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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase I/II Study: Zevalin Radioimmunotherapy for Patients With Post Transplant Lymphoproliferative Disease Following Solid Organ Transplantation

Brief Summary: 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

Detailed Summary:

OBJECTIVES:

I. Determine the safety and tolerability of yttrium Y 90 ibritumomab tiuxetan (IDEC-Y2B8) in patients with post-transplant lymphoproliferative disorder.

II. Determine the safety and toxicity profile of IDEC-Y2B8 and rituximab in these patients.

III. Correlate the Epstein-Barr virus viral load with response and relapse in patients treated with this regimen.

OUTLINE: This is a multicenter, dose-escalation study of yttrium Y 90 ibritumomab tiuxetan (IDEC-Y2B8).

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.Cohorts of 6 patients receive escalating doses of IDEC-Y2B8 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 1 of 6 patients experience dose-limiting toxicity.

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.


Sponsor: National Cancer Institute (NCI)

Current Primary Outcome: Response rate [ Time Frame: Up to 4 years ]

Estimated using binomial proportions and their 95% confidence intervals.


Original Primary Outcome:

Current Secondary Outcome:

  • Time to response [ Time Frame: Up to 4 years ]
    Analyzed by the Kaplan-Meier non-parametric methods.
  • Time to progression [ Time Frame: From the date of first study treatment to the first date when progressive disease is documented, assessed up to 4 years ]
    Analyzed by the Kaplan-Meier non-parametric methods.
  • Incidence of toxicity related dose reductions graded according to the NCI CTCAE version 3.0 [ Time Frame: Up to 4 years ]
    Presented by severity for each dose group.


Original Secondary Outcome:

Information By: National Cancer Institute (NCI)

Dates:
Date Received: July 8, 2003
Date Started: July 2003
Date Completion:
Last Updated: January 24, 2013
Last Verified: January 2013