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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT00033423
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • rituximab — BIOLOGICAL
  • yttrium Y 90 ibritumomab tiuxetan — RADIATION

Study Details

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.

Key Dates

First listed
Jan 27, 2003
Start date
Aug 31, 2001
Status verified
Dec 2013
Primary completion
May 31, 2009
Completion
May 31, 2009

Study Design

Enrollment
18 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    First radiation dose regimen of yttrium Y 90 ibritumomab tiuxetan
  • Experimental: Cohort II
    Second radiation dose regimen of yttrium Y 90 ibritumomab tiuxetan
  • Experimental: Cohort III
    Third radiation dose regimen of yttrium Y 90 ibritumomab tiuxetan
  • Experimental: Cohort IV
    Fourth radiation dose regimen of yttrium Y 90 ibritumomab tiuxetan
  • Experimental: Cohort V
    MTD radiation dose regimen of yttrium Y 90 ibritumomab tiuxetan

Primary Outcome Measure

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). [ Time Frame: baseline through 4 years ]

Locations (3)

FacilityCityStateZIPSite coordinators
Lurleen Wallace Comprehensive Cancer at University of Alabama-BirminghamBirminghamAlabama35294-
Stanford Comprehensive Cancer Center - StanfordStanfordCalifornia94305-
Mayo Clinic Cancer CenterRochesterMinnesota55905-

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