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

This study is currently recruiting patients.

Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

Purpose

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 Treatment or Intervention
primary central nervous system lymphoma
 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

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapy;   Lymphoma;   Neurologic Diseases

Study Type: Interventional
Study Design: Treatment

Official Title: Pilot Study of Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan in Patients With Recurrent Primary CNS Lymphoma

Further Study Details: 

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

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 4.

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.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

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

Chemotherapy

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

Location and Contact Information


New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States; Recruiting
Lauren E. Abrey, MD  212-639-5122    abreyl@mskcc.org 

Study chairs or principal investigators

Lauren E. Abrey, MD,  Principal Investigator,  Memorial Sloan-Kettering Cancer Center   

More Information

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

Study ID Numbers:  CDR0000360857; MSKCC-04009; NCT00082836
Record last reviewed:  April 2004
Last Updated:  March 10, 2005
Record first received:  May 14, 2004
ClinicalTrials.gov Identifier:  NCT00082836
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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