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Sponsors and Collaborators: |
Mayo Clinic National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00012298 |
RATIONALE: Radiolabeled monoclonal antibodies can locate cancer cells and deliver cancer-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/II trial to study the effectiveness of combining radiolabeled monoclonal antibody therapy and rituximab with and without filgrastim and interleukin-11 in treating patients who have relapsed or refractory non-Hodgkin's lymphoma.
Condition | Intervention | Phase |
---|---|---|
Lymphoma |
Biological: filgrastim Biological: recombinant interleukin-11 Biological: rituximab Radiation: yttrium Y 90 ibritumomab tiuxetan |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I Study of Two Sequential Doses of IDEC-Y2B8 in Patients With Relapsed Low Grade and Follicular Non-Hodgkin's Lymphoma |
Estimated Enrollment: | 73 |
Study Start Date: | April 2001 |
Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a phase I dose-escalation study of yttrium Y 90 ibritumomab tiuxetan (IDEC-^90Y2B8) followed by a phase II open-label study.
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.
After completion of study treatment, 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 73 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven relapsed or refractory low-grade or follicular CD20+ non-Hodgkin's lymphoma, including 1 of the following:
However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Minnesota | |
Mayo Clinic Cancer Center | Recruiting |
Rochester, Minnesota, United States, 55905 | |
Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 |
Study Chair: | Thomas E. Witzig, MD | Mayo Clinic |
Investigator: | Gregory Wiseman, MD | Mayo Clinic |
Responsible Party: | Mayo Clinic Cancer Center ( Thomas E. Witzig ) |
Study ID Numbers: | CDR0000068503, MAYO-MC998C, NCI-312 |
Study First Received: | March 3, 2001 |
Last Updated: | March 11, 2009 |
ClinicalTrials.gov Identifier: | NCT00012298 History of Changes |
Health Authority: | Unspecified |
recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma Waldenstrom macroglobulinemia recurrent marginal zone lymphoma |
recurrent small lymphocytic lymphoma extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue nodal marginal zone B-cell lymphoma splenic marginal zone lymphoma |
Immunoproliferative Disorders Immunologic Factors Rituximab Lymphoma, Follicular Lymphoma, B-Cell, Marginal Zone Follicular Lymphoma Recurrence Antibodies, Monoclonal Lymphoma, B-Cell Lymphoma, Small Cleaved-cell, Diffuse Lymphatic Diseases Antibodies |
Chronic Lymphocytic Leukemia Waldenstrom Macroglobulinemia Oprelvekin B-cell Lymphomas Leukemia, Lymphocytic, Chronic, B-Cell Antirheumatic Agents Leukemia, B-cell, Chronic Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Immunoglobulins |
Neoplasms by Histologic Type Immunoproliferative Disorders Immunologic Factors Immune System Diseases Rituximab Antineoplastic Agents Physiological Effects of Drugs Lymphoma, Follicular Pharmacologic Actions |
Antibodies, Monoclonal Lymphatic Diseases Neoplasms Oprelvekin Therapeutic Uses Antirheumatic Agents Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma |