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Chemotherapy and Rituximab With or Without Total-Body Irradiation and Peripheral Stem Cell Transplantation in Treating Patients With Lymphoma Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Chemotherapy and Rituximab With or Without Total-Body Irradiation and Peripheral Stem Cell Transplantation in Treating Patients With Lymphoma conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Chemotherapy and Rituximab With or Without Total-Body Irradiation and Peripheral Stem Cell Transplantation in Treating Patients With Lymphoma Clinical research trials and Chemotherapy and Rituximab With or Without Total-Body Irradiation and Peripheral Stem Cell Transplantation in Treating Patients With Lymphoma healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Chemotherapy and Rituximab With or Without Total-Body Irradiation and Peripheral Stem Cell Transplantation in Treating Patients With Lymphoma. Chemotherapy and Rituximab With or Without Total-Body Irradiation and Peripheral Stem Cell Transplantation in Treating Patients With Lymphoma Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Chemotherapy and Rituximab With or Without Total-Body Irradiation and Peripheral Stem Cell Transplantation in Treating Patients With Lymphoma clinical trial. Test subjects typically receive the most effective healthcare possible for their Chemotherapy and Rituximab With or Without Total-Body Irradiation and Peripheral Stem Cell Transplantation in Treating Patients With Lymphoma condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Chemotherapy and Rituximab With or Without Total-Body Irradiation and Peripheral Stem Cell Transplantation in Treating Patients With Lymphoma  Chemotherapy and Rituximab With or Without Total-Body Irradiation and Peripheral Stem Cell Transplantation in Treating Patients With Lymphoma
Chemotherapy and Rituximab With or Without Total-Body Irradiation and Peripheral Stem Cell Transplantation in Treating Patients With Lymphoma
For Condition: stage 3 adult diffuse large cell lymphoma,noncontiguous stage 2 adult diffuse large cell lymphoma,stage 4 adult diffuse large cell lymphoma,stage 1 adult diffuse large cell lymphoma,contiguous stage 2 adult diffuse large cell lymphoma
Status: Recruiting
Sponsor(s): Memorial Sloan-Kettering Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy, total-body irradiation, and peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase II trial to determine the effectiveness of combining chemotherapy with rituximab followed by combination chemotherapy with or without rituximab, total-body irradiation, and peripheral stem cell transplantation in treating patients who have lymphoma.
Details: OBJECTIVES: - Determine the complete remission rate in patients with low-intermediate or high-intermediate-risk, CD20-positive, diffuse large B-cell lymphoma treated with induction chemotherapy and rituximab followed by consolidation chemotherapy with or without rituximab, total body irradiation, and autologous peripheral blood stem cell transplantation. - Compare gallium and positron emission tomography imaging for risk stratification of aggressive lymphoma by biopsy confirmation of residual lesions at interim restaging in patients treated with these regimens. - Determine the safety and toxicity of these regimens in these patients. OUTLINE: Patients are stratified according to risk (low-intermediate vs high-intermediate). Patients receive induction chemotherapy comprising cyclophosphamide IV, doxorubicin IV over 15 minutes, and vincristine IV over 1-2 minutes on day 1; oral prednisone once daily on days 1-5; and filgrastim (G-CSF) subcutaneously (SC) once daily on days 7-11. Patients also receive rituximab IV 2-3 days apart for a total of 2 doses during the week prior to the first course of chemotherapy and on day 1 of courses 2-4 of chemotherapy. Treatment repeats every 14 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity. After the completion of induction chemotherapy, patients undergo CT, gallium, or positron emission tomography (PET) scanning. If the gallium or PET scan is positive in one or more nodal sites, a repeat biopsy is performed. Patients with a negative gallium or PET scan OR a negative repeat biopsy (including no evidence of lymphoma on repeat bone marrow biopsy) are assigned to receive regimen A for consolidation therapy. Patients with a positive repeat biopsy are assigned to receive regimen B for consolidation therapy. - Regimen A: Patients receive consolidation chemotherapy comprising etoposide IV over 1 hour on days 1-3, ifosfamide IV continuously over 24 hours on day 2, carboplatin IV on day 2, and G-CSF SC once