Ibritumomab tiuxetan |
Zevalin |
Clinical Trial: Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Post-Transplant Lymphoproliferative Disorder
This study has been completed.
Purpose
RATIONALE: 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.
PURPOSE: 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.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| adult Burkitt's lymphoma adult diffuse large cell lymphoma indolent, adult non-Hodgkin's lymphoma post-transplant lymphoproliferative disorder | Drug: rituximab Drug: yttrium Y 90 ibritumomab tiuxetan Procedure: antibody therapy Procedure: biological response modifier therapy Procedure: isotope therapy Procedure: monoclonal antibody therapy Procedure: radiation therapy Procedure: radioimmunotherapy | Phase I Phase II |
MedlinePlus related topics: Cancer; Cancer Alternative Therapy; Lymphoma; Viral Infections
Study Type: Interventional
Study Design: Treatment
Official Title: Phase I/II Study of Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Patients With Post-Transplant Lymphoproliferative Disorder
OBJECTIVES:
- Determine the safety and tolerability of yttrium Y 90 ibritumomab tiuxetan (IDEC-Y2B8) in patients with post-transplant lymphoproliferative disorder.
- Determine the safety and toxicity profile of IDEC-Y2B8 and rituximab in these patients.
- 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).
- 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.
PROJECTED ACCRUAL: A total of 13-28 patients will be accrued for this study within 2 years.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
DISEASE CHARACTERISTICS:
- 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 NOTE: *Must be B-cell and CD20+
- Must not have completely responded during OR progressed after prior rituximab with or without chemotherapy
- No history of rapid disease progression while receiving prior chemotherapy
- Measurable disease
- Must have less than 25% bone marrow involvement with lymphoma
- Prior solid organ transplantation required
- Evaluation of malignant cells for Epstein-Barr virus (EBV) required
- EBV positive or negative allowed
- No pleural effusion
- No CNS lymphoma, including leptomeningeal disease
- No pulmonary involvement by NHL in patients with prior lung transplantation
- No HIV or AIDS-related lymphoma
- No hypocellular bone marrow (i.e., less than 15% cellularity)
- No marked reduction in bone marrow precursors of one or more cell lines (i.e., granulocytic, megakaryocytic, or erythroid)
PATIENT CHARACTERISTICS: Age
- 18 and over
Performance status
- Karnofsky 50-100%
Life expectancy
- At least 3 months
Hematopoietic
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 150,000/mm^3
Hepatic
- Bilirubin no greater than 2.5 mg/dL
Renal
- Creatinine no greater than 2.5 mg/dL
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 6 months after study participation
- HIV negative
- No serious nonmalignant disease or infection that would compromise study objectives
- No presence of antimurine antibody reactivity
- No other concurrent active malignancy requiring therapy
PRIOR CONCURRENT THERAPY: Biologic therapy
- See Disease Characteristics
- More than 2 weeks since prior filgrastim (G-CSF) or sargramostim (GM-CSF)
- More than 6 weeks since prior rituximab
- No prior allogeneic bone marrow or hematopoietic stem cell transplantation
- No prior radioimmunotherapy for NHL
Chemotherapy
- See Disease Characteristics
- More than 4 weeks since prior chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- See Biologic therapy
- No prior radiotherapy to more than 25% of active bone marrow (involved field or regional)
Surgery
- See Disease Characterisics
- More than 4 weeks since prior major surgery except diagnostic surgery
Other
- No other concurrent anticancer therapy
Location Information
David Thomas Scadden, MD, Study Chair, Massachusetts General Hospital
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Record last reviewed: November 2004
Last Updated: November 4, 2004
Record first received: July 8, 2003
ClinicalTrials.gov Identifier: NCT00064246
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Ibritumomab tiuxetan (Drug Digest)
- Zevalin (Drug Digest)

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