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Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With Stage III or Stage IV Low-Grade Non-Hodgkin's Lymphoma Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With Stage III or Stage IV Low-Grade Non-Hodgkin's Lymphoma conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With Stage III or Stage IV Low-Grade Non-Hodgkin's Lymphoma Clinical research trials and Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With Stage III or Stage IV Low-Grade Non-Hodgkin's Lymphoma medical trials take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With Stage III or Stage IV Low-Grade Non-Hodgkin's Lymphoma. Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With Stage III or Stage IV Low-Grade Non-Hodgkin's Lymphoma Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With Stage III or Stage IV Low-Grade Non-Hodgkin's Lymphoma clinical trial. Test subjects typically obtain the finest healthcare available for their Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With Stage III or Stage IV Low-Grade Non-Hodgkin's Lymphoma condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With Stage III or Stage IV Low-Grade Non-Hodgkin's Lymphoma  Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With Stage III or Stage IV Low-Grade Non-Hodgkin's Lymphoma
Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With Stage III or Stage IV Low-Grade Non-Hodgkin's Lymphoma
For Condition: stage 3 grade II follicular mixed cell lymphoma,stage 4 grade III follicular large cell lymphoma,stage 3 diffuse small lymphocytic/marginal zone lymphoma,stage 4 diffuse small lymphocytic/marginal zone lymphoma,stage 3 grade III follicular large cell lymphoma,stage 4 grade II follicular mixed cell lymphoma,stage 3 grade I follicular small cleaved cell lymphoma,stage 4 grade I follicular small cleaved cell lymphoma
Status: No longer recruiting
Sponsor(s): Eastern Cooperative Oncology Group , 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. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known which regimen of combination chemotherapy, with or without rituximab, is more effective for non-Hodgkin's lymphoma. PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of combination chemotherapy followed by rituximab or observation in treating patients who have stage III or stage IV low-grade non-Hodgkin's lymphoma.
Details: OBJECTIVES: - Compare response rate, time to progression, time to treatment failure, and survival of patients with low grade non-Hodgkin's lymphoma treated with a cyclophosphamide and fludarabine regimen (closed as of 9/2000) or standard treatment with cyclophosphamide, vincristine, and prednisone. - Determine the effect of maintenance with rituximab (IDEC-C2B8 monoclonal antibody) on time to progression, times to treatment failure, and survival, as well as its effects on lymphocyte number, subsets, and quantitative immunoglobulin levels over time in these patients. OUTLINE: This a two step, stratified, randomized study. Patients are stratified for arms I and II (step 1) by age (under 60 vs 60 and over), tumor burden (high vs low), histology (follicular vs other), and B symptoms (present vs absent). After arms I and II have been completed, patients are stratified in arms III and IV (step 2) by extent of residual disease (minimal vs gross), histology (follicular vs other), and initial tumor burden. - Arm I (closed as of 9/2000): Patients receive cyclophosphamide IV over 30-45 minutes on day 1 and fludarabine IV over 10-20 minutes on days 1-5. Treatment repeats every 28 days in the absence of disease progression for a minimum of 4 courses and a maximum of 6 courses. - Arm II: Patients receive cyclophosphamide IV over 30-45 minutes and vincristine IV on day 1, and oral prednisone on days 1-5. Treatment repeats every 21 days in the absence of disease progression for a minimum of 6 courses and a maximum of 8 courses. After completion of therapy on arm I or II, patients are randomized into step 2 of this study comprising arms III and IV. - Arm III: Patients receive maintenance therapy with rituximab (IDEC-C2B8 monoclonal antibody) IV weekly for 4 weeks. Courses repeat every 6 months for 2 years. Maintenance therapy begins 4 weeks after the last chemotherapy. - Arm IV: Patients undergo no maintenance therapy and are observed. Patients are followed every 3 months for 2 years, every 6 months for the next 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 515 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed stage III-IV low grade non-Hodgkin's lymphoma - Small lymphocytic - Follicular small cleaved cell - Follicular mixed cleaved cell - Follicular large cell - Measurable disease by at least one of the following: - Radiographic findings must provide clear-cut measurements - Bidimensionally measurable, clearly defined defect or mass measuring at least 2 cm in diameter on a radionuclide or CT scan - An enlarged spleen extending at least 2 cm below the costal margin, provided that no explanation other than lymphomatous involvement is likely - An enlarged liver with proof of lymphoma in the liver by biopsy - May have low or high tumor burden - High tumor burden defined as: - Nodal or extranodal mass at least 7 cm - 3 or more nodal masses greater than 3 cm - Systemic symptoms or B symptoms - Risk of extrinsic compression of vital organ - Leukemia phase with lymphocyte count of greater than 5,000/mm3 - Absolute neutrophil count less than 1,500/mm3 - Hemoglobin less than 10 g/dL - Platelet count less than 100,000/mm3 - Patients with both diffuse and follicular architectural elements are eligible if histology is predominantly