daily on days 5-12. Treatment repeats every 14 days for a total of 3 courses in the absence of disease progression or unacceptable toxicity. - Regimen B: Patients receive consolidation chemotherapy as in regimen A for 3 courses. Patients also receive rituximab IV on days -3 to -1 of course 3 of chemotherapy. Patients undergo leukapheresis at the completion of course 3 (G-CSF continues from day 5 until the end of leukapheresis). After completion of leukapheresis, patients begin a regimen of high-dose chemoradiotherapy comprising total body irradiation twice daily on days -10 to -7 and ifosfamide IV over 1 hour and etoposide IV continuously on days -6 to -2. Autologous peripheral blood stem cells (APBSC) are reinfused on day 0. Patients also receive G-CSF SC daily beginning on day 5 and continuing until blood counts recover. Beginning on day 42 post-APBSC, if blood counts have recovered, patients receive rituximab IV once weekly for 4 weeks. Rituximab is repeated beginning on day 180 in the absence of disease progression. Patients who receive consolidation therapy on regimen A are followed at 4-6 weeks after chemotherapy and patients who receive consolidation therapy on regimen B are followed at 90-120 days after transplantation. All patients are followed closely for 5 years and then annually thereafter. PROJECTED ACCRUAL: A total of 40-98 patients (28-66 low-intermediate-risk patients and 12-32 high-intermediate-risk patients) will be accrued for this study within 4 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/59 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed aggressive diffuse large B-cell lymphoma - CD20-positive disease - Age-adjusted International Prognostic Index II or III defined by the presence of at least 1 of the following: - Karnofsky performance status 10-70% - Lactate dehydrogenase greater than 200 U/L - Stage III or IV disease - Gallium/positron emission tomography avid measurable disease - No CNS involvement PATIENT CHARACTERISTICS: Age: - 18 to 59 Performance status: - See Disease Characteristics Life expectancy: - Not specified Hematopoietic: - Absolute neutrophil count greater than 1,000/mm^3 - Platelet count greater than 50,000/mm^3 Hepatic: - Bilirubin less than 2.0 mg/dL unless history of Gilbert's disease or pattern consistent with Gilbert's disease - Hepatitis B surface antigen and hepatitis C antibody negative - No chronic, active, or persistent hepatitis Renal: - Creatinine no greater than 1.5 mg/dL OR - Creatinine clearance greater than 60 mL/min - No chronic renal insufficiency Cardiovascular: - Ejection fraction at least 50% by echocardiogram or MUGA scan - No myocardial infarction within the past 6 months - No unstable angina - No cardiac arrhythmias except chronic atrial fibrillation Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective barrier contraception - HIV negative - No other medical illness that would preclude study - No uncontrolled infection - No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior biologic therapy for malignancy Chemotherapy: - No prior chemotherapy for malignancy Endocrine therapy: - Prior steroids allowed if received no more than 1 week of therapy Radiotherapy: - No prior radiotherapy for malignancy Surgery: - No prior surgery for malignancy Other: - No other prior therapy for malignancy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
CraigMoskowitz, Study Chair, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Andrew Zelenetz 212-639-2656
Additional Information:
Study ID Numbers: CDR0000069362; NCI-G02-2069,MSKCC-01142
Study Start Date:
Record last reviewed: June 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00039195
Other Stage 1 Adult Diffuse Large Cell Lymphoma Studies:
1. Combination Chemotherapy and Monoclonal Antibody Therapy in Treating Older Patients With Previously Untreated Non-Hodgkin's Lymphoma
2. Combination Chemotherapy With or Without Rituximab in Treating Patients With Newly Diagnosed Non-Hodgkin's Lymphoma
3. High Dose Chemotherapy With or Without Bone Marrow Transplantation in Treating Patients With Intermediate- or High-Grade Non-Hodgkin's Lymphoma
4. Rituximab and Combination Chemotherapy Combined With Yttrium Y 90 Ibritumomab Tiuxetan in Treating Older Patients With Previously Untreated B-Cell Lymphoma
5. Combination Chemotherapy in Treating Older Patients With Non-Hodgkin's Lymphoma
Related Studies:
Other stage 1 adult diffuse large cell lymphoma Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Chemotherapy and Rituximab With or Without Total-Body Irradiation and Peripheral Stem Cell Transplantation in Treating Patients With Lymphoma
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