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Sponsored by: |
Technische Universität München |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00397800 |
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiolabeled monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan, can find cancer cells and carry cancer-killing substances to them without harming normal cells. Giving rituximab and chemotherapy together with yttrium Y 90 ibritumomab tiuxetan may kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of yttrium Y 90 ibritumomab tiuxetan when given together with rituximab, fludarabine, and cyclophosphamide and to see how well they work in treating patients with relapsed B-cell non-Hodgkin's lymphoma.
Condition | Intervention | Phase |
---|---|---|
Lymphoma |
Biological: rituximab Drug: cyclophosphamide Drug: fludarabine phosphate Radiation: yttrium Y 90 ibritumomab tiuxetan |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label |
Official Title: | Safety and Efficacy of Sequential Treatment With a Combination of Rituximab, Fludarabine and Cyclophosphamide Followed by Zevalin (Rituximab and Y-Ibritumomab Tiuxetan) - A Phase I/II Study for Treatment of Patients With Relapsed Indolent and Transformed CD20-Positive B-Cell Non-Hodgkin's-Lymphoma Ineligible for High-Dose Chemo(Radio)Therapy Supported by Autologous Peripheral Blood Stem-Cells |
Estimated Enrollment: | 12 |
Study Start Date: | June 2005 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a prospective, nonrandomized, multicenter, phase I dose-escalation study of yttrium Y 90 (^90Y) ibritumomab tiuxetan followed by a phase II open-label study.
Phase I:
Cohorts of 3-6 patients receive escalating doses of ^90Y ibritumomab tiuxetan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for up to 2 years.
PROJECTED ACCRUAL: A total of 12 patients will be accrued for this study.
Ages Eligible for Study: | 50 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed CD20-positive B-cell non-Hodgkin's lymphoma (NHL), including any of the following subtypes:
Indolent NHL, including any of the following:
In at least first relapse with an indication for systemic antineoplastic treatment, as defined by the following:
PATIENT CHARACTERISTICS:
No concurrent severe and/or uncontrolled medical disease that would preclude study compliance, including any of the following:
No bleeding risks or disorders, including any of the following:
PRIOR CONCURRENT THERAPY:
Germany | |
Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm | Recruiting |
Ulm, Germany, D-89081 | |
Contact: Andreas Viardot, MD 49-731-5000 | |
Klinikum der Universitaet Regensburg | Recruiting |
Regensburg, Germany, D-93042 | |
Contact: Stefan W. Krause, MD 49-941-944-5538 | |
Klinikum Rechts Der Isar - Technische Universitaet Muenchen | Recruiting |
Munich, Germany, D-81675 | |
Contact: Christian Peschel, MD 49-89-4140-4111 christian.peschel@lrz.tu-muenchen.de | |
LMU-Klinikum Grosshadern | Recruiting |
Munich, Germany, D-81366 | |
Contact: Christian Buske, MD 49-89-7095-3017 | |
Medizinische Klinik III - Universitaetsklinikum Erlangen | Recruiting |
Erlangen, Germany, D-91054 | |
Contact: Jurgen Rech, MD 49-9131-853-3430 | |
Medizinische Klinik und Poliklinik II - Universitaetsklinikum Wuerzburg | Recruiting |
Wuerzburg, Germany, D-97080 | |
Contact: Hermann Einsele, MD 49-931-201-700-00 einsele_h@klinik.uni-wuerzburg.de | |
Universitatsklinik Mainz | Recruiting |
Mainz, Germany, D-55101 | |
Contact: Georg Hess, MD 49-0131-175-040 g.hess@3-med.klinik.uni-mainz.de | |
Universitaetsklinikum Goettingen | Recruiting |
Goettingen, Germany, D-37075 | |
Contact: L. Trumper 49-551-398-600 | |
Universitaetsklinikum Schleswig-Holstein - Campus Luebeck | Recruiting |
Luebeck, Germany, D-23538 | |
Contact: Thomas Wagner, MD, PhD 49-451-500-2670 thomas.wagner@uni-luebeck.de | |
Universitaetsklinikum Tuebingen | Recruiting |
Tuebingen, Germany, D-72076 | |
Contact: Wolfgang Bethge, MD 49-4707-1298-2711 | |
Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg | Recruiting |
Magdeburg, Germany, D-39120 | |
Contact: Michael Koenigsmann, MD 49-394-672-791 | |
Medizinische Klinik, Klinikum Augsburg | Recruiting |
Augsburg, Germany, D-86156 | |
Contact: Michael Sandherr, MD 49-821-400-2704 |
Study Chair: | Christian Peschel, MD | Technische Universität München |
Study ID Numbers: | CDR0000515982, KRDI-TUM-R-F-015-V-0030-I, EU-20633 |
Study First Received: | November 9, 2006 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00397800 History of Changes |
Health Authority: | Unspecified |
recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma Waldenstrom macroglobulinemia recurrent mantle cell lymphoma |
recurrent marginal zone lymphoma extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue nodal marginal zone B-cell lymphoma splenic marginal zone lymphoma |
Antimetabolites Immunologic Factors Lymphoma, Mantle-Cell Lymphoma, Follicular Lymphoma, B-Cell, Marginal Zone Mantle Cell Lymphoma Cyclophosphamide Follicular Lymphoma Lymphoma, Small Cleaved-cell, Diffuse Lymphoma, B-Cell Antibodies, Monoclonal Alkylating Agents Lymphoma Immunoglobulins |
Immunoproliferative Disorders Rituximab Fludarabine monophosphate Immunosuppressive Agents Recurrence Lymphatic Diseases Waldenstrom Macroglobulinemia Antibodies B-cell Lymphomas Antineoplastic Agents, Alkylating Fludarabine Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Antirheumatic Agents |
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Cyclophosphamide Lymphoma, B-Cell Antibodies, Monoclonal Therapeutic Uses Lymphoma Alkylating Agents Immunoproliferative Disorders Neoplasms by Histologic Type |
Immune System Diseases Rituximab Fludarabine monophosphate Immunosuppressive Agents Pharmacologic Actions Lymphatic Diseases Neoplasms Myeloablative Agonists Fludarabine Antineoplastic Agents, Alkylating Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Antirheumatic Agents |