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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: | Treatment, Open Label |
| 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: | Beth Israel Deaconess Medical Center ( Robin Joyce ) |
| Study ID Numbers: | CDR0000341437, BIDMC-2003P-000182 |
| Study First Received: | December 10, 2003 |
| Last Updated: | July 7, 2009 |
| ClinicalTrials.gov Identifier: | NCT00073957 History of Changes |
| Health Authority: | Unspecified |
|
recurrent adult diffuse large cell lymphoma recurrent adult immunoblastic large cell lymphoma anaplastic large cell lymphoma |
|
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Reproductive Control Agents Antibodies, Monoclonal Lymphoma, B-Cell Therapeutic Uses Abortifacient Agents Methotrexate Dermatologic Agents Lymphoma |
Nucleic Acid Synthesis Inhibitors Cytarabine Immunoproliferative Disorders Neoplasms by Histologic Type Immune System Diseases Rituximab Enzyme Inhibitors Folic Acid Antagonists Abortifacient Agents, Nonsteroidal Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Lymphatic Diseases Neoplasms Antirheumatic Agents |