|
Combination Chemotherapy Plus Rituximab in Treating Patients With Intermediate-Grade or High-Grade Non-Hodgkin's Lymphoma Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Combination Chemotherapy Plus Rituximab in Treating Patients With Intermediate-Grade or High-Grade Non-Hodgkin's Lymphoma conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Combination Chemotherapy Plus Rituximab in Treating Patients With Intermediate-Grade or High-Grade Non-Hodgkin's Lymphoma Clinical research trials and Combination Chemotherapy Plus Rituximab in Treating Patients With Intermediate-Grade or High-Grade Non-Hodgkin's Lymphoma medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Combination Chemotherapy Plus Rituximab in Treating Patients With Intermediate-Grade or High-Grade Non-Hodgkin's Lymphoma. Combination Chemotherapy Plus Rituximab in Treating Patients With Intermediate-Grade or High-Grade Non-Hodgkin's Lymphoma Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Combination Chemotherapy Plus Rituximab in Treating Patients With Intermediate-Grade or High-Grade Non-Hodgkin's Lymphoma clinical trial. Subjects typically recieve the finest healthcare available for their Combination Chemotherapy Plus Rituximab in Treating Patients With Intermediate-Grade or High-Grade Non-Hodgkin's Lymphoma condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "C" Clinical Trials Conditions > Combination Chemotherapy Plus Rituximab in Treating Patients With Intermediate-Grade or High-Grade Non-Hodgkin's Lymphoma  Combination Chemotherapy Plus Rituximab in Treating Patients With Intermediate-Grade or High-Grade Non-Hodgkin's Lymphoma
Combination Chemotherapy Plus Rituximab in Treating Patients With Intermediate-Grade or High-Grade Non-Hodgkin's Lymphoma
For Condition: Lymphoma
Status: No longer recruiting
Sponsor(s): Amgen ,
Synopsis: RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one chemotherapy drug with rituximab may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of rituximab plus combination chemotherapy in treating patients who have intermediate-grade or high-grade non-Hodgkin's lymphoma.
Details: OBJECTIVES: I. Determine the rate of complete response and partial response in patients with intermediate or high grade non-Hodgkin's lymphoma treated with rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). II. Determine the toxicity of this regimen in these patients. III. Determine the disease-free and overall survival, time to response, and time to disease progression in patients treated with this regimen. PROTOCOL OUTLINE: This is a multicenter study. Patients are stratified according to the number of risk factors (0-2 vs 3-5). Risk factors include age (no greater than 60 vs greater than 60), tumor stage (II vs III or IV), number of extranodal sites (no more than 1 vs more than 1), performance status (0-1 vs 2-4), and serum LDH level (no greater than normal vs greater than normal). Patients receive rituximab IV on day 1; cyclophosphamide, doxorubicin, and vincristine IV on day 3; and oral prednisone on days 3-7. Patients over 60 also receive filgrastim (G-CSF) subcutaneously beginning on day 4 and continuing until blood counts recover (all other patients receive G-CSF as secondary prophylaxis). Treatment continues every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients who respond receive 2 more courses. Patients who have no measurable disease after 6 courses receive rituximab IV once weekly for 4 consecutive weeks. This treatment continues every 6 months for 4 courses in the absence of disease progression or unacceptable toxicity. Patients who have measurable disease after 6 courses of chemotherapy receive 2 more courses for a maximum of 8 courses of CHOP, followed by maintenance therapy with rituximab (as described above). Patients are followed every 6 months for 2 years. PROJECTED ACCRUAL: Approximately 100 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed intermediate or high grade non-Hodgkin's lymphoma; Stage II, III, or IV disease; B-cell where lymphoid cells are CD20 or CD19 positive - No mantle cell, lymphoblastic, or peripheral T-cell non-Hodgkin's lymphoma - Measurable or evaluable disease - No prior treatment for lymphoma - No known CNS metastases [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.] --Prior/Concurrent Therapy-- - Biologic therapy: See Disease Characteristics; No concurrent biologic therapy except epoetin alfa; No white blood cell transfusions - Chemotherapy: See Disease Characteristics; No concurrent