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| Sponsor: | Beth Israel Deaconess Medical Center |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00073957 |
Purpose
RATIONALE: Monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan and rituximab, can locate cancer cells and either kill them or deliver radioactive cancer-killing substances to them without harming normal cells. Combining yttrium Y 90 ibritumomab tiuxetan with rituximab may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combining yttrium Y 90 Ibritumomab tiuxetan with rituximab in treating patients who have relapsed or refractory diffuse large B-cell non-Hodgkin's lymphoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Biological: rituximab Drug: cytarabine Drug: liposomal cytarabine Drug: methotrexate Radiation: yttrium Y 90 ibritumomab tiuxetan |
Phase II |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Zevalin And Rituxan For The Treatment Of Relapsed Or Refractory Diffuse Large B-Cell Non-Hodgkin's Lymphoma |
| Estimated Enrollment: | 40 |
| Study Start Date: | December 2003 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is an open-label, multicenter study.
Patients are followed every 3 months for 2 years and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 2 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed diffuse large B-cell non-Hodgkin's lymphoma, including any of the following:
Relapsed or refractory disease after at least 1 prior chemotherapy regimen and requires further treatment
Relapsed disease, defined as the following:
Progressive disease, defined as the following:
Bidimensionally measurable disease
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, Massachusetts | |
| Beth Israel Deaconess Medical Center | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Contact: Clinical Trials Office - Beth Israel Deaconess Medical Center 617-667-9925 | |
| United States, Vermont | |
| Fletcher Allen Health Care - Medical Center Campus | Recruiting |
| Burlington, Vermont, United States, 05401 | |
| Contact: Clinical Trials Office - Fletcher Allen Heakth Care 802-656-8990 | |
| Study Chair: | Robin Joyce, MD | Beth Israel Deaconess Medical Center |
More Information
| Responsible Party: | Robin Joyce, Beth Israel Deaconess Medical Center |
| ClinicalTrials.gov Identifier: | NCT00073957 History of Changes |
| Other Study ID Numbers: | CDR0000341437, BIDMC-2003P-000182 |
| Study First Received: | December 10, 2003 |
| Last Updated: | July 7, 2009 |
| Health Authority: | Unspecified |
|
recurrent adult diffuse large cell lymphoma recurrent adult immunoblastic large cell lymphoma anaplastic large cell lymphoma |
|
Lymphoma Lymphoma, Non-Hodgkin Lymphoma, B-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Cytarabine Methotrexate Rituximab Antibodies, Monoclonal Antimetabolites, Antineoplastic Antimetabolites |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists |