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| Tracking Information | |||||
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| First Received Date ICMJE | May 14, 2004 | ||||
| Last Updated Date | February 6, 2009 | ||||
| Start Date ICMJE | January 2004 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Dosimetry at 1, 24, and 48 hours [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Dosimetry at 1, 24, and 48 hours | ||||
| Change History | Complete list of historical versions of study NCT00082836 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||||
| Brief Title ICMJE | Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Recurrent Primary CNS Lymphoma | ||||
| Official Title ICMJE | A Pilot Study of Radiolabeled Indium-111 and Yttrium-90 Ibritumomab Tiuxetan in Primary CNS Lymphoma | ||||
| Brief Summary | 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. PURPOSE: This clinical trial is studying how well giving yttrium Y 90 ibritumomab tiuxetan together with rituximab works in treating patients with recurrent primary CNS lymphoma. |
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| Detailed Description | OBJECTIVES: Primary
Secondary
Tertiary
OUTLINE: Patients receive rituximab IV on day 1. Within 4 hours after rituximab administration, patients receive indium In 111 ibritumomab tiuxetan IV over 10 minutes. Patients then undergo whole body imaging. Patients whose dosimetry indicates that their CNS lesion would receive a sufficient radioimmunotherapy dose receive a therapeutic dose of yttrium Y 90 ibritumomab tiuxetan IV over 20-30 minutes on day 7. Patients are followed monthly for 3 months, every 3 months for 2 years, and then every 6 months for 2 years. PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment | ||||
| Condition ICMJE | Lymphoma | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 10 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00082836 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000360857, MSKCC-04009 | ||||
| Study Sponsor ICMJE | Memorial Sloan-Kettering Cancer Center | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | September 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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