Combination Chemotherapy in Treating Patients With Non-Hodgkin's Lymphoma or Acute Lymphocytic Leukemia
NCT ID: NCT00002494
Last Updated: 2016-07-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
134 participants
INTERVENTIONAL
1992-05-31
2006-01-31
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and alternating regimens of chemotherapy in treating patients who have non-Hodgkin's lymphoma or acute lymphocytic leukemia.
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Detailed Description
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OUTLINE: Patients are stratified by participating institution and disease type (diffuse small noncleaved cell lymphoma vs L3 ALL). Patients receive cyclophosphamide IV over 5-10 minutes on days 1 through 5 and oral prednisone on days 1 through 7, followed by alternating courses of: 2) ifosfamide IV over 1 hour on days 8 through 12, methotrexate IV over 24 hours on day 8; leucovorin calcium IV over 36 hours after initiation of methotrexate, then IV (or orally as tolerated, after the first 24 hours) every 6 hours until the serum methotrexate level is below 5 x 10 to the minus eighth M; vincristine IV on day 8; cytarabine IV over 48 hours and etoposide IV over 60 minutes on days 11 and 12; and oral dexamethasone on days 8 through 12, plus triple intrathecal therapy (TIT) with methotrexate, cytarabine, and hydrocortisone on days 8 and 12, and 3) cyclophosphamide IV over 5-10 minutes on days 29 through 33; methotrexate IV over 24 hours and vincristine IV on day 29; leucovorin calcium IV over 36 hours after initiation of methotrexate, then IV (or orally as tolerated, after the first 24 hours) every 6 hours until the serum methotrexate level is below 5 x 10 to the minus eighth M; doxorubicin IV on days 32 and 33; and oral dexamethasone on days 29 through 33, plus TIT on day 29, with doses as above. Patients with CNS disease at diagnosis continue TIT once weekly until the CSF clears, then weekly for 4 more weeks. TIT must be completed prior to initiation of radiotherapy. All patients must complete at least the first 3 courses of chemotherapy. Courses 2 and 3 each repeat 3 times in the absence of disease progression or unacceptable toxicity. On days 134-139, patients who have had prior bone marrow involvement receive cranial radiation therapy. Patients who achieve less than a complete response and who have an HLA-matched sibling should undergo allogeneic bone marrow transplant on protocol CLB-9113. Patients are followed monthly for 6 months, every 2 months for 18 months, every 6 months for 2 years, and thereafter for survival.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Combination therapy
Patients receive combination therapy as described in the study description. All patients must complete at least the first 3 courses of chemotherapy. Courses 2 and 3 each repeat 3 times in the absence of disease progression or unacceptable toxicity. On days 134-139, patients who have had prior bone marrow involvement receive cranial radiation therapy. Patients who achieve less than a complete response and who have an HLA-matched sibling should undergo allogeneic bone marrow transplant on protocol CLB-9113. Patients are followed monthly for 6 months, every 2 months for 18 months, every 6 months for 2 years, and thereafter for survival.
cyclophosphamide
cytarabine
dexamethasone
doxorubicin hydrochloride
etoposide
ifosfamide
leucovorin calcium
mesna
methotrexate
prednisone
therapeutic hydrocortisone
vincristine sulfate
low-LET cobalt-60 gamma ray therapy
low-LET photon therapy
Interventions
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cyclophosphamide
cytarabine
dexamethasone
doxorubicin hydrochloride
etoposide
ifosfamide
leucovorin calcium
mesna
methotrexate
prednisone
therapeutic hydrocortisone
vincristine sulfate
low-LET cobalt-60 gamma ray therapy
low-LET photon therapy
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: 15 and over Performance status: Any status Life expectancy: At least 2 years Hematopoietic: Not specified Hepatic: Bilirubin no greater than 1.5 times normal (unless further elevation is directly attributable to malignancy) Renal: Creatinine no greater than 1.5 times normal (unless further elevation is directly attributable to malignancy) Cardiovascular: No uncontrolled or severe cardiovascular disease, e.g.: No myocardial infarction within the past 6 months No congestive heart failure Other: HIV negative No active, uncontrolled bacterial, viral, or fungal infection No active, uncontrolled duodenal ulcer No other serious medical illness No serious psychiatric condition that would preclude informed consent or protocol compliance No second malignancy within 5 years except: Curatively treated carcinoma in situ of the cervix Curatively treated basal cell carcinoma Not pregnant Effective contraception required of fertile patients
PRIOR CONCURRENT THERAPY: Biologic: No concurrent growth factors Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: No concurrent palliative radiotherapy Surgery: Not specified Other: No prior therapy
15 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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Edward Lee, MD
Role: STUDY_CHAIR
Central Maryland Oncology Center
Locations
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University of California San Diego Cancer Center
La Jolla, California, United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, United States
CCOP - Christiana Care Health Services
Wilmington, Delaware, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, United States
Barnes-Jewish Hospital
St Louis, Missouri, United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
CCOP - North Shore University Hospital
Manhasset, New York, United States
State University of New York - Upstate Medical University
Syracuse, New York, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, United States
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States
Rhode Island Hospital
Providence, Rhode Island, United States
University of Tennessee, Memphis Cancer Center
Memphis, Tennessee, United States
MBCCOP - Massey Cancer Center
Richmond, Virginia, United States
Countries
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References
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Rizzieri DA, Johnson JL, Niedzwiecki D, Lee EJ, Vardiman JW, Powell BL, Barcos M, Bloomfield CD, Schiffer CA, Peterson BA, Canellos GP, Larson RA. Intensive chemotherapy with and without cranial radiation for Burkitt leukemia and lymphoma: final results of Cancer and Leukemia Group B Study 9251. Cancer. 2004 Apr 1;100(7):1438-48. doi: 10.1002/cncr.20143.
Lee EJ, Petroni GR, Schiffer CA, Freter CE, Johnson JL, Barcos M, Frizzera G, Bloomfield CD, Peterson BA. Brief-duration high-intensity chemotherapy for patients with small noncleaved-cell lymphoma or FAB L3 acute lymphocytic leukemia: results of cancer and leukemia group B study 9251. J Clin Oncol. 2001 Oct 15;19(20):4014-22. doi: 10.1200/JCO.2001.19.20.4014.
Other Identifiers
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CLB-9251
Identifier Type: -
Identifier Source: secondary_id
CDR0000077643
Identifier Type: REGISTRY
Identifier Source: secondary_id
CALGB-9251
Identifier Type: -
Identifier Source: org_study_id
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