Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Post-Transplant Lymphoproliferative Disorder

Part of paid clinical trials in Rockville, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00064246
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Post-transplant Lymphoproliferative Disorder
  • Recurrent Adult Burkitt Lymphoma
  • Recurrent Adult Diffuse Large Cell Lymphoma
  • Stage III Adult Burkitt Lymphoma
  • Stage III Adult Diffuse Large Cell Lymphoma
  • Stage IV Adult Burkitt Lymphoma
  • Stage IV Adult Diffuse Large Cell Lymphoma
  • Waldenström Macroglobulinemia

Eligibility Criteria

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

Interventions

  • rituximab — BIOLOGICAL
    Given IV
  • indium In 111 ibritumomab tiuxetan — RADIATION
    Given IV
  • yttrium Y 90 ibritumomab tiuxetan — RADIATION
    Given IV

Study Details

Phase I/II trial to study the effectiveness of combining yttrium Y 90 ibritumomab tiuxetan with rituximab in treating patients who have localized or recurrent lymphoproliferative disorder after an organ transplant. Monoclonal antibodies such as yttrium Y 90 ibritumomab tiuxetan and rituximab can locate cancer cells and either kill them or deliver radioactive cancer-killing substances to them without harming normal cells

Key Dates

Start date
Jul 31, 2003
Status verified
Jan 2013
Primary completion
Sep 30, 2004

Study Design

Enrollment
28 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (rituximab, yttrium Y 90 ibritumomab tiuxetan)
    Phase I: Patients receive rituximab IV and indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1. Patients undergo 2 (or 3 if needed) imaging scans between days 1-6. In the absence of altered biodistribution, patients receive rituximab IV followed within 4 hours by IDEC-Y2B8 IV over 10 minutes on day 8. Phase II: Patients receive treatment as in phase I at the MTD of IDEC-Y2B8. Patients are followed monthly for 3 months, every 3 months for 2 years, and then every 6 months for 2 years.

Primary Outcome Measure

Response rate [ Time Frame: Up to 4 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
AIDS - Associated Malignancies Clinical Trials ConsortiumRockvilleMaryland20850-

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