- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00082836
Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Recurrent Primary CNS Lymphoma
A Pilot Study of Radiolabeled Indium-111 and Yttrium-90 Ibritumomab Tiuxetan in Primary CNS Lymphoma
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10021
- Memorial Sloan - Kettering Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Dosimetry at 1, 24, and 48 hours
|
Secondary Outcome Measures
Outcome Measure |
---|
Safety by NCI common toxicty criteria
|
Radiographic response at 1 and 3 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Lauren E. Abrey, MD, Memorial Sloan Kettering Cancer Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 04-009
- MSKCC-04009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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