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Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Relapsed or Refractory Diffuse Large B-Cell Non-Hodgkin's Lymphoma Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Relapsed or Refractory Diffuse Large B-Cell Non-Hodgkin's Lymphoma conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Relapsed or Refractory Diffuse Large B-Cell Non-Hodgkin's Lymphoma Clinical research trials and Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Relapsed or Refractory Diffuse Large B-Cell Non-Hodgkin's Lymphoma medical trials occur in many of places across 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 generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Relapsed or Refractory Diffuse Large B-Cell Non-Hodgkin's Lymphoma. Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Relapsed or Refractory Diffuse Large B-Cell Non-Hodgkin's Lymphoma Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Relapsed or Refractory Diffuse Large B-Cell Non-Hodgkin's Lymphoma clinical trial. Participants oftentimes recieve the finest healthcare available for their Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Relapsed or Refractory Diffuse Large B-Cell Non-Hodgkin's Lymphoma condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "Y" Clinical Trials Conditions > Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Relapsed or Refractory Diffuse Large B-Cell Non-Hodgkin's Lymphoma  Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Relapsed or Refractory Diffuse Large B-Cell Non-Hodgkin's Lymphoma
Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Relapsed or Refractory Diffuse Large B-Cell Non-Hodgkin's Lymphoma
For Condition: recurrent adult immunoblastic large cell lymphoma,anaplastic large cell lymphoma,recurrent adult diffuse large cell lymphoma
Status: Recruiting
Sponsor(s): Beth Israel Deaconess Medical Center ,
Synopsis: RATIONALE: Monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan and rituximab, can locate cancer cells and either kill them or deliver radioactive cancer-killing substances to them without harming normal cells. Combining yttrium Y 90 ibritumomab tiuxetan with rituximab may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining yttrium Y 90 Ibritumomab tiuxetan with rituximab in treating patients who have relapsed or refractorydiffuselarge B-cell non-Hodgkin's lymphoma.
Details: OBJECTIVES: - Determine the best overall response in patients with relapsed or refractory diffuse large B-cell non-Hodgkin's lymphoma treated with yttrium Y 90 ibritumomab tiuxetan and rituximab. - Determine the event-free survival of patients treated with this regimen. - Determine the toxicity of this regimen in these patients. OUTLINE: This is an open-label, multicenter study. - Radioimmunotherapy: Patients receive indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1 (for imaging only); yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8; and rituximab IV over 3-4 hours on days 1, 8, 15, 22, 29, and 36. - CNS prophylaxis: Patients receive CNS prophylaxis comprising intrathecal (IT) methotrexate or IT cytarabine on days 15, 22, 29, and 36 OR IT cytarabine (liposomal) on days 15 and 29. - Maintenance rituximab: Patients are assessed for response at week 14. Beginning at month 6, patients with stable or responding disease receive maintenance therapy comprising rituximab IV over 3-4 hours once weekly for 4 weeks. Maintenance therapy repeats every 6 months for 2 years (total of 4 courses) in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years and then every 6 months for 2 years. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed diffuse large B-cell non-Hodgkin's lymphoma, including any of the following: - B-cell diffuse large cell variant - Immunoblastic - Mediastinal (thymic) large cell - T-cell/histiocyte-rich - Anaplastic large B-cell - Intravascular large B-cell - Lymphomatoid granulomatosis - Relapsed or refractory disease after at least 1 prior chemotherapy regimen and requires further treatment - Relapsed disease, defined as the following: - Appearance of any new lesion OR increase of at least 50% in the size of a previously involved site - 50% increase in greatest diameter of any previously identified node greater than 1 cm in the short axis OR in the sum of the perpendicular diameter (SPD) of more than 1 node - Progressive disease, defined as the following: - 50% increase from nadir in the SPD of any previously identified abnormal node - Appearance of any new lesion during or at the end of therapy - CD20-positive disease by immunohistochemistry - Bidimensionally measurable disease - At least 1 lesion at least 2.0 cm by CT scan - Less than 25% bone marrow involvement by lymphoma - No transformed lymphoma from indolent to aggressive - No HIV- or AIDS-related lymphoma - No hypocellular bone marrow - No marked reduction in bone marrow precursors of 1 or more cell lines (e.g., granulocytic, megakaryocytic, or erythroid) - No CNS lymphoma - Ineligible for myeloablative therapy OR refused transplantation - Ineligible for any other open yttrium Y 90 ibritumomab tiuxetan investigational protocols PATIENT CHARACTERISTICS: Age - 18 and over Performance status - WHO 0-2 Life expectancy - At least 3 months Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - Lymphocyte count no greater than 5,000/mm^3 (for patients with small lymphocytic lymphoma) - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin no greater than 2.0 mg/dL Renal - Creatinine no greater than 2.0 mg/dL Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 1 year after study participation - No concurrent serious nonmalignant disease or infection that would preclude study participation - No human antimurine antibody reactivity PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics - No prior autologous bone marrow transplantation - No prior peripheral blood stem cell rescue - No prior failed stem cell collection - Prior rituximab within the past 90 days allowed provided patient has fludeoxyglucose-avid disease that is also indium In 111 ibritumomab tiuxetan-avid disease in at least 1 lesion - More than 2 weeks since prior filgrastim (G-CSF) or sargramostim (GM-CSF) Chemotherapy - See Disease Characteristics Endocrine therapy - Not specified Radiotherapy - No prior radioimmunotherapy - No prior external beam radiotherapy (involved field or regional) to more than 25% of active bone marrow Surgery - More than 4 weeks since prior major surgery (except diagnostic surgery) Other - Recovered from all prior therapy - More than 4 weeks since prior therapy for lymphoma - More than 8 weeks since prior phase II investigational drugs - No other concurrent antineoplastic therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RobinJoyce, Study Chair, Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center *Recruiting*
Boston, Massachusetts, 02215
United States
Recruiting Robin Joyce 617-667-9920
Additional Information:
Study ID Numbers: CDR0000341437; BIDMC-2003P-000182
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00073957
Other Recurrent Adult Diffuse Large Cell Lymphoma Studies:
1. Radiolabeled Monoclonal Antibody, Combination Chemotherapy, and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory B-Cell Cancer
2. Etoposide in Treating Patients With Relapsed Non-Hodgkin's Lymphoma
3. Rituximab and Interleukin-2 in Treating Patients With Relapsed or Refractory Intermediate- or High-Grade Non-Hodgkin's Lymphoma
4. Monoclonal Antibody Therapy in Treating Patients With Lymphoproliferative Disorder Associated With Immunosuppression Therapy
5. Chemotherapy Plus Bone Marrow Transplantation in Treating Patients With Refractory Non-Hodgkin's Lymphoma, Hodgkin's Disease, or Multiple Myeloma
Related Studies:
Other recurrent adult diffuse large cell lymphoma Clinical Trials
Other Massachusetts Clinical Trials
Other Boston Clinical Trials
Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Relapsed or Refractory Diffuse Large B-Cell Non-Hodgkin's Lymphoma
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