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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00082836
First received: May 14, 2004
Last updated: January 15, 2013
Last verified: January 2013
  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 Intervention
Lymphoma
Biological: rituximab
Radiation: yttrium Y 90 ibritumomab tiuxetan

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Pilot Study of Radiolabeled Indium-111 and Yttrium-90 Ibritumomab Tiuxetan in Primary CNS Lymphoma

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • Dosimetry at 1, 24, and 48 hours [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety by NCI common toxicty criteria [ Designated as safety issue: Yes ]
  • Radiographic response at 1 and 3 months [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: December 2004
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00082836

Locations
United States, New York
Memorial Sloan - Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Lauren E. Abrey, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00082836     History of Changes
Other Study ID Numbers: 04-009, MSKCC-04009
Study First Received: May 14, 2004
Last Updated: January 15, 2013
Health Authority: United States: Federal Government

Keywords provided by Memorial Sloan-Kettering Cancer Center:
primary central nervous system non-Hodgkin lymphoma

Additional relevant MeSH terms:
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
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 July 23, 2014