follicular (at least 50% of the cross-sectional area) - If diagnosis of low grade non-Hodgkin's lymphoma had been made over 1 year ago, diagnostic confirmation using either fine needle aspiration or nodal biopsy is required NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-1 Life expectancy: - Not specified Hematopoietic: - See Disease Characteristics - WBC greater than 3,000/mm^3 (unless documented bone marrow involvement) - Platelet count greater than 100,000/mm^3 (unless documented bone marrow involvement) Hepatic: - Bilirubin less than 2.0 mg/dL - SGOT no greater than 5 times upper limit of normal (ULN) - Alkaline phosphatase no greater than 5 times ULN Renal: - Creatinine no greater than 1.5 mg/dL Other: - No other malignancy within the past 5 years except treated carcinoma in situ of the cervix or basal or squamous cell carcinoma of the skin - No active, uncontrolled infections - Adequate contraception required of all fertile patients PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior immunotherapy Chemotherapy: - No prior chemotherapy Endocrine therapy: - Not specified Radiotherapy: - No prior radiotherapy Surgery: - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HowardHochster, Study Chair, Kaplan Cancer Center
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, 60612
United States
Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis, Indiana, 46202
United States
CCOP - Southeast Cancer Control Consortium
Winston Salem, North Carolina, 27104-4241
United States
CCOP - Scott and White Hospital
Temple, Texas, 76508
United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, 54301
United States
CCOP - North Shore University Hospital
Manhasset, New York, 11030
United States
CCOP - Metro-Minnesota
St. Louis Park, Minnesota, 55416
United States
Lifespan: The Miriam Hospital
Providence, Rhode Island, 02906
United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, 57104
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
CCOP - Mount Sinai Medical Center
Miami, Florida, 33140
United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, 65201
United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203
United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756-0002
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294-3300
United States
Veterans Affairs Medical Center - White River Junction
White River Junction, Vermont, 05009
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
CCOP - Christiana Care Health Services
Wilmington, Delaware, 19899
United States
Mount Sinai Medical Center, NY
New York City, New York, 10029
United States
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
United States
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, 85259-5404
United States
State University of New York - Upstate Medical University
Syracuse, New York, 13210
United States
Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242-1009
United States
CCOP - Oklahoma
Tulsa, Oklahoma, 74136
United States
University of Massachusetts Memorial Medical Center - University Campus
Worcester, Massachusetts, 01655
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15213-3489
United States
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, 14215
United States
Green Mountain Oncology Group
Bennington, Vermont, 05201
United States
North Shore University Hospital
Manhasset, New York, 11030
United States
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, 92093-0658
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-7680
United States
Veterans Affairs Medical Center - San Francisco
San Francisco, California, 94121
United States
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, 13210
United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, 55417
United States
CCOP - MainLine Health
Wynnewood, Pennsylvania, 19096
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
Weill Medical College of Cornell University
New York City, New York, 10021
United States
UCSF Comprehensive Cancer Center
San Francisco, California, 94143-0128
United States
MBCCOP - Massey Cancer Center
Richmond, Virginia, 23298-0037
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, 13217
United States
Vermont Cancer Center
Burlington, Vermont, 05401-3498
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1082
United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
United States
Lombardi Cancer Center
Washington D.C., District of Columbia, 20007
United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
United States
Veterans Affairs Medical Center - Durham
Durham, North Carolina, 27705
United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289
United States
Barnes-Jewish Hospital
St. Louis, Missouri, 63110
United States
Additional Information:
Study ID Numbers: CDR0000066056; E-1496,CLB-59902
Study Start Date:
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003204
Other Stage 4 Grade Iii Follicular Large Cell Lymphoma Studies:
1. Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With Stage III or Stage IV Low-Grade Non-Hodgkin's Lymphoma
2. Vaccine Therapy Plus Sargramostim Following Chemotherapy in Treating Patients With Stage III or Stage IV Non-Hodgkin's Lymphoma
3. Interferon alfa-2b in Treating Patients With Advanced Low-Grade Non-Hodgkin's Lymphoma
4. Rituximab in Treating Patients With Non-Hodgkin's Lymphoma or Hodgkin's Disease
Related Studies:
Other stage 4 grade III follicular large cell lymphoma Clinical Trials
Other New York Clinical Trials
Other Manhasset Clinical Trials
Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With Stage III or Stage IV Low-Grade Non-Hodgkin's Lymphoma
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