Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Recurrent Primary CNS Lymphoma

Not Applicable

Completed

• Conditions: Lymphoma

• Registration Number: NCT00082836
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Study Timeline

• Study First Submitted: 2004-05-14
• Study First Submitted QC: 2004-05-18
• Study First Posted: 2004-05-19
• Study Start: 2004-12
• Primary Completion: 2007-05
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-15
• Last Update Posted: 2013-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dosimetry at 1, 24, and 48 hours

Secondary Outcome Measures

Name	Time	Method
Safety by NCI common toxicty criteria
Radiographic response at 1 and 3 months

Trial Locations

Locations (1)

Memorial Sloan - Kettering Cancer Center; 🇺🇸 New York, New York, United States