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


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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.

Sponsors and Collaborators: AIDS Associated Malignancies Clinical Trials Consortium
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

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

Further Study Details: 

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

Chemotherapy

  • See Disease Characteristics
  • More than 4 weeks since prior chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

Surgery

  • See Disease Characterisics
  • More than 4 weeks since prior major surgery except diagnostic surgery

Other

  • No other concurrent anticancer therapy

Location Information

Study chairs or principal investigators

David Thomas Scadden, MD,  Study Chair,  Massachusetts General Hospital   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000310158; AMC-037
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

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Page Updated: June 1, 2005
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