|
Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Post-Transplant Lymphoproliferative Disorder Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Post-Transplant Lymphoproliferative Disorder 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 Post-Transplant Lymphoproliferative Disorder Clinical research trials and Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Post-Transplant Lymphoproliferative Disorder healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Post-Transplant Lymphoproliferative Disorder. Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Post-Transplant Lymphoproliferative Disorder Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Post-Transplant Lymphoproliferative Disorder clinical trial. Human subjects often obtain the finest healthcare possible for their Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Post-Transplant Lymphoproliferative Disorder condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "Y" Clinical Trials Conditions > Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Post-Transplant Lymphoproliferative Disorder  Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Post-Transplant Lymphoproliferative Disorder
Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Post-Transplant Lymphoproliferative Disorder
For Condition: post-transplant lymphoproliferative disorder,Waldenstrom's Macroglobulinemia,adult diffuse large cell lymphoma,adult Burkitt's lymphoma
Status: Not yet recruiting
Sponsor(s): AIDS Associated Malignancies Clinical Trials Consortium , National Cancer Institute (NCI)
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. PURPOSE: Phase I/II trial to study the effectiveness of combining yttrium Y 90 ibritumomab tiuxetan with rituximab in treating patients who have localized or recurrentlymphoproliferative disorder after an organtransplant.
Details: OBJECTIVES: - Determine the safety and tolerability of yttrium Y 90 ibritumomab tiuxetan (IDEC-Y2B8) in patients with post-transplant lymphoproliferative disorder. - Determine the safety and toxicity profile of IDEC-Y2B8 and rituximab in these patients. - Correlate the Epstein-Barr virus viral load with response and relapse in patients treated with this regimen. OUTLINE: This is a multicenter, dose-escalation study of yttrium Y 90 ibritumomab tiuxetan (IDEC-Y2B8). - Patients receive rituximab IV and indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1. Patients undergo 2 (or 3 if needed) imaging scans between days 1-6. In the absence of altered biodistribution, patients receive rituximab IV followed within 4 hours by IDEC-Y2B8 IV over 10 minutes on day 8. Cohorts of 6 patients receive escalating doses of IDEC-Y2B8 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 1 of 6 patients experience dose-limiting toxicity. - Phase II: Patients receive treatment as in phase I at the MTD of IDEC-Y2B8. Patients are followed monthly for 3 months, every 3 months for 2 years, and then every 6 months for 2 years. PROJECTED ACCRUAL: A total of 13-28 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 post-transplant lymphoproliferative disorder (PTLD) of 1 of the following stages: - Stage III or IV - Localized (not amenable to localized radiotherapy or excision) - Recurrent - The following histologies* are eligible: - Polyclonal PTLD - Monoclonal PTLD - Diffuse large B-cell non-Hodgkin's lymphoma (NHL) - Lymphoplasmacytic NHL - Burkitt/Burkitt-like NHL NOTE: *Must be B-cell and CD20+ - Must not have completely responded during OR progressed after prior rituximab with or without chemotherapy - No history of rapid disease progression while receiving prior chemotherapy - Measurable disease - Must have less than 25% bone marrow involvement with lymphoma - Prior solid organ transplantation required - Evaluation of malignant cells for Epstein-Barr virus (EBV) required - EBV positive or negative allowed - No pleural effusion - No CNS lymphoma, including leptomeningeal disease - No pulmonary involvement by NHL in patients with prior lung transplantation - No HIV or AIDS-related lymphoma - No hypocellular bone marrow (i.e., less than 15% cellularity) - No marked reduction in bone marrow precursors of one or more cell lines (i.e., granulocytic, megakaryocytic, or erythroid) PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Karnofsky 50-100% Life expectancy - At least 3 months Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 150,000/mm^3 Hepatic - Bilirubin no greater than 2.5 mg/dL Renal - Creatinine no greater than 2.5 mg/dL Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 6 months after study participation - HIV negative - No serious nonmalignant disease or infection that would compromise study objectives - No presence of antimurine antibody reactivity - No other concurrent active malignancy requiring therapy PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics - More than 2 weeks since prior filgrastim (G-CSF) or sargramostim (GM-CSF) - More than 6 weeks since prior rituximab - No prior allogeneic bone marrow or hematopoietic stem cell transplantation - No prior radioimmunotherapy for NHL Chemotherapy - See Disease Characteristics - More than 4 weeks since prior chemotherapy Endocrine therapy - Not specified Radiotherapy - See Biologic therapy - No prior radiotherapy to more than 25% of active bone marrow (involved field or regional) Surgery - See Disease Characterisics - More than 4 weeks since prior major surgery except diagnostic surgery Other - No other concurrent anticancer therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DavidScadden, Study Chair, Massachusetts General Hospital
Additional Information:
Study ID Numbers: CDR0000310158; AMC-037
Study Start Date:
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00064246
Other Adult Diffuse Large Cell Lymphoma Studies:
1. Bone Marrow Transplantation in Treating Patients With Lymphoma
2. Interferon alfa-2b Following Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory Hodgkin's Disease or Non- Hodgkin's Lymphoma
3. Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Waldenstrom's Macroglobulinemia
4. Rituximab in Treating Patients With Waldenstrom's Macroglobulinemia
5. Etoposide in Treating Patients With Relapsed Non-Hodgkin's Lymphoma
Related Studies:
Other adult diffuse large cell lymphoma Clinical Trials
Other Clinical Trials
Other Clinical Trials
Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Post-Transplant Lymphoproliferative Disorder
|
|
|
|
|
|
|
|
