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

Primary Purpose

Lymphoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
rituximab
yttrium Y 90 ibritumomab tiuxetan
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring primary central nervous system non-Hodgkin lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial Sloan - Kettering Cancer Center

Outcomes

Primary Outcome Measures

Dosimetry at 1, 24, and 48 hours

Secondary Outcome Measures

Safety by NCI common toxicty criteria
Radiographic response at 1 and 3 months

Full Information

First Posted
May 14, 2004
Last Updated
January 15, 2013
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00082836
Brief Title
Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Recurrent Primary CNS Lymphoma
Official Title
A Pilot Study of Radiolabeled Indium-111 and Yttrium-90 Ibritumomab Tiuxetan in Primary CNS Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
primary central nervous system non-Hodgkin lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
rituximab
Intervention Type
Radiation
Intervention Name(s)
yttrium Y 90 ibritumomab tiuxetan
Primary Outcome Measure Information:
Title
Dosimetry at 1, 24, and 48 hours
Secondary Outcome Measure Information:
Title
Safety by NCI common toxicty criteria
Title
Radiographic response at 1 and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lauren E. Abrey, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan - Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

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

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