A Phase I/II Study: Zevalin Radioimmunotherapy for Patients With Post Transplant Lymphoproliferative Disease Following Solid Organ Transplantation
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Post-transplant Lymphoproliferative Disorder
- Sponsor
- National Cancer Institute (NCI)
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Response rate
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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 Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically confirmed post-transplant lymphoproliferative disorder (PTLD) of 1 of the following stages:
- •Stage III or IV
- •Localized (not amenable to localized radiotherapy or excision)
- •Recurrent
- •The following histologies\* are eligible:
- •Polyclonal PTLD
- •Monoclonal PTLD
- •Diffuse large B-cell non-Hodgkin's lymphoma (NHL)
- •Lymphoplasmacytic NHL
- •Burkitt/Burkitt-like NHL
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Response rate
Time Frame: Up to 4 years
Estimated using binomial proportions and their 95% confidence intervals.
Secondary Outcomes
- Time to response(Up to 4 years)
- Time to progression(From the date of first study treatment to the first date when progressive disease is documented, assessed up to 4 years)
- Incidence of toxicity related dose reductions graded according to the NCI CTCAE version 3.0(Up to 4 years)