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Clinical Trials/NCT00082836
NCT00082836
Completed
Not Applicable

A Pilot Study of Radiolabeled Indium-111 and Yttrium-90 Ibritumomab Tiuxetan in Primary CNS Lymphoma

Memorial Sloan Kettering Cancer Center1 site in 1 country10 target enrollmentDecember 2004
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ConditionsLymphoma

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lymphoma
Sponsor
Memorial Sloan Kettering Cancer Center
Enrollment
10
Locations
1
Primary Endpoint
Dosimetry at 1, 24, and 48 hours
Status
Completed
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Detailed Description

OBJECTIVES: Primary * Determine the absorbed radiation doses of CNS lesions after administration of indium In 111 ibritumomab tiuxetan (for imaging) in patients with recurrent primary CNS lymphoma. Secondary * Determine the safety of a therapeutic dose of yttrium Y 90 ibritumomab tiuxetan in these patients. Tertiary * Determine the radiographic response in patients treated with this drug. 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.

Registry
clinicaltrials.gov
Start Date
December 2004
End Date
May 2007
Last Updated
13 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Dosimetry at 1, 24, and 48 hours

Secondary Outcomes

  • Safety by NCI common toxicty criteria
  • Radiographic response at 1 and 3 months

Study Sites (1)

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