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CompletedNCT00082836Updated Jan 17, 2013

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

An interventional study of rituximab and yttrium Y 90 ibritumomab tiuxetan in Lymphoma, sponsored by Memorial Sloan Kettering Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-01-17.

Sponsored by Memorial Sloan Kettering Cancer Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
10
Ages
18 Years and older
Sex
All
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Study 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.

Read the detailed description

OBJECTIVES:

Primary

  • 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.

Secondary

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

Tertiary

  • 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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Conditions studied

  • Lymphoma

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Keywords

  • primary central nervous system non-Hodgkin lymphoma
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In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's planned enrollment of 10 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,930 studies on the registry; 328 are open to participants now.

Of its 129 completed or terminated interventional studies of FDA-regulated products, 66 (51%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • Adult

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

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

Hepatic

  • Bilirubin ≤ 2.0 mg/dL

Renal

  • Creatinine ≤ 2.0 mg/dL

Other

  • 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

PRIOR CONCURRENT THERAPY:

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)

Chemotherapy

  • No more than 1 prior chemotherapy regimen

Endocrine therapy

  • Not specified

Radiotherapy

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

Surgery

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

Phase
Not applicable
Primary purpose
Treatment
Enrollment
10 participants (estimated)

Interventions

  • Biologicalrituximab
  • Radiationyttrium Y 90 ibritumomab tiuxetan
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What researchers measure

Primary outcomes

  1. Dosimetry at 1, 24, and 48 hours

Secondary outcomes

  1. Safety by NCI common toxicty criteria

  2. Radiographic response at 1 and 3 months

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Study locations

1 site
  • Memorial Sloan - Kettering Cancer Center
    New York, New York 10021, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 17, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00082836
Lead sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
First posted
May 19, 2004
Start date
Dec 2004
Primary completion
May 2007
Last update
Jan 17, 2013

Study contacts

Lauren E. Abrey, MD
principal investigator · Memorial Sloan Kettering Cancer Center
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.

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