Radiolabeled Monoclonal Antibody in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

Phase 1

Terminated

• Conditions: Lymphoma
• Interventions: Biological: rituximab; Radiation: yttrium Y 90 ibritumomab tiuxetan

• Registration Number: NCT00033423
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody in treating patients who have relapsed or refractory non-Hodgkin's lymphoma.

Detailed Description

OBJECTIVES:

* Determine the maximum tolerated dose of yttrium Y 90 ibritumomab tiuxetan when administered in combination with rituximab in patients with relapsed or refractory low-grade, follicular, or transformed CD20-positive B-cell non-Hodgkin's lymphoma (NHL).

* Determine the toxicity of different doses of yttrium Y 90 ibritumomab tiuxetan in patients treated with this regimen.

* Determine the frequency of reversal of bone marrow involvement with NHL in patients treated with this regimen.

* Determine the antitumor response in patients treated with this regimen.

OUTLINE: This is a multicenter, dose-escalation study of yttrium Y 90 ibritumomab tiuxetan.

Patients receive rituximab IV once weekly on weeks 1-4. After 4 doses of rituximab, patients without bone marrow involvement and cellularity greater than 50% expected receive rituximab IV once weekly on weeks 6 and 7 and yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes with the final dose of rituximab (day 43).

Cohorts of 5-6 patients receive escalating dose of yttrium Y 90 ibritumomab tiuxetan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 4 of 5 or 3 of 6 patients experience dose-limiting toxicity.

Patients are followed at 6 and 12 weeks, every 2-3 months for 2 years, and then every 6 months for 2 years.

PROJECTED ACCRUAL: Approximately 6-30 patients will be accrued for this study.

Study Timeline

• Study Start: 2001-08
• Study First Submitted: 2002-04-09
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-12
• Last Update Posted: 2013-12-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort 1	yttrium Y 90 ibritumomab tiuxetan	First radiation dose regimen of yttrium Y 90 ibritumomab tiuxetan
Cohort II	yttrium Y 90 ibritumomab tiuxetan	Second radiation dose regimen of yttrium Y 90 ibritumomab tiuxetan
Cohort II	rituximab	Second radiation dose regimen of yttrium Y 90 ibritumomab tiuxetan
Cohort III	rituximab	Third radiation dose regimen of yttrium Y 90 ibritumomab tiuxetan
Cohort III	yttrium Y 90 ibritumomab tiuxetan	Third radiation dose regimen of yttrium Y 90 ibritumomab tiuxetan
Cohort 1	rituximab	First radiation dose regimen of yttrium Y 90 ibritumomab tiuxetan
Cohort IV	rituximab	Fourth radiation dose regimen of yttrium Y 90 ibritumomab tiuxetan
Cohort IV	yttrium Y 90 ibritumomab tiuxetan	Fourth radiation dose regimen of yttrium Y 90 ibritumomab tiuxetan
Cohort V	rituximab	MTD radiation dose regimen of yttrium Y 90 ibritumomab tiuxetan
Cohort V	yttrium Y 90 ibritumomab tiuxetan	MTD radiation dose regimen of yttrium Y 90 ibritumomab tiuxetan

Primary Outcome Measures

Name	Time	Method
Determine the maximum tolerated dose of yttrium Y 90 ibritumomab tiuxetan when administered in combination with rituximab in patients with relapsed or refractory low-grade, follicular, or transformed CD20-positive B-cell non-Hodgkin's lymphoma (NHL).	baseline through 4 years

Secondary Outcome Measures

Name	Time	Method
Determine the frequency of reversal of bone marrow involvement with NHL in patients treated with this regimen.	baseline through 4 years
Determine the toxicity of different doses of yttrium Y 90 ibritumomab tiuxetan in patients treated with this regimen	baseline through 4 years
Determine the antitumor response in patients treated with this regimen.	baseline through 4 years

Trial Locations

Locations (3)

Mayo Clinic Cancer Center; 🇺🇸 Rochester, Minnesota, United States

Stanford Comprehensive Cancer Center - Stanford; 🇺🇸 Stanford, California, United States

Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham; 🇺🇸 Birmingham, Alabama, United States