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Radiolabeled Monoclonal Antibody Plus Rituximab With and Without Filgrastim and Interleukin-11 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Radiolabeled Monoclonal Antibody Plus Rituximab With and Without Filgrastim and Interleukin-11 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Radiolabeled Monoclonal Antibody Plus Rituximab With and Without Filgrastim and Interleukin-11 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma Clinical research trials and Radiolabeled Monoclonal Antibody Plus Rituximab With and Without Filgrastim and Interleukin-11 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Radiolabeled Monoclonal Antibody Plus Rituximab With and Without Filgrastim and Interleukin-11 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma. Radiolabeled Monoclonal Antibody Plus Rituximab With and Without Filgrastim and Interleukin-11 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Radiolabeled Monoclonal Antibody Plus Rituximab With and Without Filgrastim and Interleukin-11 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma clinical trial. Subjects frequently get the best healthcare possible for their Radiolabeled Monoclonal Antibody Plus Rituximab With and Without Filgrastim and Interleukin-11 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "R" Clinical Trials Conditions > Radiolabeled Monoclonal Antibody Plus Rituximab With and Without Filgrastim and Interleukin-11 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma  Radiolabeled Monoclonal Antibody Plus Rituximab With and Without Filgrastim and Interleukin-11 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Radiolabeled Monoclonal Antibody Plus Rituximab With and Without Filgrastim and Interleukin-11 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
For Condition: recurrent diffuse small lymphocytic/marginal zone lymphoma,recurrent grade 1 follicular lymphoma,Waldenstrom's Macroglobulinemia,recurrent grade 2 follicular lymphoma,recurrent grade 3 follicular lymphoma
Status: Recruiting
Sponsor(s): Mayo Clinic Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Radiolabeledmonoclonal antibodies can locate tumor cells and deliver tumor-killing substances to them without harming normal cells. Biological therapies such as filgrastim and interleukin-11 use different ways to stimulate the immune system and stop cancer cells from growing. PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody therapy plus rituximab with and without filgrastim and interleukin-11 in treating patients who have relapsed or refractorynon-Hodgkin's lymphoma.
Details: OBJECTIVES: - Determine the maximum tolerated dose (MTD) of yttrium Y 90 ibritumomab tiuxetan (IDEC-Y2B8) administered with rituximab with and without filgrastim (G-CSF) and interleukin-11 (IL-11) in patients with relapsed low-grade or follicular CD20+ non-Hodgkin's lymphoma. - Determine the toxicity of this regimen in these patients. - Determine the response rate in patients treated with this regimen. - Compare tumor and normal organ dosimetry with positron emission tomography and computerized tomography scans, subsequent tumor response, and normal organ toxicity by utilizing indium In 111 ibritumomab tiuxetan radioimmunoconjugate scans before each IDEC-Y2B8 dose in these patients. - Determine the immune response to this regimen, in terms of human anti-mouse and human anti-chimeric antibody formation, in these patients. - Determine whether G-CSF and IL-11 can ameliorate the effect of the MTD of IDEC-Y2B8 on bone marrow function in these patients. OUTLINE: This is a dose-escalation study of yttrium Y 90 ibritumomab tiuxetan (IDEC-Y2B8). Patients undergo peripheral blood stem cell (PBSC) harvest. Patients then receive rituximab IV on days 1 and 8, indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1 (for radioimaging), and IDEC-Y2B8 IV over 10 minutes on day 8. Treatment repeats 12-24 weeks later for a total of 2 courses in the absence of disease progression or unacceptable toxicity. Once the maximum tolerated dose (MTD) of IDEC-Y2B8 is determined, patients also receive filgrastim (G-CSF) subcutaneously (SC) daily beginning when absolute neutrophil count is less than 1,500/mm^3 and continuing until blood counts recover. Patients also receive interleukin-11 (IL-11) SC beginning when platelet count is less than 75,000/mm^3 and continuing until blood counts recover. Patients undergo PBSC transplantation only if marrow recovery is inadequate. Cohorts of 3-6 patients receive escalating doses of IDEC-Y2B8 until the MTD is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are accrued to determine the MTD of this radioimmunotherapy with the addition of the prophylactic cytokines, G-CSF and IL-11. Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually for 2 years. PROJECTED ACCRUAL: A total of 24-48 patients will be accrued for this study within 2-4 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically proven relapsed or refractory low-grade or follicular CD20+ non-Hodgkin's lymphoma, including 1 of the following: - Small lymphocytic lymphoma - Lymphoplasmacytoid lymphoma - Follicular center lymphoma (grades I, II, and III) - Extranodal marginal zone B-cell lymphoma - Nodal marginal zone B-cell lymphoma - Splenic marginal zone B-cell lymphoma (monocytoid B-cell lymphoma) - Bidimensionally measurable disease with at least 1 lesion no less than 2 cm in the greatest diameter - Less than 25% bone marrow involvement of cellular marrow with lymphoma by bilateral bone marrow aspirate and biopsy - No CNS lymphoma - No myelodysplastic syndromes or marrow chromosomal changes suggesting myelodysplasia - No HIV or AIDS-related lymphoma - No pleural effusion or ascites with lymphoma cells 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 0-2 Life expectancy: - Not specified Hematopoietic: - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 150,000/mm^3 - Total lymphocyte count less than 5,000/mm^3 for patients with small lymphocytic lymphoma Hepatic: - Bilirubin no greater than 2 mg/dL Renal: - Creatinine no greater than 2 mg/dL Other: - No active infection - No other serious non-malignant disease that would preclude study participation - No other active primary malignancy - No human anti-mouse or human anti-chimeric antibody - No prior skin rash (e.g., Stevens-Johnson's syndrome or toxic epidermal necrolysis) from rituximab therapy - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior radioimmunotherapy, including yttrium Y 90 ibritumomab tiuxetan or iodine I 131 monoclonal antibody tositumomab or Lym-1 - No prior myeloablative therapy with autologous or allogeneic bone marrow transplantation or peripheral blood stem cell support Chemotherapy: - See Biologic therapy Endocrine therapy: - No concurrent corticosteroid therapy except prednisone (or an equivalent) for adrenal failure or less than 20 mg of prednisone daily Radiotherapy: - No prior external beam radiotherapy to more than 25% of active bone marrow Surgery: - More than 4 weeks since prior surgery other than diagnostic surgery Other: - No other concurrent myelosuppressive antineoplastic agents
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ThomasWitzig, Study Chair, Mayo Clinic Cancer Center
Mayo Clinic Cancer Center *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting Thomas Witzig 507-284-2511
Additional Information:
Study ID Numbers: CDR0000068503; NCI-312,MAYO-MC998C
Study Start Date:
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00012298
Other Recurrent Grade 2 Follicular Lymphoma Studies:
1. Bortezomib and Fludarabine in Treating Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
2. Oxaliplatin in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
3. Rituximab in Treating Patients With Waldenstrom's Macroglobulinemia
4. Bortezomib in Treating Patients With Lymphoproliferative Disorders
5. Bone Marrow Transplantation in Treating Patients With Lymphoma
Related Studies:
Other recurrent grade 2 follicular lymphoma Clinical Trials
Other Minnesota Clinical Trials
Other Rochester Clinical Trials
Radiolabeled Monoclonal Antibody Plus Rituximab With and Without Filgrastim and Interleukin-11 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
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