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

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-

Find similar trials in Birmingham, AL

By research site
Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham· Birmingham, ALStanford Comprehensive Cancer Center - Stanford· Stanford, CAMayo Clinic Cancer Center· Rochester, MN

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