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Home > "C" Clinical Trials Conditions > Combination Chemotherapy in Treating Patients With Non-Hodgkin's Lymphoma or Acute Lymphocytic Leukemia  Combination Chemotherapy in Treating Patients With Non-Hodgkin's Lymphoma or Acute Lymphocytic Leukemia
Combination Chemotherapy in Treating Patients With Non-Hodgkin's Lymphoma or Acute Lymphocytic Leukemia
For Condition: stage 1 adult diffuse small noncleaved cell/Burkitt's lymphoma,noncontiguous stage 2 adult diffuse small noncleaved cell/Burkitt's lymphoma,L3 adult acute lymphoblastic leukemia,stage 3 adult diffuse small noncleaved cell/Burkitt's lymphoma,stage 4 adult diffuse small noncleaved cell/Burkitt's lymphoma,contiguous stage 2 adult diffuse small noncleaved cell/Burkitt's lymphoma,stage 2 adult diffuse small noncleaved cell/Burkitt's lymphoma,untreated adult acute lymphoblastic leukemia
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Cancer and Leukemia Group B
Synopsis: 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 and alternating regimens of chemotherapy in treating patients who have non-Hodgkin's lymphoma or acute lymphocytic leukemia.
Details: OBJECTIVES: I. Determine the response rate and disease free survival of HIV seronegative patients with diffuse small noncleaved cell lymphoma or L3 acute lymphocytic leukemia when treated with high intensity, brief duration combination chemotherapy: alternating courses of ifosfamide/cytarabine/etoposide and cyclophosphamide/doxorubicin, each with methotrexate/vincristine/dexamethasone. II. Determine the toxicity of these regimens in HIV negative patients. PROTOCOL 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. PROJECTED ACCRUAL: A total of 26-45 lymphoma patients and 2-6 leukemia patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 15 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically documented diffuse small noncleaved cell lymphoma (category J by IWF) of any stage; Nodal or abdominal masses with less than 25% lymphoblasts in marrow are defined as lymphoma OR Histologically documented L3 acute lymphocytic leukemia (ALL); Greater than 25% lymphoblasts in marrow is defined as ALL, regardless of presence of bulky nodal disease - Lymphoma requirements include: Documentation of lymphadenopathy, splenomegaly, or hepatomegaly, presence or absence of abdominal masses, and presence or absence of B symptoms - Measurable disease other than ascites and pleural effusions, bony disease, and CNS lesions; Bidimensionally measurable mass on physical exam, x-ray, or CT, or MRI OR Clearly defined hepatic mass greater than 3.5 cm on CT, MRI, or ultrasound considered to represent lymphoma OR Histologically documented hepatic lymphoma with the liver extending more than 5 cm below the costal margin on quiet respiration - ALL requirements include: Documentation of monoclonal surface immunoglobulin by surface immunophenotyping - Lymph node biopsy strongly recommended for patients with obvious marrow involvement - Disease labeled L3 but also manifested by lymphadenopathy must be evaluated as is lymphoma (see above) --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
EdwardLee, Study Chair, Cancer and Leukemia Group B
University of California San Diego Cancer Center
La Jolla, California, 92093-0658
United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203
United States
CCOP - Southeast Cancer Control Consortium
Winston Salem, North Carolina, 27104-4241
United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
United States
CCOP - Mount Sinai Medical Center
Miami, Florida, 33140
United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655
United States
CCOP - North Shore University Hospital
Manhasset, New York, 11030
United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756
United States
CCOP - Christiana Care Health Services
Wilmington, Delaware, 19899
United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94115-0128
United States
University of Tennessee, Memphis Cancer Center
Memphis, Tennessee, 38103
United States
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston Salem, North Carolina, 27157-1082
United States
Rhode Island Hospital
Providence, Rhode Island, 02903
United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
United States
MBCCOP - Massey Cancer Center
Richmond, Virginia, 23298-0037
United States
Sinai Hospital of Baltimore
Baltimore, Maryland, 21225
United States
State University of New York - Upstate Medical University
Syracuse, New York, 13210
United States
Barnes-Jewish Hospital
St. Louis, Missouri, 63110
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
Additional Information:
Study ID Numbers: CDR0000077643; CLB-9251
Study Start Date: May 1992
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002494
Other L3 Adult Acute Lymphoblastic Leukemia Studies:
1. Combination Chemotherapy in Treating Patients With Non-Hodgkin's Lymphoma or Acute Lymphocytic Leukemia
2. Combination Chemotherapy in Treating Patients With Non-Hodgkin's Lymphoma or Acute Lymphocytic Leukemia
Related Studies:
Other L3 adult acute lymphoblastic leukemia Clinical Trials
Other Missouri Clinical Trials
Other St. Louis Clinical Trials
Combination Chemotherapy in Treating Patients With Non-Hodgkin's Lymphoma or Acute Lymphocytic Leukemia
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