chemotherapy - Endocrine therapy: Not specified - Radiotherapy: See Disease Characteristics; No concurrent radiotherapy - Surgery: At least 2 weeks since prior major surgery - Other: No other concurrent investigational therapy; No prophylactic antibiotics --Patient Characteristics-- - Age: 18 and over - Performance status: Karnofsky 60-100% - Life expectancy: At least 12 weeks - Hematopoietic: Unless documented bone marrow disease: Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3 - Hepatic: SGOT and SGPT no greater than 3 times upper limit of normal; Bilirubin no greater than 1.5 mg/dL - Renal: Creatinine no greater than 2.0 mg/dL - Cardiovascular: No history of severe heart disease, cardiomyopathy, or congestive heart failure; LVEF normal by MUGA or echocardiogram - Other: Not pregnant or nursing; Fertile patients must use effective contraception; No active infection as defined by: Clinical syndrome consistent with a viral or bacterial infection (e.g., influenza, upper respiratory infection, urinary tract infection) OR Fever with a clinical site of infection identified OR Microbiologically documented infection, including, but not limited to, bacteremia or septicemia; No known HIV positivity; No known sensitivity to E. coli derivatives (e.g., asparaginase, human insulin, human growth hormone, interferon alfa-2b); No other prior malignancy within the past 5 years except surgically cured basal or squamous cell skin cancer or carcinoma in situ of the cervix; No psychiatric, addictive, or other disorder that may preclude study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
CarolBrannan, Study Chair, Amgen
Providence Saint Joseph Medical Center - Burbank
Burbank, California, 91505
United States
Associates in Oncology and Hematology
Rockville, Maryland, 20850
United States
New Mexico Oncology-Hematology
Albuquerque, New Mexico, 87109
United States
Bond Clinic
Rolla, Missouri, 65401
United States
Our Lady of Mercy Medical Center
Bronx, New York, 10466
United States
Hematology Oncology Associates
Morristown, New Jersey, 07962
United States
Montgomery Cancer Center
Montgomery, Alabama, 36106
United States
Midwest Hematology Oncology Consultants, Ltd.
St. Louis, Missouri, 63136
United States
University of Tennessee, Memphis
Memphis, Tennessee, 38163
United States
Southeast Florida Hematology-Oncology Group
Ft. Lauderdale, Florida, 33308
United States
Intermountain Hematology/Oncology Associates, Inc.
Salt Lake City, Utah, 84124
United States
Oncology/Hematology Care, Inc.
Cincinnati, Ohio, 45219
United States
North Shore Cancer Center
Peabody, Massachusetts, 01960
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
Vermont Center for Cancer Medicine, Inc.
Colchester, Vermont, 05446
United States
Maine Center for Cancer Medicine and Blood Disorders
Scarborough, Maine, 04074
United States
Cancer and Blood Institute of the Desert
Rancho Mirage, California, 92270
United States
Hematology/Oncology Care Inc.
Crestview, Kentucky, 41017
United States
HemOnCare, P.C.
Brooklyn, New York, 11235
United States
Hutchinson Clinic, P.A.
Hutchinson, Kansas, 67502
United States
Oncology-Hematology Group of South Florida
Miami, Florida, 33176
United States
Hematology-Oncology Associates, PA
Pensacola, Florida, 32501
United States
N.W. Carolina Oncology & Hematology, P.A.
Hickory, North Carolina, 28603
United States
Hematology & Oncology Associates of Virginia
Richmond, Virginia, 23226
United States
Mount Sinai Comprehensive Cancer Center
Miami, Florida, 33140
United States
Lakeland Medical Center - St. Joseph
Saint Joseph, Michigan, 49085
United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
United States
Additional Information:
Study ID Numbers: CDR0000067940; AMGEN-GCSF-990756,NCI-V00-1593
Study Start Date: December 1999
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005959
Other Lymphoma Studies:
1. Fludarabine, Total-body Irradiation, Donor Peripheral Stem Cell Transplantation, and Donor White Blood Cell Infusions in Treating Patients With Hematologic Cancer
2. Combination Chemotherapy in Treating Patients With Advanced Cancer
3. Phase I: UCN-01 and Prednisone
4. Bone Marrow and Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer
5. Bone Marrow Transplantation in Treating Patients With Hematologic Cancer
Related Studies:
Other Lymphoma Clinical Trials
Other New Mexico Clinical Trials
Other Albuquerque Clinical Trials
Combination Chemotherapy Plus Rituximab in Treating Patients With Intermediate-Grade or High-Grade Non-Hodgkin's Lymphoma
|
|
|
|
|
|
|
|
