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Sponsors and Collaborators: |
Beckman Research Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00562978 |
RATIONALE: Radiolabeled monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan, can find cancer cells and carry tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as etoposide and cyclophosphamide, work in different ways to kill cancer cells or stop them from growing. Giving radiolabeled monoclonal antibodies together with etoposide and cyclophosphamide before a peripheral blood stem cell transplant may be an effective treatment for non-Hodgkin lymphoma.
PURPOSE: This phase I/II trial is studying the side effects and best dose of yttrium Y 90 ibritumomab tiuxetan when given together with etoposide and cyclophosphamide followed by an autologous stem cell transplant and to see how well it works in treating patients with non-Hodgkin lymphoma.
Condition | Intervention | Phase |
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Lymphoma |
Drug: cyclophosphamide Drug: etoposide Drug: filgrastim Drug: yttrium Y 90 ibritumomab tiuxetan Procedure: autologous hematopoietic stem cell transplantation Procedure: peripheral blood stem cell transplantation |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase I/II Trial of Escalating Dose of Yttrium-90-Labeled Anti-CD20 Monoclonal Antibody in Combination With High-Dose Etoposide and Cyclophosphamide Followed by Autologous Stem Cell Transplantation for Patients With Relapsed B-Cell Non-Hodgkin's Lymphoma |
Estimated Enrollment: | 67 |
Study Start Date: | September 1999 |
OBJECTIVES:
OUTLINE: This is a phase I does-escalation study of yttrium Y 90 ibritumomab tiuxetan followed by an open-label phase II study.
Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Biopsy proven diagnosis of low- or intermediate-grade* non-Hodgkin lymphoma (NHL) including any of the following:
Patient either relapsed after achieving a complete (CR) or partial response (PR) to prior therapy, never responded to prior therapy, or has poor-risk disease
Sensitivity of disease based on 1 of the following:
Poor-risk disease defined as any of the following:
Age-adjusted International Prognostic Index (IPI) High- (3 risk factors) or High-Intermediate (2 risk factors) based on the following risk factors:
Normal cytogenetic study on bone marrow (prior to salvage chemotherapy or stem cell collection)
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Study ID Numbers: | CDR0000574716, CHNMC-98153 |
Study First Received: | November 22, 2007 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00562978 |
Health Authority: | United States: Food and Drug Administration |
recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma recurrent adult diffuse large cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult immunoblastic large cell lymphoma recurrent mantle cell lymphoma stage III grade 1 follicular lymphoma stage III grade 2 follicular lymphoma stage III grade 3 follicular lymphoma stage IV grade 1 follicular lymphoma |
stage IV grade 2 follicular lymphoma stage IV grade 3 follicular lymphoma stage III adult diffuse large cell lymphoma stage III adult diffuse mixed cell lymphoma stage III adult diffuse small cleaved cell lymphoma stage IV adult diffuse large cell lymphoma stage IV adult diffuse mixed cell lymphoma stage IV adult diffuse small cleaved cell lymphoma stage III mantle cell lymphoma stage IV mantle cell lymphoma stage III adult immunoblastic large cell lymphoma stage IV adult immunoblastic large cell lymphoma |
Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Rituximab Lymphoma, Mantle-Cell Lymphoma, Follicular Lymphoma, small cleaved-cell, diffuse Cyclophosphamide Etoposide phosphate Mantle cell lymphoma Lymphoma, large-cell, immunoblastic Recurrence Antibodies, Monoclonal |
Lymphoma, large-cell Lymphoma, B-Cell Lymphatic Diseases Antibodies B-cell lymphomas Lymphoma, Large-Cell, Immunoblastic Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Etoposide Lymphoma Follicular lymphoma Immunoglobulins |
Neoplasms by Histologic Type Immune System Diseases Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions |
Neoplasms Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Antineoplastic Agents, Phytogenic Alkylating Agents |