Date : | January 2003 |
| Actual Study Completion Date : | January 2003 |
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
| ClinicalTrials.gov Identifier: | NCT00002471 |
| Other Study ID Numbers: |
90-013 CDR0000076672 ( Registry Identifier: PDQ (Physician Data Query) ) NYU-97-9 NCI-V90-0104 |
| First Posted: | August 30, 2004 Key Record Dates |
| Last Update Posted: | June 20, 2013 |
| Last Verified: | June 2013 |
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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 |
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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 Leucovorin Cytarabine Dexamethasone Methylprednisolone |
Hydrocortisone Hydrocortisone 17-butyrate 21-propionate Hydrocortisone acetate Hydrocortisone hemisuccinate Cyclophosphamide Thiotepa Methotrexate Etoposide Vincristine Daunorubicin Asparaginase Levoleucovorin Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |