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Sponsors and Collaborators: |
Eastern Cooperative Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00070447 |
RATIONALE: Monoclonal antibodies, such as rituximab and yttrium Y 90 ibritumomab tiuxetan, can locate cancer cells and either kill them or deliver radioactive cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as prednisone, cyclophosphamide, doxorubicin, and vincristine, use different ways to stop cancer cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving rituximab and combination chemotherapy together with yttrium Y 90 ibritumomab tiuxetan works in treating patients with previously untreated mantle cell lymphoma.
Condition | Intervention | Phase |
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Lymphoma |
Biological: rituximab Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: prednisone Drug: vincristine sulfate Radiation: yttrium Y 90 ibritumomab tiuxetan |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Study of Rituximab (NSC 687451) + CHOP Followed by 90Y-Ibritumomab Tiuxetan (NSC 710085) in Patients With Previously Untreated Mantle Cell Lymphoma |
Study Start Date: | November 2003 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients who have responding or stable disease proceed to radioimmunotherapy.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years.
PROJECTED ACCRUAL: A total of 57 patients will be accrued for this study within 2.8 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed mantle cell lymphoma with expression of bcl-1 and CD20
Measurable or evaluable disease
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Study Chair: | Mitchell R. Smith, MD, PhD | Fox Chase Cancer Center |
Investigator: | Leo I. Gordon, MD | Robert H. Lurie Cancer Center |
Study ID Numbers: | CDR0000334470, ECOG-E1499 |
Study First Received: | October 3, 2003 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00070447 History of Changes |
Health Authority: | United States: Federal Government |
contiguous stage II mantle cell lymphoma noncontiguous stage II mantle cell lymphoma stage III mantle cell lymphoma stage IV mantle cell lymphoma |
Anti-Inflammatory Agents Prednisone Immunologic Factors Lymphoma, Mantle-Cell Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Mantle Cell Lymphoma Cyclophosphamide Hormones Antibodies, Monoclonal Anti-Bacterial Agents Lymphoma Alkylating Agents Immunoglobulins Immunoproliferative Disorders |
Antineoplastic Agents, Hormonal Rituximab Vincristine Antimitotic Agents Immunosuppressive Agents Glucocorticoids Doxorubicin Lymphatic Diseases Antibodies Tubulin Modulators Antineoplastic Agents, Alkylating Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Antirheumatic Agents Antineoplastic Agents, Phytogenic |
Anti-Inflammatory Agents Prednisone Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Lymphoma, Mantle-Cell Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Cyclophosphamide Antibiotics, Antineoplastic Hormones Antibodies, Monoclonal Therapeutic Uses Lymphoma Alkylating Agents |
Immunoproliferative Disorders Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Rituximab Mitosis Modulators Vincristine Antimitotic Agents Glucocorticoids Immunosuppressive Agents Doxorubicin Pharmacologic Actions Lymphatic Diseases Neoplasms Tubulin Modulators |