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Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Recurrent Primary CNS Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00082836
Recruitment Status : Completed
First Posted : May 19, 2004
Last Update Posted : January 17, 2013
National Cancer Institute (NCI)
Information provided by:
Memorial Sloan Kettering Cancer Center

Brief Summary:

RATIONALE: Monoclonal antibodies, such as rituximab and yttrium Y 90 ibritumomab tiuxetan, can locate cancer cells and either kill them or deliver radioactive cancer-killing substances to them without harming normal cells.

PURPOSE: This clinical trial is studying how well giving yttrium Y 90 ibritumomab tiuxetan together with rituximab works in treating patients with recurrent primary CNS lymphoma.

Condition or disease Intervention/treatment Phase
Lymphoma Biological: rituximab Radiation: yttrium Y 90 ibritumomab tiuxetan Not Applicable

Detailed Description:



  • Determine the absorbed radiation doses of CNS lesions after administration of indium In 111 ibritumomab tiuxetan (for imaging) in patients with recurrent primary CNS lymphoma.


  • Determine the safety of a therapeutic dose of yttrium Y 90 ibritumomab tiuxetan in these patients.


  • Determine the radiographic response in patients treated with this drug.

OUTLINE: Patients receive rituximab IV on day 1. Within 4 hours after rituximab administration, patients receive indium In 111 ibritumomab tiuxetan IV over 10 minutes. Patients then undergo whole body imaging. Patients whose dosimetry indicates that their CNS lesion would receive a sufficient radioimmunotherapy dose receive a therapeutic dose of yttrium Y 90 ibritumomab tiuxetan IV over 20-30 minutes on day 7.

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 10 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Primary Purpose: Treatment
Official Title: A Pilot Study of Radiolabeled Indium-111 and Yttrium-90 Ibritumomab Tiuxetan in Primary CNS Lymphoma
Study Start Date : December 2004
Actual Primary Completion Date : May 2007

Primary Outcome Measures :
  1. Dosimetry at 1, 24, and 48 hours

Secondary Outcome Measures :
  1. Safety by NCI common toxicty criteria
  2. Radiographic response at 1 and 3 months

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed non-Hodgkin's lymphoma (NHL)

    • Recurrent disease

      • Isolated CNS relapse of systemic NHL allowed
    • Primary CNS lymphoma
  • Measurable gadolinium-enhancing lesion on MRI of the brain
  • No impaired bone marrow reserve
  • No hypocellular bone marrow
  • No marked reduction in bone marrow precursors of one or more cell lines (granulocytic, megakaryocytic, erythroid)
  • No pleural effusion
  • No chronic lymphocytic leukemia
  • No AIDS-related lymphoma



  • Adult

Performance status

  • Not specified

Life expectancy

  • Not specified


  • Platelet count > 100,000/mm^3
  • Absolute neutrophil count ≥ 1,500/mm^3


  • Bilirubin ≤ 2.0 mg/dL


  • Creatinine ≤ 2.0 mg/dL


  • HIV negative
  • No serious nonmalignant disease that would preclude study participation
  • No infection
  • No anti-murine antibody reactivity*
  • No human anti-mouse antibodies
  • Not pregnant
  • Negative pregnancy test NOTE: *Results must be available prior to study entry for patients who received prior murine antibodies or proteins, other than rituximab


Biologic therapy

  • See Radiotherapy
  • No prior stem cell transplantation
  • No prior myeloablative therapies with autologous bone marrow transplantation or peripheral blood stem cell rescue
  • No prior failed stem cell collection
  • More than 2 weeks since prior filgrastim (G-CSF) or sargramostim (GM-CSF)


  • No more than 1 prior chemotherapy regimen

Endocrine therapy

  • Not specified


  • No prior radioimmunotherapy
  • No prior whole-brain radiotherapy
  • No prior external beam radiotherapy (involved field or regional) to > 25% of active bone marrow


  • More than 4 weeks since prior major surgery except diagnostic surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00082836

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United States, New York
Memorial Sloan - Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
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Principal Investigator: Lauren E. Abrey, MD Memorial Sloan Kettering Cancer Center
Layout table for additonal information Identifier: NCT00082836    
Other Study ID Numbers: 04-009
First Posted: May 19, 2004    Key Record Dates
Last Update Posted: January 17, 2013
Last Verified: January 2013
Keywords provided by Memorial Sloan Kettering Cancer Center:
primary central nervous system non-Hodgkin lymphoma
Additional relevant MeSH terms:
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Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents