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Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Post-Transplant Lymphoproliferative Disorder
This study has been completed.

First Received on July 8, 2003.   Last Updated on February 6, 2009   History of Changes
Sponsor: AIDS Associated Malignancies Clinical Trials Consortium
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00064246
  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 Intervention Phase
Lymphoma
Lymphoproliferative Disorder
Biological: rituximab
Radiation: yttrium Y 90 ibritumomab tiuxetan
Phase I
Phase II

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase I/II Study: Zevalin Radioimmunotherapy for Patients With Post Transplant Lymphoproliferative Disease Following Solid Organ Transplantation

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Detailed Description:

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).

  • 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.

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 older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00064246

Sponsors and Collaborators
AIDS Associated Malignancies Clinical Trials Consortium
Investigators
Study Chair: David T. Scadden, MD Massachusetts General Hospital
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00064246     History of Changes
Other Study ID Numbers: CDR0000310158, AMC-037
Study First Received: July 8, 2003
Last Updated: February 6, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent adult diffuse large cell lymphoma
recurrent adult Burkitt lymphoma
stage III adult diffuse large cell lymphoma
stage III adult Burkitt lymphoma
stage IV adult diffuse large cell lymphoma
stage IV adult Burkitt lymphoma
post-transplant lymphoproliferative disorder
Waldenstrom macroglobulinemia

Additional relevant MeSH terms:
Lymphoma
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Neoplasms
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on February 12, 2012