A Pilot Study of Radiolabeled Indium-111 and Yttrium-90 Ibritumomab Tiuxetan in Primary CNS Lymphoma
18 Years
N/A
Both
Lymphoma
Trial Information
A Pilot Study of Radiolabeled Indium-111 and Yttrium-90 Ibritumomab Tiuxetan in Primary CNS Lymphoma
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Outcome Measure:
Dosimetry at 1, 24, and 48 hours
Safety Issue:
No
Principal Investigator
Lauren E. Abrey, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Federal Government
Study ID:
04-009
NCT ID:
NCT00082836
Start Date:
December 2004
Completion Date:
Related Keywords:
- Lymphoma
- primary central nervous system non-Hodgkin lymphoma
- Lymphoma
Name | Location |
|---|---|
| Memorial Sloan - Kettering Cancer Center | New York, New York 10021 |
